Form
Powder
Appearance
White or slightly yellow powder.
Source
Synthetic
Impurity Profile
Impurity A| (5aR,6R)-6-[[(2R)-2-[[(4-ethyl-2,3-dioxopiperazin-1-yl)-carbonyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]-5a,6-dihydro-3H, 7H-azeto[2,1-b]furo[3,4-d][1,3]thiazine-1,7(4H)-dione|73240-08-1|C23H23N5O8S|529.53| Impurity B| (6R,7R)-7-[[(2R)-2-[[(4-ethyl-2,3-dioxopiperazin-1-yl)-carbonyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]-3-[(4-methyl-5-thioxo-4,5-dihydro-1H-tetrazol-1-yl)methyl]-8-oxo-5-thial-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid|711590-76-4|C25H26N9O8S2|644.67| Impurity C| 1-methyl-1H-tetrazole-5-thiol;|69713-31-1|C2H4N4S|116.145| Impurity D| (6R,7R)-7-amino-8-oxo-3-[(1H-1,2,3-triazol-4-yl-sulphanyl)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (7-TACA)|37539-03-0|C10H11N5O3S2|313.356| Impurity E| 7ACA|957-68-6|C10H12N2O5S|272.28| Impurity F| (6R,7S)-7-[[(2R)-2-[[(4-ethyl-2,3-dioxopiperazine-1-yl)-carbonyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)sulphanyl]methyl]-8-oxo-5-thial-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid|1315481-36-7|C25H26N9O8S2|644.67|
Water Content (Karl Fisher)
≤5%
pH
4.5-6.5
Assay
(On Dried Basis): 870-1015µg/mg