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Nitrosamines

Nitrosamine Reference Standards

Nitrosamines are described in the International Conference for Harmonization (ICH) M7(R1) Guideline 5 as Class 1 impurities which are high-potency, mutagenic. They have been studied for many years due to their presence in foods, cosmetics, tobacco products, industrial solvents, and alcoholic beverages. National Toxicology Program in the 14th Report on Carcinogens published the detail of the toxicity associated with nitrosamines. Exposure to N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) is known to produce benign and malignant tumors in variety of nonclinical species. In mid-2018, the regulatory authorities became aware of the presence of N-nitrosamines in sartan active pharmaceutical ingredients (APIs) and more specifically in valsartan. A regulatory action was instituted, including recalls of some medicines from pharmacies and measures to prohibit the use of APIs from certain manufacturers. European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) issued guidance to sartan manufacturers and established limits for sartans. Now nitrosamines have also been found in several products which are not of the sartan class of drugs eg pioglitazone, ranitidine, nizatidine, metformin. As a result, the FDA and EMA are requiring a risk evaluation and appropriate testing of nitrosamine impurities in all marketed products. Several methods have been developed to detect and monitor the amounts of these impurities in the pharma products. Reference standards that are pure, reliable and can be used for quantitative analysis are required for testing. Axios is supporting the pharma industry by providing these reference standards that are fully characterized with a detailed certificate of analysis.

Other Nitrosamines
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Abacavir Abemaciclib Abeprazan Abiraterone Abrocitinib Acalabrutinib Acarbose Acebutolol Aceclofenac Acedoben Acetamide Acetaminophen Acetazolamide Acetylglycinamide Acotiamide Acrylic Acid Acyclovir Ad-021.32 Adavosertib (mk-1775) Adrenalone Adrogolide Aegeline Afatinib Agomelatine Alanine Albendazole Alectinib Alimemazine Alizapride Allopurinol Almotriptan Alogliptin Alosetron Alpelisib Altizide Alvespimycin Alvimopan Ambroxol Ametryn Amg 900 Amidosulfuron Amine Amiodarone Amlodipine Ammuxetine Amodiaquine Amoxapine Amoxicillin Ampa Amtolmetin Guacil Anabasine Anagliptin Anagrelide Anatabine Aniline Anthranilic acid Antipyrine Apalutamide Apatinib Apixaban Apremilast Aprepitant Argatroban Aripiprazole Arotinolol Articaine Arundamine Astemizole Atazanavir Atenolol Atglistatin Atomoxetine Atorvastatin Atrazine Atropine Avacopan Avanafil Avenanthramide Avitriptan Axitinib Az-23 Azasetron Azathioprine Azd1080 Azelastine Azelnidipine Azepinomycin Azetidine Azilsartan Aziridine Azithromycin Baeocystin Balanol Balofloxacin Baloxavir marboxil Bambuterol Hydrochloride Baricitinib Bdp9066 Bedaquiline Belumosudil Benazepril Bendroflumethiazide Benperidol Benzamide Benziothiazolinone Benznidazole Benzocaine Benzonatate Benzydamine Berotralstat Betahistine Betaxolol Betrixaban Bevantolol Bezafibrate Bi-4394 Bicalutamide Bicisate Bictegravir Bilastine Binimetinib Biotin Bisoprolol Blonanserin Blu-945 Bms-986165 Boldine Boscalid Bosutinib Brexpiprazole Brilliant Blue Brimonidine Brinzolamide Brivaracetam Broflanilide Bromantane Bromchlorbuterol Bromexine Bromhexine Bromocriptine Bromopride Brompheniramine Bufuralol Bumetanide Bunitrolol Bupivacaine Bupropion Buspirone Butafosfan Butanilicaine Butanoic Acid Butopamine Cabergoline Cabotegravir Caffeine Calcium Folinate Camylofine Candesartan Candesartan Cilexetil Candoxatril Cangrelor Capsaicin Capsazepine Captopril Carazolol Carbamazepine Carbaryl Carbazole Carbidopa Carbinoxamine Carbovir Carboxin Carboxylic acid Carbuterol Carcinine Carenoprazan Cariprazine Carisoprodol Carmoxirole Carprofen Carteolol Carvedilol Caspofungin Cay10606 Cefixime Celecoxib Celiprolol Cenicriviroc Cerdulatinib Ceritinib Cetirizine Chir 99021 Chloramphenicol