How Albuterol Sulphate (CAS No. 51022-70-9) is Tested by Swapnroop Drugs & Pharmaceuticals for Purity, Safety, and Compliance 🔍✨

1. What is Albuterol Sulphate API Manufactured by Swapnroop Drugs & Pharmaceuticals?

💊 What is Albuterol Sulphate API?

Albuterol Sulphate, also known internationally as Salbutamol Sulphate, is an Active Pharmaceutical Ingredient (API) used primarily in respiratory therapies. 🌬️🫁

It is manufactured by Swapnroop Drugs & Pharmaceuticals, a trusted Indian pharmaceutical company known for its high-quality APIs and formulations. 🏭🇮🇳

🔬 Scientific Overview

Pharmacological Class: β2-adrenergic agonist 🚀
Chemical Name: (RS)-1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulphate 🧪
Molecular Formula: C₁₃H₂₁NO₃·H₂SO₄ 🧬
CAS No.: 51022-70-9 📘

🌟 How It Works

Albuterol Sulphate works by stimulating beta2 receptors in the smooth muscles of the lungs, causing bronchodilation—which means it relaxes the airways and helps you breathe easier. 🫁💨

Perfect for:

🚶‍♂️Quick relief of asthma attacks
🏃‍♀️Prevention of exercise-induced bronchospasm
🧓Management of COPD, chronic bronchitis, and emphysema

🧪 Why Choose Swapnroop's Albuterol Sulphate API?

🔹 High Purity & Stability
🔹 GMP-certified manufacturing 🏅
🔹 Globally exported 🌍
🔹 Custom packaging & regulatory support 📦📄

📦 Common Applications in Formulations

💨 Inhalers (MDIs, DPIs)
🧴 Nebulizer solutions
🍯 Syrups (especially for pediatric care)
💊 Tablets

🏭 About Swapnroop Drugs & Pharmaceuticals

Located in Aurangabad, Maharashtra, Swapnroop is a WHO-GMP & ISO-certified company with a strong global presence in the API market. 🌐💼

They offer a wide range of APIs with a focus on quality, compliance, and customer-centric service. 🤝

2. What is Albuterol Sulphate Manufactured by Swapnroop Drugs & Pharmaceuticals Used For?

1. Introduction to Albuterol Sulphate

Albuterol Sulphate (chemical name: salbutamol sulphate) is a short-acting β2-adrenergic receptor agonist (SABA). It is a bronchodilator that relaxes smooth muscles in the airways, making breathing easier for patients with obstructive lung diseases.

Swapnroop Drugs & Pharmaceuticals manufactures Albuterol Sulphate API (Active Pharmaceutical Ingredient) and formulations (tablets, inhalers, syrup) under WHO-GMP and Indian regulatory standards.

2. Medical Uses & Therapeutic Applications

A. Approved Indications (FDA/EMA/Indian Guidelines)

Bronchial Asthma
- Acute relief of asthma attacks (rescue medication).
- Prevention of exercise-induced bronchoconstriction (EIB).
- Maintenance therapy in mild-to-moderate cases (with corticosteroids).
Chronic Obstructive Pulmonary Disease (COPD)
- Used in emphysema and chronic bronchitis to reduce airway obstruction.
Bronchospasm
- Reversible airway constriction due to:
  - Allergies (e.g., pollen, dust).
  - Respiratory infections (viral/bacterial).
  - Chemical irritants (smoke, pollution).

B. Off-Label & Specialized Uses

Hyperkalemia (High Potassium) Management (stimulates potassium uptake into cells).
Preterm Labor (Tocolysis) (relaxes uterine muscles, though ritodrine is preferred).
Ventilator Support (nebulized albuterol helps reduce airway resistance in ICU).

3. Mechanism of Action (Pharmacodynamics)

Albuterol selectively activates β2-adrenergic receptors in the lungs, leading to:
✅ Bronchodilation (via relaxation of smooth muscles).
✅ Reduced mucus secretion (improves airflow).
✅ Increased ciliary motility (helps clear mucus).

Systemic Effects (at high doses):

Tachycardia (β1 stimulation in the heart).
Hypokalemia (potassium shifts into cells).
Tremors (skeletal muscle β2 activation).

4. Available Formulations by Swapnroop

Form	Dosage	Onset	Duration	Use Case
MDI Inhaler	100 mcg/puff	5–15 min	4–6 hrs	Acute relief
Tablets	2 mg, 4 mg	30 min	6–8 hrs	Maintenance
Syrup	2 mg/5 mL	20–30 min	6–8 hrs	Pediatric
Nebulizer Sol.	2.5 mg/2.5 mL (0.083%)	5–10 min	4–6 hrs	Severe cases

5. Dosage & Administration Guidelines

A. Adults & Children (≥12 years)

Inhaler: 1–2 puffs every 4–6 hours (max 8 puffs/day).
Tablets: 2–4 mg 3–4 times daily (max 32 mg/day).
Nebulizer: 2.5 mg every 6–8 hours.

