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Chlorphenamine Maleate, also known as Chlorpheniramine Maleate, is a first-generation antihistamine used to relieve symptoms of allergic conditions, such as rhinitis, urticaria, hay fever, skin rashes, and common cold. It effectively reduces sneezing, watery eyes, itching, and nasal congestion caused by histamine release.
At Bluepill Express, we manufacture and export high-quality Chlorphenamine Maleate API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring superior purity, compliance, and consistency.
Our Chlorphenamine Maleate API is available with assay purity ≥99%, controlled impurity profile, and optimized particle size suitable for tablet, capsule, syrup, and injectable formulations. Each batch undergoes rigorous quality testing to meet IP, BP, USP, and EP pharmacopoeial standards.
Therapeutic Applications:
- Treatment of allergic rhinitis (hay fever)
- Relief from urticaria (hives) and skin rashes
- Management of cold and flu symptoms
- Used in combination products with decongestants or cough suppressants
Mechanism of Action:
Chlorphenamine Maleate works by blocking histamine H1 receptors, preventing the effects of histamine — a substance responsible for allergy symptoms. It provides antihistaminic, antipruritic, and mild sedative effects, ensuring effective symptom control.
Technical Specifications:
- Chemical Name: 3-(4-Chlorophenyl)-N,N-dimethyl-3-pyridin-2-yl-propan-1-amine hydrogen maleate
- Molecular Formula: C₁₆H₁₉ClN₂·C₄H₄O₄
- Molecular Weight: 390.86 g/mol
- CAS Number: 113-92-8
- Appearance: White to pale yellow crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Melting Point: 130°C – 135°C
- Solubility: Freely soluble in water, slightly soluble in ethanol
- Storage Conditions: Store below 25°C, in a dry, cool place, protected from light
Pharmacological Classification:
- Therapeutic Class: Antihistamine / Antiallergic Agent
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Tablets (4 mg, 8 mg)
- Oral syrups and suspensions
- Injectable formulations
- Combination products with pseudoephedrine or paracetamol
Manufacturing & Quality Standards – Bluepill Express:
- Manufactured in WHO-GMP and cGMP certified facilities
- High assay purity (≥99%) and low impurity content
- Validated analytical testing: HPLC, FTIR, UV, and LC-MS
- DMF-ready documentation for global regulatory submissions
- Batch-to-batch uniformity with superior physical properties
- Compliant with ICH Q3A/B impurity standards and global pharmacopeial requirements
Advantages of Bluepill Express Chlorphenamine Maleate API:
- Pharmacopeial-grade quality (IP/BP/USP/EP compliant)
- High chemical stability and consistent particle size
- Regulatory documentation support (COA, MSDS, DMF, stability data)
- Custom packaging and labeling for international exports
- Global supply capability with competitive pricing
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
- Shelf Life: 3 years under recommended storage conditions
- Labeling: As per international pharmacopeial and export standards
- Export Markets: Asia, Africa, Middle East, Europe, and Latin America
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF)
- Stability and Validation Reports