Chlorbufam Chlorcyclizine hydrochloride Chlorimuron Chlorodiazepoxide Chloroquine Chlorothiazide Chloroxuron Chlorphenamine Chlorpromazine Chlorprothixene Chlortalidone Chlortoluron Choline Cibenzoline Cilazapril Cilostazol Cimaterol Cimetidine Cinacalcet Cinnarizine Ciprofloxacin Cisapride Citalopram Citarinostat Clarithromycin Clavulanic Acid Clenbuterol Clenisopenterol Clenproperol Clevidipine Clindamycin Clobazam Clofazimine Clofedanol Clomiphene Clomipramine Clonidine Clonixin Clopidogrel Clotrimazole Clozapine Coclaurine Colchicine Colesevelam Colestipol Corynecin Cp 93129 Crizotinib Cur 61414 Cy 208-243 Cyamemazine Cyanazine Cyclamate Cyclobenzaprine Cyclobutrifluram Cyclopentane Cyclopeptine Cyclophosphamide Cyclosporine Cyprodinil Cyproheptadine Cysteine Cytisine Dabigatran Dacomitinib Dalbavancin Daminozide Dapoxetine Daridorexant Darolutamide Darunavir Dasabuvir Dasatinib Deferiprone Degarelix Delapril Demeclocycline Desipramine Desmopressin Deterenol Dextromethorphan Diazald Diazoxide Diclofenac Diflufenican Dihexylamine Diltiazem Dimenhydrinate Dimethoate Dimethylbutylamine Dinaciclib Dinotefuran Dipentylamine Diphenhydramine Diphenylamine Dipivefrine hydrochloride Diuron Dobutamine Docarpamine Dolutegravir Domperidone Donepezil Dopa Doravirine Doripenem Dorzolamide Doxasozin Doxepin Doxycycline Doxylamine Dronedarone Droperidol Dropropizine Drotaverine Duloxetine Dutasteride Duvelisib Dye D+C Dyes Dyphylline Ebastine Edc Edoxaban Elagolix Eletriptan Elexacaftor Eliglustat Ellipticine Elmustine Elobixibat Elsulfavirine Eltrombopag Emamectin Embutramide Emetine Enalapril Enalaprilat Enarodustat Enoxacin Enpiroline Ensartinib Ensifentrine Entrectinib Enzalutamide Ephedrine Epinephrine Erdafitinib Erdosteine Ergocornine Ergocorninine Ergocristine Ergocristinine Ergostine Erismodegib Erlotinib Ertapenem Erythromycin Escitalopram Esmolol Ethambutol Ethane Ethanol Ethanolamine Ethylenediaminetetraacetic acid Etidocaine Etifoxine Etilefrine Etodolac Etomidate Etrasimod Etravirine Evocalcet Exametazime Ezetimibe Ezlopitant Falimint Famotidine Fedratinib Felodipine Fenoldopam Fenoterol Fenoxycarb Fenspiride Fexinidazole Fexofenadine Finasteride Finerenone Flecainide Florylpicoxamid Fluazinam Flubendazole Fluconazole Flufenamic Acid Flufenoxuron Flumatinib Flunixin meglumine Fluopimomide Fluorocompound Fluoxetine Fluphenazine Fluralaner Fluvalinate Fluvoxamine Folic Acid Folinic Acid Formoterol Fosdenopterin Fosfomycin Fosinopril Fostamatinib Frovatriptan Fruquintinib Furosemide Gaboxadol Gadoteridol Galantamine Gatifloxacin Geneticin Gentamicin Gentamycin Gepirone Gliclazide Glipizide Glucamine Glutathione Glycine Glycopyrrolate Go 6976 Gramine Granisetron Granisteron Guanfacine Guanidine Halofuginone Hexythiazox Higenamine Histidine Hydantoin Hydralazine Hydrazine Hydrochlorothiazide Hydroflumethiazide Hydroxychloroquine Ibandronate Ibrutinib Idazoxan Idelalisib Ifosfamide Iguratimod Imatinib Imazamox Imazethapyr Imeglimin Imidazole Imidazolidone Iminostilbene Indacaterol Indapamide Indigo Carmine Indisetron Indobufen Indole Indoramine Ingavirin Iodixanol Iopamidol Iopentol Iopromide Ioxitalamic Acid Irbesartan Irinotecan Isatin Isavuconazole Isometheptane Isometheptene Isoprenaline Isopropamide Isoproterenol Isoproturon Isoxsuprine Isradipine Istradefylline Itopride Ivabradine Ivacaftor Ixazomib Jn7-69 Ketamine Ketoconazole Ketorolac Ketotifen Kinase inhibitors and antagonists Kukoamine Labetalol Labetolol Lacosamide Lafutidine Lamivudine Landiolol Lanreotide Lansoprazole Lapatinib Larotrectinib Leflunomide Lercanidipine Lestaurtinib Letermovir Leucine Levalbuterol Levetiracetam Levobunolol Levofloxacin Levomefolate Levomepromazine Levosimendan Levothyroxine Lidocaine Lifitegrast Linagliptin Linaprazan Lincomycin Linezolid Liraglutide Lisinopril Litoxetine Lomefloxacin Lomustine Loperamide Lopinavir Loratadine Lorcaserin Lornoxicam Losartan Lufenuron Lumateperone Lumefantrine Lumiracoxib Lurasidone Lysergol Macitentan Malic Acid Manidipine Maprotiline Maraviroc Maropitant Mavacamten Mebendazole Medroxalol Mefatinib