Impurity reference standards
Pravastatin impurity standards
For Pravastatin, the Zemixal catalogue holds 19 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 9 pharmacopoeial impurities, 2 metabolites or hydroxylated analogues and 3 degradation products.
19reference materials
9pharmacopoeial
2metabolites
3degradants
Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.
By impurity type
Pharmacopoeial9EP, USP, BP or JP named impurities
Metabolites2Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Pravastatin reference materials
1–19 of 19 standards
Questions
Pravastatin impurities, answered
What Pravastatin reference materials are available?
The catalogue currently lists 19 compounds for Pravastatin, including 9 pharmacopoeial impurities, 2 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Pravastatin impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Pravastatin impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.