📘 Comprehensive Technical & Regulatory Profile of FLUVOXAMINE MALEATE (CAS No. 61718-82-9) by Swapnroop Drugs & Pharmaceuticals

❓ Q1: What is FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
💊 Drug Class: Selective Serotonin Reuptake Inhibitor (SSRI)
🌐 Pharmaceutical Use: Antidepressant / Anti-obsessional

🧪 Overview of FLUVOXAMINE MALEATE

Fluvoxamine Maleate is the maleate salt form of fluvoxamine, a potent SSRI that increases the level of serotonin in the brain by inhibiting its reuptake at the presynaptic cleft.

It is indicated primarily for:

Obsessive-Compulsive Disorder (OCD)
Major Depressive Disorder (MDD)
Social Anxiety Disorder
Panic Disorder (off-label)
Post-Traumatic Stress Disorder (PTSD) (off-label)

🔬 Key Chemical Information

Property	Value
IUPAC Name	5-Methoxy-4'-(trifluoromethyl)valeranilide maleate
CAS No.	61718-82-9
Molecular Formula	C19H25F3N2O3•C4H4O4
Molecular Weight	~434.41 g/mol
Form	White to off-white crystalline powder
Solubility	Soluble in water, methanol, ethanol
Melting Point	127–128°C (approximate, salt form)
pKa	~8.7 (basic nitrogen)
LogP	~2.8–3.1 (moderate lipophilicity)

🧠 Mechanism of Action

Fluvoxamine binds selectively to the serotonin transporter (SERT) and inhibits serotonin reuptake into presynaptic neurons. This increases serotonin availability in the synaptic cleft, enhancing neurotransmission and improving mood, behavior, and anxiety regulation.

🏭 About Manufacturing by Swapnroop Drugs & Pharmaceuticals

Swapnroop Drugs & Pharmaceuticals manufactures FLUVOXAMINE MALEATE under GMP-compliant conditions, employing:

Advanced purification methods to meet ICH impurity standards
Strict chiral and salt-form control
Packaging with desiccants in HDPE or aluminum-lined containers
Batch-to-batch reproducibility through validated SOPs

✅ Regulatory & Pharmacopoeial Status

Listed in: USP, EP, JP
Available as: API and formulated tablets (25 mg, 50 mg, 100 mg)
FDA-approved & commonly exported under DMF or CEP certification

🔍 Summary:

🧠 FLUVOXAMINE MALEATE (CAS 61718-82-9), manufactured by Swapnroop Drugs & Pharmaceuticals, is a selective serotonin reuptake inhibitor (SSRI) used to treat depression and obsessive-compulsive disorder. The company ensures high-purity API with robust quality control, regulatory compliance, and stable salt formation using the maleate moiety. 💊✅

Q2: What is FLUVOXAMINE MALEATE by Swapnroop Drugs & Pharmaceuticals used for?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
🧠 Therapeutic Class: SSRI (Selective Serotonin Reuptake Inhibitor)

💊 Primary Medical Uses of FLUVOXAMINE MALEATE

Fluvoxamine Maleate is primarily prescribed to treat psychiatric and neurological conditions involving serotonin imbalance. As manufactured by Swapnroop Drugs & Pharmaceuticals, it is intended for pharmaceutical formulations used in the following conditions:

🧠 1. Obsessive-Compulsive Disorder (OCD)

✅ FDA-approved

Helps reduce compulsive behaviors and obsessive thoughts
Often used as first-line therapy in adults and children (age ≥ 8)

😔 2. Major Depressive Disorder (MDD)

Relieves symptoms such as persistent sadness, loss of interest, and fatigue
Improves serotonin transmission in the brain
Often prescribed when patients are resistant to other antidepressants

😨 3. Social Anxiety Disorder (Social Phobia) (Off-label in some regions)

Reduces fear, avoidance, and anxiety in social interactions
Helps improve daily functioning and quality of life

🫨 4. Panic Disorder (Off-label)

Controls panic attacks, sudden fear episodes, and physical symptoms (palpitations, sweating)
Often used when other SSRIs are not tolerated

🧬 5. Post-Traumatic Stress Disorder (PTSD) (Off-label)

May help reduce flashbacks, insomnia, and anxiety symptoms
Supports emotional regulation through serotonergic modulation

🧒 6. Use in Pediatric OCD

Approved for children over 8 years (in select regions)
Must be prescribed and monitored under strict clinical guidance

🧪 Other Investigational/Off-label Uses

Bulimia nervosa
Premenstrual dysphoric disorder (PMDD)
Autism-related anxiety
COVID-19-associated inflammation (under clinical investigation)

⚠️ Important Considerations

Not a first-line antidepressant for all patients; selection depends on tolerability
Must be taken under prescription with gradual titration to avoid side effects
Contraindicated with certain MAO inhibitors and strong CYP1A2 inhibitors

✅ Summary:

Fluvoxamine Maleate, manufactured by Swapnroop Drugs & Pharmaceuticals, is primarily used for OCD, depression, and anxiety disorders. Its clinical effectiveness stems from its action as a potent SSRI, with additional off-label applications in panic disorder and PTSD. 🧠💊🧪

❓ Q3: What are the physicochemical properties of FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
🧪 Molecular Formula: C19H25F3N2O3·C4H4O4
⚖️ Molecular Weight: ~434.41 g/mol (salt form)

