Comprehensive Overview of PROPRANOLOL API (CAS No: Base 525-66-6 | HCl 318-98-9) Manufactured by Swapnroop Drugs & Pharmaceuticals

 

 Q1: What is PROPRANOLOL API manufactured by Swapnroop Drugs & Pharmaceuticals?

✅ Answer (in depth with CAS No):
Propranolol is a well-known non-selective Ξ²-adrenergic receptor blocker (beta-blocker) provided as an Active Pharmaceutical Ingredient (API) by Swapnroop Drugs & Pharmaceuticals.

It is generally supplied either as the free base or as the more commonly used hydrochloride salt (Propranolol HCl), which offers better solubility and stability for formulation development.

  • CAS Numbers:

    • Propranolol (Base): 525-66-6

    • Propranolol Hydrochloride (HCl): 318-98-9

  • IUPAC Name: (±)-1-isopropylamino-3-(1-naphthyloxy)-2-propanol

  • Molecular Formula / Molecular Weight:

    • Base: C₁₆H₂₁NO₂ — 259.34 g/mol

    • HCl: C₁₆H₂₂ClNO₂ — 295.81 g/mol

Physical & Chemical Profile:

  • Appearance: White to off-white crystalline powder

  • Solubility: Base — sparingly soluble in water; HCl — freely soluble in water and alcohols

  • pKa: ~9.5 (weak base)

  • LogP: ~3.0 (lipophilic base)

  • Melting Point (base): 96–99 °C

  • Optical Form: Racemic mixture (R/S)

Pharmacological Class & Action:
Propranolol API acts by blocking Ξ²₁ and Ξ²₂ adrenergic receptors, reducing heart rate, myocardial contractility, blood pressure, and sympathetic drive. It is widely used in hypertension, angina, arrhythmias, migraine prophylaxis, essential tremor, anxiety symptoms, and post-myocardial infarction care.

Supplied form to formulators:
Swapnroop Drugs & Pharmaceuticals typically supplies Propranolol HCl (CAS 318-98-9) in bulk form (pharmacopeial grade) to be used in tablets, capsules, oral solutions, and injections.

Storage & Handling:

  • Store in a cool, dry place (15–30 °C)

  • Protect from light and moisture

  • Packaged in HDPE/steel drums with double LDPE liners

  • Shelf life: Usually 24–36 months, depending on stability data



Q2: What is PROPRANOLOL API by Swapnroop Drugs & Pharmaceuticals used for?

✅ Answer (in depth):
Propranolol API is the active pharmaceutical ingredient used in the production of multiple cardiovascular, neurological, and endocrine therapies. It belongs to the class of non-selective beta-adrenergic blockers and is used to formulate medicines that:

  • Cardiovascular uses:

    • Treat hypertension (high blood pressure)

    • Manage angina pectoris (chest pain)

    • Control arrhythmias such as atrial fibrillation, supraventricular tachycardia, and ventricular premature beats

    • Provide secondary prevention after myocardial infarction (heart attack)

  • Neurological uses:

    • Prevent migraine attacks (prophylaxis)

    • Manage essential tremor

    • Reduce performance anxiety and situational anxiety symptoms (palpitations, sweating, tremors)

  • Endocrine & other uses:

    • Control symptoms of hyperthyroidism and thyrotoxicosis (tachycardia, tremor)

    • Adjunct therapy in pheochromocytoma (combined with alpha-blockers)

    • Reduce risk of sudden death in certain high-risk patients

Formulation focus:
Swapnroop Drugs & Pharmaceuticals supplies Propranolol API for conversion into:

  • Immediate-release (IR) tablets/capsules

  • Extended-release (ER) formulations for once-daily dosing

  • Oral solutions/syrups (commonly for pediatrics)

  • Injectable solutions (hospital use for acute control of arrhythmias or hypertension)

Key therapeutic advantage:
Because it is non-selective (blocks both Ξ²1 and Ξ²2 receptors), propranolol exerts widespread effects — lowering blood pressure, heart rate, myocardial oxygen demand, and adrenergic symptoms. This versatility makes it one of the most prescribed and widely studied beta-blockers.


Q3: What are the physicochemical properties of PROPRANOLOL API manufactured by Swapnroop Drugs & Pharmaceuticals?

✅ Answer (with CAS No and details):

Propranolol API is supplied either as the free base or more commonly as Propranolol Hydrochloride (HCl) due to its better solubility profile.

