Nitrosamines. Medical search. Frequent questions

When referring to this article, please cite it as T. Curran and J.P. Bercu, 'Managing the Risk of Nitrosamine Impurities,' Pharmaceutical Technology Regulatory Sourcebook eBook (March 2021). (pharmtech.com)
Unreported changes to synthetic processes lead to the surprise presence of nitrosamine impurities in marketed drug products. (lhasalimited.org)
Nitrosamine impurities have been in the regulatory spotlight since they were discovered in several blood pressure medicines known as sartans back in June 2018. (manufacturingchemist.com)
These molecules are of concern because nitrosamine impurities are probable human carcinogens. (manufacturingchemist.com)
Is there a risk of nitrosamines forming in the API synthetic process taking into consideration the combination of reagents, solvents, catalysts and starting materials used, intermediates formed, impurities and degradants? (manufacturingchemist.com)
PharmaLex says it can provide assessments of products for nitrosamine impurities. (manufacturingchemist.com)
Nitrosamines have been identified as significant impurities in some drugs, including ranitidine, which resulted in product recalls and regulatory actions worldwide. (rssl.com)
Regulatory and analytical aspects of determining mutagenic impurities, including nitrosamines, will also be consider. (chromatographyonline.com)
Impurities, impurity profiling and analytical challenges of detection and quantification of trace level impurities in pharmaceutical products including mutagenic nitrosamine impurities will be presented. (chromatographyonline.com)
N-nitrosamine impurities in Ph. (edqm.eu)
But there are rifapentine shortages because global demand has increased and because the sole manufacturer has voluntarily paused release of the drug due to the detection of nitrosamine impurities. (lacare.org)
This educational activity will provide an overview of nitrosamine impurities identified in several prescription and over-the-counter drug products. (aapa.org)
The agency immediately began testing to determine whether the metformin in the U.S. supply was at risk, as part of the ongoing investigation into nitrosamine impurities across medication types. (epicos.com)
We provide unparalleled risk evaluations which can identify active substances and finished products at risk of N-nitrosamine formation or (cross)-contamination with these impurities. (quinta.cz)
Since then, there has been increased scrutiny of drug products for nitrosamines impurities. (selvita.com)
The ICH M7(R1) Guideline classifies nitrosamines as Class 1 impurities, which are a significant concern. (selvita.com)
The presence of these impurities in pharmaceutical products can be attributed to a variety of factors, such as contaminated raw materials in API production, the use of nitrosating agents and recovered materials, nitrosamines contaminated starting materials and intermediates, and specific packaging materials and degradation processes. (selvita.com)
In response to this issue, the EMA has requested marketing authorization holders to review drug products containing synthetized APIs for nitrosamines impurities content. (selvita.com)
Our team is well-versed in working with challenging matrices and detecting impurities at trace levels, which is particularly important in the case of nitrosamines detection. (selvita.com)
These nitrosamines are classified as unknown genotoxic impurities according to the ICH M7(R1) Guideline, and they are required to be analyzed with a limit of 1.5 µg/day. (selvita.com)
In recent years, drugs have been recalled from the market, due to detection of low levels of impurities consisting of N-nitrosamines (NAs). (fraunhofer.de)
Finally, the FDA issued a guidance for the industry, " Control of Nitrosamine Impurities in Human Drugs" , in the fall of 2020. (ampacanalytical.com)
The calculation of AI assumes a lifelong daily administration of the maximum daily dose of the medicinal product and is based on the approach outlined in the ICH M7(R1) guideline as well as the principles described in relation to the toxicological evaluation in the assessment report of the CHMP's Article 5(3) opinion on nitrosamine impurities in human medicinal products. (ampacanalytical.com)
For example, "If the active substance itself is mutagenic or clastogenic at therapeutic concentrations, N -nitrosamine impurities should be controlled at limits for non-mutagenic impurities according to ICH M7(R1). (ampacanalytical.com)
AMPAC Analytical Laboratories - an SK pharmteco company (AAL) is an industry leader in the detection of nitrosamines and other genotoxic impurities (GTI), We have the specialized expertise, equipment, and methodologies to detect these impurities by gas chromatography or high-performance liquid chromatography coupled with mass spectrometry to support your API project. (ampacanalytical.com)
I am interested to know more about the nitrosamine impurities in drug substance and drug product, to help me in my work in consultation specially after SFDA notified manufacturers to provide a risk assessment in the initial submission for the impurities in the active pharmaceutical substance (Section 3.2.S.3.2) and impurities in the final product (Section 3.2.P.5.5). (usp.org)
Since 2018, many drug batches have been recalled because of nitrosamine impurities above acceptable levels. (senpharma.vn)
Although the concentration or risk of cancer incidence of impurities (particularly nitrosamines) in pharmaceutical products is at lower levels compared to other daily exposures, regulatory authorities always put effort into eliminating avoidable harm in drugs. (senpharma.vn)
More than 15 years of experience in developing stability-indicating methods and toxicological assessment of impurities in drug substances and drug products (degradation products, mutagenic impurities/nitrosamines, elemental impurities, extractable and leachable) using in silico tools and integrated risk assessment. (freethinktech.com)
On Wednesday 11 May 2022, our 4th Lunchwork of the year took place on the theme of nitrosamine impurities for which the regulatory deadlines are fast approaching. (atessia.fr)
Our speakers recalled that knowledge of nitrosamine impurities was constantly evolving and insisted on the need to regularly monitor the texts issued by the health authorities on this subject, in order to take into account any new root cause of formation identified and any limit applicable to a specific nitrosamine defined by the authorities on the basis of safety data. (atessia.fr)
Nitrosamine impurities have the potential to cause cancer, and have come under increasing scrutiny from regulators after their detection in a variety of drugs in recent years. (chemistryworld.com)
However, Schmidtsdorff stresses that there is currently a widespread issue with nitrosamine impurities related to drug substances (rather than those derived from solvents or other ingredients). (chemistryworld.com)
A spokesperson for the European Medicines Agency adds that scientists think nitrosamines form when amine groups in the active drug substances and trace nitrite impurities in other ingredients within the formulation react during manufacturing. (chemistryworld.com)
Owing to the huge number of drug substances that could be affected by nitrosamine impurities, Chromicent is 'currently facing a flood of requests from [manufacturers] and follow-up investigations from regulatory authorities,' Schmidtsdorff reveals. (chemistryworld.com)
The US Food and Drug Administration (FDA) will not act on Phathom Pharmaceutical's vonoprazan new drug application (NDA) for erosive esophagitis or its post-approval supplement for Helicobacter pylori until the company addresses concerns over the presence of nitrosamine impurities. (medscape.com)
This fact sheet aims to provide clinicians with general information on the presence of nitrosamine impurities found in rifampin and rifapentine and its impact on the treatment for TB. (cdc.gov)

