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    Ursodeoxycholic Acid Sichuan Xieli Coa (Ep6.0)

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    cicilia
    This certificate of analysis summarizes test results for a batch of Ursodeoxycholic Acid produced on September 20, 2016. All tests were found to conform to specifications for appearance, solubility, melting point, identification, specific optical rotation, related substances, loss on drying, heavy metals, assay, residual solvents, and microbiological tests. The batch was deemed suitable for expiration on September 19, 2019.

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    Ursodeoxycholic Acid Sichuan Xieli Coa (Ep6.0)

    Uploaded by

    cicilia
    65 views1 page
    This certificate of analysis summarizes test results for a batch of Ursodeoxycholic Acid produced on September 20, 2016. All tests were found to conform to specifications for appearance, solubility, melting point, identification, specific optical rotation, related substances, loss on drying, heavy metals, assay, residual solvents, and microbiological tests. The batch was deemed suitable for expiration on September 19, 2019.

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    Ursodeoxycholic Acid Sichuan Xieli Coa(Ep6.0)

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    This certificate of analysis summarizes test results for a batch of Ursodeoxycholic Acid produced on September 20, 2016. All tests were found to conform to specifications for appearance, solubility, melting point, identification, specific optical rotation, related substances, loss on drying, heavy metals, assay, residual solvents, and microbiological tests. The batch was deemed suitable for expiration on September 19, 2019.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    65 views1 page

    Ursodeoxycholic Acid Sichuan Xieli Coa (Ep6.0)

    Uploaded by

    cicilia
    This certificate of analysis summarizes test results for a batch of Ursodeoxycholic Acid produced on September 20, 2016. All tests were found to conform to specifications for appearance, solubility, melting point, identification, specific optical rotation, related substances, loss on drying, heavy metals, assay, residual solvents, and microbiological tests. The batch was deemed suitable for expiration on September 19, 2019.

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    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.

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