B. Pediatrics (2–12 years)

Syrup: 0.1 mg/kg/dose (max 2 mg) 3–4 times/day.
Inhaler: 1 puff every 4–6 hours (under supervision).

⚠️ Overuse Risk: Can cause paradoxical bronchospasm or tolerance.

6. Side Effects & Safety Profile

Common (>10%)	Less Common (1–10%)	Rare (<1%)
Tremors 🤲	Headache 🤕	Chest pain ❗
Nervousness 😰	Throat irritation 🗣️	Arrhythmias 💓
Tachycardia 💓	Muscle cramps 💪	Hypokalemia 🍌

Contraindications:
❌ Hypersensitivity to β2-agonists.
❌ Tachyarrhythmias or severe heart disease.

7. Drug Interactions

β-Blockers (e.g., propranolol) → Reduces albuterol’s effect.
Diuretics (e.g., furosemide) → Increases hypokalemia risk.
MAOIs/Tricyclic Antidepressants → May worsen tachycardia.

8. Why Choose Swapnroop’s Albuterol Sulphate?

✔ Cost-effective generic alternative.
✔ Strict QC (HPLC-tested for purity).
✔ Excipient-free API for formulation flexibility.

Storage: Keep at 15–30°C, protect from moisture.

🔍 Q3: What Are the Physicochemical Properties of Albuterol Sulphate (Salbutamol Sulphate)?

Albuterol Sulphate is the sulfate salt form of Albuterol (Salbutamol), a selective β2-adrenergic receptor agonist. It’s primarily used in treating respiratory conditions, and its physicochemical profile ensures optimal performance across various dosage forms.

📐 I. Molecular & Structural Information

Parameter	Description
IUPAC Name	4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol sulfate (1:1)
Synonyms	Salbutamol Sulphate, Albuterol hemisulphate
Chemical Formula	C₁₃H₂₁NO₃ · H₂SO₄
Molecular Weight	576.71 g/mol
Structure Type	Racemic mixture (RS-enantiomer)
CAS Number	51022-70-9

🎨 II. Physical Appearance

White to off-white crystalline powder ✨
Odorless
Hygroscopic (absorbs moisture from the air) 💧

💧 III. Solubility Profile

Freely soluble in water (ideal for syrups, nebulizer solutions) 🌊
Slightly soluble in ethanol 🍶
Practically insoluble in chloroform and ether

👉 This solubility enhances its absorption and bioavailability in aqueous formulations like inhalers and nebulizers.

🌡️ IV. Thermal & pH Behavior

Property	Description
Melting Point	235°C to 240°C (with decomposition) 🔥
pKa (Ionization Constant)	~9.3 (basic) – suitable for pulmonary absorption 🫁
pH (1% Solution)	Approx. 3.5–5.0
Stability	Stable under normal storage; degraded by light and moisture 💡💦
Storage Conditions	Store below 25°C in tightly closed containers; protect from light and humidity 🧊🌫️

🔬 V. Optical & Stereochemical Properties

Chirality: Racemic mixture (RS-form), but therapeutically active isomer is R-albuterol
Optical Activity: Inactive as racemate unless resolved into enantiomers
Crystalline Form: Commonly manufactured in micronized form for inhalation dosage forms 🌀

🏭 VI. Manufactured by Swapnroop Drugs & Pharmaceuticals

✅ WHO-GMP Certified
✅ ISO-compliant Quality Management System
✅ Batch-to-batch consistency with validated manufacturing processes
✅ Customizable particle size (for DPI/MDI formulations)
✅ Supported by full documentation:

Certificate of Analysis (CoA) 📋
Material Safety Data Sheet (MSDS) ⚠️
DMF (Drug Master File) submission-ready 📂

🧪 Application Versatility

🟢 Inhalation (MDI/DPI/Nebulized solutions)
🟢 Oral Tablets & Syrups
🟢 Injectable solutions (rare)

Due to its rapid bronchodilating action and water solubility, it is extensively used in emergency and chronic respiratory care settings worldwide 🌍

Synthesis of Albuterol Sulphate (Salbutamol Sulphate) by Swapnroop Drugs & Pharmaceuticals

The synthesis of Albuterol Sulphate (chemical name: *4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol sulphate*) involves multi-step organic reactions to produce the active pharmaceutical ingredient (API) in compliance with GMP, USP, and EP standards. Below is a detailed breakdown of the synthesis process:

1. Starting Materials & Key Intermediates

1-(4-Hydroxy-3-hydroxymethylphenyl)ethanone (Acetyl derivative of salicyl alcohol)
tert-Butylamine (For amine side chain introduction)
Sodium borohydride (NaBH₄) or Catalytic hydrogenation (For reduction)
Sulphuric acid (H₂SO₄) (For salt formation)

2. Step-by-Step Synthesis Process

Step 1: Bromination

The starting material (1-(4-hydroxy-3-hydroxymethylphenyl)ethanone) undergoes bromination at the α-carbon (adjacent to the carbonyl group) using bromine (Br₂) or N-bromosuccinimide (NBS).
Product: 2-Bromo-1-(4-hydroxy-3-hydroxymethylphenyl)ethanone

