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Impurity reference standards

Metformin impurity standards

This page brings together 25 Metformin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 pharmacopoeial impurity, 1 nitrosamine, 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues.

25reference materials
1pharmacopoeial
1nitrosamines
1isotope labelled
Metformin HCl structure
Parent API

Metformin HCl

CAS
1115-70-4
Formula
C4H12ClN5
MW
165.62 g/mol
Code
ZX-004135

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms

Counts are based on product names. One compound can fall into more than one type.

All Metformin reference materials

1–25 of 25 standards
Guanidine
CAS
113-00-8
Formula
CH5N3
MW
59.07 g/mol
ZX-045044
Metformin HCl
CAS
1115-70-4
Formula
C4H12ClN5
MW
165.62 g/mol
ZX-038326
Questions

Metformin impurities, answered

What Metformin reference materials are available?
The catalogue currently lists 25 compounds for Metformin, including 1 pharmacopoeial impurity, 1 nitrosamine, 1 isotope-labelled standard and 2 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 Metformin 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 Metformin 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.
Do you supply Metformin nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Metformin. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Metformin standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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