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Description
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Uses: For the treatment of urinary tract, respiratory tract, skin, ENT, and gastrointestinal infections ... More ...
Uses: For the treatment of urinary tract, respiratory tract, skin, ENT, and gastrointestinal infections caused by Staphylococcus, Streptococcus, Pneumococcus, Escherichia coli, etc.
Items
Standard
Appearance
White or almost white, crystalline powder
Identification
(1)
the IR spectrum conforms to that of reference standard.
(2)
The retention time of the major peak of the sample solution
corresponds to that of the standard solution, as obtained in the assay.
Optical
rotation
+165º ~ +178º
Crystallinity
Should meet the requirements
Ph
4-6
Water
determination
4.2-6.0%
Methanol
NMT3000ppm
Acetone
NMT5000ppm
impurities
Amoxicillin related compound I NMT0.5%
Cefadroxil r-sulfoxide NMT0.15%
Cefadroxil S-sulfoxide NMT0.15%
Cefadroxil related compound B NMT0.5%
Cefadroxil related compound D NMT0.5%
Cefadroxil related compound I NMT0.15%
Diketopiperazine derivative NMT0.5%
N phenylglyeyl delta-3 cefadroxil NMT0.15%
Cefadroxil ethyl homolog NMT0.15%
n-phenylglycyl cefadroxil NMT0.5%
3-hydroxy-4-methylthipohenone NMT0.5%
N-ethoxycarbonyl 7-aminodesace-toxycephalosporanic acid NMT0.15%
O-ethoxycarbonyl cefadroxil NMT0.3%
Cefadroxil dimer NMT0.15%
Any individual unspecified impurity NMT0.10%
Total impurities NMT2.0%
Assay
Has a potency equivalent to NLT 950ug/mg
And NMT 1050ug/mg of cefadroxil(C16H17N3O5S),calculated
on the anhydrous basis.
Bulk
density
For information only
Tapped
density
For information only
Less ...
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