| Customization: | Available |
|---|---|
| Usage Mode: | For oral administration |
| Suitable for: | Adult |
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Items |
Specifications |
Results |
Appearance |
White to off-white, crystalline powder. |
Off-white powder |
Solubility |
Sparingly soluble in water, very slightly soluble in alcohol and in chloroform, practically insoluble in ether. |
Complies |
Identification |
The IR spectrum confirm to that of reference standard. |
Complies |
Crystallinity |
Meet the requirements |
Complies |
pH |
3.5 to 6.0 |
5.0 |
Water |
Not more than 6.0% |
3.6% |
Limit of Cephalexin |
Not more than 5.0% |
1.3% |
Related substance |
||
7-ADCA |
NMT 1.0% |
Not found |
Any other impurity |
NMT 2.0% |
1.3% |
Total |
NMT 2.5% |
1.4% |
N,N-Dimethylformamide |
NMT 0.088% |
Not found |
Acetone |
NMT 0.3% |
0.004% |
Dichloromethane |
NMT 0.06% |
0.003% |
Assay |
90.0% to 105.0% |
99.2% |
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