🧪 Physicochemical Profile of FLUVOXAMINE MALEATE

Parameter	Details
Appearance	White to off-white crystalline powder
Solubility	Freely soluble in water, ethanol, and methanol
Melting Point	~127–128 °C (approximate, maleate salt form)
pH (1% aqueous solution)	~5.5–6.5
LogP (Partition Coefficient)	~2.8–3.1 (moderate lipophilicity; affects BBB penetration)
pKa	~8.7 (basic nitrogen group in the amine side chain)
Polymorphism	Known polymorphic forms exist; handled via controlled crystallization
Hygroscopicity	Slightly hygroscopic – requires moisture-protective packaging
Stability	Stable under controlled conditions; degrades in light/moisture if unprotected

🔬 Chemical Identity

IUPAC Name	5-methoxy-4′-trifluoromethylvaleranilide maleate
Structure	Fluoxetine-related SSRI with trifluoromethyl group on aromatic ring

🧪 Other Relevant Properties

UV Absorption λmax: ~260–270 nm (for identification and assay by HPLC/UV)
Refractive Index: Not typically applicable to solid drugs
Chirality: Non-chiral molecule (achiral center)

🧰 Handling & Analytical Considerations

Handling: Should be performed in a dry, low-humidity environment
Analytical Methods: HPLC, FTIR, UV-Vis, TGA, DSC (for stability, ID, assay, and polymorph testing)

⚠️ Impurity Profile

Sensitive to oxidation and hydrolysis under extreme conditions
Swapnroop likely controls:
- Related compound A (desmethyl-fluvoxamine)
- Maleic acid residuals
- Trifluoromethyl-related impurities

✅ Summary:

Fluvoxamine Maleate, manufactured by Swapnroop Drugs & Pharmaceuticals, is a moderately lipophilic, freely water-soluble crystalline compound with a defined melting point, pKa, and UV signature. Its physicochemical properties support oral bioavailability and require moisture/light protection for long-term stability. ⚗️📦🧬

Q4: How is FLUVOXAMINE MALEATE synthesized by Swapnroop Drugs & Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
⚗️ API Type: Synthetic, non-biological
🧪 Molecular Formula: C19H25F3N2O3 · C4H4O4 (maleate salt)

🧬 General Overview of the Synthesis of FLUVOXAMINE MALEATE

The synthesis of Fluvoxamine Maleate involves a multi-step organic process that includes:

Formation of a key amide intermediate
Introduction of a trifluoromethyl group on the aromatic ring
Attachment of the alkylamine side chain
Salt formation with maleic acid

🏭 Step-by-Step Synthetic Route (Representative)

🧪 Step 1: Preparation of Aromatic Intermediate

Starting compound: 4-trifluoromethylaniline
Undergoes acylation with appropriate acid chloride (e.g., 5-methoxyvaleryl chloride)
This forms a substituted trifluoromethylbenzamide intermediate

🧪 Step 2: Alkylation of Amide Intermediate

N-alkylation reaction using (2-aminoethyl)methylamine or a protected version
Introduces the secondary amine ethyl chain to create the active SSRI backbone

🧪 Step 3: Final Compound Formation

After deprotection (if needed), the free base form of fluvoxamine is isolated and purified
Recrystallization or column chromatography may be used for impurity removal

🧪 Step 4: Salt Formation (Maleate)

Fluvoxamine free base is reacted with maleic acid in ethanol or acetone under controlled pH
The resulting Fluvoxamine Maleate precipitates out as a white crystalline salt
Dried under vacuum and milled to desired particle size

🧪 Key Reagents and Conditions Used

Reagent	Purpose
Trifluoromethyl-substituted aniline	Aromatic precursor
Methoxyvaleryl chloride	Side-chain for amide coupling
(2-Aminoethyl)methylamine	Introduces SSRI pharmacophore
Maleic acid	Salt former to enhance solubility
Organic solvents (EtOH, DCM, Acetone)	Used for reactions and salt formation

🔍 Critical Parameters Controlled by Swapnroop

✅ Impurity thresholds (NMT ICH Q3A limits)
✅ Salt purity and stoichiometric balance of maleate
✅ Residual solvents (below ICH Q3C limits)
✅ Particle size distribution for formulation compatibility
✅ Polymorphic consistency for stability and bioavailability

⚠️ Regulatory & GMP Considerations

DMF (Drug Master File) may be filed for regulated markets
In-process control and final API testing includes:
- TLC, HPLC, FTIR, DSC, XRPD, Karl Fischer moisture testing

✅ Summary:

Fluvoxamine Maleate, as manufactured by Swapnroop Drugs & Pharmaceuticals, is synthesized through a precise multi-step reaction involving amide formation, alkylation, and maleate salt formation. The process is optimized for yield, purity, and regulatory compliance to ensure consistent pharmaceutical-grade API. ⚗️🧪📉

❓ Q5: What are the different dosage forms of FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
💊 API Type: SSRI antidepressant

💊 Common Dosage Forms of FLUVOXAMINE MALEATE

Swapnroop Drugs & Pharmaceuticals manufactures Fluvoxamine Maleate primarily in the following pharmaceutical dosage forms:

🔹 1. Tablets

Most widely used form for oral administration

Strengths Available	Common Sizes
25 mg	Pediatric/OCD initiation
50 mg	Mild/moderate depression
100 mg	Maintenance dosing

Usually film-coated for taste masking and stability
May be scored for dose adjustment
Immediate-release (IR) formulations

🔹 2. Extended-Release (ER) Tablets or Capsules

Available in select formulations (usually for international markets)

Designed for once-daily dosing
Offers steady plasma concentration
Reduces peak-related side effects

Note: ER formulations may be offered in collaboration with licensed partners or under NDA in regulated markets.

