Product Name
|
Betamethasone
|
CAS No
|
378-44-9
|
Catalog No
|
SC-15701
|
Quantity
|
100kg
|
Batch No
|
20130301
|
Product Date
|
2013.03.01
|
Date of analysis
|
2013.03.01
|
Items of analysis
|
Specification
|
Results
|
Appearance
|
White or almost white crystalline powder
|
White crystalline powder
|
Identification
|
IR spectrum Conforms to CRS.
|
Conforms
|
Specific optical rotation
|
It should be +118°~+126°
|
+122.6°
|
Related substance(By HPLC)
|
Single impurity ≤ 1.0%
|
0.16%
|
0.5%≤Impurity that ≤1.0%
|
Conforms
|
|
Total impurity≤2.0%
|
0.30%
|
|
Loss on drying
|
≤ 0.5%
|
0.16%
|
Organic volatile substances
|
|
|
Methanol
|
Max.3000ppm
|
Conforms
|
Acetone
|
Max.5000ppm
|
Conforms
|
Ethylacetate
|
Max.5000ppm
|
Conforms
|
DMF
|
Max.880ppm
|
Conforms
|
Dichloromethane
|
Max.600ppm
|
Conforms
|
Assay (UV)
|
97.0% ~ 103.0%
|
99.25%
|
Remark
|
Declaration: For laboratory use by technically qualified individual only
|
|
Conclusion
|
It accords with the Enterprise Standard
|
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