πŸ”Ή Identification

  • Propranolol (Base)

    • CAS No: 525-66-6

    • Molecular Formula: C₁₆H₂₁NO₂

    • Molecular Weight: 259.34 g/mol

  • Propranolol Hydrochloride (HCl)

    • CAS No: 318-98-9

    • Molecular Formula: C₁₆H₂₂ClNO₂

    • Molecular Weight: 295.81 g/mol

  • IUPAC Name: (±)-1-isopropylamino-3-(1-naphthyloxy)-2-propanol

  • Chemical Class: Non-selective Ξ²-adrenergic receptor blocker

πŸ”Ή Physical Properties

  • Appearance: White to off-white crystalline powder

  • Odor/Taste: Odorless, slightly bitter taste

  • Melting Point: Base ~96–99 °C

  • Hygroscopicity: HCl salt is mildly hygroscopic

  • Optical Activity: Racemic mixture (R/S enantiomers)

πŸ”Ή Chemical Properties

  • pKa: ~9.5 (weak base, protonated at physiological pH)

  • LogP (Base): ~3.0 (lipophilic)

  • LogD at pH 7.4: ~1–2 (improves absorption characteristics)

  • Stability: Stable under normal storage conditions; sensitive to high moisture and light

πŸ”Ή Solubility

  • Base: Sparingly soluble in water; soluble in alcohols and organic solvents

  • HCl Salt: Freely soluble in water, ethanol, and methanol → preferred for formulations

πŸ”Ή Pharmaceutical Relevance
These physicochemical properties directly influence:

  • Formulation choice (HCl form for tablets, syrups, injections)

  • Absorption & bioavailability (lipophilicity aids CNS penetration — useful for migraine and anxiety indications)

  • Stability (moisture-sensitive, requires controlled packaging and storage)


Q4: How is PROPRANOLOL API manufactured (synthesized) by Swapnroop Drugs & Pharmaceuticals?

✅ Answer (in depth):
The synthesis of Propranolol API typically follows a multi-step organic process starting from 1-naphthol. The commercial route is well established and focuses on obtaining a racemic mixture of propranolol, which is the pharmaceutically accepted form.

πŸ”Ή Stepwise Synthesis (Typical Route):

  1. Formation of Glycidyl Ether Intermediate

    • Starting material: 1-Naphthol

    • Reaction with epichlorohydrin under basic conditions

    • Produces 1-naphthyl glycidyl ether (an epoxide intermediate)

    1-Naphthol + Epichlorohydrin → 1-Naphthyl glycidyl ether\text{1-Naphthol + Epichlorohydrin → 1-Naphthyl glycidyl ether}

  1. Ring-Opening / Amination

    • The epoxide ring of 1-naphthyl glycidyl ether is opened by isopropylamine

    • This step forms Propranolol base

    1-Naphthyl glycidyl ether + Isopropylamine → Propranolol (base)\text{1-Naphthyl glycidyl ether + Isopropylamine → Propranolol (base)}

  1. Salt Formation (Optional Step)

    • The free base is converted into Propranolol Hydrochloride (HCl)

    • Reaction: Neutralization with hydrogen chloride (HCl) in a suitable solvent (ethanol or isopropanol)

    • Produces a stable, crystalline, water-soluble salt preferred for pharmaceutical use

    Propranolol (base) + HCl → Propranolol Hydrochloride\text{Propranolol (base) + HCl → Propranolol Hydrochloride}

  1. Purification & Finishing

    • Crystallization: The salt is crystallized from alcohol–water mixtures

    • Filtration & drying under controlled conditions

    • Milling & sieving: Adjust particle size distribution (important for dissolution and formulation)

    • Final API is tested for:

      • Residual solvents (GC)

      • Residual epichlorohydrin (toxic impurity)

      • Related substances (HPLC)

      • Optical rotation, assay, and purity

πŸ”Ή Key Points in Manufacturing Control:

  • Residual epichlorohydrin must be minimized (strict ICH Q3C limits, as it is genotoxic).

  • Optical activity: Racemic propranolol (RS-mixture) is the pharmacopeial standard.

  • Particle size control is critical for consistent dissolution in oral solid dosage forms.

  • Salt selection: HCl form is used because of superior solubility compared to the free base.

