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25 Gram |
Negotiable |
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Product name | Difluprednate |
CAS No.: | 23674-86-4 |
ITEM |
CRITERIA |
RESULTS |
Description |
A white or almost white crystalline powder |
almost white crystalline powder |
Identification |
UV |
Conform |
Solubility |
Soluble in 1,4-dioxane,slightly soluble in ethanol |
Conform |
Melting range |
188-198°C |
189.1°C-192. 3°C |
Loss on drying |
≤1.0% |
0.12% |
Residue on ignition |
≤0.1% |
0.04% |
Related substance |
Single impurity ≤1.0% |
0.75% |
Total impurity ≤2.0% |
1.05% |
|
Residual solvents |
Dichloromethane ≤600ppm |
Conform |
pyridine≤200ppm |
Conform |
|
Ethyl acetate≤5000ppm |
Conform |
|
Methanol ≤3000ppm |
Conform |
|
Heavy Metal |
<10ppm |
Conform |
Assay |
98.0%min |
98.80% |
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