Form
Powder
Appearance
White or almost white powder
Source
Semi-synthetic
Impurity Profile
Impurity A| (6R,7R)-7-amino-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulphanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid|30246-33-4|C11H12N4O3S3|344.44| Impurity B| (6R,7R)-7-[(2,2-dimethylpropanoyl)amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulphanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid||C16H20N4O4S3|428.55| Impurity C| (6R,7R)-3-methyl-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid|56842-77-4|C11H12N6O4S|324.32| Impurity D| (6R,7R)-3-[(acetyloxy)methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid|32510-61-5|C13H14N6O6S|382.36| Impurity E| MMTD|29490-19-5|C3H4N2S2|132.2| Impurity G| (5aR,6R)-6-[(1H-tetazol-1-ylacetyl)amino-5a,6-dihydro 3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazine-1,7(4H)-dione||C11H10N6O4S|322.30| Impurity H| 7-ACA|957-68-6|C10H12N2O5S|272.28| Impurity I| cefazoloic acid; 2-[carboxy[(1H-tetrazol-1-ylacetyl)amino]methyl]-5-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl]-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid||C14H16N8O5S3|472.53| Impurity J| hydrolysed cefazoloic acid; 2-[carboxy[(1H-tetrazol-1-ylacetyl)amino]methyl]-5-(hydroxymethyl)-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid||C11H14N6O6S|358.33| Impurity K| Cefazolinamide; (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxamide||C14H15N9O3S3|453.53| Impurity L| (6R,7S)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulphanyl]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 1H-Tetrazole-1-acetic acid|21732-17-2|C3H4N4O2|128.09|
Water Content (Karl Fisher)
≤6.0%
pH
4.0-6.0
Optical Rotation
-10° to -24°
Assay
(On Dried Basis): 89.1-110.1%