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TEST ITEM
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SPECIFICATION
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RESULTS
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Description
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White or
almost white crystalline powder
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White crystalline powder
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Solubility
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Slightly soluble in water ,very slightly soluble in methanol,
practically insoluble in ethanol
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Complies
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Identification
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A.The infrared absorption spectrum as the same as Oxaliplatin CRS
B.Test for specific optical rotation
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A.Complies
B.Complies
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Apearance of solution
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The solution is clear and colourless
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Complies
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Acidity
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Not more than 0.6ml of 0.01M NaOH is required to change the colour of
the indicator to pink
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Complies
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Specific optical rotation
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+74.5°~+78.0°
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+75.4°
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Related
substances
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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%
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Impurity D
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NMT0.10%
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N.D
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Silver
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NMT5.0ppm
|
0.08ppm
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Loss on drying
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NMT0.5%
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0.09%
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Assay
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98.0~102.0% (dried substance)
|
99.7%
|
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Bacterial endotoxins
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<1.0IU/mg
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Complies
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Total aerobic microbial count
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≤50cfu/g
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Complies
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Total combined yeasts and moulds count
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≤10cfu/g
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Complies
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Conclusion
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Complies with EP7.2.
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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.
