Product: Meloxicam

Report Date: 2004-10-13

Reference Standard: BP2002

Manufacture Date: 2004-10-11

Batch No.: 041006

Expiry Date : 2007-10-10

Batch Size: 250 kg

Package: 25 Kg/Drum

Subject

Standard BP2002

Result

Appearance

Pale Yellow Powder

Pale Yellow Powder

Identification

A. Comply to the standard

Qualified

B. Comply to the standard

Qualified

Clarity of solution

Clear

Clear

Related Substance

Ethyl 4-hydroxy-2-methyl-2H-1, 2-benzothiazine-3carboxylate 1, -dioxide ≤ 0.05%

0.0323%

5-methylthiazol-2-ylamine ≤ 0.1%

0.0007%

4-hydroxy-2-methyl-N- (5-methyl-1, 3-thiazol-2-yl)-2H-1, 2-benzothiazine-3-carboxamide 1,1-dioxide ≤ 0.05%

No trace

Methyl 4-hydroxy-2-methyl-2H-1, 2-benzothiazine-3-carboxylate 1,1-dioxide ≤ 0.1%

No trace

4-hydroxy-2-methyl-N-methyl-N- (5-methyl-1, 3-thiazol-2-yl)-2H-1, 2-benzothiazine-3-carboxamide 1,1-dioxide ≤ 0.1%

No trace

Total related substance ≤ 0.3%

0.09%

Heavy Metals

≤ 10PPM

< 10PPM

Loss On Drying

≤ 0.5%

0.04%

Sulphated Ash

≤ 0.1%

0.04%

Assay

99.0 ~ 100.5%

99.3%

Conclusion: Up To Standard BP2002