Pharmacopoeial Monograph Release Testing

Pharmacopoeial Monograph Release Testing

Monograph release testing is a critical step in the drug development and manufacturing process to ensure the quality, safety, and efficacy of active pharmaceutical ingredients (APIs) and excipients. As a leading provider of analytical services, our team specializes in conducting comprehensive monograph release testing to ensure the quality and compliance of APIs and excipients. We leverage our expertise and state-of-the-art facilities to perform testing in accordance with the guidelines and specifications outlined in the major pharmacopeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP) and Chinese Pharmacopoeia (CP).

Our extensive testing programs

Protheragen-ING Lab regularly analyzes drugs and substances according to the latest pharmacopoeia or customer-specified procedures and specifications. Our drug testing laboratories are fully equipped with analytical instruments and all methods are used only after proper validation or confirmation. Our services cover a wide range of tests to evaluate the physicochemical properties, characterization, purity and performance of your APIs and excipients, including but not limited to:

Physicochemical Testing Performance Testing
  • Appearance and description
  • Solubility
  • pH
  • Melting point
  • Boiling point
  • Specific gravity
  • Viscosity
  • Loss on drying
  • Residue on ignition
  • Particle size distribution
  • Specific surface area
  • Polymorphism
  • Dissolution
  • Disintegration
  • Moisture content
Purity Testing Identification Testing
  • Assay
  • Impurities/related substances
  • Heavy metals
  • Residual solvents
  • Microbiological testing (e.g., bioburden, endotoxins)
  • Infrared spectroscopy (IR)
  • Nuclear magnetic resonance (NMR) spectroscopy
  • X-ray powder diffraction (XRPD)
  • Thin-layer chromatography (TLC)
  • High-performance liquid chromatography (HPLC)

Strict quality assurance

To ensure the reliability and reproducibility of results, we have established a comprehensive quality management system, including:

  • Regular instrument calibration and maintenance.
  • Rigorous sample handling and analytical procedures.
  • Internal and external inter-laboratory comparison programs.
  • Data audits and report reviews.

Customer service

Our dedicated service team is on hand to provide personalized support and consultation. Whether developing a test plan or interpreting the meaning of results, we go above and beyond to ensure a highly satisfying experience. We pride ourselves on providing accurate, reliable, and timely results to support your regulatory submissions and product development efforts.

To learn more about our specialty release testing services or discuss your specific needs, please contact us. We look forward to working with you to ensure the quality and compliance of your medicines.