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Product Name |
Betamethasone |
Batch No. |
20200801 |
MFG. Date |
2020.08.01 |
Exp. Date |
2022.07.31 |
Test Date |
2020.08.01 |
Standard |
EP6.0 |
ITEMS |
SPECIFICATIONS |
RESULTS |
|
Character |
White or almost white crystalline powder |
White crystalline powder |
|
Identification |
B. Complies by IR C. Complies by TLC |
Conforms Conforms |
|
Test |
|||
Specific Rotation |
+118o to +126o |
+125.0o |
|
Related substances |
Not more than one impurity between 0.5 to 1.0% Principal impurity not more than 1.0% Total impurities not more than 2.0% |
Conforms 0.25% 0.99% |
|
Loss on drying |
Not more than 0.5% |
0.06% |
|
Assay |
Contains 97.0% to 103.0% of C22H29FO5 calculated on dried basis |
98.89% |
|
Conclusion |
The goods conforms to EP6.0 |