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Product name |
6ALPHA,9ALPHA-DIFLUORO-11BETA, 17ALPHA-DIHYDROXY -16ALPHA-METHYL-ANDROSTA-1,4-DIENE-3-ONE-17BETA-CARBOXYLIC ACID |
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Batch No. |
200302 |
Quantity |
50kg |
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Mfg. Date |
Mar.,31, 2020 |
Expiry date |
Mar.,30，2022 |
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Specification |
in-house specification |
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Items |
Specification |
Result |
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Description |
almost white or white crystalline powder |
Almost white crystalline powder |
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Identification |
IR Complies with the standard |
Complies |
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Melting Range |
280～290℃ |
288.5-289.5℃ |
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Water |
not more than 0.5% |
0.05% |
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HPLC purity |
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-flumethasone |
not more than 0.15% |
n.d |
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-21-dehydroxy |
not more than 0.3% |
n.d |
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- Any single impurity |
not more than 0.1% |
0.1% |
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- Total impurities |
not more than 1.0% |
0.2% |
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Assay(HPLC) |
98.0%--102.0% |
100.7% |
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Residual Solvents |
Tetrahydrofuran not more than 1.5% |
Complies |
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Acetone not more than 0.5% |
Complies |
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Acetic acid not more than 0.05% |
Complies |
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Conclusion: this batch of product complies with the in-house specification. |
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