Tobacco-specific nitrosamines (TSNAs) comprise one of the most important groups of carcinogens in tobacco products, particularly cigarettes (traditional and electronic) and fermented dipping snuff. (wikipedia.org)
These nitrosamine carcinogens are formed from nicotine and related compounds by a nitrosation reaction that occurs during the curing and processing of tobacco. (wikipedia.org)
FDA expressed concern to the industry over infant exposure to nitrosamines, many of which are carcinogens, and informed manufacturers that appropriate measures must be taken to reduce nitrosamine formation in rubber nipples to the lowest level that is technologically feasible. (fda.gov)
High levels of tobacco specific nitrosamines are found in tobacco cigarettes, and they are one of many known carcinogens in tobacco smoke. (ecigarettedirect.co.uk)
N -nitrosamines are known as possible carcinogens for humans. (edqm.eu)
Tobacco-specific nitrosamines (TSNAs) are known carcinogens in cured tobacco. (allenpress.com)
Nitrosamines are a type of impurity that belong to the carcinogens family and can form during the production of pharmaceutical products or substances when certain nitrogenous agents (amides, secondary amines, urea derivatives, carbamates, and other) react with a nitrogen atom in a +3 state. (selvita.com)
This study analyzed Minnesota house dust samples for nicotine and tobacco specific nitrosamine (TSNA) concentrations and evaluated cancer risks associated with the TSNA carcinogens. (sdsu.edu)

