Alatinib API (CAS No. 388082-78-8) – Label Claim Guidelines by Swapnroop Drugs & Pharmaceuticals

 

Alatinib API: Manufactured by Swapnroop Drugs & Pharmaceuticals 💊🔬

If you're searching for high-quality Alatinib API (Active Pharmaceutical Ingredient), you might have come across Swapnroop Drugs & Pharmaceuticals as a manufacturer. But what exactly is Alatinib, and what makes Swapnroop a reliable supplier? Let’s dive deep into this topic!

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🔍 What is Alatinib API?

Alatinib (also known as Alatinib Mesylate) is a targeted anticancer drug belonging to the class of tyrosine kinase inhibitors (TKIs). It is primarily used in the treatment of non-small cell lung cancer (NSCLC) and other cancers with EGFR (Epidermal Growth Factor Receptor) mutations.

Key Features of Alatinib API:

✔ Mechanism of Action: Blocks EGFR & HER2 pathways to inhibit cancer cell growth.
✔ Therapeutic Use: Effective against EGFR-mutated NSCLC.
✔ Form: White to off-white powder (API form).
✔ Solubility: Slightly soluble in water, soluble in organic solvents.

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🏭 Swapnroop Drugs & Pharmaceuticals: Manufacturer of Alatinib API

Swapnroop Drugs & Pharmaceuticals is an Indian pharmaceutical company specializing in the manufacturing of high-quality APIs, including oncology drugs like Alatinib.

Why Choose Swapnroop for Alatinib API?

✅ GMP-Compliant Manufacturing: Follows Good Manufacturing Practices (GMP) for consistent quality.
✅ Regulatory Approvals: Complies with WHO, USFDA, EMA standards (varies based on product).
✅ Research-Driven: Focuses on innovative & cost-effective API production.
✅ Global Supply Chain: Exports to multiple countries, ensuring reliable delivery.

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📜 Quality & Certifications

Swapnroop ensures that Alatinib API meets pharmacopoeial standards (USP/EP/BP). Key certifications may include:
✔ ISO Certified
✔ WHO-GMP Approved
✔ Regulatory Filings (for specific markets)

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💡 Applications of Alatinib API

Alatinib API is used by pharmaceutical companies to formulate:
🔹 Tablets/Capsules (for oral administration)
🔹 Combination therapies (with other anticancer drugs)
🔹 Clinical trial formulations

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🌍 Market Availability & Supply

Swapnroop Drugs & Pharmaceuticals supplies Alatinib API to:
✔ Generic drug manufacturers
✔ Research institutions
✔ Pharma exporters

Alatinib API by Swapnroop Drugs & Pharmaceuticals: Uses & Applications 💊🔬

Alatinib API (Active Pharmaceutical Ingredient) manufactured by Swapnroop Drugs & Pharmaceuticals is a targeted cancer therapy used primarily in the treatment of EGFR-mutated cancers, especially non-small cell lung cancer (NSCLC). Below is a detailed breakdown of its uses, mechanism, and significance in modern oncology.

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🎯 Primary Uses of Alatinib API

1️⃣ Treatment of Non-Small Cell Lung Cancer (NSCLC) 🫁

Alatinib is a tyrosine kinase inhibitor (TKI) that specifically targets EGFR (Epidermal Growth Factor Receptor) mutations, which are common in NSCLC. It is used in:
✔ First-line treatment for EGFR-positive advanced NSCLC
✔ Second-line therapy when other EGFR inhibitors fail
✔ Metastatic NSCLC cases with specific mutations (e.g., Exon 19 deletions, L858R)

2️⃣ Other EGFR/HER2-Positive Cancers 🎗️

While NSCLC is its primary use, Alatinib may also be effective against:
✔ Breast cancer (HER2-positive)
✔ Pancreatic cancer (in clinical trials)
✔ Colorectal cancer (with EGFR amplification)

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⚙️ How Does Alatinib Work? (Mechanism of Action)

Alatinib blocks EGFR (Epidermal Growth Factor Receptor) and HER2 (Human Epidermal Growth Factor Receptor 2), which are proteins that promote cancer cell growth.

🔹 Inhibits uncontrolled cell division → Stops tumor growth
🔹 Induces apoptosis (programmed cell death) in cancer cells
🔹 Reduces metastasis (spread of cancer)

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💊 How is Alatinib API Used in Drug Formulations?