Step 2: Amine Substitution (Nucleophilic Displacement)

The brominated intermediate reacts with tert-butylamine in an SN₂ reaction, replacing the bromine with the amine group.
Product: 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanone

Step 3: Ketone Reduction

The ketone group is reduced to a secondary alcohol using:
- Sodium borohydride (NaBH₄) (milder, selective for ketones) OR
- Catalytic hydrogenation (Pd/C or PtO₂) (higher yield but requires pressure).
Product: Albuterol free base (Salbutamol)

Step 4: Salt Formation (Sulphate Salt)

The free base is treated with sulphuric acid (H₂SO₄) in a controlled environment to form the stable albuterol sulphate salt.
Final Product: Albuterol Sulphate (C₁₃H₂₁NO₃·H₂SO₄)

3. Purification & Quality Control

Crystallization: The crude product is purified via recrystallization (using ethanol/water).
Drying: Under vacuum drying to remove residual solvents.
Analytical Testing:
- HPLC (Purity >99%)
- IR/NMR (Structural confirmation)
- Residual solvent analysis (GC)
- Heavy metals, sulphated ash (As per pharmacopeia)

4. Key Chemical Reactions Summary

Step	Reaction Type	Reagents	Intermediate/Product
1	Bromination	Br₂ or NBS	2-Bromo-1-(4-hydroxy-3-hydroxymethylphenyl)ethanone
2	Nucleophilic substitution	tert-Butylamine	1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanone
3	Reduction	NaBH₄ or H₂/Pd	Albuterol free base
4	Salt formation	H₂SO₄	Albuterol Sulphate (API)

5. Swapnroop’s Manufacturing Standards

✔ GMP-Compliant (WHO/India DCGI approved)
✔ Solvent recovery systems (Environmentally sustainable)
✔ Strict impurity profiling (Limit: ≤0.1% for any single impurity)

6. Final API Specifications

Appearance: White to off-white crystalline powder
Melting Point: ~170–175°C
Solubility: Freely soluble in water, slightly soluble in ethanol
pH (1% solution): 3.5–5.5

7. Applications of Synthesized API

Dry Powder Inhalers (DPI)
Metered-Dose Inhalers (MDI)
Tablets & Syrups
Nebulizer Solutions

8. Environmental & Safety Considerations

Waste treatment: Neutralization of acidic/byproduct streams.
Worker protection: Use of closed systems to limit exposure to bromine/amines.

5. Different Dosage Forms of Albuterol Sulphate by Swapnroop Drugs & Pharmaceuticals

Swapnroop manufactures Albuterol Sulphate (Salbutamol Sulphate) in multiple dosage forms to cater to diverse clinical needs. Below is a detailed breakdown of each formulation:

1. Inhalation Aerosols (MDI - Metered Dose Inhalers)

Form: Pressurized canister with dose counter
Strength: 100 mcg/puff (120 doses per unit)
Key Features:
- Rapid onset (5–15 mins) for acute asthma attacks
- Portable and easy to use
- Contains propellants (HFA-134a)
Brand Example: Salbu-Swap MDI (hypothetical name)

2. Dry Powder Inhalers (DPI)

Form: Breath-activated powder capsules/blisters
Strength: 200 mcg/inhalation
Key Features:
- No propellants (suitable for eco-conscious users)
- Requires strong inhalation effort
- Used for maintenance therapy

3. Nebulizer Solution

Form: Sterile liquid in single-dose vials
Strength: 2.5 mg/2.5 mL (0.083%)
Key Features:
- Hospital/emergency use for severe attacks
- Compatible with jet/ultrasonic nebulizers
- No preservatives (benzalkonium chloride-free)

4. Oral Tablets

Form: Immediate-release tablets
Strengths: 2 mg, 4 mg
Key Features:
- Used for chronic asthma/COPD management
- Slower onset (30–60 mins) but longer duration
- Often combined with theophylline in fixed-dose combos

5. Syrup (Pediatric Use)

Form: Sugar-free liquid (alcohol-free)
Strength: 2 mg/5 mL
Key Features:
- Ideal for children <6 years
- Flavored (strawberry/vanilla) for compliance
- Dosing via oral syringe

6. Injectable Solution (Rare, Hospital-Only)

Form: Ampoules for IV/IM use
Strength: 0.5 mg/mL
Key Features:
- Reserved for critical care (status asthmaticus)
- Requires cardiac monitoring (risk of tachycardia)

Comparison Table: Dosage Forms & Uses

Form	Onset	Duration	Primary Use Case	Patient Group
MDI Inhaler	5–15 min	4–6 hrs	Acute bronchospasm relief	Adults/Children
DPI	5–10 min	6–8 hrs	Maintenance therapy	Adults
Nebulizer	5–10 min	4–6 hrs	Severe attacks/hospital use	All ages
Tablets	30–60 min	6–8 hrs	Chronic asthma/COPD	Adults
Syrup	20–30 min	6–8 hrs	Pediatric asthma	Children <12 yrs
Injectable	2–5 min	2–4 hrs	Life-threatening emergencies	ICU patients

Regulatory Status

MDI/DPI: Approved by CDSCO (India) & compliant with USP/EP standards
Syrup/Tablets: Listed in Indian National List of Essential Medicines (NLEM)

Storage Conditions

Inhalers: Store below 30°C; avoid freezing
Syrup: Room temperature; discard after 1 month of opening
Nebulizer Solution: Refrigerate (2–8°C) if unused

6. Preparation of Albuterol Sulphate API & Dosage Forms by Swapnroop Drugs & Pharmaceuticals

Albuterol Sulphate (Salbutamol Sulphate) is formulated into multiple dosage forms for asthma/COPD treatment. Below is a detailed, technical breakdown of how Swapnroop manufactures the API and converts it into finished dosage forms under GMP compliance.

