Our Raw Material Testing and Characterization services ensure the identity, purity, and quality of all incoming materials used in manufacturing — including active pharmaceutical ingredients (APIs), excipients, and packaging components. We perform complete analytical evaluations under GMP-compliant conditions to verify conformance to compendial, regulatory, and client specifications.

By combining pharmacopeial testing with advanced analytical characterization, we help safeguard product integrity, minimize variability, and maintain consistent manufacturing performance across batches and suppliers.

Comprehensive Capabilities Include:

• Identification & Confirmation Testing

  • Verification of material identity using validated techniques (HPLC, FTIR, UV-Vis, GC, etc.)

  • Authentication of chemical and physical characteristics for APIs and excipients

  • Cross-verification against pharmacopeial standards (USP, EP, BP, JP)

• Purity, Potency & Quality Evaluation

  • Assay, related substances, residual solvents, and moisture content testing

  • Detection of trace impurities and degradation products

  • Conformance to defined acceptance criteria for critical attributes

• Physical & Chemical Characterization

  • Particle size, bulk/tap density, pH, specific gravity, and melting point determination

  • Hygroscopicity, polymorphism, and solubility assessments

  • Customized characterization studies for functional or performance-based materials

• Packaging Component Testing

  • Analysis of primary and secondary packaging materials (e.g., glass, plastic, rubber, metal)

  • Verification of extractables, leachables, and compatibility with product formulations

  • Evaluation of labeling materials and container-closure integrity where applicable

• Regulatory Compliance & Documentation

  • Full GMP documentation including COAs, method validation, and traceability

  • Alignment with pharmacopeial, ICH, and FDA/EMA requirements

  • Support for supplier qualification, audit preparation, and material release