Pharma starting materials and intermediates: Characteristics
Why impurities in a building block reach the final pill
What this tab covers The physical and chemical properties that set its grade, price and uses, with the commercial grades and the standards that define them.KSMs are sold on chemical purity and impurity profile, because impurities carried into the API must be controlled. Once a KSM supplier is in a filing, changing it costs time and validation, which makes buyers reluctant to switch even when prices differ.
Properties that matter commercially
| Property | Value / specification | Why it matters | Source |
|---|---|---|---|
| Purity | typically 98-99.5% (indicative) | carries through to API impurity profile | indicative |
| Specific impurities | per supplier specification | mutagenic impurity control under ICH M7 | ICH M7 |
Commercial grades
- Technical grade for non-regulated markets
- Registered KSM grade with supplier audit