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Impurity reference standards

Tretinoin impurity standards

78 characterised compounds linked to Tretinoin are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 2 pharmacopoeial impurities, 2 nitrosamines, 6 metabolites or hydroxylated analogues and 1 degradation product.

78reference materials
2pharmacopoeial
2nitrosamines
6metabolites

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. 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
Metabolites6Hydroxy, 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 Tretinoin reference materials

1–60 of 78 standards
2,4-Lutidine
CAS
108-47-4
Formula
C7H9N
MW
107.15 g/mol
ZX-039660
Benzofuran
CAS
271-89-6
Formula
C8H6O
MW
118.13 g/mol
ZX-040411
H-D-Leu-leu-OH
CAS
38689-31-5
Formula
C12H24N2O3
MW
244.33 g/mol
ZX-039958
Lithium
CAS
1393822-99-5
Formula
C8H11BLiNO5
MW
219 g/mol
ZX-043588
Questions

Tretinoin impurities, answered

How many Tretinoin impurity standards does Zemixal list?
The catalogue currently lists 78 compounds for Tretinoin, including 2 pharmacopoeial impurities, 2 nitrosamines, 6 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 Tretinoin 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 Tretinoin 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 Tretinoin nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Tretinoin. 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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