Among the 30 contaminants being monitored as part of the UCMR3 efforts are six nitrosamines, including NDMA. (thermofisher.com)
In 2018, certain types of nitrosamines ( N ‑nitrosodiethylamine - NDEA - and N -nitrosodimethylamine - NDMA) were detected in a number of active substances used in the treatment of hypertension and in related medicines. (edqm.eu)
SILVER SPRING, Md., May 28, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration is announcing today that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency's acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. (epicos.com)
Our experience goes far beyond N-Nitroso-N,N-dimethylamine (NDMA) determination and, till the date, we have practical experience with twenty-four Nitrosamines, including nitrosamine analogues, which confirms the versatility of the method. (quinta.cz)
The LOD of 5 different Nitrosamines: (N-Nitroso-Dimethylamine (NDMA), N-Nitroso-Piperidine (NPID), N-Nitroso-Diethylamine (NDEA), N-Nitroso-Ethylisopropylamine (NEIPA) and N-Nitroso-Diisopropylamine (NDIPA) has been evaluated with a triple quadrupole MS detector 8050 from Shimadzu using the HPLC method conditions with the XBridge C18 column. (docuchem.com)
BACKGROUND: Previous epidemiologic studies found inconsistent results for the association between red meat intake, nitrosamines [NDMA: N-nitrosodimethylamine, and ENOC (endogenous nitroso compounds)], and the risk of bladder cancer. (ox.ac.uk)

Among the tobacco-specific nitrosamines, nicotine-derived nitrosamine ketone (NNK) and N-nitrosonornicotine (NNN) are the most carcinogenic. (wikipedia.org)
Most Nitrosamines are Carcinogenic. (maclellanrubber.com)
However, the presence of these compounds can lead to the formation of potentially carcinogenic nitrosamines. (rssl.com)
To follow this guidance, manufacturers of approved APIs and drug products are directed to evaluate nitrosamines risks within the next three months, and the guideline specifies that by August 2025, any NDSRIs in drug products or APIs must comply with the FDA-recommended AI limits and corresponding carcinogenic potency categories. (selvita.com)
In Appendix 1 found on the EM A site , there is a list of more than eighty nitrosamines listed, along with CAS numbers, known medicinal sources, CPCA (Carcinogenic Potency Categorization Approach) categories, and their guidance publication dates. (ampacanalytical.com)
N-nitrosamines are carcinogenic substances often found in rubber products. (e-jehs.org)
This new material advances the elimination of contamination by the polymer into the process not only through early detection of particle contamination, but also through eradication of leachable Nitrosamine carcinogenic compounds found in many standard polymers. (sealextrusions.com)

ISO/TS 22304:2008 specifies the procedure for the determination of the tobacco specific nitrosamines (TSNAs): N-nitrosonornicotine (NNN), N-nitrosoanatabine (NAT), N-nitrosoanabasine (NAB) and 4-(methyl-nitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in ground leaf tobacco, manufactured tobacco and tobacco products. (iso.org)
The CDC laboratory method for measuring tobacco-specific nitrosamines (TSNAs) was improved by increasing the extraction efficiency (i.e., the ratio of the amount of TSNAs measured to the actual amount of TSNAs `present in the smoke sample). (cdc.gov)

The maximum level of nitrosamines found were 8.2ng/g. (ecigarettedirect.co.uk)
Average level of nitrosamines in the smoke of cigarettes sold in the United States (nanograms per cigarette). (cdc.gov)

Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products, as well as for new drug applications. (dsm.com)
Nitrosamines in nipples at levels greater than an established action level are considered avoidable contamination under section 406 of the Federal Food, Drug, and Cosmetic Act. (fda.gov)
The risk assessment should consist of the identification of hazards and the analysis and evaluation of risks associated with the arrangements for preventing nitrosamine formation as well as contamination or cross-contamination. (manufacturingchemist.com)
Is there a potential risk of nitrosamine contamination (e.g. from recovered materials such as solvents, reagents and catalysts, equipment, degradation, starting materials or intermediates)? (manufacturingchemist.com)
The scope of the risk-assessment campaign and multiple possible root causes of the contamination create imminent need of robust and reliable determination of Nitrosamines content in various types of matrices. (quinta.cz)
The presence of nitrosamines in pharmaceutical products has emerged as a public health concern, leading health authorities to provide guidance for Marketing Authorization holders and manufacturers alike to perform risk assessments and implement mitigation strategies in case of possible contamination. (sigmaaldrich.com)
In September 2019, the European Medicines Agency (EMA) determined that pharmaceutical companies must evaluate all their synthetic drug products for the risk of nitrosamines formation and contamination. (senpharma.vn)
That was because metformin, a nitrogen-rich compound like sitagliptin, was one of the first drugs to show nitrosamine contamination, rather than them previously seeing any obvious problem with sitagliptin. (chemistryworld.com)

