The purpose of the stability study is to investigate the regularity of the API or pharmaceutical preparations under the influence of temperature, humidity, and light, to provide a scientific basis for the production, packaging, storage, and transportation conditions of the drug, and to establish the validity period of the drug through experiments.
Stability research is one of the main contents of drug quality control research, and is closely related to drug quality research and the establishment of quality standards. It has a phased characteristic, which runs through the entire process of drug research and development of raw materials, preparations and intermediate products. It generally starts from the preclinical research of drugs. On-going stability study should continue during the clinical study of the drug and post-marketing.
A team led by professional scientists and data reports that meet the registration requirements of various countries
Germany Weiss walk-in stability box and Binder / MMM constant temperature and humidity equipment
Storage conditions of various climate zone type, with a total space of 2700 cubic meters
Dual power supply system, dual backup scheme for each condition, disaster recovery system
E-management system, temperature and humidity online management and on-line monitoring and alarm system
Complies with GMP regulations and FDA 21CFR Part 11 data integrity requirements
CMA / CNAS (ISO/IEC17025) Accreditation, refer to cGMP compliance laboratory
Stability studies are based on cGMP / ChP / FDA / ICH / WHO guidelines
Overall, it can reduce the cost of pharmaceutical stability research for customers by more than 50%
Stability Study Conditions
Cabinets 50 ℃, 57 ℃, 60 ℃
Storage at 2-8℃, -20℃, -40℃, -80℃
Specialized Condition (ICH Q1B Options 1 & 2)
Freeze/Thaw Cycle Condition
Storage Solutions of Semi-permeable Containers
Long-term conditions 25 ℃ / 40% RH
Intermediate conditions 30 ℃ / 35% RH
Acceleration conditions 40 ℃ / 25% RH
Stability Study Services
Current Regulations and Guidelines for Stability Study
中国药典（2020版））， ChP (2020)
ICH， Q1A-Q1F Stability，2003.
FDA， Drug Stability Guidelines，2008.
EMA，EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use，2015.
WHO，Stability testing of active pharmaceutical ingredients and finished pharmaceutical products，2016.