|
|||||||||||||||
|
INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016 Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) |
||||||||||||||
Issue: April 2024
Volume 9 | Issue 4
Review Result and Publication of Paper within : 2-3 days
Click Here For more DetailsFor Authors
Forms / Download
Published Issue Details
Editorial Board
Other IMP Links
Facts & Figure
Impact Factor : 8.76
Issue per Year : 12
Volume Published : 9
Issue Published : 95
Article Submitted :
Article Published :
Total Authors :
Total Reviewer :
Total Countries :
Indexing Partner
Join RMS/Earn 300
Licence
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
|
Published Paper Details
|
|
| Paper Title: | Control strategy of Nitrosamine impurities in Pharmaceutical Drugs |
| Authors Name: | Mr. Monik Gohil , Dr. Yogesh M. Baj |
| Download E-Certificate: | Download |
| Author Reg. ID: |
IJNRD_197890
|
| Published Paper Id: | IJNRD2305949 |
| Published In: | Volume 8 Issue 5, May-2023 |
| DOI: | |
| Abstract: | The carcinogenic properties of nitrosamines have been known for more than 50 years [1] and there are several nitrosamines that have been tested for carcinogenicity and have shown carcinogenic activities N-nitroso-dimethylamine (NDMA), N-nitroso-diethylamine (NDEA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), N-nitroso-diethanolamine (NDELA), nitroso-morpholine (NMOR), N-nitroso-N-methyl-N-ethylamine, and N-nitrosopyrrolidine (NPYR), being some of the well-known among these [2,3]. There are many more Nitrosamines are considered during the assessment as per ICH M7(R2), EMA guideline (current versions of EMA/369136/2020 & EMA/409815/2020) and Control of Nitrosamine Impurities in Human Drugs (Febuary-2021 Rev-1), as high potency mutagenic carcinogens referred to as compounds that are part of the “cohort of concern” and as such are classified as Class 1 impurities “known mutagenic carcinogens,” based on both rodent carcinogenicity and mutagenicity data [4]. In order to ensure that the presence of nitrosamine impurities in the medicinal products is mitigated as much as possible and controlled at or below a limit defined based on ICH M7(R2), EMA guideline (current versions of EMA/369136/2020 & EMA/409815/2020) and Control of Nitrosamine Impurities in Human Drugs (Febuary-2021 Rev-1). This review article reflects calculation for the control of nitrosamine impurities in drugs by considering lifetime daily exposure. |
| Keywords: | N-Nitrosamines, Cohort of Concern, ICH M7, Drugs, exposure |
| Cite Article: | "Control strategy of Nitrosamine impurities in Pharmaceutical Drugs", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 5, page no.j259-j264, May-2023, Available :http://www.ijnrd.org/papers/IJNRD2305949.pdf |
| Downloads: | 000118752 |
| ISSN: |
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
| Publication Details: |
Published Paper ID:IJNRD2305949 Registration ID: 197890 Published In: Volume 8 Issue 5, May-2023 DOI (Digital Object Identifier): Page No: j259-j264 Country: Vadodara, Gujarat, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2305949 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2305949 |
| Share Article: |
|
|
Click Here to Download This Article |
|
| Article Preview | |
|
|
|
Major Indexing from www.ijnrd.org
| Semantic Scholar | Microsaoft Academic | ORCID | Zenodo |
| Google Scholar | ResearcherID Thomson Reuters | Mendeley : reference manager | Academia.edu |
| arXiv.org : cornell university library | Research Gate | CiteSeerX | PUBLON |
| DRJI | SSRN | Scribd | DocStoc |
ISSN Details
 |
 |
|
ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
Journal Starting Year (ESTD) : 2016
DOI (A digital object identifier)
Conference
Open Access License Policy
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
Important Details
Social Media
Licence
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
Join RMS/Earn 300
| Copyright © 2024 - All Rights Reserved - IJNRD |
Facebook Twitter Instagram LinkedIn