Impurity reference standards

Mexiletine impurity standards

11 characterised compounds linked to Mexiletine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 4 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues.

11reference materials

4pharmacopoeial

3metabolites

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. 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

Pharmacopoeial4EP, USP, BP or JP named impurities

Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Mexiletine reference materials

1–11 of 11 standards

1-(2,6-Dimethylphenoxy)-2-propanone Oxime

CAS: 55304-19-3
Formula: C₁₁H₁₅NO₂
MW: 193.24 g/mol

ZX-025601

2-Hydroxy-3-methylbenzaldehyde

CAS: 824-42-0
Formula: C₈H₈O₂
MW: 136.15 g/mol

ZX-039429

6-Demethyl 4-Methyl Mexiletine Hydrochloride

CAS: 29238-40-2
Formula: C₁₁H₁₈ClNO
MW: 215.72 g/mol

ZX-030581

Mexiletine

CAS: 31828-71-4
Formula: C₁₁H₁₇NO
MW: 179.26 g/mol

ZX-030578

Mexiletine 6-Desmethyl 4-Methyl Impurity

CAS: 180966-61-4
Formula: C₁₁H₁₇NO
MW: 179.26 g/mol

ZX-030582

Mexiletine EP Impurity B

CAS: 53012-41-2
Formula: C₁₁H₁₄O₂
MW: 178.23 g/mol

ZX-022151

Mexiletine EP Impurity C

CAS: 2059988-38-2
Formula: C₂₂H₃₂N₂O₂
MW: 356.5 g/mol

ZX-030579

Mexiletine EP Impurity D

CAS: 26583-71-1
Formula: C₁₁H₁₇NO
MW: 179.26 g/mol

ZX-030580

Mexiletine HCl Impurities,KOE 5692 Cyclicl imine impurity

CAS: 284486-96-0
Formula: C₁₁H₁₃NO
MW: 175.23 g/mol

ZX-025602

Mexiletine Hydrochloride

CAS: 5370-01-4
Formula: C₁₁H₁₈ClNO
MW: 215.72 g/mol

ZX-030577

MexiletineHydrochloride EP Impurity D

CAS: 2724689-76-1
Formula: C₁₁H₁₈ClNO
MW: 215.72 g/mol

ZX-025603

Questions

Mexiletine impurities, answered

How many Mexiletine impurity standards does Zemixal list?

The catalogue currently lists 11 compounds for Mexiletine, including 4 pharmacopoeial impurities 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 Mexiletine 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 Mexiletine 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.