Nitrosamines

Critical Impurity Analysis

Molsyns Research manufactures high-purity Nitrosamine impurities and N-nitroso reference standards (NDMA, NDEA, NDIPA, etc.) to support pharmaceutical companies in risk assessment and toxicology studies. Since nitrosamines are classified as potential human carcinogens, our Ahmedabad facility synthesizes ultra-pure compounds with full analytical validation to meet stringent global regulatory standards.

FAQ

Nitrosamine Impurity Standards FAQ

Nitrosamines are chemical compounds classified as probable human carcinogens. Regulatory authorities worldwide (like USFDA, EMA, and ICH) mandate that drug manufacturers perform risk assessments and limit nitrosamine presence to safe thresholds, requiring high-purity reference standards for testing.

Yes, our R&D center specializes in the custom synthesis of complex N-Nitroso impurities, stable isotopes, and custom reference compounds that are otherwise commercially unavailable.

Every nitrosamine standard synthesized by Molsyns Research comes with complete documentation, including 1H-NMR, LC-MS/Mass Spectra, and HPLC chromatograms showing the purity levels.

Nitrosamines

N-Nitroso Abacavir

N-Nitroso Abacavir EP Impurity A

N-Nitroso Abacavir Impurity 1

N-Nitroso Abacavir Impurity 2

N-Nitroso Abacavir Impurity 3

Abemaciclib Nitroso Impurity 2

Abemaciclib Nitroso Impurity 3

Abemaciclib Nitroso Impurity 5

Abemaciclib Nitroso Impurity 7

Abemaciclib Nitroso Impurity 8

Abemaciclib Nitroso Impurity 9

Abemaciclib Nitroso Metabolites M2

Abemaciclib N-Oxide Nitroso Impurity

Abemaciclib Nitroso Impurity 1

Abemaciclib Nitroso Impurity 6

N-Nitroso Abiraterone Acetate

Abrocitinib Nitroso Impurity 1

Abrocitinib Nitroso Impurity 2

Abrocitinib Nitroso Impurity 3

Abrocitinib Nitroso Impurity 4

N-Nitroso N-Desmethyl Abrocitinib

Acalabrutinib Nitroso Impurity 1

Acalabrutinib Nitroso Impurity 2

Acalabrutinib Nitroso Impurity 3

Acalabrutinib Nitroso Impurity 4

Acalabrutinib Nitroso Impurity 5

Acalabrutinib Nitroso Impurity 6

N-Nitroso Acarbose

Acebrophylline Nitroso Impurity 1

N-Nitroso Acebutolol EP Impurity B

N-Nitroso Acebutolol EP Impurity I

N-Nitroso-Acebutolol

Aceclofenac Nitroso Impurity 1

N-Nitroso Aceclofenac

N-Nitroso Acetylcysteine

N,N'-Dinitroso Aciclovir EP Impurity K

N-Nitroso Aciclovir EP Impurity K

N-Nitroso Aciclovir

Adagrasib Nitroso Impurity 6

Adagrasib Nitroso Impurity 7

Adagrasib Nitroso Impurity 8

Adagrasib Trinitroso Impurity 8

N-DiNitroso Adagrasib Impurity 5

N-Nitroso Adagrasib Impurity 6

N-Nitroso Adagrasib Impurity 7

N-Nitroso Adagrasib Impurity 4

Adagrasib Nitroso Impurity 9

Adagrasib Dinitroso Impurity 5

Adagrasib Nitroso Impurity 1

Adagrasib Nitroso Impurity 10

Adagrasib Nitroso Impurity 2

Adagrasib Nitroso Impurity 3

N6-methyl-N6-nitroso-Adenosine

Adrenaline Nitroso Impurity 1

N-Nitroso Adrenaline EP Impurity F

N-Nitroso D-Adrenaline

Adrenalone Nitroso Impurity 1

N-Nitroso Afatinib Impurity 1

Afatinib Nitroso Impurity 1

Afatinib Nitroso Impurity 2

N-Nitroso Agomelatine

Agomelatine Nitroso Impurity 1

Albendazole Nitroso Impurity 1

N-Nitroso Albendazole

N-Nitroso Albendazole Impurity 1

N-Nitroso Alcaftadine N-Demethylated

N-Nitroso Alectinib

Alectinib Acid Nitroso Impurity

Alectinib Nitroso Impurity 10

Alectinib Nitroso Impurity 2

Alectinib Nitroso Impurity 6

Alectinib Nitroso Impurity 7

Alectinib Nitroso Impurity 8

Desethyl Alectinib Nitroso Impurity

Alfuzosin Nitroso Impurity 1

Alfuzosin Nitroso Impurity 2

N-Nitroso Alfuzosin EP Impurity C

N-Nitroso Alfuzosin EP Impurity G

N-Nitroso Desmethyl Alfuzosin