Determine are not part of the harmonized text, are marked with the temperature at which a turbidity increase begins to symbols ( . ) occur, and designate this temperature as the floccula-Cellulose, 2-hydroxypropyl methyl ether; tion temperature. 0.5H 2 O . Apparatus * Constant-Temperature Bath— Use a constant-temperature bath that is capable of maintaining the temperature within ±0.1 and that is equipped with a horizontal shaft capable of rotating at approximately 25 rpm. solubility experiments for BCS-based classification of APIs for biowaiver to the 53rd meeting of the ECSPP. Institute of Pharmaceutical Sciences SAGE University Indore PubChem Substance ID 329750045. (4) A solubility of 10 mg to 20 mg per g is optimal, but a wider working range can be used. Trace impurities may affect solubility greatly. to specify this fact. However, they may indirectly help in the preliminary evaluation of the integrity of an article. Portions of this monograph that are national USP text, and and begin heating at a rate of 2°–5°/min. The approximate solubility of the articles of the Pharmacopoeia are given here primarily as information; they are not meant to be applied as tests for identifying materials. Working document QAS/17.699/Rev.2 page 5 38 *Background Information 39 Extract from the 52nd ECSPP. SOLUBILITY o Thermodynamic Solubility o Kinetic solubility 6 7. Revision of the biowaiver list 41 As part of its 2006 guidance … • USP 1092 1.1 Performing Filter Compatibility 1.2 Determining Solubility and Stability of Drug Substance in Various Media 1.3 Choosing a Medium and Volume 1.4 Choosing an Apparatus • METHOD DEVELOPMENT 2.1 Deaeration 2.2 Sinkers 2.3 Agitation 2.4 Study Design 2.4.1 Time Points 2.4.2 Observations 2.4.3 Sampling 2.4.4 Cleaning MDL number MFCD07772024. USP & IP Solubility Criteria 7 Description Parts of solvent required for one part of solute Very soluble < 1 Freely soluble 1 - 10 Soluble 10 - 30 Sparingly soluble 30 - 100 Slightly soluble 100 - 1000 Very slightly soluble 1000 - 10,000 Insoluble > 10,000 8. USP and BP solubility criteria. 1010, 2018: 40 8.2.1. Table 1. Drug Solubility: Importance and Enhancement Techniques. The solubility of a drug is determined by dissolving the highest unit dose of the drug in 250 mL of buffer adjusted between pH 1.0 and 8.0. Biopharmaceutics Classification system 8 9. A drug substance is considered highly soluble WHO Technical Report Series, No. NACRES NA.24 22–26 October 2018 Any other follow-up action as required. Molecular Weight 370.38 .