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Impurity reference standards

Nicotine Hemisulfate impurity standards

This page brings together 13 Nicotine Hemisulfate 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, 2 nitrosamines and 1 degradation product.

13reference materials
2pharmacopoeial
2nitrosamines
1degradants

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

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Nicotine Hemisulfate reference materials

1–13 of 13 standards
Nornicotyrine
CAS
494-98-4
Formula
C9H8N2
MW
144.17 g/mol
ZX-039466
Rac-Cotinine
CAS
15569-85-4
Formula
C10H12N2O
MW
176.21 g/mol
ZX-039465
Questions

Nicotine Hemisulfate impurities, answered

What Nicotine Hemisulfate reference materials are available?
The catalogue currently lists 13 compounds for Nicotine Hemisulfate, including 2 pharmacopoeial impurities, 2 nitrosamines 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 Nicotine Hemisulfate 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 Nicotine Hemisulfate 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 Nicotine Hemisulfate nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Nicotine Hemisulfate. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
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