Appearance Yellow crystalline powder
Identification 1. HPLC: the retention time of the major peak corresponds to that of the standard sample
2. IR: the infrared absorption time spectrum exhibits maximum only at the same as that of the standard sample
3. It gives reaction of chlorides
Water content ≤1.0%
UV purity ratio ≥4.5
Trichloroammine platinate ≤1.0%
Transplatin ≤2.0%
Platinum content 64.42%-65.22%
Assay( HPLC) 98.0%-102.0%
Packing and Storage Preserve in tight containers, protected from light.
Appearance White to off white powder
Assay, HPLC 98.0%min
Identification IR, HPLC
Specific rotation (20/D) -7.0°~ -13°
Impurities Total: 1.0% max
Individual impurity: 0.5% max
Loss on drying 0.5% max
metals 0.002% max
Bacterial Endotoxins 0.36% max
Enantiomeric 2.0%max
Appearance White crystalline powder
Identification Positive
Color of solution Clear, GY4 max
Assay 99-100.5%
PH 8.0-9.5
Related substances One: 0.5% max
Others: 0.25% max
Sulphate 0.02% max
metals 0.002% max
Selenium 0.003% max
Solubility Easily soluble in water,slightly soluble in ethyl alcohol
Water 6.0-8.0%
Appearance A white or light yellow powder, odorless, hygroscpic
Identification A,B,C The positive reaction
Soluility Very soluble in water, insoluble in acetone,chloroform,ether
PH 5.5-7.5
Loss on drying 8.0% max
Assay 600 I.U/mg min(dry)
Appearance White crystalline powder
Assay 99.0-100.5%min
Melting point 128-132℃
Specific optical rotation -15.7˚~-17.3˚
Residue on ignition 0.1% max
Loss on drying 0.5%max
metals 20ppm max
Absence of reducing substance Accords with the specification
Clarity and color of the solution Accords with the specification
Appearance white crystalline powder
Optical Rotation -96˚~~ -106˚
metals Not more than 10ppm
Arsenic Not more than 2ppm
Loss on drying Not more than 5%
Residue on Ignition Not more than 0.5%
Assay Not less than 98.0%
Appearance A white crystalline powder
Assay 98.0% to 101.0%
Melting point About 185℃
Identification IR Similar with the Reference Spectrum
Optical Rotation -15.5°~-17.5°
Clearity and color of solution Clear and colourless
Metals Not more than 10ppm
Arsenic Not more than 2ppm
Related Substances Total Not more than 2.0%
GSSG Not more than 1.5%
Loss on Drying Not more than 0.5%
Residue on Ignition Not more than 0.1%
Appearance White or almost white crystalline powder
Assay, dry base 99.0-101.0%
Identification Melting point: 169.0-172.0
IR: per the spectrum of CRS
TLC: As per BP2002
Chemical test: give reaction of primary Aromatic amines
Appearance of solution The solution is clear and not more intensely colored than ref. solution Y5,BY5 or GY5
Acidity 0.3ml of 0.1M NaOH
Related substances by TLC 0.5% max
metals 20ppm max
Loss on drying 0.5% max
Sulfated ash 0.1% max