N-nitrosamines Impurities

Nitrosamine impurities analysis reaching low ppm/ppb sensitivity levels for all main impurities as well as nitrosation of APIs. 

N-nitrosamine impurities analysis includes all main impurities identified by the health authorities as well as nitrosations of APIs. Default screening limits originally established at 0.03ppm have been gradually improved, with our current sensitivity levels having reached 0.1ppb.

Kymos Group offers a competitive service owing to its dedicated nitrosamines team, significant sample analysis capabilities and two back-up methods available: Liquid chromatography-mass spectrometry (LC-MS/MS) Agilent 6490 Triple Quadrupole plus a Headspace Gas Chromatography (HS-GC-MS) Agilent 7890 with a 5977 Single Quadrupole limits.

HPLC Waters in laboratory

Available Nitrosamines at Kymos Group

  • The list below shows some of our currently available nitrosamines, but new ones can be added upon client request:

    • N-Nitrosodimethylamine (NDMA)
    • N-Nitrosodiethylamine (NDEA)
    • N-Nitrosodisopropylamine (NDIPA)
    • N-Nitroso ethylisopropylamine (NEIPA)
    • N-Nitroso-n-methyl-4-aminobutyric acid (NMBA)
    • N-Nitrosopyrrolidine (NPYR)
    • N-Nitrosodi-n-butylamine (NDBA)
    • N-Nitroso Morpholine (NMOR)
    • N-Nitrosodiethanolamine (NDELA)
    • N-nitrosopiperazine (NPIP)
    • N-nitroso-N-methylaniline (NMA)
    • N-nitrosoethylmethylamine (NMEA)
    • N-Nitrosodiphenylamine (NDPhA)
    • N-nitrosodi-n-propylamine (NDPA)
Analytical Experts
Nitrosamine AI Limit (ng/day)
NDMA 96.0
NDEA 26.5
NMBA 96.0
NMPA 26.5
NDIPA 26.5
EIPNA 26.5
MeNP 26.5
NDBA 26.5
NMOR 127.0
NN 37.0

Services

Why trust Kymos Group for your Nitrosamines Testing?

Our nitrosamines team continuously adapts our service to comply with new requests of the Regulatory Agencies:

Lower LoQs:

Initial 0.03ppm default limits were lowered to our current sensitivity of 0.1ppb

≤ 30% if the quantitative testing is performed to justify skip testing or ≤ 10% if performed to justify omission of specification.

We follow the AI’s limits recommended by the FDA and adapt our methods.

Related Services

Related services to N-nitrosamines Impurities:

Bioequivalence studies

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Sample preparation MS

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

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