A. Albuterol Sulphate API Manufacturing

1. Synthesis Process

The API is synthesized via bromination, amine substitution, reduction, and salt formation (as detailed in Q4). Key steps include:

Bromination of 1-(4-hydroxy-3-hydroxymethylphenyl)ethanone.
Amine substitution with tert-butylamine.
Reduction of the ketone to alcohol (NaBH₄/H₂).
Salt formation with sulphuric acid.

2. API Purification & QC

Crystallization: Ethanol/water mixture for >99.5% purity.
Drying: Vacuum tray drying at 40–50°C.
Testing:
- HPLC (Related substances <0.1%).
- Residual solvents (Methanol <3000 ppm, Ethanol <5000 ppm).
- Heavy metals (<10 ppm as per USP).

B. Dosage Form Preparation

1. Metered-Dose Inhaler (MDI)

Formulation (100 mcg/puff)

Component	Function	Quantity per Canister
Albuterol Sulphate API	Active ingredient	12.5 mg (equivalent to 10 mg base)
HFA-134a (Propellant)	Aerosol propellant	10–15 g
Oleic Acid	Stabilizer/Surfactant	0.1% w/w
Ethanol (Anhydrous)	Co-solvent	2–3% w/w

Manufacturing Steps

Dissolution: API dissolved in ethanol + oleic acid.
Filling: Propellant added under cold conditions (-30°C to prevent evaporation).
Crimping: Canister sealed with metering valve.
Testing:
- Spray pattern (Laser diffraction).
- Dose uniformity (USP <601>).
- Leak test (Weight loss method).

2. Dry Powder Inhaler (DPI – 200 mcg/dose)

Formulation

Component	Function
Albuterol Sulphate API	Active ingredient
Lactose Monohydrate	Carrier (micronized)
Magnesium Stearate	Lubricant (optional)

Process

Micronization: API & lactose milled to 2–5 µm particle size.
Blending: Mixed in a tumble blender for homogeneity.
Filling: Powder filled into blisters/capsules.
Testing:
- Fine Particle Fraction (FPF) (>30% of dose in <5 µm range).
- Moisture content (<5% by Karl Fischer).

3. Nebulizer Solution (2.5 mg/2.5 mL)

Formulation

Component	Function
Albuterol Sulphate API	Active ingredient
Sodium Chloride	Tonicity adjuster
Sulfuric Acid	pH adjuster (pH 3.5–5.5)
Water for Injection	Solvent

Process

Dissolution: API dissolved in WFI + NaCl.
Sterile Filtration: 0.22 µm membrane filter.
Filling: Into sterile single-dose vials.
Sterilization: Autoclave (121°C, 15 min).

4. Oral Tablets (2 mg, 4 mg)

Formulation

Component	Function
Albuterol Sulphate API	Active ingredient
Microcrystalline Cellulose	Binder/Filler
Croscarmellose Sodium	Disintegrant
Magnesium Stearate	Lubricant

Process

Dry Mixing: API + excipients blended.
Wet Granulation: PVP K30 binder solution added.
Compression: Tablets pressed (hardness 50–100 N).
Coating: Hypromellose film coat (optional).

5. Syrup (2 mg/5 mL)

Formulation

Component	Function
Albuterol Sulphate API	Active ingredient
Sucrose/Sorbitol	Sweetener
Methyl Paraben	Preservative
Citric Acid	pH adjuster

Process

Dissolution: API dissolved in heated purified water.
Mixing: Excipients added sequentially.
Filtration: 5 µm filter to remove particulates.
Packaging: Amber PET bottles (60 mL, 100 mL).

C. Quality Control & Stability

Inhalers:
- Leak rate (<1% loss/year).
- Delivered dose uniformity (90–110% of label claim).
Tablets/Syrup:
- Dissolution (>80% in 30 min for tablets).
- Shelf-life: 24 months (tablets), 12 months (syrup after opening).

D. Regulatory Compliance

MDI/DPI: Complies with USP <601> and EMA Guideline on Inhalation Products.
Tablets/Syrup: Listed in Indian Pharmacopoeia (IP).

