USP: United States Pharmacopoeia EP: European Pharmacopoeia BP: British Pharmacopoeia

API-Active pharmaceutical ingredients

A DMF has five Modules 1. Cover Letter and Admin information, Letter of Authorizations 2. Summarizes the appropriate module 3 sections (and 4 & 5 if applicable) 3. For Type II: Drug Substance, Drug Substance Intermediate and Materials used in their preparation 4. Not necessary for DMFs unless non clinical evaluations are included in the DMF - i.e. an impurity in a Type II DMF 5. Submitted for clinical information only, such as a Type V DMF

Glad you enjoyed it! We have used segments for in-house training.

HCl and NaOH are typical acids and bases used for hydrolysis conditions for forced degradation. This does not preclude the use of other acids/bases, as appropriate.

When in the video was that table put up? I will check with our analytical team.

We also have some great Blog Posts on impurity management and analytical development. www.registech.com/blog/

Sadly Paul died in 2016

Thanks and welcome

Most welcome

you may contact the presenter Mike Anisfeld at [email protected]. Perhaps he could add another element to the training.

Thank you!

Typically, hydrogen peroxide is used for oxidative forced degradation studies of APIs, but transition metal-induced oxidative degradation can be performed to mimick the exposure to metals in production. I don’t believe that there is a consensus as to which oxidative transition metal is ‘most’ commonly used for such a study, but would instead be selected based on which metal(s) the API is likely to be exposed to in the production plant. For example, Fe(III) would be a relevant choice for APIs exposed to stainless steel, likewise Cu(II) for APIs exposed to bronze.

Thanks!

@@Registech Dear Sir, do u have any vacancy ? Have more than 5 years of Regulatory Affairs experience national & international, Pharma D, trained in PV and GCP.

Not all method validations include forced degradation. If you ask for a stability indicating method, forced degradation will be included.

Not all validations include forced degradation. If you ask for a stability indicating method, forced degradation will be included.