CAS 35380-71-3 Estradiol
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China [CN] | Item | Standard | Test Results | |
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Identification |
A.H-NMR:Comply with the structure |
Complies |
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B.LC-MS:Comply with the structure |
Complies |
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C.The IR spectrum of sample should be identical with that of reference standard; |
Complies |
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D.HPLC-ESI-MS The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. |
Complies |
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Crystallinity |
meets the requirements. |
Complies |
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Loss on drying |
≤2.0% |
0.19% |
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Heavy metals |
≤10 ppm |
<10ppm |
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Water |
≤1.0% |
0.1% |
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Sulphated ash |
≤0.5%, determined on 1.0 g. |
0.009% |
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Related substances |
Unspecified impurities: for each impurity |
≤0.10% |
<0.10% |
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Total Impurity |
≤0.5% |
0.18% |
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Purity |
≥99.0% |
99.7% |
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Assay |
99.0%~101.0% (anhydrous substance). |
99.8% |
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Microbiological Analysis |
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Total plate count |
≤1000cfu/g |
Complies |
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Yeast and Moulds |
≤100cfu/g |
Complies |
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E. Coli. |
Absent |
Negative |
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Salmonella |
Absent |
Negative |
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S.aureus |
Absent |
Negative |
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Storage |
Preserve in well-closed, light-resistant and airtight containers. |
Complies |
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