Pharmaceutical Analysis

Overview:
Our Pharmaceutical Analysis services ensure the safety, efficacy, and regulatory compliance of pharmaceutical products through advanced testing methodologies and accurate reporting.

Key Inclusions:

1. Identification & Characterization

   • Verification of Active Pharmaceutical Ingredients (API)

   • Detection of impurities and related substances

2. Assay & Potency Testing

   • Quantification of active ingredients

   • Validation of dosage accuracy

3. Dissolution & Disintegration Studies

   • Assessment of drug release profiles

   • Bioavailability predictions

4. Stability Studies

   • Real-time and accelerated stability testing

   • Shelf-life prediction and degradation analysis

5. Heavy Metal & Residual Solvent Analysis

   • Compliance with ICH Q3D and other pharmacopeia guidelines

6. Physical & Chemical Properties Evaluation

   • pH, viscosity, moisture content, hardness, friability, etc.

7. Packaging Material Compatibility Testing

   • Leachables & extractables

   • Product-packaging interaction studies

8. Method Development & Validation

   • According to ICH and pharmacopeial standards

   • Custom protocol design as per client needs

9. Documentation & Regulatory Support

• COAs (Certificates of Analysis), method validation reports

• Support for audits and regulatory submissions (USFDA, WHO, etc.)