🔹 3. Capsules (Less common but possible)

Gelatin or HPMC capsules containing micronized API
Easy to swallow; may include pellets or granules inside
Optionally enteric-coated or sustained-release pellets

🔹 4. Orally Disintegrating Tablets (ODT) (Investigational or pediatric use)

Rapidly dissolves in the mouth without water
Suitable for pediatric or geriatric patients
Flavor masking applied (e.g., mint, strawberry)

🔹 5. Bulk API

Supplied for formulation by other pharmaceutical companies
Packaged in 1 kg – 25 kg HDPE drums with tamper-evident sealing
Fully compliant with WHO-GMP / ICH Q7 standards

🌐 Dosage Form Customization Options

Swapnroop may offer contract/custom formulation services including:

Blister/strip packing (10×10 tablets)
Bottled packaging (30s, 60s, 100s)
Patient compliance packs
Pediatric low-dose tablets

🏷️ Regulatory Status

💊 Film-coated IR tablets are the most regulatory-approved form
🧪 All forms tested for dissolution, disintegration, content uniformity, and impurity profile

✅ Summary:

Swapnroop Drugs & Pharmaceuticals manufactures Fluvoxamine Maleate in multiple oral dosage forms including 25 mg, 50 mg, and 100 mg tablets, with potential extended-release capsules or orally disintegrating formats for pediatric and geriatric use. These are designed for high patient compliance, regulatory approval, and consistent therapeutic action. 💊📦✅

❓ Q6: How are FLUVOXAMINE MALEATE dosage forms prepared by Swapnroop Drugs & Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
💊 Dosage Forms: Tablets (IR), Capsules (optional), ER (advanced)

🏭 Dosage Form Preparation Process at Swapnroop

Fluvoxamine Maleate oral dosage forms—primarily immediate-release tablets—are prepared using standard wet granulation or direct compression techniques under strict cGMP compliance.

🔹 Step-by-Step Process for Tablet Manufacturing

1️⃣ Raw Material Verification

API and excipients tested for identity, purity, and assay (per pharmacopeia)
Moisture content checked (Karl Fischer titration)

2️⃣ Granulation Process (for 50 mg & 100 mg tablets)

API is blended with diluents (e.g., lactose, MCC) and disintegrants (e.g., crospovidone)
Binder solution (PVP K30 or starch paste) is added to create granules
Wet mass is sieved and dried (tray or fluid bed dryer)
Dried granules are lubricated (magnesium stearate, talc) and blended

3️⃣ Tablet Compression

Granules are compressed using a rotary tablet press
Parameters monitored: weight variation, hardness, friability, and disintegration time

4️⃣ Film Coating (optional)

Tablets coated with HPMC-based polymer and opacifier (TiO₂)
May include colorants and plasticizers for appearance and swallowability

🧪 Quality Control Tests (In-process and Final)

Test	Specification
Weight variation	±5% for 100 mg tablets
Hardness	4–8 kg/cm²
Disintegration time	≤ 15 minutes
Assay	95–105% of label claim
Dissolution	≥ 80% in 30 minutes (USP apparatus II)
Uniformity of dosage unit	As per USP/Ph. Eur.

🔸 Capsules (if manufactured)

Prepared by blending API with excipients
Encapsulated in hard gelatin or HPMC shells
Optionally filled with extended-release pellets

🔐 Packaging Conditions

Tablets packed in:
- Aluminum–PVC or Alu–Alu blisters
- HDPE bottles with desiccant
Labels include batch no., Mfg/Exp dates, storage conditions

🧰 Equipment Used by Swapnroop

Rapid Mixer Granulator (RMG)
Fluid Bed Dryer (FBD)
Compression machine (Rotary)
Tablet Coater (Auto-controlled inlet/outlet air)
Blister/Bottle packing lines

✅ Summary:

The dosage forms of Fluvoxamine Maleate produced by Swapnroop Drugs & Pharmaceuticals are prepared using granulation, compression, and optional coating techniques, followed by stringent quality control testing. Manufacturing is carried out under GMP-compliant conditions ensuring high quality, uniformity, and therapeutic efficacy. 💊⚙️✅

Q7: What is the appropriate dosage form of FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
💊 Therapeutic Class: SSRI antidepressant
🧠 Primary Indication: OCD, Depression, Anxiety Disorders

💊 Most Appropriate Dosage Form: Immediate-Release (IR) Tablets

The most suitable and commonly prescribed dosage form of Fluvoxamine Maleate is the oral immediate-release (IR) tablet, especially in 25 mg, 50 mg, and 100 mg strengths.

