Term
| quality testing for all products |
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Definition
-appearance
-potency (assay)
-stability |
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Term
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Definition
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Term
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Definition
| -content of drug substance in the individual tablet/capsule |
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Term
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Definition
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Term
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Definition
for products with greater than 25mg strength
and greater than 25% drug loading |
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Term
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Definition
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Term
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Definition
| weight loss after 10 rotations |
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Term
| IR products should disintegrate in |
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Definition
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Term
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Definition
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Term
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Definition
| -describes a rate and multiple factors |
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Term
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Definition
-dissolve in solution
-dissolve into bulk (rate limiting) |
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Term
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Definition
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Term
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Definition
| disintegration,particle size,wetting |
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Term
| Diffusion coefficient factors |
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Definition
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Term
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Definition
| solvent temp pH crystallinity |
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Term
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Definition
| medium volume and drug removal |
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Term
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Definition
| stagnant layer, thickness |
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