Analytical development and quality control-Shanghai Neutan Pharmaceutical Research and Development Co., LTD

Analytical development and quality control

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Our company has a professional analytical R&D and quality study team to provide customers quality study and stability testing services of API, intermediates, pharmaceutical products that meet IND/NDA requirements. Project experience covers all stages from pre-clinical to commercialization, including analytical method development and optimization, analytical method validation and transfer, physicochemical properties study, stability study, standardization of working standard, etc., which meet the needs of different stages in drug development.

Analysis Services

Analytical method development and validation for drug substance and pharmaceutical products
Release testing of drug substance and pharmaceutical products. ICH-compliant stability testing
Analytical method development and validation for potential genetic toxicity impurities(PGI)
Research of drug degradation
Method development, validation and detection of metallic element impurities
Study on drug particle size distribution
Method development, validation and detection of chiral drugs
Study on the release and stability of clinical drugs under GMP conditions