πŸ”Ή Industrial Relevance:
This synthetic route is cost-effective, scalable, and cGMP-compliant, making it the global standard for propranolol production. Swapnroop Drugs & Pharmaceuticals follows pharmacopeial guidelines (IP/USP/EP) to ensure consistent quality of the API.


❓ Q5: What are the different dosage forms of PROPRANOLOL manufactured from this API?

Propranolol API is versatile and used to formulate several dosage forms for clinical indications ranging from cardiovascular to neurological disorders.

1. Immediate-Release (IR) Tablets

  • Typical strengths: 10 mg, 20 mg, 40 mg, 80 mg

  • Used for dose titration, arrhythmias, situational anxiety, or tremor control

2. Extended-Release (ER) Capsules/Tablets

  • Typical strengths: 60 mg, 80 mg, 120 mg, 160 mg

  • Designed for once-daily administration in hypertension, angina, or migraine prophylaxis

3. Oral Solution / Syrup

  • Example strength: 20 mg/5 mL (varies by market)

  • Pediatric use or patients with swallowing difficulties

4. Injectable Formulation (HCl Salt)

  • IV use in acute inpatient settings for arrhythmias or hypertensive emergencies

Pharmaceutical Relevance:

  • Choice of dosage form depends on patient age, condition, dosing frequency, and clinical setting.

  • IR for rapid effect, ER for sustained control, oral solution for easy administration, IV for acute situations.

Summary:
Swapnroop Drugs & Pharmaceuticals produces Propranolol API suitable for multiple dosage forms, ensuring flexibility in treatment options and consistent therapeutic outcomes.


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

The preparation of Propranolol dosage forms involves different formulation strategies depending on the type of product—immediate-release (IR), extended-release (ER), oral solution, or injectable.

1. Immediate-Release (IR) Tablets

Process:

  • Granulation: Wet or dry granulation of Propranolol API with excipients such as:

    • Diluent: Lactose, microcrystalline cellulose (MCC)

    • Binder: Polyvinylpyrrolidone (PVP) or hydroxypropyl methylcellulose (HPMC)

    • Disintegrant: Croscarmellose sodium or sodium starch glycolate

    • Lubricant: Magnesium stearate or stearic acid

  • Compression: Tablets are compressed under controlled pressure to achieve uniform weight and hardness.

  • Coating (Optional): Film-coating using polymers like HPMC or Opadry for taste masking, stability, and appearance.

2. Extended-Release (ER) Formulations

a) Multiparticulate Capsules (Pellets/Beads)

  • Propranolol API is granulated and formed into pellets or beads.

  • Coated with release-modifying polymers such as ethylcellulose, Eudragit, or HPMC.

  • Filled into capsules for controlled drug release.

b) Matrix Tablets

  • API is blended with hydrophilic polymers like HPMC or HPC.

  • Compressing into tablets forms a matrix for near-zero-order release, maintaining steady plasma concentration.

3. Oral Solutions / Syrups

  • Propranolol HCl is dissolved in purified water.

  • pH adjusted with buffer system (e.g., citrate).

  • Additives: Sweeteners, flavors, preservatives (e.g., sodium benzoate), antioxidants (if required).

  • Solution is filtered, filled, and sealed under hygienic conditions.

4. Injectable Formulations (IV)

  • Propranolol HCl is dissolved in sterile water for injection (WFI).

  • pH adjusted to ~3–6 for stability and tolerability.

  • Sterile filtration ensures microbial safety.

  • Filled aseptically into vials or ampoules.

Quality Control Considerations

  • Blend uniformity to ensure content consistency

  • Particle size control for dissolution and bioavailability

  • Moisture and light protection during processing

  • Assay and purity checks before final packaging

Summary:
Swapnroop Drugs & Pharmaceuticals prepares Propranolol dosage forms using standardized pharmaceutical manufacturing processes tailored to the form:

  • IR tablets: rapid onset

  • ER tablets/capsules: sustained release

  • Oral solutions: easy administration

  • IV injections: acute care

This ensures therapeutic efficacy, patient safety, and regulatory compliance.



❓ Q7: What is the appropriate dosage form of PROPRANOLOL API manufactured by Swapnroop Drugs & Pharmaceuticals?

The appropriate dosage form of Propranolol depends on the clinical indication, patient requirements, and treatment goals. Swapnroop Drugs & Pharmaceuticals produces API that can be formulated into multiple dosage forms to optimize therapy.

