Other name: (RS)-1(Isopropoxycarbonyloxy)ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-[(Z)methoxyimino]acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
CAS NO.: 87239-81-4
MF: C21H27N5O9S2
MW: 557.59
Density:1.58 g/cm3
Melting Point:111-113 °C
Appearance: white or almost white powder
Standard: USP/CP/BP/EP
Analysis Certificate
Specification:
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Test Item
Analysis Specification
Result
Description
A slightly yellowish or white power
complies
Identification
UV spectrum according to Ph.Eur.7.0
TLC according to Ph.Eur.7.0
Colorimetric test according to Ph.Eur.7.0
Conform
Solubility
Slightly soluble I water, freely soluble in acetone in ethanol(96%)and in methanol
Conform
pH
8.5~10.5
10.0
Specific optical rotation
-85°~ -80°
-82°
Related Substances
Impurity A ≤2.0%
Impurity B ≤2.0%
Impurity D ≤2.0%
Impurity E ≤2.0%
Impurity F ≤2.0%
Impurity G ≤2.0%
Impurity H ≤2.0%
Any other impurity ≤2.0%
Total impurities ≤10.0%
0.1%
1.0%
1.2%
ND
1.6%
0.1%
ND
0.12%
Conforms
Loss on drying
≤3.5%
0.9%
Sulphated ash
Not more than 0.1%
0.06%
Heavy metals
≤20ppm
<20ppm
Assay
Not less than 4100iu/mg calculated with reference to the substances
China