Mefenamic Acid Mefenidil Mefloquine Meglumine Melatonin Melphalan Mepyramine Maleate Meropenem Metamizole Metaraminol bitartrate Metformin Methamphetamine Methimazole Methotrexate Methylene Blue Methylergonovine Methylphenidate Metoclopramide Metolazone Metoprolol Metronidazole Mianserin Mifepristone Migalastat Minocycline Minoxidil Mirabegron Miramistin Mirtazapine Misc Misc. Miscellaneous Mitomycin Mitoxantrone Moclobemide Moexipril Molnupiravir Molsidomine Morantel Morinidazole Morniflumate Morpholine Moxifloxacin Moxonidine Myristamidopropyl Dimethylamine Naftifine Naphazoline Naratriptan Nateglinide Nebivolol Neotame Neratinib Nicardipine Nicergoline Nicorandil Nicotine Nicotinic Acid Nifedipine Nifekalant Niflumic acid Nilotinib Nimodipine Nintedanib Nipecotic Acid Niraparib Nisoldipine Nistrosamine Nitazoxanide Nitrendipine Nitrosamine Nitrosamines Nizatidine Nnal Nonivamide Norepinephrine Nornarceine Northiadene Nortriptyline Nortropine Nortropinone Novaluron Ofloxacin Olanzapine Olopatadine Omadacycline Ondansetron Orlistat Orphenadrine Osimertinib Other Nitrosamines Oxazolidine Oxybutynin Paclitaxel Padimate o Palbociclib Paliperidone Pantoprazole Papaverine Hydrochloride Pardoprunox Paroxetine Pazopanib Pemetrexed Penbutolol Penicillamine Penicillin Pentazocine Pentoxifylline Peramivir Perhexiline Perindopril Phenethylamine Pheniramine Phentolamine Phenylephrine Phenylhydrazine Phenyltoloxamine Phenyramidol Phenytoin Pidobenzone Pidotimod Pimavanserin Pimozide Pindolol Pipamperone Pipecolic Acid Pipemidic Acid Piperaquine Piperazine Piperidine Piracetam Pirbuterol Pirfenidone Pirlimycin Pirlindole Piroxicam Plazomicin Plerixafor Polythiazide Pomalidomide Posaconazole Pradofloxacin Pramipexol Pramipexole Pranlukast Praziquanamine Prilocaine Primaquine diphosphate Procarbazine Procaterol Prochlorperazine Proline Promazine Promethazine Propafenon Propafenone Propamocarb Propylhexedrine Protriptyline Prucalopride Pseudoephedrine Pyrazole Pyribambenz Pyridine Pyrimidine Pyronaridine Pyrrole Quetiapine Quinapril Quinine Rabeprazole Racecadotril Ractopamine Raltegravir Ramipril Ranitidine Ranolazine Rasagiline Rebamipide Regadenoson Relebactam Relugolix Remifentanil Repaglinide Reproterol Retigabine Revaprazan Revefenacin Ribociclib Rifabutin Rilpivirine Rimegepant Riociguat Risdiplam Risperidone Ritalinic Acid Ritodrine Rivaroxaban Rivastigmine Rizatriptan Robenacoxib Rodatristat Rolapitant Rosuvastatin Rotigotine Rucaparib Ruxolitinib Sacubitril Safinamide Salbutamol Salcaprozate Salmeterol Sapropterin Sarafloxacin Sarcosine Sarizotan Saxagliptin Sb 242084 Scopolamine Selatinib Selegiline Selexipag Sertraline Sevelamer Sildenafil Silodosin Siponimod Sitagliptin Solifenacin Sorafenib Sotalol Sotorasib Sparfloxacin Spectinomycin Spinosad Spiramycin Staurosporine Streptomycin Succinimide Sugammadex Sulfasalazine Sulpiride Sumatriptan Sunitinib Suvorexant Synephrine Tacrolimus Tadalafil Tafenoquine Talinolol Tamoxifen Tamsulosin Tapentadol Tasimelteon Taurine Tegoprazan Telavancin Telithromycin Telmisartan Temazepam Temocapril Temocaprilat Teneligliptin Tenofovir Terazosin Terbinafine Terbutaline Teriflunomide Tetracaine Tetracycline Tetrahydrobiopterin Tetryzoline Theophylline Thiamazole Thioridazine Thonzylamine Tianeptine Ticagrelor Tigecycline Tiletamine Timolol Tirofiban Tizanidine Toceranib Tofacitinib Tolfenamic Acid Tolterodine Tolvaptan Torasemide Tosedostat Tramadol Trandolapril Tranexamic Acid Trazodone Tretoquinol Triamterene Triazole Trichlormethiazide Trientine Trientine hydrochloride Trifluorothymine Trimebutine Trimetazidine Trimethobenzamide Trimipramine Triptycene Trolamine Trometamol Tryptophan Tryptophol Tulobuterol Tyramine Ulipristal Upadacitinib Uracil Urapidil Urea Valacyclovir Valganciclovir Valsartan Vancomycin Varenicline Venetoclax Venlafaxine Ver-246608 Verapamil Vibegron Vigabatrin Vilanterol Vilazodone Vildagliptin Vismodegib Voclosporin Vonoprazan Vortioxetine Xanomeline YCT-529 Zanubrutinib Ziprasidone Zolmitriptan ZOLPIDEM Zopiclone

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