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CERTIFICATE OF ANALYSIS
|
Product Name |
Loperamide Hydrochloride |
Batch No |
20220820 |
|
CAS NO. |
34552-83-5 |
Manufacture Date |
Aug.20,2022 |
|
Standard |
USP40 |
Expiration Date |
Aug.19,2027 |
|
Test |
Specification |
Results |
|
Appearance |
White or almost white powder |
white powder |
|
Solubility |
Freely soluble in methanol, and in chloroform. |
Complies |
|
Identication IR UV |
A.The IR absorption Spectrum of the test specimen,exhibits maxima only at the same wavelengths as that of a similar preparation of the corresponding loperamide hydrochloride reference standard(working standard)
B. the UV absorption spectrum between 250 and 300 nm of this solution exhibits maxima and minima at the same wavelengths . |
Complies
Complies |
|
Loss on drying |
≤0.50% |
0.2% |
|
Residue on ignition |
≤0.20% |
0.069% |
|
Heavy Metal |
≤20PPM |
Complies |
|
Chromatographic purity by TLC |
No Secondary spot are observed |
Complies |
|
Chloride content |
Between 13.52% and 14.20% |
14.08% |
|
Assay(on dried basis) |
98.0-102% |
99.84% |
|
Conclusion : The product Conforms to USP40 Specifications
|
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