EP7.2 OXALIPLATIN 61825-94-3
Basic Information
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Product Name
EP7.2 OXALIPLATIN 61825-94-3
Details
Substance
Manufacturer(s)
Specifications
- Certification Standard: Complies with USP, BP, EP, JP pharmacopoeial monograph(s)
- IUPAC Name: oxalate;platinum(2+);trans-(1R,2R)-cyclohexane-1,2-diamine
- EC Number: 621-248-1
- Molecular Weight: 397.29
- Chemical Formula: C8H14N2O4Pt
- CAS Number: 61825-94-3
- Purity: Assay 98.0%-102.0%, dried-substance basis
- Endotoxin Level: <1.0 IU/mg
- Formulation Type: White to almost white crystalline powder
- Application: Platinum-based anticancer agent for colorectal and ovarian cancer
- Test Item: SPECIFICATION
- Description: White or almost white crystalline powder
- Solubility: Slightly soluble in water ,very slightly soluble in methanol, practically insoluble in ethanol
- Identification: A.The infrared absorption spectrum as the same as Oxaliplatin CRS B.Test for specific optical rotation
- Acidity: Not more than 0.6ml of 0.01M NaOH is required to change the colour of the indicator to pink
- Specific optical rotation: +74.5Β°~+78.0Β°
- 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%
- Impurity D: NMT0.10%
- Silver: NMT5.0ppm
- Loss on Drying: NMT0.5%
- Assay: 98.0~102.0% (dried substance)
- Bacterial endotoxins: <1.0IU/mg
- Total aerobic microbial count: β€50cfu/g
Documents
ISO9001
GMP regulated workshops
GMP
CEP certificates with DMF documents are available
FDA
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