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|
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| SOME
QUALITY PARAMETERS - Results
are given for standard 20 mg omeprazole capsule |
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|
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WATER
CONTENT |
|
| |
Standard |
:
1.5-3.0% K.F. (Karl Fischer) |
| |
Eskayef
result |
:
1.97% K.F. |
| |
Advantage |
:
Less chance of degradation due to moisture |
| |
|
|
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UNIFORMITY
OF WEIGHT |
|
| |
Standard |
:
303-357 mg |
| |
Eskayef
result |
:
312-343 mg |
| |
Advantage |
:
Uniform drug content in every unit of medicine |
| |
|
|
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MICROBIAL
LIMIT TEST |
|
| |
Standard |
:
Total aerobic microbial count (TAMC) less than or equal to 1000 cfu/g |
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|
:
Total fungi less than or equal to 100 cfu/g (cfu = colony forming
unit) |
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|
:
E.coli should be negative/g |
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|
:
Salmonella sp. should be negative/g |
| |
Eskayef
result |
: Within standard range |
| |
Advantage |
: Aseptic formulation |
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e
