Certificate of Analysis of

Ketoprofen Sustained Release pellets

Characters : white homogenous micro-granules

Disintegration : NMT 30 min.

Dissolution

- After 1 h in 0.1 N HCL : 0-5%

- After 2 H in pH 7.4 : 28-38%

- After 4 h in pH 7.4 : 60-70%

- After 6 h in pH 7.4 : 75-100 %

Identification

- Ultraviolet : must Comply

Assay : 667- 737 mg/g

Related substance

- impurity A : NMT 0.2%

- impurity C : NMT 0.2%

- Any secondary peak : NMT 0.2%

- Sum of any secondary peaks : NMT 0.5%

Microbial Limits

- Total bacterial count : NMT 1000 cfu/g

- Moulds and yeast : NMT 100 cfu/g

- Escherichia coli : Absent

- Salmonella species : Absent

- Staph.species : Absent