ITEMS

SPECIFICATIONS

RESULTS

Appearance

White crystalline powder, soluble in water, very slightly soluble in e and in alcohol

 Conforms

Identification

 IR

Conforms

Appearance of solution

Solution is clear and colorless

Conforms

Acidity

To 10ml of solution S1 add 0.1ml of

phenolphthalein solution R1,the solution is colourless,not more than 0.7 ml of 0.01Me is required to change the colour of the indicator to pink

Conforms

PH

5.0~7.0

6.3

Loss on drying

≤05%

0.08%

Residue on Ignition

≤0.3%

0.3%

Transmittance

≥97%

97.2%

Water-insoluble matter

≤0.5%

0.21%

Limit of 1,1-cyclobutane-

dicarboxylic acid

≤0.5%

N.D

Chromatographic purity:

   Individual impurity:

    All impurities:

≤0.25%

≤0.5%

0.077%

0.19%

Platinum content

52.0% - 53.0%

52.33%

Chlorides

≤100ppm

Conforms

Ammonium

≤100ppm

Conforms

      Silver

                    ≤10ppm

Conforms

      Soluble barium

                    ≤10ppm

Conforms

Assay

98.0%-102.0% 

99.2%

Conclusiion

This product complied with the standard of USP