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This section provides an overview for nitrosamine as well as their applications and principles. Also, please take a look at the list of 2 nitrosamine manufacturers and their company rankings. Here are the top-ranked nitrosamine companies as of December, 2024: 1.Pharmaffiliates.
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Nitrosamine is the generic name for amine derivatives that have the hydrogen atom on the amine nitrogen replaced by a nitroso group (-N=O).
Nitrosamines are found in trace amounts in the air, water, food, cosmetics, cigarettes, etc. Some of them are known to be carcinogens. Typical carcinogens are N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
In recent years, NDMA and NDEA have been detected as impurities in bulk pharmaceuticals for sartan and ranitidine drugs, leading to a product recall.
Nitrosamines are widely used in industry as plasticizers and additives. For example, N,N'-dinitrosopentamethylenetetramine (N,N'-Dinitrosopentamethylenetramine) is used as an organic foaming agent for rubber and other materials.
Nitrosamines are a group of compounds, many of which are known to be carcinogenic. For example, N-nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) are known to be toxic substances found in tobacco.
While it is toxic, it may also be produced as an impurity in the manufacturing process of pharmaceutical products. In recent years, the risk of contamination has been evaluated and measures taken to reduce the risk of contamination. For the purpose of these tests and analyses, standard and mixed standard solutions of nitrosamines are used as control experiments, and outsourced testing is also actively conducted.
In addition, since there have been cases of contamination of food products, especially processed products, with trace amounts of nitrosamines, the risk of contamination is now being evaluated in areas other than pharmaceuticals.
In some cases, heme iron in meat promotes the formation of carcinogenic nitrosamines, and nitrosamines are also formed when meat is smoked. In addition, sodium nitrite and sodium nitrate, which are added to processed meats, are responsible for the formation of nitrosamines.
Cooking foods has been shown to alter the amount of nitrosamines in them; cooking at temperatures below 100°C (182°F) almost never increases the amount of Nitrosamines, while cooking at higher temperatures tends to increase it.
Of the nitrosamines that have recently been implicated in pharmaceuticals and other products, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are the simplest in structure. In addition, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), N-nitrosomethylphenylamine (NMPA), and N-nitrosoisopropylethylamine (NIPEA) have been found in active pharmaceutical ingredients and preparations, as well as N-nitrosodiisopropylamine (NDIPA) and N- N-nitrosodibutylamine (NDBA) have been identified as theoretical contamination hazards.
Tolerable intake levels (ng/day) for these compounds have been established by the Ministry of Health, Labour and Welfare (MHLW). Currently, manufacturers are requested to conduct voluntary inspections to ensure that the amount of nitrosamines in bulk pharmaceuticals is below the control level.
Nitrosamines are known to be formed by the reaction of secondary amines with nitrous acid. In recent years, nitrosamines have been detected as impurities in pharmaceuticals. In sultan-based pharmaceuticals, this is thought to be due to the reaction of the solvent dimethylformamide (DMF) with nitrous acid.
The nitrous acid used in this reaction is added to quench the azide used in the formation of the tetrazole ring. NDMA has also been detected in ranitidine hydrochloride preparations and APIs. Ranitidine is a compound that has an N-dimethyl structure, the source of NDMA, and a nitro group.
Therefore, it is believed that in the case of ranitidine, the cause of NDMA formation is temperature and the structure of ranitidine itself. In fact, it has been reported that NDMA increases significantly in ranitidine when exposed to high temperatures.
*Including some distributors, etc.
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Pharmaffiliates, established in 2001 and located in Gurgaon, India, is a manufacturer of pharmaceutical standards and services. The company provides Certified Reference Standards (CRS) used in analytical methods, as well as drug delivery systems like tablets, capsules, injectables, and deuterated compounds that aid in research and development, studying drug metabolism and pharmacokinetics. Pharmaffiliates also offers various services to the pharmaceutical industry, including custom synthesis, analytical research, stability studies, and formulation development.
ChemSrc, established in 2014, is a supplier of pharmaceutical products, a chemical database platform, and a search engine. This platform serves as a gateway to an extensive repository of chemical knowledge, offering access to unique CAS-encoded product records including synthesis routes, literature references, physical and chemical properties, and supplier information. The chemical catalog spans various categories, including organic raw materials, dyes and pigments, chemical pesticides, catalysts, additives, and more. The repository information plays a vital role in supporting research and development efforts across diverse industries by fostering scientific advancements and serving as a valuable resource.
Ranking as of December 2024
Derivation Method| Rank | Company | Click Share |
|---|---|---|
| 1 | Pharmaffiliates |
100.0%
|
Derivation Method
The ranking is calculated based on the click share within the nitrosamine page as of December 2024. Click share is defined as the total number of clicks for all companies during the period divided by the number of clicks for each company.Number of Employees
Newly Established Company
Company with a History
*Including some distributors, etc.
| Country | Number of Companies | Share (%) |
|---|---|---|
|
India
|
1 | 100.0% |
