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Impurity reference standards

Tetracaine impurity standards

Zemixal lists 10 reference materials related to Tetracaine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 2 pharmacopoeial impurities, 2 nitrosamines, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue and 1 degradation product.

10reference materials
2pharmacopoeial
2nitrosamines
2isotope labelled

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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
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 Tetracaine reference materials

1–10 of 10 standards
Questions

Tetracaine impurities, answered

How many Tetracaine impurity standards does Zemixal list?
The catalogue currently lists 10 compounds for Tetracaine, including 2 pharmacopoeial impurities, 2 nitrosamines, 2 isotope-labelled standards, 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 Tetracaine 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 Tetracaine 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 Tetracaine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Tetracaine. 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 Tetracaine standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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