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Email ：PharmaSources@imsinoexpo.com
Whatsapp ：+86-13621645194
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
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.
Twenty years of qualification
Audited Supplier
Pharma Sources Insight JANUARY 2024
