Certificate of Analysis
Carboplatin
(Paraplatin)

Batch Number:

031229

Quantity:

1000grams

Description:

A white crystalline powder

Identification:

 

(1). IR the infrared absorption spectrum exhibits maximal only at the same wavelengths at that of the standard sample.

(Yes)

 

(2). TCL the only spot exists and it corresponds in appearance and Rf to that of the standard sample.

(Yes)

Impurities:

 

(1). Insoluble substances.

(0.08%)

 

(2). 1,1-cyclobutanedicarboxylate salt.

(0.20%)

 

(3). Water content.

(0.17%)

 

(4). Harmful metals.

(Ag, Pb<10ppm, As<2ppm)

 

(5). Chromatographic Purity.

(Single<0.10%, total<0.30%)

Test and Assay:

 

(1). Transmittance.

(99.4%, 10mg/mL)

 

(2). PH.

(6.1, 10mg/mL)

 

(3). Platinum content.

(52.5%)

 

(4). Carboplatin content.

(99.4% by HPLC)

 

Standard:

USP24

Mfg. Date:

Dec. 29, 2003

Exp. Date:

Dec. 29, 2008