✅ Reasons Why IR Tablets Are Preferred

Feature	Description
💡 Ease of Administration	Simple once or twice daily oral dosing
⏱️ Rapid Onset	Immediate-release allows quicker therapeutic response
🎯 Dose Flexibility	Tablets available in 25/50/100 mg can be titrated as per patient need
📦 Stable & Scalable	IR tablets offer long shelf life and are easily packaged in blisters/bottles
💲 Cost-Effective	Economical compared to modified-release forms

🧒 For Pediatric OCD

25 mg tablets are ideal for children (starting dose)
Doses can be increased gradually under medical supervision
May be split if the tablets are scored

💼 Special Populations

Elderly: Start with lower doses (25–50 mg)
Hepatic impairment: Use caution and monitor response
Avoid high doses in renal dysfunction unless necessary

🧪 Alternative/Advanced Forms (if available)

Formulation Type	Use Case	Remarks
Extended-Release (ER)	Once-daily use for improved compliance	May reduce side effects; less common
Orally Disintegrating Tablets (ODT)	Pediatric/geriatric who have difficulty swallowing	Under development by some firms
Capsules	Optional form with similar bioavailability	May contain IR or ER pellets

⚠️ Not Suitable As:

Injectable
Transdermal
Sublingual or buccal (due to bitter taste and poor mucosal absorption)

✅ Summary:

The most appropriate dosage form of Fluvoxamine Maleate, as manufactured by Swapnroop Drugs & Pharmaceuticals, is the oral immediate-release tablet in 25 mg, 50 mg, and 100 mg strengths. It offers ideal dosing flexibility, rapid onset of action, and compliance for treatment of OCD and depressive disorders. 💊🧠✅

Q8: When should FLUVOXAMINE MALEATE API manufactured by Swapnroop Drugs & Pharmaceuticals be taken?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
🕒 Timing of Administration: Depends on indication, formulation, and patient tolerance

🕒 General Guidelines for Taking FLUVOXAMINE MALEATE

Fluvoxamine Maleate is usually administered once or twice daily by mouth, and its timing is crucial to maximize therapeutic effect and minimize side effects.

🔹 For Immediate-Release (IR) Tablets

Starting Dose	Common Timing	Rationale
25–50 mg daily	At bedtime 🛏️	Minimizes drowsiness, GI upset
≥100 mg/day	Split doses (morning + night) ☀️🌙	Ensures steady plasma levels

💡 Start low, go slow — especially important for OCD and depression

💊 When to Take Based on Condition

Condition	Recommended Timing	Notes
OCD	Night or split dosing	Often requires higher doses
Major Depressive Disorder (MDD)	Evening	Sedative effects help with insomnia
Social Anxiety / Panic Disorder	Evening (initially)	Gradually titrated to avoid GI disturbances
Pediatric OCD	Night (start with 25 mg)	Monitor for behavior or mood changes

🍽️ With or Without Food?

✅ With food is recommended
- Reduces risk of nausea, vomiting, and gastric discomfort
- Slows down absorption slightly but does not affect efficacy
❌ Avoid taking with alcohol or MAO inhibitors (contraindicated)

🔄 Dosing Adjustment Timing

Week 1–2: Start with low dose (25–50 mg)
Week 3 onward: Adjust gradually to target dose (100–300 mg/day)
Effect typically begins after 1–2 weeks, full response in 4–6 weeks

🧠 Pharmacokinetics Overview

Property	Value
Half-life	~15–20 hours
Time to peak (Tmax)	~3–8 hours
Duration of action	~24 hours (once-daily suitable)
Steady state	Achieved in ~10–14 days

⚠️ Clinical Notes

Take consistently at the same time each day
Do not abruptly stop—taper dose to avoid withdrawal symptoms
May cause drowsiness or dizziness: avoid driving if affected
Monitor for serotonin syndrome if used with other serotonergic agents

✅ Summary:

Fluvoxamine Maleate, manufactured by Swapnroop Drugs & Pharmaceuticals, is typically taken at bedtime (or in divided doses for higher strengths). It should be taken with food to reduce GI side effects, and dosing must be gradually increased to ensure safe and effective treatment of psychiatric conditions like OCD and depression. 🕒💊🧠

❓ Q9: What are the effects and side effects of FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
💊 Drug Class: Selective Serotonin Reuptake Inhibitor (SSRI)
🧠 Main Use: Treatment of OCD, depression, anxiety disorders

🌟 Therapeutic Effects of Fluvoxamine Maleate

Fluvoxamine Maleate enhances serotonin levels in the brain by inhibiting its reuptake at synapses — improving mood and reducing obsessive or anxious thoughts.

Effect	Clinical Outcome
⬆️ Serotonin availability	Improved mood, reduced anxiety
🧠 Anti-obsessive action	Relief in OCD, reduction in compulsive behaviors
😌 Anxiolytic effect	Calmer mental state, less panic or social fear
💤 Mild sedative property	May help with insomnia or restlessness at night
🔁 Stabilization of mood	Long-term remission in depression and anxiety

⚠️ Common Side Effects

Most side effects are mild and transient, especially during the first 1–2 weeks.

