highly water soluble drugs
- Guideline or reference source
- ICHQ6A Specifications: new chemical drug substances and products
- Definition
- Drugs with a dose/solubility volume of less than or equal to 250 mL over a pH range of 1.2 to 6.8. (Example: Compound A has as its lowest solubility at 37± 0.5°C, 1.0 mg/mL at pH 6.8, and is available in 100 mg, 200 mg, and 400 mg strengths. This drug would be considered a low solubility drug as its dose/solubility volume is greater than 250 mL (400 mg/1.0 mg/mL = 400 mL).
- Related Term
- rapidly disolving products
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