rapidly disolving products
- Guideline or reference source
- ICHQ6A Specifications: new chemical drug substances and products
- Definition
- An immediate release solid oral drug product is considered rapidly dissolving when not less than 80% of the label amount of the drug substance dissolves within 15 minutes in each of the following media: (1) pH 1.2, (2) pH 4.0, and (3) pH 6.8.
- Related Term
- highly water soluble drugs
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