Preparation Stability-IPHASE

Pharmaceutical Research

Preparation stability study

The stability study of the preparation should be designed based on the understanding of the characteristics of the drug substance and the test results obtained from the stability study of the drug substance and the clinical prescription study. Huizhi Taikang should fully comply with the guidance requirements of the International Coordinating Organization (ICH) and the GLP/cGMP management requirements of domestic and foreign pharmaceutical regulatory agencies, and explain the possible changes in the storage process and the setting considerations of the stability test investigation items.

service content

Relying on the fully equipped analysis and detection technology platform, Huizhi Taikang has accumulated rich experience in drug standard establishment and quality control in drug content analysis, impurity analysis and stability research. Huizhi Taikang promises to carry out the entrusted research work for customers in full compliance with the guidance requirements of the International Coordinating Organization (ICH), the standard requirements of the Chinese Pharmacopoeia and the GLP/cGMP management requirements of domestic and foreign pharmaceutical regulatory agencies.