System Affected	Common Symptoms
🧠 Central Nervous System	Drowsiness, dizziness, headache
🧬 GI Tract	Nausea, vomiting, constipation, dry mouth
😴 Sleep	Insomnia or, conversely, sedation
😶 Psychiatric	Agitation, restlessness (early phase)
👄 Others	Sweating, loss of appetite, tremors

⚠️ Less Common or Serious Side Effects

🚨 Condition	Description
Serotonin Syndrome	High serotonin — agitation, fever, confusion
Hyponatremia	Especially in elderly — low sodium levels
Mania/hypomania	In bipolar patients
QT prolongation	Rare — ECG changes, cardiac arrhythmia risk
Withdrawal syndrome	If stopped suddenly — dizziness, anxiety, nausea

👩‍⚕️ Precautions & Monitoring

Monitor for suicidal thoughts in young adults
Caution in hepatic impairment — dose adjustments may be needed
Do not use with MAO inhibitors or thioridazine
Inform physician if patient is on warfarin, theophylline, or clozapine

🧪 Drug Interactions

Drug Class	Effect
MAO inhibitors	🚫 Life-threatening serotonin syndrome
CYP1A2 substrates	⬆️ Inhibited metabolism (e.g., theophylline)
Alcohol	⛔ Increases CNS depression
NSAIDs/Antiplatelets	⬆️ Bleeding risk when used together

✅ Summary:

Fluvoxamine Maleate, by Swapnroop Drugs & Pharmaceuticals, is a powerful SSRI that treats OCD, depression, and anxiety. While generally well-tolerated, it may cause GI upset, drowsiness, or dizziness, especially early in treatment. Serious side effects like serotonin syndrome or QT prolongation are rare but require careful monitoring. Always start with low doses and titrate gradually under medical supervision. 🧠💊⚠️

❓ Q10: How is FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs & Pharmaceuticals tested?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
🔬 Testing Phase: API (Active Pharmaceutical Ingredient) and Finished Dosage Form (FDF)
📜 Standards Followed: ICH, WHO-GMP, USP/Ph. Eur.

🔬 Comprehensive Testing of FLUVOXAMINE MALEATE

Swapnroop Drugs & Pharmaceuticals employs a multi-layered quality control (QC) process to ensure purity, identity, potency, and stability of Fluvoxamine Maleate—both in bulk API and formulated dosage forms.

✅ 1. API (Active Pharmaceutical Ingredient) Testing

Test Name	Purpose	Method
🔍 Identification (IR/UV/HPLC)	Confirms molecular structure	Infrared spectroscopy, HPLC retention time
📏 Assay (Content)	Measures API strength	HPLC or UV spectroscopy
🧪 Impurity profiling	Detects related substances & degradation	HPLC/GC per ICH Q3A/B
💧 Water content (moisture)	Affects shelf life	Karl Fischer titration
🌡️ Melting point	Ensures correct polymorph/form	USP melting point method
⚖️ Residual solvents	Ensures safety compliance (ICH Q3C)	GC with headspace sampling
🧫 Microbial limit test (if needed)	Confirms absence of bacterial contamination	Plate culture method
💎 Appearance	Verifies color, texture, crystal form	Visual/Microscopy

💊 2. Finished Dosage Form Testing (e.g., Tablets)

Test	Purpose
💊 Weight variation	Uniformity in individual tablets
🧱 Hardness/Friability	Ensures mechanical strength during handling
⏱️ Disintegration Time	Confirms breakdown within 15 minutes
🔁 Dissolution test	Ensures drug release in gastrointestinal pH
📊 Uniformity of dosage units	Every tablet/capsule contains same dose
🧪 Assay (content uniformity)	Ensures label claim within 95–105% range
📉 Stability testing (ICH Q1A)	Assesses shelf-life and long-term quality
⚠️ Heavy metal limits	Verifies safety from lead, mercury, etc.

📦 Batch Release Process

Once all tests pass:

Certificate of Analysis (CoA) is prepared
QA team reviews compliance with internal and external specs
Product is released for market or export

📚 Compliance Standards Followed

WHO-GMP, ICH Q7, EU GMP
USP, Ph. Eur., IP monographs
DMF data (if registered in regulated markets)

🧪 Equipment Used

HPLC with UV/Fluorescence detectors
FTIR/ATR-IR spectrometers
Gas Chromatograph with headspace module
UV-VIS Spectrophotometers
Dissolution testers (USP apparatus 1/2)
Karl Fischer titrator
Stability chambers (25°C/60%RH, 40°C/75%RH)

✅ Summary:

Fluvoxamine Maleate manufactured by Swapnroop Drugs & Pharmaceuticals undergoes extensive quality testing covering identification, potency, purity, impurities, and performance parameters. Both API and dosage forms comply with international pharmacopoeial standards, ensuring safe, effective, and globally compliant products. 🔬💊📈

Q11: What tests are performed on FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
📋 Test Scope: API (raw material) & Finished Dosage Form (FDF)
📜 Standards Used: ICH, WHO-GMP, USP, Ph. Eur.

🔬 Testing Overview

Fluvoxamine Maleate from Swapnroop is subjected to comprehensive analytical and QC testing to confirm:

Identity
Purity
Assay (strength)
Stability
Release performance

These tests are conducted during raw material acceptance, in-process checks, and finished product release.

