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Certificate of Analysis
CARPROFEN EP8
|
BATCH NUMBER |
20221001 |
TEST DATE |
Oct.11,2022 |
|
BATCH SIZE |
/ |
MANUFACTURE DATE |
Oct.11,2022 |
|
QUANTITY |
16.885kgs |
EXPIRATION DATE |
Oct.10,2024 |
|
TEST |
SPECIFICATION |
RESULT |
|
Appearance |
White or almost white crystalline powder. |
Conforms |
|
Solubility |
Practically insoluble in water,freely soluble in acetone,soluble in methanol,slightly soluble in 2-propanol. |
Conforms |
|
Identification |
Infrared absorption spectrum corresponds to that of the reference standard |
Conforms |
|
Appearance of solution |
The solution is clear and not more than intensely Coloured than reference solution BY3 |
Conforms |
|
Loss On Drying |
Not More Than 0.5% |
0.33% |
|
Sulphated ash |
Not More Than 0.1% |
0.08% |
|
Heavy Metals |
Not More Than 0.002% |
Conforms |
|
Related Substances |
|
|
|
Unspecified impurities |
Not More Than 0.2% |
0.14% |
|
Total impurities |
Not More Than 0.5% |
0.32% |
|
Assay |
98.5% to 101.5% on the dried basis |
99.4% |
|
Residual Solvents |
||
|
Acetone |
Not More Than 5000ppm |
Not detected |
|
Organic Volatile Impurity |
||
|
Methylene Chloride |
Not More Than 500ppm |
Not detected |