1. Immediate-Release (IR) Tablets

  • Typical Strengths: 10 mg, 20 mg, 40 mg, 80 mg

  • Indications:

    • Arrhythmias (e.g., supraventricular tachycardia)

    • Situational anxiety or stress-induced tachycardia

    • Essential tremor

  • Advantages:

    • Rapid onset of action

    • Allows dose titration for precise therapy

2. Extended-Release (ER) Capsules/Tablets

  • Typical Strengths: 60 mg, 80 mg, 120 mg, 160 mg

  • Indications:

    • Hypertension (high blood pressure)

    • Angina pectoris

    • Migraine prophylaxis

  • Advantages:

    • Once-daily dosing → improves patient compliance

    • Provides steady plasma concentration, minimizing peaks and troughs

3. Oral Solution / Syrup

  • Strength Example: 20 mg/5 mL (varies by market)

  • Indications:

    • Pediatric patients

    • Adults with swallowing difficulties

  • Advantages:

    • Easy to administer

    • Flexible dosing for weight-based titration

4. Injectable Formulation (IV)

  • Indications:

    • Acute inpatient use for arrhythmias, hypertensive crises, or acute myocardial infarction

  • Advantages:

    • Rapid onset

    • Controlled dosing in hospital settings

Clinical Considerations

  • Selection of dosage form is physician-directed, based on:

    • Patient age and ability to swallow

    • Desired onset and duration of action

    • Frequency of administration

    • Specific clinical condition (e.g., hypertension vs. acute arrhythmia)

Summary:
Swapnroop Drugs & Pharmaceuticals provides Propranolol API suitable for:

  • IR tablets: rapid effect and dose titration

  • ER capsules/tablets: once-daily therapy for chronic conditions

  • Oral solutions: pediatric and dysphagic patients

  • IV injections: acute inpatient management

The appropriate form ensures therapeutic effectiveness, patient safety, and compliance while maintaining flexibility for formulation development.



❓ Q8: When should PROPRANOLOL finished dosage forms manufactured by Swapnroop Drugs & Pharmaceuticals be taken?

✅ Answer (In-Depth)

The timing and frequency of Propranolol administration depend on the dosage form, indication, and patient-specific factors.

1. Immediate-Release (IR) Tablets

  • Frequency: Usually 2–3 times daily

  • Timing: Take consistently with respect to meals (with or without food, but maintain consistency)

  • Purpose: Maintains effective plasma concentration for acute symptom control like arrhythmias, situational anxiety, or essential tremor

2. Extended-Release (ER) Tablets/Capsules

  • Frequency: Typically once daily

  • Timing: Same time each day, preferably morning for blood pressure control

  • Purpose: Provides steady-state plasma levels for hypertension, angina, and migraine prophylaxis

3. Oral Solution / Syrup

  • Frequency & Timing: Per pediatric or adult prescription; usually mirrors IR dosing

  • Purpose: Flexible dosing, especially for weight-based adjustments

4. Injectable (IV)

  • Use: Acute inpatient situations

  • Timing: Administered under medical supervision, titrated to effect

Important Clinical Notes:

  • Do not stop Propranolol abruptly → risk of rebound tachycardia, hypertension, or angina

  • Adherence to prescriber guidance is critical for safety and efficacy

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

Propranolol, as a non-selective Ξ²-blocker, exerts therapeutic cardiovascular, neurological, and systemic effects, but also has potential side effects.

Therapeutic Effects:

  1. Lowers heart rate (HR) and blood pressure (BP)

  2. Reduces myocardial oxygen demand → protects against angina

  3. Prevents arrhythmias (e.g., supraventricular tachycardia)

  4. Suppresses tremors and adrenergic symptoms (palpitations, anxiety)

  5. Reduces migraine frequency and severity

  6. Provides symptomatic control in hyperthyroidism

Common Side Effects:

  • Cardiovascular: Bradycardia, hypotension

  • Neurological: Fatigue, dizziness, sleep disturbances, vivid dreams

  • Peripheral: Cold hands and feet

  • Gastrointestinal: Nausea, mild GI upset

Serious/Precautionary Effects:

  • Bronchospasm → avoid in asthma or COPD

  • Masks hypoglycemia symptoms in diabetics

  • Can worsen peripheral vascular disease or heart block

  • Rare: Depression, sexual dysfunction

Drug Interactions:

  • Other rate-limiting drugs: Verapamil, Diltiazem

  • Other antihypertensives → additive effect

  • Clonidine withdrawal → risk of hypertensive crisis

  • CYP1A2/2D6 modulators may affect Propranolol metabolism

  • Insulin/oral hypoglycemic agents → monitor glucose



❓ Q10: How is PROPRANOLOL API manufactured by Swapnroop Drugs & Pharmaceuticals tested?

