Powered by OpenAIRE graph
Found an issue? Give us feedback
ZENODOarrow_drop_down
ZENODO
Article . 2025
License: CC BY
Data sources: Datacite
ZENODO
Article . 2025
License: CC BY
Data sources: Datacite
versions View all 2 versions
addClaim

This Research product is the result of merged Research products in OpenAIRE.

You have already added 0 works in your ORCID record related to the merged Research product.

Impurity profiling of pharmaceutical Formulation

Authors: Rajnanda Patil*, Srushti Aoundhkar, Priyanka Mohite, Dr. D. R. Jadge;

Impurity profiling of pharmaceutical Formulation

Abstract

Impurity profiling is an essential tool for the pharmaceutical business, and this article delves into that role extensively. Drug safety and effectiveness might be jeopardized when active pharmaceutical ingredients (APIs) are mixed with impurities, which are undesirable chemical compounds. To guarantee the detection and control of contaminants in both APIs and formulated goods, numerous regulatory agencies have set rigorous purity standards, such as ICH, FDA, and CDHA. Particular emphasis is placed on the limits that can be tolerated for organic, inorganic, and residual solvent contaminants. The concept of impurity profiling is described, including its use in medication design, quality assurance, and safety evaluation. It includes steps such as quantitative determination, structural elucidation, and identification. Hyphenated processes such as liquid chromatography-mass spectrometry and liquid chromatography-nuclear spectrometry are addressed in the article, along with accelerated solvent extraction, gas chromatography, nuclear magnetic resonance, mass spectrometry, and more. To ensure the efficacy and safety of pharmaceutical goods, impurity profiling plays a crucial role, as this comprehensive review shows

Keywords

Impurities, pharmaceutical products, impurity profiling, regulatory authorities, analytical techniques

  • 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).
    0
    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
Powered by OpenAIRE graph
Found an issue? Give us feedback
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!
0
Average
Average
Average
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!