Meropenem Sterile

CAS number: 96036-03-2

Molecular formula: C17H25N3O5S

molecular weight: 383.4625

Chemical structure:


Product Name

Meropenem with Sodium Carbonate

Shelf Life2 years

ANALYSIS TEST

SPECIFICATIONS

RESULTS

Appearance

White to yellowish crystalline powder

Conformed

Identification

positive

Conformed

PH7.3~8.37.9
Loss on drying9.0%~12.0%10.1%
Colour of solution Y5# orK5# of reference solution K1#
Clarity of solution 05# of reference suspension0.5#
Visible matterComply with the requirement complies

 

Limit of Acetone≤0.05%0.01%
Bulk densityInformative 043g/cm3

Related substance

 

On dry basis
PRT(0.45)≤0.80%0.02%
PRT(1.90)≤0.60%ND
Particulate Matter≥10um≤4000 per container 126 per container
≥25um≤400 per container0 per container
Uniformity of dosage unitsMeets the requirementsConformed
Bacterial endotoxinsunder≤0.125EU/mgConformed
SterilityMeets the requirementsConformed

Assay(C17H25N3O5S) on anhydrous basis

≥78.0%82.3%