Swapnroop’s Alatinib API is supplied to pharmaceutical companies for manufacturing:
✔ Oral tablets/capsules (most common form)
✔ Combination therapies (with chemotherapy/immunotherapy)
✔ Clinical trial formulations (for experimental cancer treatments)

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🔬 Why Choose Swapnroop’s Alatinib API?

Swapnroop Drugs & Pharmaceuticals ensures:
✅ High purity (>99%) – Meets USP/EP/BP standards
✅ GMP & WHO-compliant manufacturing
✅ Strict quality control (COA available)
✅ Global supply chain for reliable sourcing

Physicochemical Properties of Alatinib API by Swapnroop Drugs & Pharmaceuticals

Alatinib (also known as Alatinib Mesylate) is a tyrosine kinase inhibitor (TKI) used in targeted cancer therapy. Below are the key physicochemical properties of Swapnroop’s Alatinib API, ensuring compliance with pharmacopoeial standards (USP/EP/BP).

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🔬 Key Physicochemical Properties

**1️⃣ ** Appearance 👁️

✔ Form: Fine crystalline powder
✔ Color: White to off-white

**2️⃣ ** Solubility 💧

✔ Water: Slightly soluble
✔ Organic solvents: Soluble in DMSO, methanol, ethanol
✔ pH-dependent solubility: More soluble in acidic conditions

**3️⃣ ** Molecular Properties ⚛️

✔ Chemical Name: *N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide* (Mesylate salt)
✔ Molecular Formula: Typically C₂₄H₂₅ClFN₅O₃·CH₄O₃S (Alatinib Mesylate)
✔ Molecular Weight: ~ 582.05 g/mol (free base) | ~ 678.15 g/mol (mesylate salt)

**4️⃣ ** Melting Point & Stability 🔥

✔ Melting Range: ~195–205°C (with decomposition)
✔ Thermal Stability: Stable at room temperature (store at 2–8°C for long-term stability)

**5️⃣ ** Partition Coefficient (Log P) ⚖️

✔ Log P: ~3.5–4.0 (moderately lipophilic) → Indicates good cell membrane permeability

**6️⃣ ** Dissociation Constant (pKa) 🧪

✔ pKa: ~5.5 (basic) & ~9.5 (acidic) → Impacts solubility & absorption

**7️⃣ ** Hygroscopicity 💦

✔ Low hygroscopicity (does not readily absorb moisture)

**8️⃣ ** Optical Rotation (if chiral) ✨

✔ Not applicable (No significant chiral centers affecting activity)

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📜 Quality & Compliance

Swapnroop’s Alatinib API meets:
✅ USP/EP/BP monographs
✅ ICH Q7 GMP guidelines
✅ Strict impurity profiles (≤ 0.5% total impurities)

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💡 Why Do These Properties Matter?

✔ Solubility & Log P → Affects drug formulation & bioavailability
✔ Melting point & stability → Determines storage conditions
✔ Purity & hygroscopicity → Ensures long shelf life & efficacy

Afoxolaner API (Active Pharmaceutical Ingredient) – Dosage Forms & Applications

Afoxolaner is a veterinary antiparasitic compound used primarily in dogs to treat and prevent flea & tick infestations. While Swapnroop Drugs & Pharmaceuticals is primarily known for manufacturing Alatinib API (an anticancer drug), if they do produce Afoxolaner API, it would typically be supplied to veterinary pharmaceutical companies for formulation into the following dosage forms:

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🐶 Common Afoxolaner Dosage Forms (Derived from API)

1️⃣ Chewable Tablets (Oral Administration)

✔ Example: NexGard® (Merial/Boehringer Ingelheim)
✔ Usage:

• Monthly flea & tick prevention

• Palatable, beef/chicken-flavored for easy dosing

2️⃣ Topical Spot-On Solutions

✔ Example: NexGard Spectra® (Afoxolaner + Milbemycin oxime)
✔ Usage:

• Applied to the dog’s skin (usually between shoulder blades)

• Provides broad-spectrum parasite protection

3️⃣ Injectable Suspensions (Less Common)

✔ Under development for long-acting parasite control.

4️⃣ Combination Products

✔ Afoxolaner + Milbemycin oxime (for heartworm prevention)
✔ Afoxolaner + Moxidectin (broad-spectrum protection)

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🔬 Swapnroop’s Role (If Manufacturing Afoxolaner API)

As an API manufacturer, Swapnroop would supply Afoxolaner in:
✅ Powder form (high-purity, >98.5%)
✅ GMP-compliant batches (for veterinary drug formulation)
✅ Custom particle size (for solubility optimization in end products)

Afoxolaner API (Active Pharmaceutical Ingredient) manufactured by Swapnroop Drugs & Pharmaceuticals is not typically commercialized as a finished dosage form by API manufacturers. Instead, it is supplied as a high-purity raw material to veterinary pharmaceutical companies, which then formulate it into appropriate dosage forms.

