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Product : Latamoxef sodium
CAS No: 64953-12-4
Product introduction :

High quality Latamoxef sodium

CERTIFICATE OF ANALYSIS

Product Name:

Latamoxef sodium

CAS No.:

64953-12-4

Quantity

500mg

Rep Date

Nov.03.2013

Batch NO.

20131103

MFG. Date

Nov.03.2013

Expiry Date

Nov.02.2015

Item

Specifications

Results

Characters

White or light yellow powder or block

Conforms

Identification

(1)The retention time of principal peak in the substance being examined in the chromatogram obtained in the Assay is identical with that of the principal peak in the chromatogram of the reference solution correspondingly

Conforms

(2)Infrared absorption spectrum should be consistent with the comparison of map

(3)Show the identification reaction of sodium salt

Turbidity of solution

The solution should be clear and colorless; if show turbidity, compared with the No.1 turbidity standard solution, concentrations shall not be thicker

Reference

suspension 1

Color of Solution

If Color Renderingcompared with yellow or Green Yellow No. 6 standard color solution (Appendix K A first law), shall not be deeper

Y6

PH

5.07.0

6.5

Water

5.0%

3.6%

Related Substances

Latamoxef R, S isomer two peak separation degree should not be less than 3 degrees of separation, two peak and the adjacent impurity peak should meet the requirements.

Such as impurity peaks in the chromatogram of the test solution, a single impurity peak area shall not be greater than the control solution two peak area and 2 times (2%), the area of each impurity peak and shall not be greater than the control solution two peak area and 5 times (5%)

Conforms

Isomer

In the determination of chromatogram recorded under, latamoxef R isomers and latamoxef isomers of S peak area ratio should be 0.8 ~ 1.4

1.1

Residual solvent

Ethyl acetate, methyl ethyl ketone, acetone, dichloromethane and methanol by internal standard method by peak area ratio of computing, shall comply with the provisions of.

Conforms

Bacterial Endotoxins

Each 1mg latamoxef containing endotoxin content shall be less than 0.050EU

Conforms

Assay

 On dry basis (C20H20N6Na2O9S830ug/mg

856ug

Conclusion

The results conforms with JP16 standards

Analyst:Liya                Checker:Weichen                 Q.C.Director:Xuleilei

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