| Product name | Cephradine |
| CAS No. | 38821-53-3 |
| Molecular formula | C16H19N3O4S |
| Molecular weight | 349.4 |
| Purity | 99% |
| Appearance | White or almost white powder |
| Package | Aluminum Bag;Drums |
| Shelf life | 2 years |
|
Test Items |
Specification |
Result |
|
Description |
White or slightly yellow crystalline powder |
Conforms |
|
Solubility |
Sparingly soluble in water, practically insolublein alcohol |
Conforms |
|
Identification |
Conforms |
Conforms |
|
Appearance of solution |
Solutions is not more opalescent than referencesuspension II |
Conforms |
|
Clearance of solution |
Clear |
Clear |
|
Absorbance at 450nm |
Not more than 0.2 |
0.045 |
|
PH |
Between3.5 and 6.0 |
4.9 |
|
Specific Optical Rotation |
Between +80and +90on anhydrous basis |
+85.9 |
|
Absorbance at 330nm |
Not more than 0.050 |
0.007 |
|
Specific Absorbance at 262nm |
Between 215 to 240 on anhydrous basis |
226 |
|
Particle size |
6-14%≥40 mesh, 60-80% between 100-40 mesh, 15-25%≤100mesh |
Confirms |
|
Related substances: 7-ADCA Cyclohexa-1, 4-dienylglycine Any other impurity |
Not more than 1.0% by TLC Not more than 1.0% by TLC Not more than 1.0% by TLC |
Confirms Confirms Confirms |
|
Water |
Not more than 6.0% |
4.5% |
|
Cephalexin content |
Not more than 5.0% |
1.0% |
|
Sulfated Ash |
Not more than 0.20% |
0.06% |
|
Loose Density |
0.62-0.68 GR/ML |
0.65GR/ML |
|
Tapped Density |
≥0.85 GR/ML |
Confirms |
|
Assay |
Not less than 90.0% w/w as cefradine on anhydrousbasis by HPLC Between 95.0% and 102.0% w/w on anhydrous basis byHPLC (sum of the percentage contents of cephradine) |
96.3% 99.2% |