Shipping to 128 countriesCOA and SDS with every lotQuotes within one business day
contact@zemixal.com
Bulk CASAccount
Impurity reference standards

Tenofovir impurity standards

Zemixal lists 40 reference materials related to Tenofovir, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 pharmacopoeial impurity, 1 nitrosamine, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 1 degradation product.

40reference materials
1pharmacopoeial
1nitrosamines
1isotope labelled
Tenofovir structure
Parent API

Tenofovir

CAS
147127-20-6
Formula
C9H14N5O4P
MW
287.21 g/mol
Code
ZX-003986

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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, 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 Tenofovir reference materials

1–40 of 40 standards
Questions

Tenofovir impurities, answered

How many Tenofovir impurity standards does Zemixal list?
The catalogue currently lists 40 compounds for Tenofovir, including 1 pharmacopoeial impurity, 1 nitrosamine, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues 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 Tenofovir 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 Tenofovir 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 Tenofovir nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Tenofovir. 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 Tenofovir standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

Nearby APIs in the index

Tenapanor 2Teneligliptin 12Tenivastatin 1Tenoxicam 10All APIs
Compare 0 of 4Compare now