Impurity profiling emerging trends in quality control of pharmaceuticals

Authors

  • Poonam P. Patil Department of Pharmaceutical Chemistry, SRES
  • Veena S. Kasture Department of Pharmaceutical Chemistry, SRES
  • Vanitha Prakash K. Department of Pharmaceutical Chemistry, SSJ College Of Pharmacy Vattinagula Pally, Gandipet, Hyderabad, Rangareddy Dist. Telangana

DOI:

https://doi.org/10.7439/ijpc.v5i1.1539

Abstract

Impurities are nothing but the unidentified, unintended substance present along with desired substance. The newer regulations of US FDA, MHRA intends for the requirements of impurities rather than purity of pharmaceuticals. The impurity profiling of pharmaceuticals can be done by using various analytical methods like UV, HPLC, LC-MS, GC-MS, SCFC etc. Mostly RP-HPLC method commonly adopted for the qualification as well as quantification of impurities. The present review is an attempt made in the respect of highlighting the some important methods, quality guidelines and applications of impurity profiling.

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. S?d?ka Erturk, Esra Sevinc

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Published

2015-01-31

Issue

Section

Review Article

How to Cite

1.
Impurity profiling emerging trends in quality control of pharmaceuticals. Int J of Pharm Chem [Internet]. 2015 Jan. 31 [cited 2025 Jun. 4];5(1):01-10. Available from: https://ssjournals.co.in/index.php/ijpc/article/view/1539