The nitrosamine crisis first erupted in July 2018, when the FDA announced a voluntary recall of several drugs containing Valsartan: a medicine used to treat high blood pressure and heart failure. (lhasalimited.org)
Since 2018, the detection of nitrosamines has become an important topic for the pharmaceutical industry. (selvita.com)
Indeed, since 2018, health authorities have implemented various action plans in order to protect patients' health, including a worldwide batch recall for medicines containing nitrosamines above the defined acceptable daily intake limit. (atessia.fr)
Recognising a need in the market for an alternative to silicone based Metal Detectable materials and with recent technical advances in producing Nitrosamine-free materials, TSEC's partners have developed a Blue Metal Detectable Nitrile Rubber which we are launching in the UK 2018. (sealextrusions.com)

Under the direction of Lee Yoo , Laboratory Director, the lab performs complete California Title 22 drinking water analyses, wastewater analyses, microbiological coli form and heterotrophic bacteria testing, VOCs, base/neutral organic compounds, emerging contaminants, nitrosamines in water, and many others types of analysis. (thermofisher.com)
Nitrite and nitrate analysis is important in controlling nitrosamine formation as it helps to monitor the levels of these compounds in pharmaceutical products. (rssl.com)
API index of Reference standards of Nitrosamine compounds. (pharmaffiliates.com)
Consumer exposure to nitrosamines, compounds that can form in food during its preparation and processing, raises a health concern. (europa.eu)
A common theme resonating from these unnecessary lifestyle trends is that we have inadvertently increased our chronic exposures to nitrosamines (R1N(-R2)-N = O) and related compounds. (biomedcentral.com)
Therefore, although research on nitrosamine-related compounds has been focused on their mutagenic properties, thorough characterization of their non-neoplastic and degenerative effects is clearly warranted. (biomedcentral.com)
Three subobjectives were created to track various toxic chemicals (nitrosamines, polyaromatic hydrocarbon compounds, and volatile organic compounds) in the smoke of cigarettes. (cdc.gov)

The situation escalated with the 2021 recall of Chantix (varenicline) due to the presence of a nitrosamine drug-substance-related impurity (NDSRI) named nitrosovarenicline. (synthinkchemicals.com)
Both letters address specifications and controls for a nitrosamine drug substance-related impurity, N -nitroso-vonoprazan (NVP), which was detected in the initial commercial launch materials of both products. (medscape.com)

We have the scientific know-how and cutting-edge technology you need to mitigate the risk of nitrosamines in your oral solid, semisolid, liquid or injectable formulations. (dsm.com)

On October 31, 2023, there was a Presentation from CDER's OPPQ & OPQ titled 'Nitrosamine Research Studies Inform FDA on Potential Strategies and BE Approaches' at PQS 2023. (usp.org)

Global regulatory bodies, including the FDA and EMA, have introduced a legal obligation for drug manufacturers to implement mitigation strategies that aim to minimize the risk of nitrosamine formation in drug products. (dsm.com)
Our latest whitepaper explores the current nitrosamine regulatory climate that the pharmaceutical market is facing. (dsm.com)
Nitrosamines guidelines and regulations have been published by regulatory agencies across the globe, requiring the industry to perform such risk assessments for their portfolios. (lhasalimited.org)
For example, since our blog series on nitrosamines, there have been some regulatory updates from the European Medicines Agency (EMA). (ampacanalytical.com)
The wide Thermo Scientific portfolio is proven to be excellent for nitrosamine analysis, ensuring your exploratory and routine methods are performed as accurately and reliably as possible while maintaining requirements from regulatory bodies worldwide. (metrolab.blog)
I like to get updated regularly with scientific & regulatory information about Nitrosamine topic. (usp.org)
The Nitrosamine (NA) issue, often termed the "Saga," has been a focal point of attention for both the pharmaceutical sector and regulatory entities over the past half-decade. (synthinkchemicals.com)

