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Impurity reference standards

Thioctic acid impurity standards

This page brings together 11 Thioctic acid 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 metabolite or hydroxylated analogue and 1 degradation product.

11reference materials
1pharmacopoeial
1metabolites
1degradants

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Thioctic acid reference materials

1–11 of 11 standards
Questions

Thioctic acid impurities, answered

What Thioctic acid reference materials are available?
The catalogue currently lists 11 compounds for Thioctic acid, including 1 pharmacopoeial impurity, 1 metabolite or hydroxylated analogue 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 Thioctic acid 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 Thioctic acid 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.
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