Aztreonam CAS NO.78110-38-0

Items

Specification

Analysis Result

Appearance

White, odorless crystalline powder

Conform

Identification

The retention times of the major peaks in the chromatogram of the assay preparation correspond to those of the Standard preparation obtained in the assay

Conform

Color of Solution

Not more than yellow or

greenish- yellow Reference Solution II

Conform

Clarity of solution

Not more than Turbidity Standard I

Conform

PH

4.5~7.5

5.2

Related

Impurities

Single impurities

Not more than1.0%

0.34%

Total impurities

Not more than3.0%

1.25%

Water Content

Not more than 2.0%

0.3%

Residue of ignition

Not more than 0.1%

Conform

Heavy Metals

Not more than 30ppm

Conform

Bacterial Endotoxins

Not more than 0.17EU/mg (Aztreonam)

Conform

Sterility Test

Sterile (without germs in 14 days)

Conform

Particulate matter

≥10µm, no more than 2500/g

≥25µm, no more than 250/g

1084

67

Assay

Contain C13H17N5O8S2 90.0% ~105.0%

(Calculated on anhydrous substance without L-Arginine )

99.5%

L-Arginine content

42%~45%

43.4%