✅ Answer (In-Depth)

Propranolol API undergoes rigorous testing to ensure quality, purity, safety, and compliance with pharmacopeial and regulatory standards (IP/USP/EP/ICH).

1. Identification Tests

  • Infrared (IR) Spectroscopy: Confirms functional groups.

  • UV Spectroscopy: Confirms absorbance characteristics.

  • HPLC Retention Time: Confirms identity against reference standard.

  • Chloride Test: For HCl salt verification.

2. Assay / Content Determination

  • HPLC-based potency measurement ensures API meets label claim.

  • Ensures correct active ingredient concentration for dosage form development.

3. Related Substances / Impurities

  • HPLC analysis for process-related impurities.

  • GC for residual solvents (e.g., epichlorohydrin, methanol).

  • Ensures compliance with ICH Q3A/Q3C guidelines.

4. Chiral / Optical Purity

  • Specific rotation measurement ensures racemic mixture within limits.

  • Optional chiral HPLC if required by regulatory specifications.

5. Water Content

  • Karl Fischer titration for precise moisture determination.

6. Particle Size & Polymorph Control

  • Particle size distribution: Laser diffraction or sieve analysis.

  • Polymorphic form verified by PXRD (Powder X-ray Diffraction) or DSC (Differential Scanning Calorimetry).

7. Heavy Metals / Elemental Impurities

  • ICP-OES/ICP-MS per ICH Q3D for toxic metals.

8. Microbial Limits

  • Non-sterile API tested for microbial contamination.

9. Stability Studies

  • ICH Q1A(R2) long-term and accelerated studies for shelf-life and storage guidance.

❓ Q11: What tests are performed on PROPRANOLOL dosage forms manufactured by Swapnroop Drugs & Pharmaceuticals?

Testing of dosage forms ensures efficacy, safety, and regulatory compliance.

1. Tablets / Capsules

  • Appearance & Identification: Color, shape, imprint

  • Assay & Content Uniformity: HPLC or UV methods

  • Dissolution Testing: Paddle/basket apparatus; multi-point testing for ER forms; similarity factor (f2) for batch consistency

  • Hardness & Friability: Mechanical integrity of tablets

  • Weight Variation: Ensures uniform dosing

2. Oral Solutions / Syrups

  • Assay & Identification: Confirms API concentration

  • Microbial Limits: Ensures product is safe for consumption

  • pH & Viscosity: Stability and palatability

  • Stability Testing: Includes in-use and accelerated studies

3. Injectable Formulations

  • Sterility Testing: To prevent microbial contamination

  • Particulate Matter Test: Ensures safety for IV administration

  • Assay & pH: Confirms correct concentration and tolerability

  • Endotoxin Testing: LAL test to detect pyrogens

4. General Stability & Impurities

  • Degradation Products: Monitored under stress conditions

  • Long-Term & Accelerated Stability Studies: Confirm shelf life

  • Packaging Interaction Studies: Ensure no leaching or reaction with container


 Q12: What are the challenges in manufacturing PROPRANOLOL API by Swapnroop Drugs & Pharmaceuticals?

✅ Answer (In-Depth)

The synthesis of Propranolol API involves several chemical steps and process controls, and manufacturers face multiple challenges:

1. Control of Residual Epichlorohydrin

  • Epichlorohydrin is toxic and potentially carcinogenic.

  • Requires strict monitoring via GC to meet ICH Q3C residual solvent limits.

2. Management of Related Substances

  • Impurities from glycidyl ether formation and amination steps can affect safety and efficacy.

  • HPLC analysis ensures related substances are within pharmacopeial limits.

3. Particle Size and Blend Uniformity

  • API particle size affects dissolution, content uniformity, and compressibility.

  • Milling and sieving must be optimized for consistent particle distribution.

4. Polymorph and Crystal Habit Consistency

  • Polymorphic form influences solubility, stability, and bioavailability.

  • PXRD or DSC is used for control, but maintaining consistent polymorph is challenging during scale-up.