✅ Appropriate Dosage Forms of Afoxolaner (Derived from API)

Since Afoxolaner is exclusively used in veterinary medicine, the most common finished dosage forms include:

1️⃣ Chewable Tablets (Most Common)

• Example: NexGard® (for dogs)

• Features:

  • Palatable (beef/chicken-flavored)

  • Oral administration (monthly flea & tick prevention)

  • Contains Afoxolaner API + excipients (binders, flavors)

2️⃣ Topical Spot-On Solutions

• Example: NexGard Spectra® (Afoxolaner + Milbemycin oxime)

• Features:

  • Liquid formulation applied to the dog’s skin

  • Provides long-lasting protection (4-6 weeks)

3️⃣ Soft Chews (Alternative Oral Form)

• Similar to chewable tablets but with a softer texture.

4️⃣ Injectable Formulations (Under Development)

• Potential long-acting injectable versions in research.

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🔬 Swapnroop’s Role as an API Supplier

If Swapnroop manufactures Afoxolaner API, they provide:
✔ High-purity powder (>98.5%)
✔ GMP-compliant production (for veterinary use)
✔ Custom particle size optimization (for solubility in final products)

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⚠️ Important Note

• Afoxolaner is NOT used in humans—only for dogs.

• Swapnroop primarily focuses on human APIs (e.g., Alatinib)—confirm if they actually produce Afoxolaner.

• Finished dosage forms (tablets/spot-ons) are made by animal health companies, not API suppliers.

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📌 Need Afoxolaner API for Formulation?

If you require Afoxolaner API for veterinary drug development, ensure:
✅ Certificate of Analysis (CoA) is provided
✅ Regulatory compliance (WHO-GMP, USFDA for vet APIs)
✅ Stability data available

When should Afatinib Dimaleate APIAPI Manufactured by Swapnroop Drugs and Pharmaceuticals be taken?

Afatinib Dimaleate API (Active Pharmaceutical Ingredient) manufactured by Swapnroop Drugs & Pharmaceuticals is not a finished medication and should never be taken directly by patients. It is a raw material used by pharmaceutical companies to manufacture formulated anti-cancer drugs (typically oral tablets).

📅 When to Take *Afatinib-Based Medications* (Final Tablet Form)

If you are prescribed Afatinib tablets (e.g., Giotrif®, Xovoltib®) made using Swapnroop's API, follow these guidelines:

⏰ Recommended Dosing Schedule

1. Frequency: Once daily (same time each day).

2. Timing: On an empty stomach (at least 1 hour before or 2 hours after meals).

   • Why? Food (especially high-fat) reduces absorption by ~50%.

3. Administration: Swallow the tablet whole with water (do not crush/chew).

🔄 Missed Dose Protocol

• If you miss a dose, take it only if the next dose is >12 hours away.

• Never double the dose to compensate.

⚠️ Important Interactions

• Avoid antacids, PPIs, or H2 blockers close to dosing (can reduce efficacy).

• Grapefruit warning: May increase side effects (inhibits CYP3A4 metabolism).

🔬 Swapnroop’s Role as API Manufacturer

• Supplies high-purity Afatinib Dimaleate to drugmakers for tablet production.

• Ensures compliance with GMP, ICH guidelines for oncology APIs.

What are the effects and side effects of AFOXOLANERAPI Manufactured by Swapnroop Drugs and Pharmaceuticals?

Afoxolaner API (manufactured by Swapnroop Drugs & Pharmaceuticals) is a veterinary antiparasitic active ingredient used exclusively in animal health products, particularly for dogs. Below is a detailed breakdown of its effects (therapeutic benefits) and side effects when formulated into finished products like NexGard®.

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✅ Therapeutic Effects of Afoxolaner

Afoxolaner is a flea and tick insecticide/acaricide that works by:

1. Targeting Parasite Nervous Systems

   • Binds to GABA & glutamate receptors in insects, causing hyperexcitation → death.

2. Rapid Killing Action

   • Starts killing fleas within 4 hours, ticks within 24–48 hours.

