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Drug Stability Studies
We provide stability studies of pharmaceutical products that comply with ICH Q1 and Chinese Pharmacopoeia guidelines, including influence factor tests, accelerated tests and long-term tests. Our laboratory is managed in strict accordance with cGMP quality management system, equipped with Labsolution CS, Empower_CDS, paperless record system (stability chamber) and other network version softwares, and laboratory information management system (LIMS) for department management configuration.
The stability conditions meet the requirements in ICH Q1 and the Chinese Pharmacopoeia guidelines: accelerated conditions of 40°C ± 2°C/ RH 75% ± 5%, intermediate or long-term conditions of 30°C ± 2°C/ RH 65% ± 5%, long-term conditions of 25°C ± 2°C/ RH 60% ± 5%, high temperature conditions of 40°C/ 60°C, high humidity conditions of RH 90% ± 5%/ 75% ± 5%, and light conditions with total illumination of not less than 1.2×106 Lux?hr and near UV energy of not less than 200 w?hr/㎡. Stability studies support FDA/NMPA approval of new or generic drug applications.