High-purity pharmaceutical impurities and N-nitrosamine reference standards in mg scale — synthesized by the team that makes the parent APIs. CoA with NMR, HPLC, MS and Karl Fischer data.
Four families, all manufactured in-house at milligram scale. Availability list and quotations by email.
N-nitrosamine impurities reshaped global drug testing since 2019. Every batch released for a susceptible API now needs LC-MS/MS or GC-MS testing against certified reference materials — and demand for these mg-scale standards permanently outstrips supply. We manufacture nitrosamine standards and their labelled isotopic internal standards against FDA/TGA acceptable-intake frameworks.
USP and EP monographs list named related substances (e.g. Phenylephrine Impurities 1–7) for each monograph API. Registrants must resolve and quantify them; labs need the compounds themselves. Our synthesis team prepares pharmacopeial and non-compendial impurities for the sympathomimetic, antihistamine and CNS APIs we manufacture — with CoA (NMR, HPLC, MS, water content by KF). Send us the impurity list from the monograph you are working to and we will confirm what we can supply.
Off-catalogue impurities — forced-degradation products, metabolites, process-related unknowns flagged in your CoA — are quoted as custom synthesis projects (mg scale). For in-house work standards we support assignment/qualification packages aligned with USP <11> principles.
Isotopically labelled analogues (e.g. d6-NDMA, 13C2-NDMA) are the quantitation backbone of LC-MS/MS nitrosamine methods — and chronically scarce. We supply labelled internal standards with full isotopic abundance data on the CoA.
Unbiased single-isomer N-nitrosamines with assigned purity — the compounds every susceptible API now has to be tested against.
Acceptable-intake (AI) values shown are taken from the FDA CDER and TGA published tables (checked October 2026) for orientation only; regulators update them — always work to the current official list.
Chinese generic names overlap heavily across salts and esters, so we identify every compound by its CAS number — that is the only reliable key — and always state which parent API an impurity belongs to. Browse below; confirm stock, size and price by email.
CAS Registry Number™ is our primary identifier; names are for orientation only.
Send the CAS number (and, if you have it, the monograph impurity letter). We confirm identity against our reference sample database before any quotation — one CAS, one compound, no name ambiguity.
Because we are the manufacturer of the parent APIs — phenylephrine, epinephrine, isoproterenol, doxylamine and their relatives — we hold the synthetic knowledge, the reference batches and the degradation profiles of their impurities. That vertical integration is why our impurity standards match the material you actually test.
We confirm what we can supply, at what purity, in what size — with lead time, in one reply.
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