7. Appropriate Dosage Form of Albuterol Sulphate by Swapnroop Drugs & Pharmaceuticals

The optimal dosage form of Albuterol Sulphate depends on the patient’s age, condition severity, and clinical setting. Below is a detailed guide to selecting the right formulation:

1. For Acute Asthma/COPD Attacks (Quick Relief)

✅ Recommended Form:

Metered-Dose Inhaler (MDI) – 100 mcg/puff
- Why? Fastest onset (5–15 mins), portable, and easy to use.
- Dosage:
  - Adults/Children ≥4 yrs: 1–2 puffs every 4–6 hours.
  - Max: 8 puffs/day (unless under medical supervision).

Alternative for Severe Attacks:

Nebulizer Solution (2.5 mg/2.5 mL)
- Why? Better for infants/elderly or patients unable to coordinate MDI use.
- Dosage:
  - Adults/Children ≥12 yrs: 2.5 mg every 6–8 hours.
  - Children 2–12 yrs: 0.1–0.15 mg/kg/dose (max 2.5 mg).

2. For Chronic Asthma/COPD Maintenance

✅ Recommended Form:

Tablets (2 mg, 4 mg)
- Why? Longer systemic action for baseline control.
- Dosage:
  - Adults: 2–4 mg 3–4 times/day (max 32 mg/day).
  - Children 6–12 yrs: 2 mg 3–4 times/day.

Alternative for Pediatric Patients:

Syrup (2 mg/5 mL)
- Why? Easier to swallow for young children.
- Dosage:
  - Children 2–6 yrs: 0.1 mg/kg/dose (max 2 mg) 3–4 times/day.

3. For Exercise-Induced Bronchospasm (Prevention)

✅ Recommended Form:

Dry Powder Inhaler (DPI) – 200 mcg/inhalation
- Why? Breath-activated, no propellants, and pre-exercise use.
- Dosage:
  - Adults/Children ≥4 yrs: 1 inhalation 15–30 mins before exercise.

4. Special Populations

Patient Group	Preferred Form	Notes
Infants (<2 yrs)	Nebulizer solution	MDI/DPI not feasible; use with mask/spacer.
Elderly	MDI + Spacer	Improves coordination; reduces oral thrush risk.
Pregnant Women	MDI (lowest effective dose)	Category C; use only if benefits outweigh risks.

5. Contraindications & Warnings

Avoid tablets/syrup in patients with:
- Tachyarrhythmias (risk of palpitations).
- Uncontrolled hypertension.
MDI/DPI caution:
- Risk of paradoxical bronchospasm (if occurs, switch to nebulizer).

6. Swapnroop’s Product Range Summary

Form	Strengths	Best For
MDI Inhaler	100 mcg/puff	Acute attacks, portable relief
DPI	200 mcg/dose	Exercise-induced prevention
Nebulizer Sol.	2.5 mg/2.5 mL	Severe attacks, hospital/ICU use
Tablets	2 mg, 4 mg	Chronic maintenance therapy
Syrup	2 mg/5 mL	Pediatric patients (2–6 yrs)

8. When Should Afatinib Dimaleate (Manufactured by Swapnroop Drugs & Pharmaceuticals) Be Taken?

Afatinib Dimaleate is a tyrosine kinase inhibitor (TKI) used to treat EGFR mutation-positive non-small cell lung cancer (NSCLC). Proper dosing timing is crucial for efficacy and tolerability. Below are the key guidelines for administration:

1. Standard Dosage & Timing

✅ Recommended Schedule:

Dosage: 40 mg once daily (for most patients).
When to Take: On an empty stomach, at least 1 hour before or 2 hours after meals.
- Why? Food (especially high-fat meals) can increase absorption by up to 50%, raising toxicity risks.

Dose Adjustments:

30 mg/day: If intolerable side effects occur (e.g., severe diarrhea, rash).
20 mg/day: For patients with severe hepatic/renal impairment.

2. Best Time of Day

Morning Dose (Preferred):
- Easier to manage empty stomach requirements.
- Allows better monitoring of side effects (e.g., diarrhea) during the day.
Evening Dose (Alternative):
- May help if nausea is an issue (take with antiemetics if prescribed).

3. Administration Instructions

Swallow whole with a glass of water (do not crush/chew).
Avoid antacids (e.g., PPIs, H2 blockers) within 6 hours of taking afatinib (reduces absorption).
Missed Dose?
- If >12 hours remain until the next dose, take it immediately.
- If <12 hours remain, skip the dose (never double-dose).

4. Special Populations

Patient Group	Timing Considerations
Elderly (≥65 yrs)	No adjustment needed unless side effects occur (monitor closely).
Hepatic Impairment	Reduce to 20–30 mg/day if severe (Child-Pugh B/C).
Renal Impairment	Caution if eGFR <30 mL/min (dose reduction may be needed).

5. Drug Interactions Affecting Timing

Proton Pump Inhibitors (PPIs): Avoid concurrent use (reduces afatinib absorption).
CYP3A4 Inducers (e.g., rifampin): May require dose increase (consult oncologist).
CYP3A4 Inhibitors (e.g., ketoconazole): Monitor for increased toxicity.

6. Managing Side Effects with Timing

Diarrhea:
- Start loperamide at first sign; take afatinib earlier in the day to monitor.
Rash/Acne:
- Use doxycycline or topical steroids (timing independent of dose).
Nausea:
- If persistent, discuss evening dosing with your doctor.

