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Reliable impurity analysis starts with the reference standard behind it. CIFGA develops and produces analytical standards for pharmaceutical impurities, with an initial focus on nitrosamines and nitrosamine drug substance related impurities (NDSRI). Produced in-house and supplied to laboratories that develop, validate and run methods under ICH, FDA and EMA requirements.
CIFGA is building a catalogue of pharmaceutical impurity standards produced in-house, from synthesis and characterization to final documentation. The first references target the nitrosamines under active regulatory scrutiny, with the range expanding towards NDSRI and further impurity families over time.
Impurity control is one of the most heavily regulated parts of pharmaceutical quality. Confirming and quantifying impurities at the low levels required by current guidance depends on well-characterised reference standards behind every validated method.
Impurities are unwanted compounds that can appear in an active pharmaceutical ingredient (API) or a finished product at any stage of manufacturing. They arise from the synthetic route, from degradation, from storage conditions or from interaction with excipients, and controlling them is central to the safety, efficacy and quality of a medicine.
Since 2018, nitrosamines have become one of the most pressing regulatory concerns worldwide. Classified as probable human carcinogens, their detection in several medicines triggered product recalls and a wave of new requirements from health authorities. Laboratories now need increasingly sensitive analytical methods, and the reference standards that make those methods traceable and defensible.
The major regulators have each published specific expectations for nitrosamine control. The U.S. Food and Drug Administration requires manufacturers and marketing authorisation holders to assess risk, define control strategies and apply suitable analytical methods to detect nitrosamines. The European Medicines Agency requires risk evaluations, in-process controls and mitigation strategies to prevent nitrosamine formation in medicines placed on the European market.
Underpinning both, the ICH M7 guideline sets the framework for assessing and controlling mutagenic and carcinogenic impurities in pharmaceutical products. Meeting these expectations at the required detection levels, typically low ng/g or low ppm, depends on characterised standards for method development, validation and routine testing.
CIFGA is an ISO 17034-accredited reference material producer with more than 15 years developing standards for highly regulated sectors. Pharmaceutical impurity standards are produced in-house, with full control over the manufacturing and characterisation process rather than the redistribution of third-party material.
These standards are supplied initially as quality control standards, with values assigned in-house by NMR and identity and quality confirmed by chromatographic techniques such as LC-MS/MS. The roadmap extends towards certified reference materials (CRMs) as the range matures, so laboratories can start method work now on documented material and move to certified values as they become available.
CIFGA supplies laboratories in more than 40 countries. As one of the few reference standard producers based in Europe, intra-EU deliveries carry no customs complications and reach European laboratories faster than equivalent material shipped from outside the region.
Custom requirements, including specific concentrations, mixed-impurity formulations and contract purification, are handled through our tailored services, with technical support from the team that produces the standards.
The initial range targets the regulated nitrosamines under active scrutiny, including NDMA, NDEA, NMBA, DIPNA, EIPNA and NDBA, extending towards NDSRI over time.
Nitrosamine drug substance related impurities are nitrosamines specific to a particular API, formed through reaction of the active substance itself, and a growing regulatory focus.
They are supplied initially as quality control standards, with values assigned in-house by NMR, and follow a defined roadmap towards certified reference materials as the range matures.
They support LC-MS/MS, UHPLC-MS/MS, HPLC-UV, GC-MS, GC-MS/MS and HRMS methods used to detect nitrosamines at the low ng/g and low ppm levels required by current guidance.
Yes. They are produced for method development, validation and routine QC aligned with ICH M7 and with FDA and EMA nitrosamine control requirements.
Specific concentrations, mixed-impurity formulations and compounds outside the standard range are produced through tailored services and contract purification.
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