NEWS
Rapid temperature change chambers and other environmental equipment test equipment standard-
Rapid temperature change chambers and other environmental equipment test equipment standard
2024-04-22
1, constant temperature and humidity test chamber This product is in strict accordance with GB/T5170.5-96 humidity and heat test equipment GB10586-89 humidity and heat test chamber technical conditions, GB/T2423.3-1993 constant humidity and heat test methods and other standards (1) GB/11158-2008 High-temperature test chamber technical conditions (2) GB/T10589-2008 "low-temperature test chamber technical conditions (3) GB/T5170.2-2008 Temperature Test Equipment and so on. Test Methods Satisfied (1) GB/T2423.1-2008 International Electrotechnical Commission standard "Test Ab: Low Temperature Test Methods". (2) National standard GB/T2423.2-2008 "Test Bb: High temperature test method" and so on. 2、Heat and cold shock test chamber (1) GB/T2423.1-1989 low-temperature test methods (2) GB/T2423.2-1989 high temperature test method (3) GB/T2423.22-1989 temperature change test (4) GJB150.5-86 temperature impact test (5) GJB360.7-87 temperature impact test (6) GJB367.2-87 405 temperature shock test. (7) SJ/T10187-91Y73 series of temperature change test box - a box type (8) SJ/T10186-91Y73 series of temperature change test chamber - two box type (9) Meet the standard IEC68-2-14 Test Method N Temperature Change (10) GB / T 2424.13-2002 test method temperature change test guidelines (11) GB / T 2423.22-2002 temperature change (12) QC/T17-92 General rules for weathering test of automotive parts and components Rules (13) EIA 364-32 thermal shock (temperature cycling) test procedures for electrical connectors and sockets environmental impact assessment 3、Rapid temperature change test chamber (1) GB/T5170.2-2008 "Temperature test equipment". (2) GB/T2423.1-2008 (IEC60068-2-1:2007) "low-temperature test methods Ab (3) GB/T2423.2-2008 (1EC60068-2-2:2007) "Low temperature test method Bb". (4) IEC 60068-2-14 2009 "Environmental Tests. Part 2-14 Test . Test N temperature change". 4、High and low temperature test chamber
STABILITY TESTING OFNEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2)-
STABILITY TESTING OFNEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2)
2024-02-21
Stability Testing ofNew Drug Substances and Products 2.1.1. General Information on the stability of the drug substance is an integral part of thesystematic approach to stability evaluation. 2.1.2. Stress Testing Stress testing of the drug substance can help identify the likely degradation products.which can in turn help establish the degradation pathways and the intrinsic stabilityof the molecule and validate the stability indicating power of the analyticalprocedures used. The nature of the stress testing will depend on the individual drugsubstance and the type of drug product involved. Stress testing is likely to be carried out on a single batch of the drug substance. Itshould include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C, etc.)above that for accelerated testing), humidity(e.g., 75% RH or greater) whereappropriate, oxidation, and photolysis on the drug substance. The testing should alsoevaluate the susceptibility of the drug substance to hydrolysis across a wide range ofpH values when in solution or suspension. Photostability testing should be anintegral part of stress testing. The standard conditions for photostability testing aredescribed in ICH Q1B. Examining degradation products under stress conditions is useful in establishingdegradation pathways and developing and validating suitable analytical procedures.However, it may not be necessary to examine specifically for certain degradationproducts if it has been demonstrated that they are not formed under accelerated orlong term storage conditions. Results from these studies will form an integral part of the information provided toregulatory authorities. 2.1.3. Selection ofBatches Data from formal stability studies should be provided on at least three primarybatches of the drug substance. The batches should be manufactured to a minimum ofpilot scale by the same synthetic route as, and using a method of manufacture andprocedure that simulates the final process to be used for, pro