CERTIFICATE OF ANALYSIS

 

 

NAME OF PRODUCT: KETOPROFEN                           BATCH NO.: 990202

REPORT DATE: FEB 28,1999

 

ITEMS

STANDARDS

RESULTS

CHARACTERISTICS:

WHITE OR ALMOST WHITE, CRYSTALLINE POWDER

PASS

IDENTIFICATION:

A. MELTING POINT: 94.0 – 97.0

B. UV AS STIPULATED

C. IR AS STIPULATED

94.0 – 95.5

PASS

PASS

APPEARANCE OF SOLUTION:

AS STIPULATED

PASS

RELATED SUBSTANCES (HPLC):

1.       3-ACETYLBENZOPHENONE:

2.       2-(3-CARBOXYPHENYL) PROPIONIC ACID:

3.       OTHER RELATED SUBSTANCES:

 

0.2% MAX.

 

0.2% MAX.

0.2% MAX. OF EACH

0.4% MAX. OF TOTAL

 

<0.01%

 

<0.01%

<0.2%

0.38%

HEAVY METALS:

10 PPM MAX.

PASS

LOSS ON DRYING:

0.5% MAX.

0.02%

SULFATED ASH:

0.1% MAX.

0.04%

ASSAY:

98.5 – 100.5%

100.18%

 

CONCLUSION: CONFORMS TO BP93.