Impurity reference standards
Calcitriol impurity standards
Zemixal lists 11 reference materials related to Calcitriol, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 pharmacopoeial impurities, 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue and 1 degradation product.
11reference materials
3pharmacopoeial
1isotope labelled
1metabolites
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.
By impurity type
Pharmacopoeial3EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Calcitriol reference materials
1–11 of 11 standards
Questions
Calcitriol impurities, answered
How many Calcitriol impurity standards does Zemixal list?
The catalogue currently lists 11 compounds for Calcitriol, including 3 pharmacopoeial impurities, 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Calcitriol 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 Calcitriol 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 Calcitriol standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.