Exposure assessment for the proper management and communication of N-nitrosamines in rubber balloons should be carried out. (e-jehs.org)
This study was conducted to determine the concentrations of N-nitrosamines in rubber balloons in the South Korean market and assess exposure among Korean children. (e-jehs.org)
We evaluated the N-nitrosamines contained in rubber balloons purchased in the domestic market and assessed oral exposure among South Korean children. (e-jehs.org)
For integrated risk management of N-nitrosamines, further studies and discussion regarding exposure and risk assessment are required. (e-jehs.org)
The recalled drugs are not our only source of exposure to nitrosamines. (senpharma.vn)
Early limited exposure to nitrosamines exacerbates the adverse effects of later chronic high dietary fat intake in promoting T2DM and neurodegeneration. (biomedcentral.com)
Fibrosis induction following exposure to diethyl nitrosamine resulted in more numerous and larger liver tumor nodules in Socs1ΔHSC mice than in Socs1fl/fl mice. (bvsalud.org)

They are called tobacco-specific nitrosamines because they are found only in tobacco products, and possibly in some other nicotine-containing products. (wikipedia.org)
Thus, considerable evidence supports the role of tobacco-specific nitrosamines as important causative factors for cancers of the lung, pancreas, esophagus, and oral cavity in people who use tobacco products. (wikipedia.org)
Nitrosamines have also been found at low levels in Scandinavian smokeless tobacco, but a 2009 systematic review by Lee and Hamling couldn't find any link between Scandinavian Snus and cancer. (ecigarettedirect.co.uk)
A recent journal article that I read titled, Identification of Tobacco-Specific Nitrosamines as Disinfection Byproducts in Chloraminated Water (link to abstract) enticed me into reading more about the water treatment process and the resultant disinfection byproducts. (thermofisher.com)

Certain biogenic amines, notably spermidine and putrescine, have been spotlighted as precursors of specific volatile nitrosamines. (synthinkchemicals.com)

The Complex Nitrosamines Data Sharing Initiative allows consortium members to use the mutagenicity studies from the database to further understand the risks associated with potential nitrosamines. (lhasalimited.org)
In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regards a potential nitrosamines formation, using quality risk management principles. (edqm.eu)

The addition of antioxidants to drug formulations is a safe and viable, FDA-recommended mitigation strategy for inhibition of nitrosamine formation in drug products. (dsm.com)
Nitrosamines are potential mutagens and need to be controlled in human drug products. (dsm.com)
The control of nitrosamine formation is essential to ensure the safety and efficacy of pharmaceutical products. (rssl.com)
This on-demand webinar details a qualified automated approach to nitrosamine testing in products, which simultaneously prepares samples for LC-MS and GC-MS. (europeanpharmaceuticalreview.com)
In June 2020, the EMA finalised a review under Article 5(3) of EU Regulation (EC) No 726/2004 to provide guidance to Marketing Authorisation Holders (MAHs) on how to avoid the presence of nitrosamines in human medicinal products. (edqm.eu)
The reason is that risk assessments for the presence of nitrosamines in active substances should be available early enough to allow MAHs to collect the relevant data for their medicinal products. (edqm.eu)
1 The updated section answers the crucial question, "Which limits apply for nitrosamines in medicinal products? (ampacanalytical.com)
My project is focused on the detection of Nitrosamines in processed meat samples in order to develop Nitrite free products. (usp.org)
Currently performing test method validation at one of the US sites for the analysis of nitrosamine leachables in aqueous finished drug products (such as 0.9% sodium chloride injection and PD solutions by LCMSMS (APCI). (usp.org)
ㆍ N-nitrosamines and N-nitrosatable substances were detected in 44 products and 23 balloons exceeded the European limit. (e-jehs.org)
Forty eight rubber balloon products in the domestic market were purchased and a total of 68 balloons were analyzed for N-nitrosamines and N-nitrosatable substances. (e-jehs.org)
The below video will summarize risk assessment methods for nitrosamines in drug products. (senpharma.vn)

this has highlighted the potential presence of novel drug-like nitrosamines (NDSRIs) for which little or no publicly available toxicity data exists. (lhasalimited.org)

However, nitrite converts to nitrosamines, which can cause cancer in animals. (msdmanuals.com)