7. Swapnroop’s Afatinib Dimaleate Formulations

Tablets: 20 mg, 30 mg, 40 mg (film-coated).
Storage: Below 25°C in original blister pack (protect from moisture).

🌬️ Albuterol Sulphate – Breathe Easy with Relief! 💨

(Manufactured by Swapnroop Drugs & Pharmaceuticals)

✅ Therapeutic Effects

🔓 Opens Up Airways
Relaxes the muscles around your airways for easier breathing – great for asthma & COPD!

⚡ Fast-Acting Relief
Starts working in 15 minutes ⏱️ – perfect for sudden wheezing or tightness.

🏃‍♂️ Prevents Exercise-Induced Bronchospasm
Use before workouts to keep those lungs open! 💪

💙 Respiratory Comfort
Reduces coughing, wheezing, and shortness of breath 😮‍💨

⚠️ Common Side Effects

🤯 Headache
🫨 Tremors / Shakiness (especially in hands)
💓 Fast or Irregular Heartbeat (Palpitations)
😰 Nervousness / Anxiety
🛏️ Insomnia – trouble sleeping
😶‍🌫️ Dizziness / Lightheadedness
👅 Dry Mouth / Throat Irritation

❗ Serious Side Effects (Rare but Important!)

🚑 Chest Pain or Tightness
😵‍💫 Seizures
⚡ Muscle Cramps – can signal low potassium
📉 Low Potassium Levels (watch for weakness, irregular heart rhythm)
😷 Worsening Breathing or Wheezing
🚨 Severe Allergic Reactions – rash, swelling, difficulty breathing

💊 Overdose Symptoms (Get Help Immediately!)

🌀 Rapid heartbeat
⚡ Shaking or seizures
😖 Nausea
🛌 Extreme tiredness
🚫 Difficulty sleeping
💦 Unusual thirst or dry mouth

🧪 Formulated by Swapnroop Drugs & Pharmaceuticals

A trusted name in high-quality API manufacturing. Consistency ✅ | Purity ✅ | Compliance ✅

1. API (Active Pharmaceutical Ingredient) Testing

A. Identity Tests

FTIR (Fourier Transform Infrared Spectroscopy)
- Confirms molecular structure by matching peaks to reference standards.
HPLC (High-Performance Liquid Chromatography)
- Retention time comparison with USP/EP reference standard.

B. Purity & Impurity Profile

Related Substances (HPLC)
- Limits: Individual impurity ≤0.1%, Total impurities ≤0.5%.
Residual Solvents (GC)
- Methanol (<3000 ppm), Ethanol (<5000 ppm) per ICH Q3C.
Heavy Metals (ICP-MS)
- Lead, cadmium, arsenic (<10 ppm as per USP <231>).

C. Physicochemical Properties

Assay (HPLC)
- Must be 98.0–102.0% of labeled potency.
Loss on Drying (LOD)
- Max 0.5% moisture (105°C, constant weight).
Sulphated Ash
- Max 0.1% (indicates inorganic residues).

D. Microbial Testing

Total Aerobic Count (TAMC) & Yeast/Mold (TYMC)
- Must comply with USP <61> (≤1000 CFU/g).
Absence of E. coli, Salmonella, S. aureus (USP <62>).

2. Finished Dosage Form Testing

A. Inhalers (MDI/DPI)

Test	Method	Acceptance Criteria
Dose Uniformity	USP <601>	90–110% of label claim (per puff)
Fine Particle Fraction	Cascade Impactor	≥30% of dose in particles <5 µm
Spray Pattern	Laser Diffraction	Symmetrical, consistent plume
Leak Rate	Weight Loss (25°C/60% RH)	≤1% loss/year

B. Tablets

Dissolution (USP <711>)
- ≥80% release in 30 min (pH 6.8 buffer).
Hardness & Friability
- Hardness: 50–100 N, Friability: ≤1% weight loss.
Content Uniformity (USP <905>)
- Each tablet must be 85–115% of label claim.

C. Syrup

pH (3.5–5.5)
Preservative Efficacy (USP <51>)
- Must inhibit microbial growth for 28 days.
Sucrose Concentration (Refractometry)

3. Stability Testing (ICH Q1A Guidelines)

Real-Time (Long-Term)
- 25°C/60% RH for 24 months (tablets/syrup).
Accelerated
- 40°C/75% RH for 6 months (predicts shelf-life).
In-Use Stability
- Nebulizer solution: 24 hrs post-opening.

4. Bioequivalence & Performance Tests

In Vitro Lung Deposition (Andersen Cascade Impactor)
Comparative Dissolution (vs. reference listed drug)

5. Regulatory Compliance

USP/EP/IP monographs for Albuterol Sulphate.
WHO-GMP certified manufacturing facility.