🧪 API Testing (Fluvoxamine Maleate Powder)

Test	Purpose	Method
🔍 Identification	Confirms chemical structure	IR spectroscopy / HPLC
📊 Assay (API content)	Measures actual drug strength	HPLC / UV spectroscopy
🧬 Impurities / Degradants	Detects related or toxic impurities	HPLC (per ICH Q3A/B)
💧 Loss on drying / Water	Measures moisture affecting shelf-life	Karl Fischer titration
🔬 Appearance / Color	Ensures material meets physical quality	Visual/Microscopy
💥 Melting point	Verifies compound’s thermal identity	USP method
⚖️ Residual solvents	Detects solvents used in synthesis	Gas Chromatography (GC)
🧫 Microbial limits	Ensures absence of contamination (if applicable)	Culture tests

💊 Dosage Form Testing (Tablets/Capsules)

Test	Purpose	Limits / Acceptance Criteria
💊 Weight variation	Uniform dose across tablets	±5–10% depending on weight
🧱 Hardness & Friability	Confirms tablet strength during handling	>4 kg/cm²; <1% friability
🧪 Assay (label claim)	Confirms drug quantity per unit dose	95–105% of label claim
💧 Disintegration time	Confirms breakdown in GI tract	≤15 minutes (IR tablets)
🌊 Dissolution test	Measures drug release profile	≥80% release in 30 min (USP)
⚖️ Content uniformity	Dose variation among tablets/capsules	85–115% for individual units
🧫 Microbial limit test	Checks for harmful bacteria/fungi	As per USP/Ph. Eur.
🧪 Stability testing	Long-term and accelerated conditions (ICH)	6M @ 40°C/75% RH, 12M @ 25°C
⏳ Shelf life prediction	Based on stability and impurity growth	Typically 24–36 months

🧰 Additional Product Tests (as needed)

Heavy metals testing (ICP-MS/AAS)
Particle size distribution (for API)
Bulk & tapped density (for granule handling)
Polymorphic purity (via XRPD or DSC, if critical)

🔒 Batch Release Criteria

A batch is released only if:

✔️ All pharmacopoeial and internal specs are met
✔️ Stability data is compliant
✔️ CoA (Certificate of Analysis) is verified by QA
✔️ Documentation is in place (BMR/BPR reviewed)

✅ Summary:

Swapnroop Drugs & Pharmaceuticals conducts a broad spectrum of quality control tests on Fluvoxamine Maleate—from raw material to finished dosage—to ensure safety, efficacy, and compliance. Each batch must pass stringent checks on identity, purity, potency, disintegration, dissolution, and microbial safety before reaching patients. 🧪✅📦

Q12: What are the challenges in manufacturing FLUVOXAMINE MALEATE API by Swapnroop Drugs and Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
⚙️ API Focus: Fluvoxamine Maleate (an SSRI antidepressant)

🏭 Key Manufacturing Challenges for Fluvoxamine Maleate API

Producing high-purity, GMP-compliant Fluvoxamine Maleate API involves multiple synthetic, purification, regulatory, and scale-up challenges. These challenges can impact yield, consistency, impurity control, and cost-effectiveness.

⚗️ 1. Multi-step Chemical Synthesis

Challenge: The synthesis of Fluvoxamine Maleate involves several steps including:
- Formation of 2-aminoethyl ether intermediate
- Subsequent N-alkylation and amidation
Risk: Side reactions can lead to unwanted isomers or impurities

🧪 2. Impurity Profile Management (ICH Q3A/B)

Key Concern: Presence of genotoxic impurities, related substances, and residual solvents
Challenge: Requires robust purification steps and tight analytical monitoring
Solution: Validated HPLC and GC methods, forced degradation studies

🌡️ 3. Crystallization and Polymorphism

Issue: Different polymorphic forms can affect solubility, stability, and bioavailability
Challenge: Reproducible crystallization conditions must be controlled
Tool: Use of PXRD (X-ray diffraction) to confirm API consistency

🧬 4. Moisture Sensitivity

Fluvoxamine Maleate is slightly hygroscopic, which complicates drying and storage
Mitigation: Use of vacuum drying, inert atmosphere (e.g., nitrogen)

⚖️ 5. Residual Solvent Removal (ICH Q3C)

Use of solvents like methylene chloride, toluene, ethanol in synthesis stages
Regulatory limits must be met
Efficient solvent recovery & removal systems are required

🏗️ 6. Scale-up Reproducibility

Lab-to-pilot-to-commercial scale-up often affects:
- Reaction kinetics
- Yield & purity
- Heat control
Requires process validation at every stage

📜 7. Regulatory & Documentation Burden

Need to generate full Drug Master File (DMF) and ICH-compliant dossier
Full stability data, impurity justification, and method validation required for filings (e.g., USFDA, EU, India)

♻️ 8. Environmental and Safety Concerns

Handling of hazardous reagents, waste solvents
Requires effluent treatment, fume hoods, PPE, and safe disposal methods
Compliance with local pollution control norms

🔍 Summary Table of Challenges

🔧 Category	⚠️ Challenge
Synthetic Chemistry	Side reactions, low yield, long reaction time
Purification & QA	Controlling impurities and residual solvents
Crystallization	Reproducibility of API polymorphs
Moisture Sensitivity	Requires controlled drying and storage
Regulatory Compliance	DMF, ICH Q7, Q3C, Q1A data requirements
Scale-up	Reproducibility and yield drop at scale
Safety & Environment	Hazardous reagents, solvent management

✅ Summary:

Manufacturing Fluvoxamine Maleate API at Swapnroop Drugs & Pharmaceuticals involves tackling synthetic complexity, impurity control, crystallization reproducibility, and regulatory compliance. Overcoming these challenges ensures a high-quality API that meets global standards for efficacy, safety, and stability. 🏭🧪📊

❓ Q13: What are the challenges in manufacturing FLUVOXAMINE MALEATE dosage forms by Swapnroop Drugs and Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
💊 Dosage Forms: Immediate-release tablets, controlled-release formulations, capsules

🏗️ Key Manufacturing Challenges in FLUVOXAMINE MALEATE Dosage Forms

Producing oral formulations of Fluvoxamine Maleate—especially tablets and capsules—presents several technical, formulation, and regulatory challenges. These affect product uniformity, bioavailability, stability, and patient compliance.

