CERTIFICATE OF ANALYSISProduct Ursodeoxycholic Acid (UDCA) Batch No. 201705002 Expiry Date 2017.APR.26 Retest Date 2020.APR.25 Quantity 100KG CAS NO. 128-13-2
Item Specification Results Appearance White or almost white powder Complies Solubility Practically insoluble in water, freely soluble in ethnol (96%), slightly soluble in acetone, Practically insoluble in methylene chloride. Complies Identification Infrared Absorption, TLC and chrominance test Complies Melting Point 200-204ºC202.5ºCSpecific Optical
Rotation +58.0°~ +62.0°+60.2°Heavy metals ≤20 ppm Complies Loss on drying ≤1.0% 0.12% Sulphated ash ≤0.1% 0.04% Residual solvents Acetone ≤0.5% 0.10% Methanol ≤0.3% None Secondary butyl alcohol ≤0.5% None Related substance (TLC) Lithocholic Acid: ≤ 0.1% Complies Cholic Acid: ≤ 0.5% Complies Chenodeoxycholic Acid: ≤ 1.0% Complies Others: ≤ 0.25% Complies Assay 99.0-101.0% 99.8%
Microbiological TestsSpecificationsStandardTesting ResultTotal Plate Count/1g1000MAX10MAXYeast & Mould/1g100 MAX10MAXE.coli /1gAbsentAbsent