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Raw materials & finished products (in any dosage forms)

Raw Materials & Finished Products Testing

All Dosage Forms – Compendial & Custom Methods

Overview Service

Capzer Pharmaceuticals offers full cGMP testing for raw materials (APIs, excipients) and finished products in tablets, capsules, liquids, creams, ointments, injectables, and suspensions. Our FDA/DEA-registered laboratory follows USP/NF, EP, JP, BP, ChP, FCC, and client methods to support vendor qualification, release, and stability.

Raw Materials Testing

APIs and excipients undergo identity (HPLC/FTIR), assay, impurities, residual solvents (USP <467>), heavy metals, and microbial limits. Vendor qualification includes full monograph compliance and method transfer for formulation development and manufacturing release.

Finished Products Testing

Products receive content uniformity, dissolution (Apparatus I/II), potency, degradation products, particulates (injectables), sterility (aseptic), and preservative efficacy (USP <51>). Dosage form versatility covers solids, semi-solids, and liquids for batch certification.

Key Capabilities

  • Chemical: HPLC/UPLC-MS/MS, GC-FID/MS, ICP-MS, KF titration.
  • Microbiology: Bioburden, MLT (USP /), endotoxin (LAL).
  • Specialized: Nitrosamines, elemental impurities (ICH Q3D), cleaning validation.

Benefits for Partners

Partners accelerate Gabapentin and Empagliflozin ANDA timelines with CoAs from our ISO 17025 facility, ensuring supply chain reliability and regulatory compliance across global pharmacopeias.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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