Cilastain acid CAS NO.82009-34-5

tems

requirements

results

appearance

white to off-white or pale yellow powder

off-white powder

identification

the retention times of the peaks for imipenem

and cilastatin in the chromatogram of the

assay preparation correspond to those in the

chromatogram of standard preparation, as

obtained in the assay.

confirms

constituted solution

constitute the solution as directed in the labeling

supplied by the manufacturer for the sterile dry

dosage form; the solid dissolves completely,

leaving no visible residue as undissolved matter;

the constituted solution is not significantly less

clear than an equal volume of the diluent or of

purified water contained in a similar vessel and

examined similarly; the solution is essentially

free from particles of foreign matter that can

be observed on visual inspection.

confirms

loss on drying

≤3.5%

1.0%

ph

6.5~8.5

7.5

particulate matter

particle≥10um: ≤6000/g

550

particle≥25um: ≤600/g

0

imipenem assay

42.5~48.0%(on dried basis)

46.4%

cilastatin assay

42.5~48.0%(on dried basis)

45.1%

bacterial endotoxins

≤0.17eu/mg

<0.003eu/mg

sterility

meets the requirements

confirms

conclusion: this product conforms to the usp detection.