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Mérieux NutriSciences
Pharma & Healthcare | One-stop shop solution


NITROSAMINE IMPURITIES ANALYSIS ON APIS AND DRUG PRODUCTS

Mérieux NutriSciences’ GMP Labs offers advanced solutions through a cutting-edge
technology to guarantee the safety and conformity of your pharmaceutical
products

Request a Personalised Consultation

On September 26th, 2019 the CMDh (Heads of Medicines Agencies) published the
notice “Information on nitrosamines for marketing authorisation holders” asking
to all Marketing Authorization Holders (MAHs) of human medicinal products
containing chemically synthesised active pharmaceutical ingredients to evaluate
the risk of the presence of nitrosamine impurities in their products.

Soon after, similar requirements have been extended rapidly and globally to
other Countries, drug products (e.g. biological medicinal products) and new
complex nitrosamines (NDSRIs) requiring high levels of expertise, technology and
capacity in order to ensure product safety and mandatory deadlines.


MÉRIEUX NUTRISCIENCES PHARMA NITROSAMINES LABS GLOBAL SERVICE 

Method development and validation, screening and confirmatory tests of small
nitrosamines and NDSRIs in APIs and drug products.

Multiresidual Analysis

NDMA, NDEA, NDELA, NMOR and many others

Targeted methods for almost 50 NDSRIs

N-Nitroso-Atenolol, N-Nitroso-Betahistin,
N-Nitroso-Diclofenac and many others

Multiresidual analysis (standard set) ~ NDMA, NDEA, NDELA, NMOR and many others

N-Nitrosodimethylamine (NDMA)
N-Nitrosodiethylamine (NDEA)
N-Nitrosomethylethylamine (NMEA)
N-nitrosoethylisopropylamine (NEIPA)
N-methyl-4-aminobutyric acid (NMBA)
N-nitrosodiphenylamine (NDPHA)
N-nitrosodi-n-propylamine (NDPA)
N-nitroso-diisopropylamine (NDIPA)
N-nitroso-di-n-butylamine (NDBA)
N-nitrosomethylaniline (NMA)
N-nitroso-di-ethanolamine (NDELA)
N-nitroso-piperidine (NPIP)
N-nitroso-pyrrolidine (NPYR)
N-nitroso-morpholine (NMOR)
Nitroso-4-methyl piperazine (MeNP)

Targeted methods for almost 50 NDSRIs (on demand /R&D level) ~
N-Nitroso-Atenolol, N-Nitroso-Betahistin, N-Nitroso-Diclofenac and many others

Glycazide impurity B
1-nitroso-4-(2-hydroxyethyl)-piperazine (Opipramol, Aripiprazol)
N-methyl-N-nitrosophenylethylamine (NMPEA)
Methyl-N-Nitroso-Indoline (Indapamide)
N-nitroso-desalkylquetiapine (NDAQ) (Quetiapine)
N-Nitroso-Azathioprine
N-Nitroso-Atenolol
N-Nitroso-Benazepril
N-Nitroso-Impurity A Benzydamine
N-Nitroso-Betahistin
N-Nitroso-Biotin
N-Nitroso-CAF (Calcium Folinate)
N-Nitroso-Ciprofloxacin
N-Nitroso-Clonidine
N-Nitroso-Diclofenac
N-nitroso-Diphenhydramine
N-Nitroso-Dorzolamide
N-Nitroso-Duloxetine
N-Nitroso-Enalapril
N-Nitroso-Fluoxetine
N-Nitroso-Folic Acid
N-Nitroso-Furosemide
N-Nitroso-Flumazenil
N-Nitroso-Guanidine (Triamterene)
4-Nitroso-Hydrochlorothiazide
N-Nitroso-Lisinopril
N-Nitroso-Metoprolol
N-Nitroso-Naphazoline
N-Nitroso-Nebivolol
N-Nitroso-Nortriptyline (Amitriptyline, Nortryptyline)
N-Nitroso-Paroxetine
N-Nitroso-Perindopril
N-Nitroso-Phenylephrine
N-Nitroso-Piroxicam
N-Nitroso-Pramipexole
N-Nitroso-Proline
N-Nitroso-Propranolol
N-Nitroso-Pseudoephedrine
N-Nitroso-Quinapril
N-Nitroso-Ramipril
N-Nitroso-Rasagiline
N-Nitroso-Ropivacaine
N-Nitroso-Salbutamol
N-Nitroso-Sertraline
N-Nitroso-Sotalol
N-Nitroso-Tadalafil
N-Nitroso-Tamsulosin
N-Nitroso-Tetryzoline
N-Nitroso-Zolmitriptan
Methyl N-methyl-N-nitrosoanthranilate.

Request a Personalised Consultation


EXPERTISE, CAPACITY, AND EMERGENCIES MANAGEMENT

The GMP facility of Mérieux NutriSciences is equipped with a dedicated lab and
all analytical techniques suitable for the detection of nitrosamine impurities
in different products.

 




ACKNOWLEDGEMENTS & AUTHORIZATIONS




THE RISK EVALUATION PROCESS

RISK EVALUATION

MAHs should perform risk evaluation of their medicinal products containing
chemically synthesised APIs.

CONFIRMATORY TESTING

Confirmatory tests should be carried out using validated and sensitive methods.
MAHs should inform the competent authorities immediately if tests confirm the
presence of a nitrosamine impurity irrespective of the amount detected.

CHANGES TO THE MARKETING AUTHORISATION

MAHs should apply for a variation in a timely manner to introduce any required
changes, such as amendment of the manufacturing process or changes to product
specifications.

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OUR EXPERTS, OUR LABS

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