CERTIFICATE OF ANALYSISProductUrsodeoxycholic Acid (UDCA)Batch No.201705002Expiry Date2017.APR.26Retest Date2020.APR.25Quantity100KGCAS NO.128-13-2
ItemSpecificationResultsAppearanceWhite or almost white powderCompliesSolubilityPractically insoluble in water, freely soluble in ethnol (96%), slightly soluble in acetone, Practically insoluble in methylene chloride.CompliesIdentificationInfrared Absorption, TLC and chrominance testCompliesMelting Point200-204ºC202.5ºCSpecific Optical
Rotation+58.0°~ +62.0°+60.2°Heavy metals≤20 ppmCompliesLoss on drying≤1.0%0.12%Sulphated ash≤0.1%0.04%Residual solventsAcetone ≤0.5%0.10%Methanol ≤0.3%NoneSecondary butyl alcohol ≤0.5%NoneRelated substance (TLC)Lithocholic Acid: ≤ 0.1%CompliesCholic Acid: ≤ 0.5%CompliesChenodeoxycholic Acid: ≤ 1.0%CompliesOthers: ≤ 0.25%CompliesAssay99.0-101.0%99.8%
Microbiological TestsSpecificationsStandardTesting ResultTotal Plate Count/1g1000MAX10MAXYeast & Mould/1g100 MAX10MAXE.coli /1gAbsentAbsent