Product Name:Oxaliplatin
Synonyms: [SP-4-2-(1R-TRANS)]-(1,2-CYCLOHEXANEDIAMINE-N,N')[ETHANEDIOATA(2-)-O,O']PLATINUM;OXALIPLATIN;trans-l-diaminocyclohexane oxalatoplatinum;(1,2-cyclohexanediamine-n,n’)(ethanedioato(2-)-o,o’)-platinu(sp-4-2-(1r-tr;1-ohp;oxalato(1r,2r-cyclohexanediammine)platinum(ii);oxalatoplatin;oxalatoplatinum
CAS NO:61825-94-3
Molecular Formula:C8H14N2O4Pt
Molecular Weight:397.29
Appearance:White to off-white crystalline power
Assay:98.0%-102.0%
RIDADR:UN2811,Class6.1,PGII
Usage:A antitumor agent with activity against colorectal cancer.
COA of high quality Oxaliplatin 61825-94-3 in USP34:
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Test Items
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Specifications
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Appearance
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White to off-white crystalline power
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Identification
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1 IR spectrum
The retention time of the major peak in the sample solution corresponds to that in the standard solution, as obtained in the Assay.
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Acidity
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The solution is colorless, and NMT 0.6ml of 0.01M sodium hydroxide is required to change the color to pink.
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Loss on drying
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≤0.5%
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Optical rotation
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+74.5°~+78.0°
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Limit of Silver
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≤5ppm
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Heavy Metals
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≤20ppm
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Content of Platinum
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48.1%~50.1% of the Oxaliplatin taken, on the dried basis
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Limit of Oxalic acid
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≤0.1%
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Limit of (SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N’]platinum, Oxaliplatin Related compound C and unspecified impurities
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(SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N’]platinum≤0.1%
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Oxaliplatin Related compound C≤0.1%
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Diaquodiaquamino cyclohexane platinum dimer≤0.1%
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Any individual unspecified impurity≤0.10%
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Total impurities≤0.30%
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Limit of Oxaliplatin related compound D
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≤0.1%
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Assay
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Not less than 98.0%~102.0% of C8H14N2O4Pt, calculated on the dried basis.
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Bacterial Endotoxins Test
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≤1.0EU/mg of Oxaliplatin
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Microbial Enumeration Tests and Tests for Specified Microorganisms
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Total aerobic microbial count≤20CFU/g
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Total combined molds and yeast count≤5CFU/g
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Packaging and storage:Keep in tight containers, protected from light.
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Conclusion:Conforms to the USP34
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