Powered by OpenAIRE graph
Found an issue? Give us feedback
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao ZENODOarrow_drop_down
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
ZENODO
Article . 2020
Data sources: Datacite
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
ZENODO
Article . 2020
Data sources: ZENODO
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
ZENODO
Article . 2020
Data sources: Datacite
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
ZENODO
Article . 2020
Data sources: ZENODO
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
ZENODO
Article . 2020
Data sources: Datacite
versions View all 3 versions
addClaim

Nitrosamine Impurities in Drug Substances and Drug Products

Authors: Dr. Tabrez Shaikh; Dr. Amit Gosar; Dr. Hussain Sayyed;

Nitrosamine Impurities in Drug Substances and Drug Products

Abstract

{"references": ["Antonis Manolis (April 26, 2019), \"Carcinogenic Impurities in Generic Sartans: An Issue of Authorities' Control or a Problem with Generics\", Rhythmos; Volume 14, Issue 2, pp.23-26. DOI: 10.1021/cen-09708.", "FDA Press Release (July, 2018), \"FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity,\" APHA.", "EMA Press Release (September 21, 2018), \"Valsartan: Review of Impurities Extended to Other Sartan Medicines,\" EMA, Available at https://www.ema.europa.eu.", "Jennifer L. Caulfield (1997), \"The chemistry of nitric oxide-induced deamination and cross-linking of DNA\", (Doctoral dissertation), Massachusetts Institute of Technology, pp. 1-153.", "R. Nilsson (July, 2011), \"The molecular basis for induction of human cancers by tobacco specific nitrosamines\", Regulatory Toxicology and Pharmacology, Volume 60, Issue 2, pp. 268-80. Available at https://doi.org/10.1016/j.yrtph.2011.02.014.", "Lijinsky W. Andrews AW. (October, 1983), \"The superiority of hamster liver microsomal fraction for activating nitrosamines to mutagens in Salmonella typhimurium\", Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis. Volume 111, Issue 2, pp.135-144. DOI: 10.1016/0027-5107(83)90058-1.", "Aloka Srinivasan (2019), \"Proactive Evaluation of Possible Genotoxic Impurities during the Early Stages of Drug Development\", http://www.pharmtech.com.", "G. Subba Rao (1980), \"N-Nitrosarnines from drugs and nitrite: potential source of chemical carcinogens in humans\", Pharmacy International, Volume 1, pp. 187-190.", "\"Information on nitrosamines for marketing authorization holders\", European Medicines Agency, pp. 1-10, EMA/CHMP/428592/2019 Rev. 2.", "U. S. Food and Drug Administration update (Jan 25, 2019), \"Statement on the FDA's ongoing investigation into valsartan and ARB class impurities and the agency's steps to address the root causes of the safety issues\", https://www.fda.gov."]}

Nitrosamine impurities are known to be mutagenic and carcinogenic, very small exposure of these impurities can lead to cancer. These impurities may be formed and get incorporated into drug substance or drug product through reagent, catalyst, solvent or raw materials used in the process of manufacturing. The various regulatory authority has published the press release or notice regarding the control of these impurities with the interim limit. Nitrosamine impurities can be avoided by taking precaution in the manufacturing of drug substance and drug products. Validated analytical methods are to be used to identify and quantify these impurities hence it needs highly sensitive instrument which can detect these impurities to the trace level at given interim limit. Liquid chromatography or Gas chromatography, along with mass detector is majorly used for their determination.

Keywords

Classification, drug substances, drug product, impurities, nitrosamine and guidelines, http://matjournals.com/Pharmacy-Journals.html

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    3
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
    OpenAIRE UsageCounts
    Usage byUsageCounts
    visibility views 100
  • 100
    views
    Powered byOpenAIRE UsageCounts
Powered by OpenAIRE graph
Found an issue? Give us feedback
visibility
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
views
OpenAIRE UsageCountsViews provided by UsageCounts
3
Average
Average
Average
100
Upload OA version
Are you the author of this publication? Upload your Open Access version to Zenodo!
It’s fast and easy, just two clicks!