CEFADROXIL CEFADROXIL CEFADROXIL
1. ISO AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
ITEMS |
SPECIFICATIONS |
RESULTS |
Appearance |
White or almost white crystalline powder |
Almost white crystalline powder |
Identification |
The IR spectrum conforms to that of reference standard. |
Complies |
|
The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay |
Complies |
Optical Rotation |
+165.0° ~ +178.0° |
+174.3° |
Crystallinity |
Should meet the requirements |
Complies |
pH |
4.0 ~ 6.0 |
5.0 |
Water determination |
4.2% ~6.0% |
5.0% |
Methanol |
NMT 3000ppm |
198ppm |
Acetone |
NMT 5000ppm |
106ppm |
Impurities |
7-ADCA NMT 0.5% |
0.06% |
|
P-hydroxyphenylglycine NMT 0.5% |
0.06% |
|
Delta-3 cefadroxil NMT 0.15% |
0.02% |
|
Any individual unspecified impurity NMT 0.10% |
0.07% |
|
Total impurities NMT 2.0% |
0.41% |
Assay |
Has a potency equivalent to NLT 950ug/mg and NMT 1050ug/mg of cefadroxil (C16H17N3O3S),calculated on the anhydrous basis. |
1002ug/mg |
Bulk Density |
For information only |
0.64g/ml |
Tapped Density |
For information only |
0.75g/ml |
Remarks |
N,N-Dimethylaniline in this process is not utilized |
|
Conclusion |
The product complies with specification USP44 |
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