DEXAMETHASONE powder DEXAMETHASONE micro DEXAMETHASONE base
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
ITEM |
SPECIFICATIONS |
RESULTS |
Appearance |
White or almost white crystalline powder |
White crystalline powder |
Solubility |
Practically insoluble in water ,sparingly soluble in anhydrous ethanol ,slightly soluble in methylene chloride. |
Complies |
Identification |
B,C or A,C,D and E |
Complies |
Specific optical rotation |
+86°~+92 ° |
+90.0° |
Related substances |
Impurity G ≤0.3% |
0.02% |
Impurity B ≤0.15% |
0.09% |
|
Impurity F ≤0.15% |
Not Detected |
|
Impurity J ≤0.15% |
Not Detected |
|
Impurity K ≤0.15% |
Not Detected |
|
Unspecified impurity ≤0.1% |
0.09% |
|
Total impurities ≤0.5% |
0.43% |
|
Loss on Drying |
≤0.5% |
0.03% |
Assay |
97.0%~103.0% (UV,basis on drying) |
99.8% |
Conclusion: It conforms to the requirements of EP9.0 |
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