Hi,
What kind of degradation to what kind of pharmaceutical will you be doing and what kind of HPLC (and detection!) are you planning to use?
There are several 'mass balances and degradation'.
1. Mass balance in forced degradation: The decrease in API moles = increase in moles of 'related substances (RS)'. The RS is identified by retention time and does not exist in a similarly treated placebo (it is solely sourced to the API).
2. Mass balance at expiry: Samples are stability samples. Again the decrease in API moles =Sum of increase in moles of ,related substances (RS)'. Note, that these RS do not have to be the same RS in forced degradation.
In neither case do you get 100%, since water from de-esterification is quantitated (acid and base FD). Most APIs are esters (like Sumatriptan Succinate, Clorpheniramine Maleate...).
HPLC (a form of chromatography or separation) is very common since the molecules of interest (both the API and RS) are similar and soluble in the mobile phases. I use a 5 cm HPLC column because a gradient method (via partitioning the concentration between the column and mobile phases) can differentiate between these molecules. 'Forced Degradation' is typically inserted in the specificity section of the 'analytical method validation (AMV)' protocol. Demonstration of separation is proved by 'peak purity'.
HPLC (a form of chromatography or separation) is very common since the molecules of interest (both the API and RS) are similar and soluble in the mobile phases. I use a 5 cm HPLC column because a gradient method (via partitioning the concentration between the column and mobile phases) can differentiate between these molecules. 'Forced Degradation' is typically inserted in the specificity section of the 'analytical method validation (AMV)' protocol. Demonstration of separation is proved by 'peak purity'.
HPLC (a form of chromatography or separation) is very common since the molecules of interest (both the API and RS) are similar and soluble in the mobile phases. I use a 5 cm HPLC column because a gradient method (via partitioning the concentration between the column and mobile phases) can differentiate between these molecules. 'Forced Degradation' is typically inserted in the specificity section of the 'analytical method validation (AMV)' protocol. Demonstration of separation is proved by 'peak purity'.
- Badges
- Science topic
- Similar topics
- Chemistry
- Pharmacology
- Pharmaceuticals