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API Analytical Development

Our Analytical Development group provides dedicated services and support to customers for all phases of API development. All work is performed in compliance with GMP and ICH guidelines. Our Analytical Development services include : analytical method development / validation / transfer, stability testing with -20±5°C, 5±3°C, 25±2°C/60±5% RH, 40±2°C/75±5% RH, photostability chamber and API / reference material characterization, specification development and supporting IND filing.

Analytical method development, validation and transfer: We have already experienced method development and validation for some clinical APIs based on ICH Q2 guideline and transferred in timely manner.

Stability testing: We have provided stability-indicating methods and been conducting stability testing for some clinical APIs according to ICH Q1 guidelines. All the stability chambers are qualified with written procedures and are as follows:

20±5°C for storage in a freezer

5±3°C for storage in a refrigerator

25±2°C/60±5% RH for general case

40±2°C/75±5% RH for general case

API / reference material characterization: We are providing characterization services for API and reference materials with the art of technology and identification services for impurities which are generated during process development and should be appropriately controlled by ICH Q3 guidelines.

Specification development: We are able to recommend proper and scientific specification derived from results of process and analytical development according to ICH Q6A guideline.

Supporting IND filing: We support the service related to preparation of IND CMC part and directly prepare IND CMC part as scheduled if needed.

All the above services are provided by suitably controlling laboratory and document under GMP (concept) and the entire instrument are qualified and regularly calibrated with written procedures and pre-determined acceptance criteria.