Impurity reference standards
Ergocalciferol impurity standards
For Ergocalciferol, the Zemixal catalogue holds 11 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 5 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues.
11reference materials
5pharmacopoeial
1isotope labelled
3metabolites
Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. 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
Pharmacopoeial5EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Ergocalciferol reference materials
1–11 of 11 standards
Questions
Ergocalciferol impurities, answered
What Ergocalciferol reference materials are available?
The catalogue currently lists 11 compounds for Ergocalciferol, including 5 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Ergocalciferol 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 Ergocalciferol 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 Ergocalciferol standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.