Impurity reference standards
Calcifediol impurity standards
For Calcifediol, the Zemixal catalogue holds 7 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 4 pharmacopoeial impurities, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.
7reference materials
4pharmacopoeial
1isotope labelled
1metabolites
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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
Pharmacopoeial4EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Calcifediol reference materials
1–7 of 7 standards
Questions
Calcifediol impurities, answered
What Calcifediol reference materials are available?
The catalogue currently lists 7 compounds for Calcifediol, including 4 pharmacopoeial impurities, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Calcifediol 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 Calcifediol 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.
Are isotope-labelled Calcifediol standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.