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Chlorpheniramine Maleate
CAS No.: 113-92-8
Synonym: Piriton
Mol. Formula: C₁₆H₁₉ClN₂ · C₄H₄O₄
Mol. Weight: 390.86 g/mol
ATC Code: R06AB04
Therapeutic Category: Antihistamine
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Chlorpheniramine Maleate API is manufactured under stringent quality standards to ensure high purity, potency, and consistency. Each batch undergoes thorough analytical testing, including assay, identification, impurity profiling, moisture content, and particle size analysis. Advanced quality control techniques such as HPLC and UV spectroscopy verify compliance with pharmacopeial standards like USP, EP, and IP. This ensures the API’s suitability for antihistamine formulations with reliable therapeutic performance.

2) Comprehensive Documentation
Amber Lifesciences provides full regulatory and technical documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), stability reports, impurity profiles, and Drug Master File (DMF) support. Accurate and transparent documentation facilitates regulatory approvals, formulation development, and audit readiness in both domestic and international markets.

3) Secure Supply Chain
The supply chain for Chlorpheniramine Maleate API is robust and secure, ensuring product integrity from manufacturing to delivery. Controlled storage, validated transportation, and tamper-evident packaging protect the API from contamination and degradation. End-to-end traceability and risk management strategies ensure timely and uninterrupted supply for global pharmaceutical manufacturers.

4) Manufacturer & Supplier Expertise
Produced by experienced manufacturers in cGMP-certified facilities, Chlorpheniramine Maleate API benefits from advanced production techniques and quality-driven processes. Expert teams ensure scalable production, consistent batch performance, and compliance with international standards, enabling reliable supply for large- and small-scale pharmaceutical requirements.

5) Amber Lifesciences’ Role
Amber Lifesciences serves as a trusted global supplier of Chlorpheniramine Maleate API. They provide high-quality material, complete documentation, and secure logistics. Their focus on compliance, reliability, and customer-centric services supports pharmaceutical companies in developing safe and effective antihistamine formulations worldwide.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.