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29 Cards in this Set
- Front
- Back
- 3rd side (hint)
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3 non pharmacopeial or non official tests |
Tablet hardness Friability test Tablet thickness |
TFT |
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2 characteristics of pharmacopeial test |
Described in official compendia Standardized test procedures |
DS |
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2 medium used for the disintegration test of delayed release or enteric coated tablet |
Gastric fluid Intestinal fluid |
GI |
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Limit for the gastric fluid TS |
No evidence of disintegration after 1 hour |
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Limit for the disintegration test of BUCCAL tablets |
After 4 hours |
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Used to characterize the dissolution properties of the active drug |
Dissolution test |
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Used to formulate the drug dosage form |
Dissolution |
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Used to develop QC specs for its manufacturing process |
Dissolution test |
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Dissolution apparatus I |
Basket |
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Dissolution apparatus II |
Paddle |
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Dissolution apparatus III |
Reciprocating cylinder |
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Dissolution apparatus IV |
Flow-through cells |
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Dissolution apparatus V |
Paddle over disk |
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Dissolution apparatus VI |
Cylinder |
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Dissolution apparatus VII |
Reciprocating disk |
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Rotation speed of basket |
50-120 rpm |
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Rotation speed of paddle |
25-50 rpm |
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Rotation speed of reciprocating cylinder |
635 dips per minute |
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Rotation speed of flow through cells |
None |
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Rotation speed of paddle over disk |
25-50 rpm |
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Rotation speed of cylinder |
None |
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Rotation speed of reciprocating disk |
30 rpm |
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3 DF to be tested in basket |
Immediate release Delayed release Extended release |
IDE |
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3 DF to be tested in paddle |
Immediate release Delayed release Extended release |
IDE |
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2 DF to be tested in reciprocating cylinder |
Immediate release Extended release |
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2 DF to be tested in flow through cells |
Extended release Poorly soluble drug |
EP |
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1 DF to be tested in paddle over disk |
Transdermal |
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1 DF to be tested in cylinder |
Transdermal |
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1 DF to be tested reciprocating disk |
Extended release |
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