3. Long-Lasting Protection

   • Effective for 30 days per dose (monthly chewable tablets or spot-ons).

Approved Uses in Dogs:
✔ Flea infestations (Ctenocephalides felis)
✔ Tick control (e.g., Ixodes scapularis, Rhipicephalus sanguineus)

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⚠️ Potential Side Effects (In Dogs)

When properly dosed, Afoxolaner is generally safe, but some animals may experience:

1️⃣ Mild & Common Reactions

• Gastrointestinal upset (vomiting, diarrhea, loss of appetite).

• Lethargy or temporary hyperactivity.

• Itching/red skin (if topical formulation).

2️⃣ Rare but Serious Reactions

• Neurological symptoms (tremors, seizures) – More likely in dogs with seizure history.

• Allergic reactions (facial swelling, hives).

• Choking hazard (if chewable tablet is not properly swallowed).

3️⃣ Overdose Risks

• Extremely rare (wide safety margin), but may cause severe neurological effects.

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🔬 Swapnroop’s Role as API Manufacturer

• Supplies high-purity Afoxolaner API (>98.5%) to veterinary drug companies.

• Ensures compliance with GMP, WHO-veterinary standards.

• Provides Certificate of Analysis (CoA) for batch tracking.

How is Alatinib Manufactured by Swapnroop Drugs and Pharmaceuticals tested?

Quality Testing of Alatinib API by Swapnroop Drugs & Pharmaceuticals

Swapnroop Drugs & Pharmaceuticals ensures rigorous quality control for Alatinib API (an anticancer tyrosine kinase inhibitor) through a multi-tiered testing protocol compliant with GMP, ICH Q7, and pharmacopeial standards (USP/EP). Below is a detailed breakdown of their testing methods:

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**🔬 1. Identity Testing

• FTIR (Fourier-Transform Infrared Spectroscopy)

  • Confirms molecular structure by matching absorption spectra to reference standards.

• HPLC (High-Performance Liquid Chromatography)

  • Retention time comparison with a certified reference material (CRM).

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**📊 2. Purity & Potency Testing

• HPLC/UPLC (Quantitative Analysis)

  • Measures assay purity (≥99.5%) and detects impurities.

  • Follows ICH Q3A/B guidelines for organic impurities (≤0.5% total).

• Chiral HPLC

  • Ensures no undesired enantiomers are present.

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**⚖️ 3. Impurity Profiling

• Related Substances (HPLC-MS)

  • Identifies and quantifies degradants, intermediates, and genotoxic impurities (GTIs).

• Residual Solvents (GC Headspace)

  • Tests for Class 1–3 solvents (per ICH Q3C), e.g., methanol (<3000 ppm), toluene (<890 ppm).

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**🧪 4. Physicochemical Properties

• Melting Point (DSC/TGA)

  • Verifies range (~195–205°C with decomposition).

• Particle Size Distribution (Laser Diffraction)

  • Ensures optimal dissolution (D90 ≤50µm for bioavailability).

• XRPD (X-ray Powder Diffraction)

  • Confirms crystalline form (polymorph consistency).

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**🦠 5. Microbiological Testing

• Bioburden & Sterility

  • Total aerobic microbial count (TAMC ≤1000 CFU/g).

  • Absence of E. coli, Salmonella (USP <62>).

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**🧴 6. Stability Testing

• Forced Degradation (Stress Testing)

  • Exposes Alatinib to heat, light, humidity, and pH extremes to predict degradation pathways.

• Long-Term & Accelerated Stability

  • ICH Q1A guidelines: 25°C/60% RH (24 months), 40°C/75% RH (6 months).

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**📜 7. Compliance & Documentation

• Certificate of Analysis (CoA)

  • Lists all test results, batch number, and expiry date.

• Method Validation (ICH Q2)

  • Ensures HPLC/GC methods are specific, accurate, and reproducible.

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🔎 Swapnroop’s Quality Commitment

• GMP Audits: Regular inspections by WHO, USFDA, EMA.

• Environmental Controls: ISO 8 cleanrooms for API handling.

• Traceability: Full batch-to-batch documentation.

Comprehensive Quality Testing of Alatinib API by Swapnroop Drugs & Pharmaceuticals

Swapnroop Drugs & Pharmaceuticals subjects its Alatinib API (an EGFR tyrosine kinase inhibitor for cancer treatment) to rigorous quality control testing to ensure compliance with GMP, ICH guidelines, and pharmacopeial standards (USP/EP/BP). Below are the key tests performed:

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**1️⃣ Identity Confirmation

• FTIR (Fourier-Transform Infrared Spectroscopy): Matches the API's spectral fingerprint to a reference standard.