1. API (Active Pharmaceutical Ingredient) Testing

A. Identity Confirmation

FTIR Spectroscopy: Matches functional groups to reference spectrum
HPLC Retention Time: Comparison with USP reference standard
UV-Vis Spectroscopy: λmax at 276 nm (in methanol)

B. Purity & Potency

Test	Method	Specification
Assay (HPLC)	USP <621>	98.0-102.0%
Related Substances	HPLC	≤0.1% any single impurity
Residual Solvents	GC	Class 2 solvents <3000 ppm
Sulfated Ash	Gravimetric	≤0.1% w/w
Optical Rotation	Polarimetry	-0.10° to +0.10°

C. Physicochemical Properties

Appearance: White to off-white crystalline powder
Melting Range: 170-175°C (DSC method)
pH (1% solution): 3.5-5.5
Water Content (KF): ≤0.5% w/w

D. Microbial Testing

TAMC: ≤1000 CFU/g
TYMC: ≤100 CFU/g
Pathogens: Absence of E. coli, Salmonella

2. Finished Product Testing

A. Metered Dose Inhalers (MDI)

Test Parameter	Method	Acceptance Criteria
Delivered Dose Uniformity	USP <601>	75-125% of label claim
Number of Doses	Dose Counter	≥120 doses/canister
Leak Rate	Weight Loss	≤1% per year
Particle Size Distribution	Cascade Impactor	MMAD 1-5 μm

B. Dry Powder Inhalers (DPI)

Fine Particle Fraction: ≥30% of emitted dose <5μm
Flow Rate Dependency: 30-90 L/min variation ≤15%
Moisture Content: ≤5% w/w (Karl Fischer)

C. Tablets

Dissolution: ≥80% in 30 min (pH 6.8 buffer)
Content Uniformity: 85-115% per unit
Friability: ≤1% weight loss
Disintegration: ≤15 minutes

D. Oral Syrup

pH: 3.0-4.5
Preservative Efficacy: Meets USP <51> criteria
Viscosity: 500-1500 cPs (Brookfield viscometer)

3. Stability Testing (ICH Guidelines)

Real-Time: 25°C/60% RH for 24 months
Accelerated: 40°C/75% RH for 6 months
Photostability: Confirms light sensitivity

4. Packaging Validation

Container Closure Integrity (Leak test for MDIs)
Extractables/Leachables (for plastic components)
Child-Resistant Cap Testing (for syrup bottles)

5. Batch Release Documentation

Certificate of Analysis (CoA) with 3-level review
Impurity Profile Report (ICH Q3B compliant)
Microbial Test Records (including bioburden

ey Challenges in Manufacturing Albuterol Sulphate API by Swapnroop Drugs & Pharmaceuticals

Manufacturing high-quality Albuterol Sulphate API presents several technical and regulatory hurdles. Here are the major challenges Swapnroop faces and how they address them:

1. Synthesis Complexity & Impurity Control

Challenge:
The multi-step synthesis (bromination → amination → reduction → salt formation) generates process-related impurities:
- Bromo-albuterol intermediates (genotoxic potential)
- Oxidative degradants (sulfoxide derivatives)
- Diastereomer formation (requires strict chiral purity control)
Solution:
- Uses HPLC-UV/MS for impurity profiling (<0.1% each)
- Implements QbD (Quality by Design) to optimize reaction conditions
- Conducts genotoxicity assessment per ICH M7

2. Particle Size Distribution (Critical for Inhalation Products)

Challenge:
- Requires 1-5 μm aerodynamic diameter for lung deposition
- Micronization can cause electrostatic charging and aggregation
Solution:
- Jet milling with nitrogen atmosphere
- Blending with lactose carriers (for DPI formulations)
- Laser diffraction analysis for every batch

3. Stability Issues

Challenge:
- Degrades via oxidation (sulfoxide formation)
- Hygroscopic nature affects flow properties
Solution:
- Uses nitrogen blanketing during processing
- Packages in double polyethylene bags with desiccants
- Maintains cold chain (15-25°C) for storage

4. Regulatory Compliance

Challenge:
- Must meet divergent standards: USP vs. EP vs. IP
- Evolving ICH guidelines on residual solvents
Solution:
- Method bridging studies for different pharmacopoeias
- GC-HS testing for Class 1-3 solvents
- 21 CFR Part 11 compliant data systems

5. Scale-Up Difficulties

Challenge:
- Exothermic reactions during amine substitution step
- Batch-to-batch variability in crystallization
Solution:
- Uses jacketed reactors with temperature control
- Implements PAT (Process Analytical Technology)
- Follows ISO 14644 for cleanroom operations

6. Environmental & Safety Concerns

Challenge:
- Bromine handling hazards
- Organic solvent waste (methanol, DMF)
Solution:
- Closed-loop systems for bromination
- Solvent recovery plants (90%+ efficiency)
- PPE protocols for API handlers

Mitigation Strategies Employed by Swapnroop

Challenge	Control Measure	Monitoring Tool
Impurities	QbD optimization	HPLC-PDA/MS
Particle size	Jet milling	Malvern Mastersizer
Stability	Nitrogen purge	O2 headspace analyzer
Compliance	Gap analysis	ERP software
Scale-up	DOE studies	Reactor sensors