Nitrosamines are formed when nitrites or nitrates react with amines, which can be present in drug substances, excipients, or contaminants. (rssl.com)
Nitrosamines form by chemical reactions between nitrites and secondary amines or proteins. (biomedcentral.com)

The impact of fibrosis on the development of diethyl nitrosamine-induced hepatocellular carcinoma was evaluated. (bvsalud.org)

Formulators are now confronted with new guidelines that may lead to the reassessment of certain drug formulations at risk of nitrosamine formation. (dsm.com)
Learn from leading experts how antioxidants in drug formulation can minimize the risk of nitrosamine formation. (dsm.com)
Whether it's supporting you with the reformulation of your existing drug product, or helping to bring new innovative therapies to market, we can assist you in implementing a proven mitigation strategy to reduce the risk of nitrosamine formation in your pharmaceuticals. (dsm.com)
Manufacturers altered product formulas and manufacturing processes to reduce nitrosamine formation. (fda.gov)
The EMA has recently released a publication instructing Marketing Authorisation Holders (MAH) to take precautionary measures to mitigate the risk of nitrosamine formation or presences during the manufacture of all medicines containing chemically synthesised active substances. (manufacturingchemist.com)
Is there any potential of nitrosamine formation during the manufacture of the finished product and/or during storage throughout its shelf life? (manufacturingchemist.com)
Given that about 80% of APIs contain nitrogen atoms in their structures, there is a wide range of possibilities for the formation of this type of nitrosamine. (selvita.com)
Also, I will work on modeling the formation of nitrosamines in relation to different food processing and formulation to find a better understanding of nitrosamine formation in food. (usp.org)

Depending on the Nitrosamines that the costumer needs to analyze and the other substances contained in the sample, the previously listed HPLC methods can be used to achieve suitable resolutions between the analytes. (docuchem.com)
ㆍ Total of 68 balloons purchased from Korean market were analysed to determine the migration of N-nitrosamines and N-nitrosatable substances. (e-jehs.org)

The consortium also aims to use the data to improve structure-activity relationships (SARs) for complex nitrosamines - identifying trends in compound complexity versus mutagenic potential whilst maintaining the confidentiality of the data. (lhasalimited.org)
How well their molecular structure fits into those enzymes significantly affects the nitrosamines' mutagenic potential. (chemistryworld.com)

As a critical priority for global agencies, developing nitrosamine mitigation strategies is imperative for the safety of future pharmaceuticals. (dsm.com)

About 20-30% of all drugs and their intermediates could form nitrosamines, Schmidtsdorff estimates. (chemistryworld.com)

There is also guidance when one or more than one nitrosamines may be present. (ampacanalytical.com)
Nitrosamine guidance worldwide is ever-evolving, yet the impetus to quantify and regulate them is clear. (ampacanalytical.com)

US drug giant Merck & Co has found the cause of nitrosamine contaminants in three blockbuster diabetes drugs containing the active ingredient sitagliptin. (chemistryworld.com)

The second part of the webinar presents data from the Orange County Water District where eight nitrosamines, 1, 4-dioxane and other emerging contaminants are monitored at sub parts per trillion levels. (thermofisher.com)
Based on his experience with nitrosamine contaminants, Schmidtsdorff notes that intake limits like the revised FDA levels depend strongly on molecular structures. (chemistryworld.com)

Essentially the plant's natural alkaloids combine with nitrate forming the nitrosamines. (wikipedia.org)

There has been plenty of concern about nitrosamine levels in the e-liquid in e-cigarettes, and whether it has the potential to cause harm. (ecigarettedirect.co.uk)

CONCLUSIONS: Our findings do not support an effect of red meat intake, nitrosamines (endogenous or exogenous), or heme iron intake on bladder cancer risk. (ox.ac.uk)

Over time, the focus on nitrosamine determination has expanded to include not only the seven basic nitrosamines but also those derived from active pharmaceutical ingredients (API). (selvita.com)

Quinta-Analytica decided to contribute to patients' safety and to support the pharmaceutical industry by developing versatile proprietary ULPC/MS/MS method for quantitative determination of Nitrosamines under full GMP conditions. (quinta.cz)

Nitrosamines refer to any molecule containing the nitroso functional group. (manufacturingchemist.com)
The chemical structure of nitrosamines contains an amine bonding with a nitroso group, which is formed by a reaction between secondary or tertiary amines with nitrosating agents. (senpharma.vn)

