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OXALIPLATIN 61825-94-3

OXALIPLATIN 61825-94-3

EP7.2 , Medical Grade
  • Product Details

COA of Oxaliplatin


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.


Usage


Function of Oxaliplatin

Oxaliplatin is the third-generation platinum-based anticancer drug, a platinum compound of diaminocyclohexane, that is, a 1,2-diaminocyclohexane group is substituted for the amino group of cisplatin. It has the same effect as other platinum drugs, that is, it takes DNA as the target site of action, and platinum atoms form a cross-link with DNA to antagonize its replication and transcription. Combined application with fluorouracil (5-FU) has a synergistic effect; in vitro and in vivo studies have shown no cross-resistance with cisplatin. Oxaliplatin has a good effect on colorectal cancer and ovarian cancer, and has a certain effect on gastric cancer, non-Hodgkin's lymphoma, non-small cell lung cancer, and head and neck tumors. Colorectal cancer patients who are not effective for 5-FU treatment are still effective for other platinum-resistant patients.

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