🔬 1. Poor Flow Properties of API Powder

Problem: Fluvoxamine Maleate is often fine, fluffy, and poorly flowing
Effect: Issues with die filling, weight variation, and blend uniformity
Solution: Use of granulation, glidants, or direct compression aids

🧪 2. Dose Uniformity and Content Consistency

Low-dose tablets (e.g., 25 mg) require precision in blending
Risk: Segregation during blending or tableting can lead to variable doses
Control: In-process checks (IPQC), content uniformity test (CU), validated mixing time

🌊 3. Dissolution and Bioavailability

Fluvoxamine’s solubility is pH-dependent
Challenge: Ensuring consistent dissolution profile across batches
Tools: Dissolution method development, use of disintegrants or surfactants

🧬 4. Stability and Shelf Life

Factors Affecting Stability	Examples
Heat & humidity	Accelerate degradation
Light exposure	May cause discoloration or breakdown
Residual moisture	Leads to hydrolysis

Solution: Use protective packaging, desiccants, moisture-resistant coatings

💊 5. Tablet Coating and Palatability

Tablets often require film coating for:
- Improved taste masking (some bitterness)
- Protection from moisture
- Improved swallowability
Poor coating may cause:
- Tablet sticking, rough surface, or film cracking

⚖️ 6. Compression Issues

Problem	Result	Control
Capping/Lamination	Tablet splits or breaks	Optimize compression force
Picking/Sticking	Film sticks to punch	Modify lubricant/coating
Weight Variation	Inconsistent dosage	Flow-improving excipients

📦 7. Packaging Challenges

Moisture protection required (e.g., blister packs with aluminum foil)
Regulatory demands for tamper-evidence and serialization

📜 8. Regulatory and Bioequivalence (BE) Study Requirements

Need to meet:
- Dissolution profile similarity (f2 test) with innovator product
- Bioequivalence data for regulatory submission
For exports: must match USP, EP, or IP monographs as required

✅ Summary of Challenges

🔧 Area	⚠️ Challenge
Powder handling	Poor flow, segregation
Dose uniformity	Critical at low strength (e.g., 25 mg)
Dissolution	Solubility issues at different pH levels
Stability	Moisture/light-sensitive API
Coating	Required for taste and protection
Compression/tableting	Risk of mechanical failures
Packaging	High barrier protection needed
Regulatory compliance	Bioequivalence, pharmacopoeial specs

✅ Final Word:

Swapnroop Drugs & Pharmaceuticals must address formulation complexity, flow issues, dissolution control, and stability to ensure that Fluvoxamine Maleate dosage forms are effective, uniform, and meet global regulatory standards. Every step—from granulation to packaging—requires tight process control. 💊⚙️📦

Q14: What are the storage conditions for FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
🔒 Purpose: To ensure stability, efficacy, and safety of the API and dosage forms throughout shelf life.

🧊 Recommended Storage Conditions (API & Tablets)

Parameter	Specification
🌡️ Temperature	Store below 25°C (77°F)
💧 Humidity	Store in a dry place, protect from moisture
☀️ Light	Store away from direct sunlight / UV light
🧴 Container type	Keep in tightly closed, light-resistant container
🚫 Avoid	Freezing, excessive heat, high humidity areas

📦 API (Raw Material) Storage Requirements

Primary Container: Double-layer LDPE or HDPE bags
Secondary Protection: Inside a fiberboard drum or HDPE drum with tamper seal
Environment: Controlled room temperature with humidity monitoring (≤60% RH)
Precautions:
- Use nitrogen blanketing if sensitive to oxidation
- Store in dedicated API zone to avoid cross-contamination

💊 Finished Dosage Forms (Tablets/Capsules)

Packaging	Purpose
Blister packs (PVC/Alu)	Moisture & light protection
HDPE bottles + desiccant	Controls humidity inside container
Strip packs (Alu-Alu)	Maximum barrier properties for export stability

Include silica gel or molecular sieve in containers
Store in original packaging until use

🧪 Stability Testing (ICH Guidelines)

Condition	Purpose
25°C ± 2°C / 60% RH ± 5%	Long-term real-time stability
40°C ± 2°C / 75% RH ± 5%	Accelerated degradation study
30°C ± 2°C / 65% RH ± 5%	Intermediate (if required)

📦 Results from these studies determine the final shelf life and packaging requirements.

🧯 Hazard Classification (for Storage Areas)

Store in non-flammable, well-ventilated areas
Ensure MSDS (Material Safety Data Sheet) is available on site
Label as pharmaceutical active substance with caution if applicable

✅ Summary:

Fluvoxamine Maleate, manufactured by Swapnroop Drugs & Pharmaceuticals, must be stored below 25°C, in a dry, light-protected environment with sealed containers. Whether in API or dosage form, adherence to proper temperature, humidity, and packaging ensures drug integrity throughout its shelf life. 📦🌡️🧪

Q15: What is the packaging for FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
🎯 Goal: Ensure protection from light, moisture, contamination, and physical damage during transport and storage of both API and dosage forms.

