When we are hired to develop a
stability indicating method for our clients, what do we do?
The types of questions that need
to be addressed depends on the stage of development that the method will be
used for. First a few basic definitions.
What is a stability indicating method?
A stability indicating method is a quantitative test method that can detect possible degradants and impurities of drug substance (API) and drug products, normally using High Performance Liquid Chromatography (HPLC). Stability information is needed for regulatory submissions such as IND (Investigational New Drug Application) and NDA (New Drug Application) and to set expiration dates for the API or drug product. Stability indicating methods are also used to screen excipients when performing formulation development, in order to ensure that the possible excipients do not chemically react with the API.
Before performing stability studies, a
stability indicating method is necessary so that any possible degradants
generated during storage conditions (such as 5°C, 25°C/60%RH and 40°C/75%RH)
can be separated, detected, and quantitated.
The method should meet several criteria
based on the stage of development. Nominally, the method should be
selective, sensitive, and provide precise and accurate results.
Sometimes Tamilnadu Test House is asked
by a client to use a previously developed API method and determine whether it
will work for the drug product. Other times, we develop full methods from
scratch. Obviously time and money requirements are less when existing
methods are used. However, sometimes a method isn’t fully appropriate for
its new use and changes need to be made.
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