Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

2° Amines to N-Nitrosamines: Reaction with NaNO201:20

2° Amines to N-Nitrosamines: Reaction with NaNO2

4.8K
Secondary amines react with nitrous acid to form N-nitrosamines, as depicted in Figure 1. Nitrous acid, a weak and unstable acid, is formed in situ from an aqueous solution of sodium nitrite and strong acids, such as hydrochloric acid or sulfuric acid, in cold conditions. In the presence of an acid, the nitrous acid gets protonated. The subsequent loss of water results in the formation of the electrophile known as nitrosonium ion.
4.8K
Physical Properties of Amines01:26

Physical Properties of Amines

3.6K
Amines with low molecular weight are usually gaseous at room temperature, while those with high molecular weight are liquid or solids in nature. Usually, low molecular weight amines have a rotten fish-like smell. Diamines typically have a pungent smell. For instance, cadaverine and putrescine, depicted in Figure 1, are two molecules responsible for decaying tissue.
3.6K
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

34
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
34
Preparation of Amines: Reduction of Oximes and Nitro Compounds01:29

Preparation of Amines: Reduction of Oximes and Nitro Compounds

4.2K
Oximes can be reduced to primary amines using catalytic hydrogenation, hydride reduction, or sodium metal reduction. The reduction of aliphatic and aromatic nitro compounds to primary amines takes place by either catalytic hydrogenation or by using active metals like Fe, Zn, and Sn in the presence of an acid.
Though catalytic hydrogenation can reduce nitrobenzenes, the reduction is nonselective in the presence of other functional groups. For instance, if nitrobenzene contains an aldehyde group,...
4.2K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Design Verification Testing for Prefilled Syringes: A Structured Best-Practice Framework.

Pharmaceutics·2026
Same author

Overcoming device component-related challenges and risks in prefilled syringe development.

PDA journal of pharmaceutical science and technology·2026
Same author

There Is Still Room for Improvement: Presentation of a Neutral Borosilicate Glass with Improved Chemical Stability for Parenteral Packaging.

PDA journal of pharmaceutical science and technology·2016
Same journal

A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas.

PDA journal of pharmaceutical science and technology·2026
Same journal

Using Positive Controls to Define the Defect Detection Range for CCIT Method Development and Validation.

PDA journal of pharmaceutical science and technology·2026
Same journal

Patient-Centric Drug Delivery: Establishing Injection Hold Time Limits for Large Volume Autoinjectors.

PDA journal of pharmaceutical science and technology·2026
Same journal

Gas flow through micro-capillaries â which flow law is most suitable to predict the flow rate through micro-capillaries?

PDA journal of pharmaceutical science and technology·2026
Same journal

Peer Review.

PDA journal of pharmaceutical science and technology·2026
Same journal

In-situ Verification of Disinfection Rotation for Contamination Control.

PDA journal of pharmaceutical science and technology·2026
See all related articles

Related Experiment Video

Updated: Oct 27, 2025

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s
07:38

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s

Published on: September 25, 2017

10.3K

Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging.

Bettine Boltres1

  • 1Principal Scientific Affairs, Packaging & Delivery Systems, Scientific Affairs, West Pharmaceutical Services Deutschland GmbH & Co KG, Stolberger Str. 21 - 41, 52249 Eschweiler, Germany. bettine.boltres@westpharma.com.

PDA Journal of Pharmaceutical Science and Technology
|July 20, 2021
PubMed
Summary
This summary is machine-generated.

Nitrosamines, found in pharmaceuticals, require risk assessments. This review covers their chemistry, regulation, and analytical challenges, focusing on elastomeric components as a potential source.

Keywords:
ElastomersNitrosaminesPharmaceutical Primary PackagingRubber

More Related Videos

Detection of 3-Nitrotyrosine in Atmospheric Environments via a High-performance Liquid Chromatography-electrochemical Detector System
07:32

Detection of 3-Nitrotyrosine in Atmospheric Environments via a High-performance Liquid Chromatography-electrochemical Detector System

Published on: January 30, 2019

7.6K
Integration of Miniaturized Solid Phase Extraction and LC-MS/MS Detection of 3-Nitrotyrosine in Human Urine for Clinical Applications
08:41

Integration of Miniaturized Solid Phase Extraction and LC-MS/MS Detection of 3-Nitrotyrosine in Human Urine for Clinical Applications

Published on: July 14, 2017

9.5K

Related Experiment Videos

Last Updated: Oct 27, 2025

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s
07:38

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s

Published on: September 25, 2017

10.3K
Detection of 3-Nitrotyrosine in Atmospheric Environments via a High-performance Liquid Chromatography-electrochemical Detector System
07:32

Detection of 3-Nitrotyrosine in Atmospheric Environments via a High-performance Liquid Chromatography-electrochemical Detector System

Published on: January 30, 2019

7.6K
Integration of Miniaturized Solid Phase Extraction and LC-MS/MS Detection of 3-Nitrotyrosine in Human Urine for Clinical Applications
08:41

Integration of Miniaturized Solid Phase Extraction and LC-MS/MS Detection of 3-Nitrotyrosine in Human Urine for Clinical Applications

Published on: July 14, 2017

9.5K

Area of Science:

  • Pharmaceutical Chemistry
  • Drug Safety
  • Materials Science

Background:

  • Nitrosamines are a class of chemical compounds that have recently been detected at high levels in pharmaceutical products.
  • Regulatory bodies now mandate nitrosamine risk assessments for drug development and marketed products.
  • Evaluating all potential nitrosamine sources is crucial for comprehensive risk management.

Purpose of the Study:

  • To provide a chemical overview of nitrosamines and elastomeric formulations.
  • To discuss the current regulatory landscape for nitrosamines across industries.
  • To explore the analytical difficulties in measuring nitrosamines.

Main Methods:

  • Literature review of nitrosamine chemistry and elastomeric materials.
  • Analysis of current regulatory guidelines for pharmaceuticals and other sectors.
  • Discussion of analytical methodologies for nitrosamine detection and quantification.

Main Results:

  • Elastomeric components in drug packaging are identified as a potential source of nitrosamine contamination.
  • The chemical interactions between nitrosamines and elastomeric formulations are detailed.
  • Analytical challenges in detecting low-level nitrosamines are highlighted.

Conclusions:

  • Elastomeric materials require careful consideration as a potential nitrosamine source in pharmaceutical risk assessments.
  • Understanding the chemical basis and analytical methods is key to mitigating nitrosamine risks.
  • This review offers a framework for incorporating elastomeric component evaluation into drug product safety assessments.