Assuring quality of drugs by monitoring impurities.
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.
Ahuja
Satinder Sut
SS
Ahuja Consulting, 1061 Rutledge Court, Calabash, NC 28467, USA. sutahuja@atmc.net
D002626:Chemistry, Pharmaceutical; D004340:Drug Contamination; D004355:Drug Stability; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013726:Terbutaline / Q000032:analysis
D004364:Pharmaceutical Preparations; D013726:Terbutaline