CERTIFICATE OF ANALYSIS

PRODUCT NAME: Ursodeoxycholic Acid EP6

MANUFACTURING DATE: September 20, 2016 BATCH NO.: C043B160902
EXPIRY DATE: September 19, 2019 BATCH SIZE:125kg

SPECIFICATION:C043B
NATURE OF TEST QUALITY STANDARD TEST RESULTS
CHARACTERS:
-Appearance White or almost white powder Conforms
-Solubility Practically insoluble in water, freely Conforms
soluble in ethanol (96 per cent), slightly
soluble in acetone, practically insoluble in
methylene chloride.
TESTS:
-Melting point About 202 ℃ 202℃
-Identification
- IR The spectrum obtained is similar to Conforms
that of CRS
-Sepcific optical rotation + 58.0~+62.0 +61.3°
-Sulphate Ash ≤ 0.1 % 0.04%
-Related substances(TLC)
- Chenodeoxycholic Acid ≤1% <1%
- Lithocholic Acid ≤ 0.1 % not detected
- Cholic Acid ≤ 0.5 % not detected
- any other impurity ≤ 0.25 % not detected
-Loss on Drying ≤ 1.0 % 0.04%
-Heavy metal ≤ 20 ppm < 20 ppm
ASSAY :
-On dry substance 99.0 %~101.0 % 100.7%
CONCLUSION: THE TEST RESULTS CONFORM TO C043B.

RESIDUAL SOLVENTS:
- Methanol ≤3000 ppm not detected
- Isopropanol ≤5000 ppm not detected
- Ethylacetate ≤5000 ppm not detected
MICROBIOLOGICAL TESTS:
-Total Plate Count /1 g ＜ 1000 ＜ 10
-Yeast & Mould /1 g ＜ 100 ＜ 10
-E. coli /1 g Absent Absent
CONCLUSION: THE TEST RESULTS CONFORM TO MICROBIOLOGICAL TESTS.