📦 Packaging of FLUVOXAMINE MALEATE API (Active Pharmaceutical Ingredient)

🏗️ Primary Packaging:

Component	Material	Purpose
🛍️ Inner Liner	LDPE (Low-Density Polyethylene) Bag	Provides chemical and moisture barrier
🧴 Secondary Bag	HDPE or Double PE Bag	Reinforcement and secondary moisture protection
📦 Outer Drum	HDPE container or fiber drum	Structural protection during storage & transit
🏷️ Labeling	External label with product name, CAS, batch no., manufacturing/expiry date, net weight, storage instructions, manufacturer details

🔐 Tamper-Proof Sealing:

All containers are heat-sealed, tamper-evident, and include batch integrity seals

💊 Packaging of FLUVOXAMINE MALEATE Finished Dosage Forms

1. Blister Packs

Type	Details
PVC/Alu Blister	Protects from mechanical damage & humidity
Alu-Alu Blister (Cold Form)	Offers superior moisture/light barrier for humid climates
Pack Size	10x10 tablets (or as per market requirement)
Branding	Custom artwork, batch details, QR/barcode

2. HDPE Bottles (with Desiccant)

Used in bottles of 30, 60, or 100 tablets
Contains silica gel sachet or molecular sieve canister
Induction-sealed caps with child-resistant options
Tamper-evident shrink band included

3. Strip Packs

Alu-Alu strip with individual cavities
Often used for export or government tenders

4. Secondary & Tertiary Packaging

Type	Function
Printed Carton Box	Holds blister strips/bottles
Corrugated Shipping Box	Outer case for transport (as per UN/WHO guidelines)
Cushioning Materials	Prevent damage during bulk transport
Barcode & Serialization	For global traceability (as per 21 CFR Part 11, GS1)

🌐 Regulatory Packaging Compliance

Complies with:
✅ WHO-GMP
✅ Indian D&C Act
✅ EU GMP / US FDA guidelines (if for regulated markets)
Packaging validation includes:
- Drop tests
- Moisture ingress testing
- Photostability protection validation

🏷️ Sample Label for API:

yaml
Product: FLUVOXAMINE MALEATE  
CAS No.: 61718-82-9  
Batch No.: FVM-2025-006  
Manufacturing Date: 06/2025  
Expiry Date: 06/2027  
Net Weight: 25.00 kg  
Storage: Store below 25°C, protect from moisture  
Manufacturer: Swapnroop Drugs & Pharmaceuticals

✅ Summary:

Swapnroop Drugs & Pharmaceuticals uses robust, compliant, and tamper-proof packaging for both Fluvoxamine Maleate API and dosage forms, ensuring product safety, stability, and regulatory acceptance across global markets. 📦🔐💊

Q16: What is the shelf life of FLUVOXAMINE MALEATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS Number: 61718-82-9
🏭 Manufacturer: Swapnroop Drugs & Pharmaceuticals
🧪 Product Forms: API (raw material) and oral solid dosage (tablet/capsule)

📆 Standard Shelf Life Guidelines

Form	Typical Shelf Life	Conditions
✅ API (Fluvoxamine Maleate)	36 months (3 years)	Stored below 25°C, in sealed drums
💊 Tablets/Capsules	24–36 months (formulation-dependent)	Blister-packed or in HDPE bottles with desiccants

🧪 Based on ICH Stability Studies

Shelf life is determined by real-time and accelerated stability studies following ICH guidelines (Q1A–Q1F):

Condition	Study Duration	Purpose
25°C ± 2°C / 60% RH ± 5%	12–36 months	Real-time shelf life
40°C ± 2°C / 75% RH ± 5%	6 months	Accelerated degradation check
30°C ± 2°C / 65% RH ± 5%	Optional	Intermediate stability zone

📊 Stability Parameters Assessed

API Stability:
- Assay (% potency)
- Moisture content
- Impurities / degradation products
- Appearance (color, odor, texture)
Dosage Form Stability:
- Dissolution
- Disintegration
- Hardness/Friability
- Microbial limits
- Packaging integrity

💡 Factors Influencing Shelf Life

Factor	Impact
Moisture exposure	Degradation, hydrolysis
Light exposure	Photo-instability of drug compound
Packaging type	Barrier strength against environment
Excipients used	May accelerate or slow degradation
Manufacturing quality	Affects initial stability and homogeneity

🧴 Packaging Contribution

API is stored in sealed HDPE drums with double LDPE liners and nitrogen flushing
Dosage forms use:
- Alu-Alu blisters or HDPE bottles with desiccants
- Protect from humidity, heat, and oxygen

✅ Label Claim on Commercial Products

vbnet
SHELF LIFE: 36 MONTHS FROM DATE OF MANUFACTURE  
STORAGE: STORE BELOW 25°C. KEEP CONTAINER TIGHTLY CLOSED. PROTECT FROM LIGHT AND MOISTURE.

📌 Summary:

The shelf life of Fluvoxamine Maleate, manufactured by Swapnroop Drugs & Pharmaceuticals, is typically:

36 months for the API, and

24–36 months for tablets or capsules,
based on ICH-compliant stability studies, suitable packaging, and strict storage control. ⏳🧪📦