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Analytical R&D Platform

Novast is a professional pharmaceutical company with rich experience, professional knowledge and skilled problem-solving skills, and the company has the complete drug analysis development capabilities and meets international GMP standards, including the following aspects:

①Analytical method development and validation: follows the requirement in accordance with ChP、USP and ICH related guidelines.

②Impurity Profile Analysis: Using HPLC and LC/MS methods to separate and identify impurities, distinguish in-process and degradation impurities, and establish an acceptable impurity specification that is compliant to regulatory requirements.

③Dissolution Study: Develop a dissolution method with the discriminating ability and IVIVC power, and provide directions for bio-equivalence studies. So far, multiple dissolution methods of Novast products have been incorporated into USP.

④Stability Study of Drug product includes Stress Study, Influencing Factor study, Long-term and Accelerated Condition Study.