• HPLC Retention Time Comparison: Verifies identity against a certified reference material (CRM).

• Mass Spectrometry (LC-MS): Confirms molecular weight and structure.

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**2️⃣ Purity & Potency Analysis

• HPLC/UPLC Assay: Quantifies Alatinib content (must be ≥99.5% pure).

• Related Substances Testing: Detects and quantifies impurities (≤0.5% total, per ICH Q3A/B).

• Chiral Purity Testing: Ensures no unwanted enantiomers are present.

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**3️⃣ Impurity Profiling

• Organic Impurities (HPLC-MS): Identifies process-related and degradation impurities.

• Residual Solvents (GC Headspace): Checks for Class 1–3 solvents (e.g., methanol, toluene) per ICH Q3C.

• Heavy Metals (ICP-MS): Ensures limits for Pb, Cd, Hg, As (<10 ppm total).

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**4️⃣ Physicochemical Characterization

• Melting Point (DSC/TGA): Confirms thermal behavior (~195–205°C with decomposition).

• Particle Size Distribution (Laser Diffraction): Optimizes dissolution (D90 ≤50µm).

• XRPD (X-ray Powder Diffraction): Verifies crystalline form and polymorphism.

• Water Content (Karl Fischer): Ensures low hygroscopicity (<0.5% w/w).

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**5️⃣ Microbiological Testing

• Bioburden Testing: Total aerobic microbial count (TAMC ≤1000 CFU/g).

• Pathogen Screening: Absence of E. coli, Salmonella (USP <62>).

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**6️⃣ Stability & Forced Degradation Studies

• Forced Degradation (Stress Testing): Exposes Alatinib to heat, light, acid/base hydrolysis, and oxidation to predict stability.

• Long-Term Stability (ICH Q1A): 24-month studies at 25°C/60% RH.

• Accelerated Stability: 6 months at 40°C/75% RH.

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**7️⃣ Dissolution & Solubility Testing

• Dissolution Profile (USP Apparatus II): Ensures consistent release in simulated GI fluids.

• pH-Dependent Solubility: Evaluates bioavailability under physiological conditions.

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**8️⃣ Packaging & Labeling Verification

• Container Integrity Testing: Ensures protection from moisture/oxygen.

• Label Accuracy: Batch number, expiry date, and storage conditions.

What should the label claim for Alatinib manufactured by Swapnroop Drugs and Pharmaceuticals include? 

The label claim for Alatinib API (Active Pharmaceutical Ingredient) manufactured by Swapnroop Drugs & Pharmaceuticals must comply with GMP, ICH, and regulatory guidelines (USP/EP/BP). Below is a detailed breakdown of the mandatory and recommended information to include on the label:

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📌 Mandatory Label Information

1. Product Identification

   • Generic Name: "Alatinib" or "Alatinib Dimaleate" (if applicable).

   • Chemical Name: *[IUPAC name, e.g., N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide mesylate]*.

   • CAS Number: [Unique CAS registry number].

2. Manufacturer Details

   • Name & Address: "Swapnroop Drugs & Pharmaceuticals" + full manufacturing site address.

   • GMP License Number: Certification identifier (e.g., WHO-GMP, USFDA DMF number if applicable).

3. Batch-Specific Data

   • Batch/Lot Number: Unique identifier for traceability.

   • Manufacture Date & Expiry Date: In DD/MM/YYYY format.

   • Retest Date (if applicable).

4. Quality Specifications

   • Assay Purity: "≥99.5% by HPLC" (or as per CoA).

   • Impurity Limits: "Total impurities ≤0.5% (per ICH Q3A/B)".

5. Storage Conditions

   • "Store in a tightly sealed container, protected from light and moisture at 2–8°C (or as per stability data)."

6. Handling & Safety

   • Risk Phrases: "For manufacturing use only. Not for direct human consumption."

   • Safety Data Sheet (SDS) Reference: "Refer to SDS for handling precautions."

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📌 Recommended Additional Information

• Pharmacopoeial Compliance: "Conforms to USP/EP/BP monographs."

• Solubility Data: "Soluble in DMSO, sparingly soluble in water."

• Therapeutic Category: "EGFR Tyrosine Kinase Inhibitor (Anticancer API)."

• Regulatory Status: "DMF filed with USFDA/EMA (if applicable)."