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Cefuroxime Sodium Salt Sterile CAS 56238-63-2

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    2017-11-23 16:44

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Fengchen Group Co.,Ltd

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Cefuroxime Sodium Salt Sterile CAS 56238-63-2                                             

Product Name:  Cefuroxime Sodium Salt Sterile

Synonyms:  Cefuroximum natricum

CAS Number: 56238-63-2

Characteristics:  White or almost white powder.

Assay and Potency:  855µg/mg ~ 1000µg/mg calculated by Cefuroxime (C16H16N4O8S) in USP;

96%~102% in BP standard

Formula: C16H15N4NaO8S

Package:  “10Kg/Tin/Ctn”  or  “7Kg/Tin, 2Tins/Ctn”

Usage: Cefuroxime Sodium is a cef anti-Bacterial substance with a broad spectrum. It is mainly used to produce Cefuroxime Sodium  intravenous Injections.

RS of Cefuroxime Sodium:

COA—Cefuroxime Sodium Sterile

TEST

REFERENCE

RESULTS

Description

A   white to slight yellow powder

Complies

Identification

The   retention time of sample corresponds to the retention time of cefuroxime RS.

Complies

Yields   the flame reaction of sodium salts

Complies

PH

6.0~8.5

7.1

Clarity   of solution

≤ 1   #

≤   0.25#

Color   of solution

≤ Y6   or YG6

≤ 2   #

Water

≤   3.5%

2.1%

Residual   solvents

Methanol   ≤ 0.3%

Ethanol   ≤ 0.5%

Acctone   ≤0.5%

0.08%

0.19%

0.19%

Bacterial   endotoxins

<   0.10 EU/mg

Complies

Sterility

Should   be sterile

sterile

Related   substances

Individual   Impurity ≤ 1.0%;

Total   impurities ≤ 3.0%

Complies

Complies

Cefuroxime   polymer

≤   0.2%

0.02%

Visible   parlicles

≤ 5   /3g

Complies

2-Ethylhexanoic   acid

≤   0.5%

0%

Assay(Cefuroxime)

855ug/mg   ~ 1000ug/mg

949ug/mg

Conclusion:   The product complies as per above USP38 specifications.