5. Hygroscopicity of HCl Salt

  • HCl salt is mildly hygroscopic, sensitive to moisture during drying, milling, and packaging.

  • Requires controlled humidity and desiccants.

6. Chiral/Optical Specification

  • Propranolol is a racemic mixture, but optical rotation must remain within pharmacopeial limits.

  • Maintaining consistency in large-scale batches requires stringent process control.

Summary:
The key challenges in manufacturing Propranolol API are controlling toxic residuals, impurities, particle size, polymorphs, hygroscopicity, and optical purity to ensure safe, high-quality, and pharmacopeially compliant API.

❓ Q13: What are the challenges in manufacturing PROPRANOLOL dosage forms by Swapnroop Drugs & Pharmaceuticals?

Formulating Propranolol into stable, effective dosage forms involves several technical and process-related challenges:

1. Extended-Release (ER) Formulation Stability

  • Achieving consistent drug release profiles across pH variations and fed/fasted states.

  • Avoiding dose dumping under alcohol or stress conditions.

2. Content Uniformity at Low Strengths

  • Low-dose IR tablets (e.g., 10–20 mg) require precise blending to avoid dose variability.

3. Taste Masking and Palatability

  • Oral solutions/syrups may require flavoring, sweeteners, and preservatives without affecting stability.

4. Moisture Sensitivity

  • Propranolol HCl is hygroscopic → tablets/capsules may cake or dissolve differently if exposed to humidity.

  • Requires moisture-controlled production and packaging.

5. Lubricant Sensitivity

  • Magnesium stearate and other excipients can alter dissolution, particularly in ER formulations.

  • Optimization of mixing and compression parameters is necessary.

6. Injectable Formulation Challenges

  • Sterile compounding, pH adjustment, and filtration require aseptic manufacturing.

  • Particulate matter and endotoxin control are critical for safety.

Summary:
Challenges in Propranolol dosage form manufacturing include maintaining ER kinetics, content uniformity, palatability, moisture control, and sterile handling. Overcoming these ensures safe, effective, and stable products for patients.




❓ Q14: What are the storage conditions for PROPRANOLOL API manufactured by Swapnroop Drugs & Pharmaceuticals?

✅ Answer (In-Depth)

Proper storage of Propranolol API ensures stability, potency, and safety during its shelf life.

Recommended Storage Conditions:

  1. Temperature: Store at 15–30 °C (room temperature); avoid excessive heat.

  2. Humidity Control: HCl salt is mildly hygroscopic, so moisture protection is essential. Use desiccants in containers.

  3. Light Protection: Keep in light-resistant containers to prevent photodegradation.

  4. Container Requirements: Tight, sealed containers (e.g., HDPE drums with LDPE liners) prevent moisture and contamination.

  5. Avoid Oxidizers: Store away from strong oxidizing agents to prevent degradation.

Summary: Proper storage ensures API integrity, stability, and quality compliance throughout the shelf life.

❓ Q15: What is the packaging for PROPRANOLOL API manufactured by Swapnroop Drugs & Pharmaceuticals?

✅ Answer (In-Depth)

Packaging is designed to protect the API from moisture, light, and contamination while ensuring safe handling.

Typical Packaging Details:

  1. Primary Packaging: HDPE drums with double LDPE liners

  2. Sealing: Tamper-evident caps, optionally nitrogen-purged to reduce oxidation

  3. Net Weight: Usually 5–25 kg per drum, depending on batch and client requirements

  4. Labeling: Includes batch number, manufacturing/expiry dates, storage instructions, and retest date

  5. Secondary Packaging: Corrugated boxes or pallets for transportation and warehousing

Summary: Packaging ensures protection, traceability, and compliance with GMP standards.

❓ Q16: What is the shelf life of PROPRANOLOL API manufactured by Swapnroop Drugs & Pharmaceuticals?

✅ Answer (In-Depth)

Shelf life is the period during which the API retains its potency, purity, and quality under recommended storage conditions.

Typical Shelf Life:

  1. API: 24–36 months from manufacturing or per retest period based on stability data

  2. Finished Products: Also typically 24–36 months, depending on:

    • Dosage form (IR, ER, solution, injection)

    • Strength and excipient compatibility

    • Packaging and storage conditions

  3. Stability Monitoring: Periodic stability studies under ICH long-term and accelerated conditions validate shelf life.

Summary: Proper storage and packaging ensure that Propranolol API remains safe, effective, and pharmacopeially compliant throughout its shelf life.