Limited early exposures to nitrosamines that are widely present in the environment, enhance the deleterious effects of high fat intake in promoting T2DM and neurodegeneration. (biomedcentral.com)

Should the risk evaluation lead to the identification of nitrosamines confirmatory testing should be performed using appropriately validated and sensitive testing methods. (manufacturingchemist.com)

Collaborative industry efforts have shed light on ways industry standards can help pharma companies better understand the risks nitrosamines pose to the supply chain. (pharmtech.com)

Nitrosamines in E-Cigarettes: Do You Need to Worry? (ecigarettedirect.co.uk)
According to studies conducted, most e-cigarettes don't even seem to contain nitrosamines. (ecigarettedirect.co.uk)
In a survey of 16 electronic cigarette studies, Cahn and Siegel (2011) found that just two studies detected trace levels of nitrosamines in the ingredients (but not the vapour) produced by electronic cigarettes. (ecigarettedirect.co.uk)
An analysis by Professor Siegel came to a similar conclusion, arguing that Marlboro cigarettes contain levels of nitrosamines of 11,190 per billion compared to just over 8 per billion for vaping devices. (ecigarettedirect.co.uk)
The FDA only tested the contents of e-cigarettes for nitrosamines, not the vapor that smokers inhale. (ecigarettedirect.co.uk)

Below is a list of nitrosamines for which analytical methods have been developed and validated under full GMP/GLP requirements. (selvita.com)
Nitrosamine impurity analysis requires robust and sensitive analytical methods to ensure confidence in the obtained results. (metrolab.blog)

In response to the nitrosamine impurity crisis within the pharmaceutical industry, the Complex Nitrosamines data sharing initiative was launched in 2021. (lhasalimited.org)
Sebastian Schmidtsdorff, deputy head of the quality unit at Berlin, Germany-based chromatography specialist Chromicent , and colleagues, had published a method for analysing nitrosamines in sitagliptin-metformin combinations like Janumet in April 2021. (chemistryworld.com)

Nitrosamine risk mitigation is a huge challenge for drug manufacturers and the wider pharmaceutical industry. (dsm.com)
Discover how dsm-firmenich can help you navigate nitrosamine risk mitigation through our reliable customized solutions and expert services. (dsm.com)
Think nitrosamine mitigation. (dsm.com)
To learn more about our advanced formulation expertise and solutions for nitrosamine mitigation, connect with one of our experts today. (dsm.com)

A German study on the occurrence of volatile N-nitrosamines (nitrosamines) in rubber baby bottle nipples was presented at the meeting of the American Chemical Society in the spring of 1981. (fda.gov)
Nitrosamines are a chemical compound. (ecigarettedirect.co.uk)
Chemical analysis was conducted by HPLC-MS/MS according to the method EN 71-12. (e-jehs.org)

The lab found just one nitrosamine present in the vapour - but the nitrosamine was not a toxic one. (ecigarettedirect.co.uk)
Nitrosamines exert their toxic and mutagenic effects by alkylating N-7 of guanine, leading to increased DNA damage [ 5 ] and generation of reactive oxygen species such as superoxide (O 2 -) and hydrogen peroxide (H 2 O 2 ). (biomedcentral.com)

The total daily intake of all identified N -nitrosamines is not to exceed the AI of the most potent N -nitrosamine identified. (ampacanalytical.com)
Bulky nitrosamines may have higher acceptable intake levels or not be mutagenic at all. (chemistryworld.com)

Anatomy3

Organisms5

Diseases14

Chemicals and Drugs36

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Psychiatry and Psychology1

Phenomena and Processes5

Anthropology, Education, Sociology and Social Phenomena1

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Impurities37

Carcinogens8

NDMA6

Carcinogenic7

TSNAs2

Level of nitrosamines2

Contamination8

20184

Compounds7

Drug-substance-related impurity2

Mitigate the risk of nitrosamines1

20231

Regulatory7

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Tobacco4

Volatile nitrosamines1

Potential nitrosamines2

Products12

NDSRIs1

Nitrite1

Nitrites2

Hepatocellular carcinoma1

Formation8

Substances2

Mutagenic potential2

Pharmaceuticals1

Intermediates1

GUIDANCE2

Blockbuster diabetes drugs1

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Nitroso2

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20212

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