THE CERTIFICATE OF ANALYSIS

PRODUCT NAME: IRINOTECAN

BATCH NO: 010501 MFG. DATE: MAY, 2001

QUANTITY: 100G EXP. DATE: MAY, 2002

CHECK ACCORDING TO THE FACTORY DRUG STANDARD.

TEST RESULT

DESCRIPTION: IT IS A YELLOW CRYSTALLINE POWDER

IDENTIFICATION: STANDARD CONFORMS

[α ]20D +60° TO +73° +72.2°

RESIDUE ON IGNITION: NMT 0.1% 0.06%

WATER: 7.0% TO 9.0% 7.9%

HEAVY METALS: NMT 20 PPM 20 PPM MAX

PH: 3.0 TO 5.0 5.0

CHROMATOGRAPHIC PURITY

TOTAL NMT 2.0% 0.8%

INDIVIDUAL NMT 0.5% 0.3%

ASSAY: 97.0 TO 103.0% 99.4%

RESULT: IN ACCORDANCE WITH THE FACTORY DRUG STANDARD.