        

 https://wa.me/+919420294801



#πŸ’Š #PropranololAPI #SwapnroopPharma #CardioCare #BetaBlocker #Hypertension #AnginaRelief #HeartHealth #ArrhythmiaTreatment #MigrainePrevention #EssentialTremor #AnxietyRelief #Pharmaceuticals #DrugDevelopment #IRTablets #ERTablets #OralSolution #IVInjection #APIQuality #PharmaIndustry #ClinicalTherapy #DosageForm #PharmaResearch #MedicineProduction #HealthcareSolutions #PharmaManufacturing #ActivePharmaceuticalIngredient #DrugSafety #PatientCompliance #TherapeuticEffect #PharmaScience #QualityControl

Comments

Post a Comment

Popular posts from this blog

🌿 Probiotics IR Pellets – Fast-Acting Gut Health Solution by Swapnroop Drugs & Pharmaceuticals 🌿

Image
  🌿 Probiotics IR Pellets – Fast-Acting Gut Health Solution by Swapnroop Drugs & Pharmaceuticals 🌿 In today’s busy lifestyle, digestive issues, weak immunity, and imbalance in gut flora are becoming very common. To solve these challenges, Swapnroop Drugs & Pharmaceuticals brings you Probiotics IR Pellets — a scientifically designed, fast-acting probiotic delivery system that helps restore gut health naturally and quickly. πŸ”¬ What Are Probiotics IR Pellets? Probiotics IR (Immediate Release) Pellets are small, uniform granules containing beneficial “good bacteria” 🦠 designed to release immediately after swallowing. Unlike EC (Enteric-Coated) pellets, IR pellets dissolve fast , helping probiotics become active right away in the upper gastrointestinal tract. These pellets are formulated by Swapnroop Drugs & Pharmaceuticals using advanced pelletization technology for: ✨ High stability ✨ Faster release ✨ Better absorption ✨ Enhanced viability of probiotic st...
Read more

🌱 Probiotics EC Pellets – Stabilized Gut Health Powerhouses by Swapnroop Drugs & Pharmaceuticals

Image
  🌱 Probiotics EC Pellets – Stabilized Gut Health Powerhouses by Swapnroop Drugs & Pharmaceuticals In today’s health-conscious world, probiotics have become essential for supporting digestive wellness, immunity, and overall health. Traditional probiotic products often struggle with poor stability , acid degradation , and low survival rates during transit through the stomach. To overcome these challenges, Swapnroop Drugs & Pharmaceuticals offers advanced Probiotics EC Pellets , designed to deliver maximum probiotic viability and targeted intestinal release. This blog explains the benefits, technology, manufacturing, and applications of Probiotics EC Pellets manufactured by Swapnroop Drugs & Pharmaceuticals . 🧬 What Are Probiotics EC Pellets by Swapnroop Drugs & Pharmaceuticals? Probiotics EC Pellets are enteric-coated spherical granules containing beneficial live microorganisms such as: Lactobacillus species Bifidobacterium species Saccharomyce...
Read more

Azithromycin Taste-Masked Powder: A Pediatric-Friendly Innovation by Swapnroop Drugs & Pharmaceuticals

Image
  🌟 Azithromycin Taste-Masked Powder – A Palatable Innovation by Swapnroop Drugs & Pharmaceuticals 🌟 ✨πŸ’ŠπŸ˜·πŸ‘ΆπŸ§ͺ🌈 When it comes to oral antibiotics, taste plays a major role —especially for children and elderly patients. Many APIs, including Azithromycin , have an inherently bitter taste, often leading to poor patient compliance. To overcome this challenge, Swapnroop Drugs & Pharmaceuticals proudly presents Azithromycin Taste-Masked Powder , engineered for superior palatability, stability, and effectiveness . πŸŒŸπŸ’ŠπŸ§ 🍭 What is Azithromycin Taste-Masked Powder? Azithromycin Taste-Masked Powder is a specialized formulation where the bitter taste of Azithromycin is blocked using advanced taste-masking techniques . This ensures a pleasant taste profile , making it ideal for oral suspensions , especially pediatric formulations. πŸ‘Ά❤️πŸ’§ πŸ’‘ Why Taste Masking is Important? ✔️ Improves patient compliance 😊 ✔️ Reduces gag reflex 🀒❌ ✔️ Enhances overall medication expe...
Read more