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CERTIFICATE OF ANALYSIS
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Product Name: Calcipotriol |
Batch No.: 231201 |
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Batch Size: 17g |
Manufacturing Date:Dec. 01, 2023 |
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Ref. Standard: EP7.0 |
Report Date: Dec. 01, 2023 |
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Items |
Spcifications |
Results |
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Appearance |
White or almost white crystalline powder |
Conforms |
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Identification |
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a) IR |
IR chromatograph Conforms to the characteristic peak of R.S. |
Conforms |
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b) HPLC |
chromatogram Conforms to the characteristic peak of R.S. |
Conforms |
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Related substances |
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Known impurity |
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Impurity B((7Z)-calcipotriol) |
Not more than 0.5% |
ND |
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Impurity C((5E)-calcipotriol) |
Not more than 1.0% |
0.19% |
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Impurity D (24-epi-calcipotriol) |
Not more than 1.0% |
0.33% |
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Any other impurity |
Not more than 0.1% |
ND |
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Total impurities |
Not more than 2.5% |
0.50% |
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LOD |
Not more than 1.0% |
0.35% |
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Solvent residue |
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Acetone |
Not more than0.5% |
0.25% |
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Tetrahydrofuran |
Not more than0.072% |
ND |
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Ethyl acetate |
Not more than0.5% |
0.15% |
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Methanol |
Not more than0.3% |
0.132% |
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Toluene |
Not more than0.089% |
ND |
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Ethanol |
Not more than0.5% |
0.11% |
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Assay |
95.5~102.0% |
99.1% |
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Conclusion：It conforms to the Enterprise Standard |
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Storage: Store in a -20 ℃, keep sealed and kept from light. |
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Shelf Life: 2years |
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