To create a stable temperature, humidity and light environment for drug failure evaluation with scientific methods, which is suitable for accelerated test, long-term test, high-humidity test and high-light irradiation test of drugs and new drugs in pharmaceutical enterprises, is the best choice for pharmaceutical enterprises to conduct drug stability test.
Pharmacopoeia 2020 version of the drug stability test guidelines and GB/T10586-2006 related provisions manufactured
Low speed test: 40 ℃ plus or minus 2.0 ℃ / 75% RH + / - 5% RH, or 30 ℃ plus or minus 1.0 ℃ / 60% RH + / - 5% RH for 180 days
Low long-term experiment: 25 ℃ plus or minus 2.0 ℃ / 60% RH + / - 5% RH, or 30 ℃ + / 2.0 ℃ / 60% RH + / - 5% RH for 365 days
● For accelerated testing of pharmaceutical preparations packaged in semi-permeable containers, such as infusion bags made of low-density polyethylene, plastic ampoules, ophthalmic preparation containers, etc., the tests should be carried out at a temperature of 40℃±2℃/ 25% RH
● For long-term testing of pharmaceutical preparations packaged in semi-permeable containers, the tests should be carried out at a temperature of 2 ° C /40%±5%RH or 30 ° C /35% ±5%RH
