Reference standards for HPLC and UHPLC
HPLC with UV or DAD detection is the backbone of pharmacopoeial impurity methods and of in-house related-substance methods. Those methods are written around a reference standard: system suitability, relative response factors and the calculation of each impurity all trace back to it.
What this method asks of a standard
| Requirement | Why it matters |
|---|---|
| Pharmacopoeial impurities | EP, USP, BP and JP impurity standards are used where the method is the compendial one, so that the result can be compared with the monograph. |
| Non-compendial impurities | Where no monograph exists, the method is validated against an in-house standard; the certificate then carries the identity evidence and the assigned content. |
| Relative response factors | Impurity methods that quantify against the parent peak need the response factor of each impurity, which can only be established with a characterised standard of that impurity. |
| System suitability | A standard that is chromatographically pure enough to give a single, well-shaped peak is a prerequisite for a meaningful suitability check. |
Standard types used with HPLC and UHPLC
These are the catalogue groups most often quoted for HPLC and UHPLC work. They are entry points into the catalogue, not a statement that any particular lot suits any particular method — that is established in your own validation, against the certificate for the lot.
- Impurity Reference Standards
- API Reference Standards
- Drug Metabolite Standards
- Browse by drug substance
- Certificate of analysis
Frequently asked
What is the difference between a pharmacopoeial and a non-compendial impurity standard?
Why does the certificate state an assigned content for an impurity standard?
Related
Need a standard for a HPLC and UHPLC method you are validating? Send the catalogue number or the structure and the quantity you need — a technical contact answers with availability and a quotation. Request a quote.