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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:

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

② Impurity 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.

③ Dissolution 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.

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

Analytical methods developed at Novast have unique technical advantages. Multiple analysis methods with high sensitivity are applied for several low dose drugs. And for combo products, the specific, sensitive and accurate impurity methods have been successfully developed and validated, including HPLC-FLD, high-resolution LC/MS, SPE, ICP-MS, and so on. As a result, the generated analytical data are accurate and reliable, ascertaining the quality of company’s products consistently at a high level and enhancing the product market competitiveness.

Currently, our company has successfully solved genotoxic impurity issues for multiple drugs and finalized multiple analysis methods of sulfonates, nitrosamines, anilines and etc. Besides, Novast’s analytical team has a extensive experience on the analysis of complex drug products.