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Oxaliplatin 61825-94-3 Oxaliplatin 61825-94-3

Oxaliplatin 61825-94-3
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Maklumat asas Oxaliplatin 61825-94-3

Name

Oxaliplatin

Alias

trans-l-diaminocyclohexane oxalatoplatinum; oxalato(1r,2r-cyclohexanediammine)platinum(ii); oxalatoplatin; oxalatoplatinum

CAS NO.

61825-94-3

Molecular Formula

C8H14N2O4Pt

Molecular Weight

397.29

Quality Standard

EP7.2

Package Size

Aluminium bag;

Brief Introduction

Third generation platinum complex. An antitumor agent with activity against colorectal cancer.

Penggunaan Oxaliplatin 61825-94-3

  • Ejen antitumor dengan aktiviti menentang kanser kolorektal; Antineoplastic.
  • Vasodilator

COA of Oxaliplatin 61825-94-3

TEST ITEM

SPECIFICATION

RESULTS

Description

White or almost white crystalline powder

White crystalline powder

Solubility

Slightly soluble in water ,very slightly soluble in methanol, practically insoluble in ethanol

Complies

Identification

A.The infrared absorption spectrum as the same as Oxaliplatin CRS

B.Test for specific optical rotation

A.Complies


B.Complies

Apearance of solution

The solution is clear and colourless

Complies

Acidity

Not more than 0.6ml of 0.01M NaOH is required to change the colour of the indicator to pink

Complies

Specific optical rotation

+74.5°~+78.0°

+75.4°




Related substances

ImpurityA: NMT0.10%

ImpurityB: NMT0.10%

ImpurityC: NMT0.10%

Any other impurity: NMT0.10%

Total of other impurities: NMT0.10%

(include impurity C)

Total of impurities: NMT0.30%

ImpurityA 0.01%

ImpurityB:0.01%

ImpurityC: 0.001% Any

other impurities: 0.003%

Total of other impurities:

0.01%

Total of impurities: 0.03%

Impurity D

NMT0.10%

N.D

Silver

NMT5.0ppm

0.08ppm

Loss on drying

NMT0.5%

0.09%

Assay

98.0~102.0% (dried substance)

99.7%

Bacterial endotoxins

<1.0IU/mg

Complies

Total aerobic microbial count

≤50cfu/g

Complies

Total combined yeasts and moulds count

≤10cfu/g

Complies

Conclusion

Complies with EP7.2.


MORE_DETAIL Oxaliplatin 61825-94-3

Maklumat asas Oxaliplatin 61825-94-3

Name

Oxaliplatin

Alias

trans-l-diaminocyclohexane oxalatoplatinum; oxalato(1r,2r-cyclohexanediammine)platinum(ii); oxalatoplatin; oxalatoplatinum

CAS NO.

61825-94-3

Molecular Formula

C8H14N2O4Pt

Molecular Weight

397.29

Quality Standard

EP7.2

Package Size

Aluminium bag;

Brief Introduction

Third generation platinum complex. An antitumor agent with activity against colorectal cancer.

Penggunaan Oxaliplatin 61825-94-3

  • Ejen antitumor dengan aktiviti menentang kanser kolorektal; Antineoplastic.
  • Vasodilator

COA of Oxaliplatin 61825-94-3

TEST ITEM

SPECIFICATION

RESULTS

Description

White or almost white crystalline powder

White crystalline powder

Solubility

Slightly soluble in water ,very slightly soluble in methanol, practically insoluble in ethanol

Complies

Identification

A.The infrared absorption spectrum as the same as Oxaliplatin CRS

B.Test for specific optical rotation

A.Complies


B.Complies

Apearance of solution

The solution is clear and colourless

Complies

Acidity

Not more than 0.6ml of 0.01M NaOH is required to change the colour of the indicator to pink

Complies

Specific optical rotation

+74.5°~+78.0°

+75.4°




Related substances

ImpurityA: NMT0.10%

ImpurityB: NMT0.10%

ImpurityC: NMT0.10%

Any other impurity: NMT0.10%

Total of other impurities: NMT0.10%

(include impurity C)

Total of impurities: NMT0.30%

ImpurityA 0.01%

ImpurityB:0.01%

ImpurityC: 0.001% Any

other impurities: 0.003%

Total of other impurities:

0.01%

Total of impurities: 0.03%

Impurity D

NMT0.10%

N.D

Silver

NMT5.0ppm

0.08ppm

Loss on drying

NMT0.5%

0.09%

Assay

98.0~102.0% (dried substance)

99.7%

Bacterial endotoxins

<1.0IU/mg

Complies

Total aerobic microbial count

≤50cfu/g

Complies

Total combined yeasts and moulds count

≤10cfu/g

Complies

Conclusion

Complies with EP7.2.

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