Impurity reference standards
Alendronate impurity standards
This page brings together 6 Alendronate related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 2 pharmacopoeial impurities, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.
6reference materials
2pharmacopoeial
1isotope labelled
1metabolites
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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.
By impurity type
Pharmacopoeial2EP, 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 Alendronate reference materials
1–6 of 6 standards
5-(3-Aminopropyl)-4,5,6-trihydroxy-1,3,2,4,6-dioxatriphosphinane 2,4,6-trioxide
- CAS
- 165043-19-6
- Formula
- C4H11NO8P3+
- MW
- 294.05 g/mol
ZX-027764
Questions
Alendronate impurities, answered
What Alendronate reference materials are available?
The catalogue currently lists 6 compounds for Alendronate, including 2 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 Alendronate 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 Alendronate 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 Alendronate standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.