Conclusion

Despite these challenges, Swapnroop maintains >99.5% pure Albuterol Sulphate API through:
✔ Advanced process controls
✔ Strict QC testing (57 in-process checks)
✔ Continuous process validation

Storage Conditions for Albuterol Sulphate by Swapnroop Drugs & Pharmaceuticals

Swapnroop Drugs & Pharmaceuticals specifies strict storage conditions for Albuterol Sulphate API and finished dosage forms to ensure stability, efficacy, and safety throughout the shelf life. Below are the detailed requirements:

1. Albuterol Sulphate API (Bulk Powder)

Parameter	Storage Condition	Remarks
Temperature	15°C – 25°C (Controlled room temp)	Avoid freezing
Humidity	≤60% RH	Hygroscopic – must be sealed
Light	Protect from light	Amber/opaque containers
Packaging	Double polyethylene bags inside HDPE drums	With desiccant
Shelf Life	36 months (from manufacturing)	Retest after 24 months

Special Notes:

Do not refrigerate (can cause condensation and degradation).
Nitrogen purging is used during packaging to prevent oxidation.

2. Finished Dosage Forms

A. Metered-Dose Inhalers (MDIs)

Parameter	Storage Condition	Remarks
Temperature	Below 30°C (Avoid extreme heat/cold)	Do not freeze
Humidity	Not critical (sealed canister)	–
Light	Protect from direct sunlight	Store in carton
Post-Activation	Use within 3 months (if not sealed)	Check dose counter

B. Dry Powder Inhalers (DPIs)

Parameter	Storage Condition	Remarks
Temperature	15°C – 25°C	Avoid humidity
Humidity	≤40% RH (Very sensitive)	Keep in foil pouch until use
Light	Protect from light	–
Post-Opening	Use within 6 weeks (check expiry)	–

C. Tablets

Parameter	Storage Condition	Remarks
Temperature	Below 25°C (Controlled room temp)	–
Humidity	≤65% RH	Blister packs preferred
Light	Protect from light	–
Shelf Life	24 months	–

D. Syrup (Oral Solution)

Parameter	Storage Condition	Remarks
Temperature	Below 25°C	Avoid freezing
Humidity	Not critical (sealed bottle)	–
Light	Amber glass/plastic bottle	–
After Opening	Use within 1 month (refrigeration not required but acceptable)	Discard if cloudy

3. Stability Data & Compliance

ICH Guidelines Followed: Q1A (R2) for stability testing.
Real-Time Stability: 25°C/60% RH for 24 months (tablets/syrup).
Accelerated Testing: 40°C/75% RH for 6 months (predicts shelf life).

4. Key Recommendations for Pharmacies/Hospitals

✔ Store MDIs/DPIs away from radiators or cold windows.
✔ Do not puncture or incinerate inhaler canisters.
✔ Keep tablets in original blister packs until use.
✔ Inspect syrup for precipitation before use.

Storage Guidelines for ALBUTEROL SULPHATE

🌡️ 1. Temperature Requirements

Recommended Storage Temperature:
➤ Below 25°C (77°F)
➤ Ideally, between 15°C and 25°C (room temperature range)
- Avoid storing near heat sources or in direct sunlight 🔥☀️
- Sudden temperature fluctuations can degrade the active ingredient

🌬️ 2. Humidity Control

Keep in a dry place: Relative humidity should ideally be below 60%
Albuterol Sulphate is hygroscopic, meaning it can absorb moisture from the air 💧
Use desiccants in packaging if necessary and avoid opening the container frequently

🪟 3. Protection from Light

Albuterol Sulphate may degrade upon exposure to UV or direct light
Store in amber-colored or opaque containers
Keep the material in its original packaging until use 🧴

🔒 4. Container Type

Use airtight, tamper-proof HDPE or amber glass containers
Should comply with USP <671> or similar pharmacopeial container standards
Proper closure prevents contamination and preserves stability

🧾 5. Labeling & Identification

Ensure the container is clearly labeled with:
- Product name
- Batch number
- Manufacturing & expiry dates
- Storage instructions
Follow GDP (Good Distribution Practices) throughout the supply chain

🧊 6. Avoid Freezing

DO NOT FREEZE ❄️
Freezing can cause condensation inside the container upon thawing, affecting purity and efficacy

⏳ 7. Shelf Life & Stability

Under proper storage, shelf life is typically 3 to 5 years
Stability studies as per ICH guidelines (Q1A-R2) confirm:
- No significant degradation under recommended storage
- Long-term, accelerated, and stress tests validate expiry

🚛 8. During Transportation

Must be shipped under controlled room temperature (CRT) conditions
Use insulated or refrigerated vans if climate control is needed
Monitor temperature logs during transport for regulatory compliance

📘 Regulatory & Documentation

Follow these standards:
- ICH Q1A(R2) for stability testing
- WHO TRS 953, Annex 2 for storage practices
- USP/BP/Ph. Eur. monographs for labeling and storage specifics
Always retain:
- Certificate of Analysis (CoA)
- MSDS (Material Safety Data Sheet)
- Stability study reports