Product: Meloxicam
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Report Date: 2004-10-13
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Reference Standard: BP2002
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Manufacture Date: 2004-10-11
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Batch No.: 041006
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Expiry Date : 2007-10-10
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Batch Size: 250 kg
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Package: 25 Kg/Drum
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Subject
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Standard BP2002
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Result
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Appearance
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Pale Yellow Powder
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Pale Yellow Powder
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| Identification |
A. Comply to the standard
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Qualified
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| B. Comply to the standard |
Qualified
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Clarity of solution
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Clear
|
Clear
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Related Substance
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Ethyl 4-hydroxy-2-methyl-2H-1, 2-benzothiazine-3carboxylate 1, -dioxide ≤ 0.05%
|
0.0323%
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5-methylthiazol-2-ylamine ≤ 0.1%
|
0.0007%
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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
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Methyl 4-hydroxy-2-methyl-2H-1, 2-benzothiazine-3-carboxylate 1,1-dioxide ≤ 0.1%
|
No trace
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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
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Total related substance ≤ 0.3%
|
0.09%
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Heavy Metals
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≤ 10PPM
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< 10PPM
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Loss On Drying
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≤ 0.5%
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0.04%
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Sulphated Ash
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≤ 0.1%
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0.04%
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Assay
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99.0 ~ 100.5%
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99.3%
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Conclusion: Up To Standard BP2002
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