Submitting a Monograph
Technical Information Requirements For Monograph Review
Approved April 2014
5. Control of Drug Substance
Specifications for the raw material shall be provided.
Analytical procedures for the raw material used for the clinical batches shall be provided.
6. Reference Standards or Materials
Non-official Reference Standards
It is recommended that when a national or international reference standard is not available, a sponsor’s internal reference material that is representative of multiple source points may be used as a reference material, against which batches would be tested prior to their release. If this is the case, it is recommended that the sponsor’s internal reference material be described.
7. Special Storage Conditions
Special storage conditions
Any special storage conditions necessary to maintain the stability of the starting materials (and subsequent attenuations, if applicable) shall be described.
8. Stability
Stability
Sponsor shall demonstrate that the starting material met specifications at the time the active ingredient was manufactured and the dosage form remained stable throughout the duration of the clinical studies.