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Analytical Method

Analytical Method

1. Pre-formulation analytical study

Support formulation department with different types of analytical testing including dissolution profiles, assay, related compounds, water content, viscosity, specific rotation, melting point, particle size (API and excipients), crystal form and all wet chemistry tests.

2. Analytical testing for new chemical entities and sample analysis

Analytical methods available for tablets, capsules, ointment, cream, injectable, eye drop, API and excipient, biological samples (trace amount of metal elements and impurities)

3. Analytical methods for formulation screening

With rich experienced scientists and stat-of-the art analytical instruments, by reverse engineering study, we can determine the composition of reference products accurately. Our screening methods ensure that the quality of products developed are equivalent to the one of reference products.

4. Method development and validation

Variety of analytical method development, method validation and method transfer including dissolution, assay, related compounds, enantiomeric impurity, elemental impurity, particle size, crystal form and residual solvents methods.

5. Stability testing

Stability testing for drug substance and drug product stored at different stress conditions (25℃/65%RH,30℃/70%RH,40℃/75%RH) and the conditions requested by our sponsors.

6. Product and packaging material compatibility study (E & L)

Compatibility studies on injectable, eye drop and other solution products with packaging material, production components, and drug delivery systems.

Analytical methods

  • Semi-volatile extractive,GC-FID/MS;

  • Non-volatile extractive, LC-DAD/MS;

  • Volatile extractive, HS-GC-FID/MS; 

  • Metal ions, ICP-MS

(E & L procedures)

  • Collection and evaluation of information

  • Material extraction test

  • Simulated extraction test

  • Methodology design and validation

  • Migration test

  • Safety evaluation and conclusion