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Fentanyl impurities and related standards

Opioid analgesics are a pharmacopoeial category in their own right, and fentanyl citrate sits in it as the synthetic piperidine member: the active substance is N-(1-phenethyl-4-piperidyl)propionanilide citrate in a 1:1 ratio with citric acid, supplied as an injection for intravenous or intramuscular use as an opioid analgesic supplement in general and regional anaesthesia and for short analgesic cover around the anaesthetic period. Two structural features dominate the impurity question. The anilide amide is the obvious hydrolysis site, and the tertiary piperidine nitrogen is the oxidation site, so a degradant panel built from acid, base and oxidative stress normally contains amide-cleavage material and N-oxide species. The citrate counter-ion raises a second set of questions: dose is declared as fentanyl base equivalent, so a standard has to state whether its content refers to the base or to the citrate salt, and water content has to be read in the same frame. Process chemistry contributes late-stage material from the phenethyl and anilide side chains. Specified limits belong to the monograph where one exists, while the ICH Q3A/Q3B impurity framework sets reporting and qualification thresholds for everything else, and the M7 mutagenic-impurity framework is assessed separately for any structural alert in the route. Before use, confirm identity by NMR and mass measurement, purity against an assigned content, and the salt basis.

Sources: DailyMed - Fentanyl Citrate Injection, FDA-approved label (NLM DailyMed).

50 reference standards related to Fentanyl held in the RSSE catalogue — pharmacopoeial impurities, non-compendial impurities, metabolites and labelled analogues where available.

In this group: 16 impurity reference standards · 12 fine chemicals · 9 stable isotope labelled standards · 5 pharmaceutical intermediates. CAS numbers are listed for 50 of 50; 50 entries carry a structure drawing.

On this page

50 reference standards

All entries — structure, identifiers and pack sizes

50 reference standards

Frequently asked

How many Fentanyl-related reference standards do you hold?
50 standards are listed on this page as of the latest catalogue build. CAS numbers are published for 50 of them and 50 entries carry a structure drawing. The catalogue is extended as new lots are released.
Can you supply a Fentanyl impurity that is not listed here?
Yes. Non-compendial impurities can be quoted from a structure — a CAS number is not required. Send the structure, a SMILES string or the parent drug substance with your enquiry and we will come back with availability.
What documentation is supplied with Fentanyl impurities?
Every lot ships with its own certificate of analysis. The certificate records the catalogue number, the batch number, the tests performed, the specification applied and the result obtained for that lot. A safety data sheet is supplied with the shipment.
Do you publish prices or a lead time for Fentanyl impurities?
No price list is published: quotations are prepared per enquiry, because availability and packing depend on the lot and the quantity you need. Send the catalogue number and the quantity and a technical contact will answer with availability and a quotation.

Cannot find the impurity you need? Non-compendial impurities can be quoted from a structure — a CAS number is not required. Write to sales@rssechem.com.