ICH guideline
ICH Q3C(R9): Guideline for Residual Solvents
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q3C(R9) |
|---|---|
| Title | Guideline for Residual Solvents |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The Q3C ICH Guideline was finalised under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of drug substances and dosage forms, and setting pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. Maintenance ProcessAs part of the… |
| File | Support Documents |
| File type | Zip |
| File on ich.org | database.ich.org |
At a glance
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About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.