|
Product name
|
Piperacillin USP
|
|
CAS NO.
|
66258-76-2
|
|
Description
|
White to off-white crystalline powder
|
|
Specific rotation
|
+155 to +175°
|
|
Identification
|
The infrared absorption spectrum of the substance should correspond to the spectrum of the reference standard
|
|
Water
|
2.0-4.0%
|
|
Heavy metals
|
0.002%max
|
|
Related substances (HPLC)
|
|
|
Ampicillin
|
0.2%max
|
|
Related compound A
|
1.0%max
|
|
Related compound B
|
0.2%max
|
|
Related compound C
|
0.4%max
|
|
Any unknown compound
|
0.1%max
|
|
Related compound D
|
2.0%max
|
|
The sum of all impurities
|
3.8%max
|
|
Residual solvents(GC)
|
Dichloromethane: 600ppm max
Ethyl acetate:5000ppm max
|
|
Assay
|
960-1030ug/mg
|
|
Bacterial endotoxins
|
Contains not more than 0.07 USP Endotoxin unit/mg of piperacillin
|
|
Microbial limits
|
|
|
Total aerobic microbial count
|
100cfu/g max
|
|
Total combined moulds and yeasts count
|
20cfu/g max
|
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