Original
By certification 
Cephradine and Cephradine with L-Arginine Sterile CAS 38821-53-3 
Product: |
Cephradine Powder |
Cephradine Compacted |
Cephradine L-Arginine Sterile |
Synonyms: |
Cefradine , Velosef |
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Appearance: |
White or slightly yellow crystalline powder |
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CAS Number: |
Cephradine CAS 38821-53-3 Cephradine Monohydrate CAS 31828-50-9 Cephradine Dihydrate CAS 58456-86-3 |
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Assay: |
900µg/mg~1050µg/mg (calculated sum of cephradine (C16H19N3O4S) and cephalexin (C16H17N3O4S)) |
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Formula: |
C16H19N3O4S |
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Package: |
Oral Grade: 25Kg/Drum Sterile injection Grade: 5Kg/Tin |
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Difference: |
Small powder to make oral drugs |
Larger powder to make oral drugs |
For injection use |
Usage: There are 3 forms of Cepharadine. They are Cephradine Powder, Cephradine Compacted, and Cephradine L-Arginine Sterile powder. They are all anti-biotic.
Cephradine Powder, Cephradine Compacted are used to make tablets, capsules, and oral medicines.
Cephradine L-Arginine sterile powder is for Injection use.
COA— Cephradine
Test Items |
Specification |
Result |
Description |
White or slightly yellow crystalline powder |
Conforms |
Solubility |
Sparingly soluble in water, practically insoluble in alcohol |
Conforms |
Identification |
Conforms |
Conforms |
Appearance of solution |
Solutions is not more opalescent than reference suspension 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 +80ｏand +90ｏon anhydrous basis |
+85.9ｏ |
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%≤100 mesh |
Confirms |
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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 anhydrous basis by HPLC Between 95.0% and 102.0% w/w on anhydrous basis by HPLC (sum of the percentage contents of cephradine) |
96.3%
99.2% |
