stability testing of drug is to provide the evidence of api or dp with time under the influence of temperature, humidity, light and other conditions, to provide a scientific basis for the determination of the production, packaging, storage, transportation conditions and period of validity of drugs to ensure the safety and effectivity. both the guidelines for stability testing of api and dp under ich and general principles 9001 of the fourth part of chp put forward specific requirements for the tests, including the type of test, sample batch selection, storage conditions, testing time, testing items, testing method specificity and accuracy. we can provide stability research services for api and dp which can meet gmp requirements.
● long-term testing
● accelerated testing
● intermediate testing
● stress testing
● photostability testing
tel: 86-400 821 5138
fax: 86-21 3327 5843
email:noa@noagroup.com