Oxaliplatin

Oxaliplatin

Oxaliplatin

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0 Metric Ton

Negotiable

  • Min.Order :0 Metric Ton
  • Purity: NLT99%
  • Payment Terms : L/C,T/T,

Keywords

Oxaliplatin 61825-94-3 Oxaliplatin supplier

Quick Details

  • Appearance:White or almost white crystalline powder
  • Application:Antineoplastic
  • PackAge:Aluminum foil bag packing seal
  • ProductionCapacity:200|Kiloliter|Year
  • Storage:Store in well closed containers and protect from light and moisture.
  • Transportation:Suitable for air

Superiority:

 

Test Items

Specifications

Appearance

White to off-white crystalline power

Identification

  1. IR spectrum
  2. The retention time of the major peak in the sample solution corresponds to that in the standard solution, as obtained in the Assay.
 

Acidity

The solution is colorless, and NMT 0.6ml of 0.01M sodium hydroxide is required to change the color to pink.

Loss on drying

≤0.5%

Optical rotation

+74.5°~+78.0°

Limit of Silver

≤5ppm

Heavy Metals

≤20ppm

Content of Platinum

48.1%~50.1% of the Oxaliplatin taken, on the dried basis

Limit of Oxalic acid

≤0.1%

Limit of (SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N]platinum, Oxaliplatin Related compound C and unspecified impurities

(SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N]platinum≤0.1%

Oxaliplatin Related compound C≤0.1%

Diaquodiaquamino cyclohexane platinum dimer ≤0.1%

Any individual unspecified impurity≤0.10%

Total impurities≤0.30%

Limit of Oxaliplatin related compound D

≤0.1%

Assay

Not less than 98.0%~102.0% of C8H14N2O4Pt, calculated on the dried basis.

Bacterial Endotoxins Test

≤1.0EU/mg of Oxaliplatin

Microbial Enumeration Tests and Tests for Specified Microorganisms

Total aerobic microbial count≤20CFU/g

Total combined molds and yeast count ≤5CFU/g

Packaging and storage: Keep in tight containers, protected from light.

 

Details:

 

Test Items

Specifications

Appearance

White to off-white crystalline power

Identification

  1. IR spectrum
  2. The retention time of the major peak in the sample solution corresponds to that in the standard solution, as obtained in the Assay.
 

Acidity

The solution is colorless, and NMT 0.6ml of 0.01M sodium hydroxide is required to change the color to pink.

Loss on drying

≤0.5%

Optical rotation

+74.5°~+78.0°

Limit of Silver

≤5ppm

Heavy Metals

≤20ppm

Content of Platinum

48.1%~50.1% of the Oxaliplatin taken, on the dried basis

Limit of Oxalic acid

≤0.1%

Limit of (SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N]platinum, Oxaliplatin Related compound C and unspecified impurities

(SP-4-2)-Diaqua[(1R, 2R)-Cyclohexane-1, 2-Diamine-N, N]platinum≤0.1%

Oxaliplatin Related compound C≤0.1%

Diaquodiaquamino cyclohexane platinum dimer ≤0.1%

Any individual unspecified impurity≤0.10%

Total impurities≤0.30%

Limit of Oxaliplatin related compound D

≤0.1%

Assay

Not less than 98.0%~102.0% of C8H14N2O4Pt, calculated on the dried basis.

Bacterial Endotoxins Test

≤1.0EU/mg of Oxaliplatin

Microbial Enumeration Tests and Tests for Specified Microorganisms

Total aerobic microbial count≤20CFU/g

Total combined molds and yeast count ≤5CFU/g

Packaging and storage: Keep in tight containers, protected from light.

 

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