DOI: 10.21276/ajptr
Fri, 19 Apr 2019

Impurity Profile of Bulk Drugs and Pharmaceutical Preparations


T.M. Kalyankar1*, U.A. Khedkar1, S. J. Wadher1

1.School of Pharmacy, Swami Ramanand Teerh Marathwada University, Nanded- 431 606.



To assure the quality of drugs, impurities must be monitored carefully. It is important to understand what constitutes an impurity and to identify potential sources of such impurities. Selective analytical methods need to be developed to monitor them. It is generally desirable to profile impurities to provide a yardstick for comparative purposes. New impurities may be observed as changes are made in the synthesis, formulation, or production procedures, albeit for improving them. At times it is necessary to isolate and characterize an impurity when hyphenated methods do not yield the structure or when confirmation is necessary with an authentic material. Availability of an authentic material can also allow toxicological studies and provide a standard for routine monitoring of the drug product.

Keywords: Impurity profiling, degradation products, hyphenated techniques, ICH guidelines, pharmaceutical analysis.

[PDF]   Viewed: 1590   Downloaded: 188
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.



  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.


  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.


web counter
web counter