Why reference materials matter in analytical method validation
Published guidance on method validation explains the role of well-characterised reference materials in establishing specificity, linearity, accuracy and precision.
Analytical method validation frameworks describe a set of characteristics — specificity, linearity, range, accuracy, precision, detection and quantitation limits, and robustness — that a laboratory demonstrates before a method is used for release testing.
Well-characterised reference materials underpin most of those characteristics: without a material of known identity and assigned content, accuracy and specificity cannot be evidenced.
Published work also stresses documentation. Lot-specific certificates, storage statements and retest dates allow a laboratory to reconstruct the provenance of any result it reports.
Peptiora Labs supplies research-use materials with lot documentation to support this kind of laboratory work.
- Source
- ICH / PubMed method-validation literature
- Original publications
- View at source
This summary references third-party research and is attributed to the original authors and publications. It is not Peptiora Labs research and is not a product claim. No dosage, administration, human-use or veterinary information is provided. All materials supplied by Peptiora Labs are for laboratory research use only — not for human or veterinary use.