Submitting a Monograph
Technical Information Requirements For Monograph Review
Approved April 2014
3. General Information
The drug substance shall be identified using current scientific nomenclature as follows:
Botanical raw materials: Scientific Name: USDA GRIN Taxonomy name. Family, Genus, species, variety and chemo-type.
Zoological raw materials: USDA Taxonomy name, Family, Genus, species, variety, tissue, fluid, part of organ, organ.
Chemical raw materials: International Nonproprietary Name or Official name. IUPAC, CAS.
It is recommended that the sponsor make reasonable attempts to provide other official nomenclature and synonyms:
Other Pharmacopoeia Names
Other Homeopathic Names
Synonyms: English, Latin, French, German, Spanish, Italian, other
It is recommended that any surrogate species within the genus or chemical class used as an active or marker compound reference shall be described according to the guidelines of nomenclature referenced under 3.1.
For botanical and zoological raw materials, the chemical class of constituents or characteristic markers, if known, shall be described.
For chemical raw materials, confirmation of the proposed chemical structure based on spectral data (especially 2D NMR and IR) and/or other relevant analytical data shall be provided, if applicable.
Information on impurities shall be provided as applicable. Appropriate limits shall be established based on safety considerations and manufacturing experience and stability data.
If applicable, any stereochemistry, including diastereoisomers and enantiomers of chemical starting materials shall be described.
For chemical raw materials, schematic amino acid sequence glycosylation sites or other post-translational modifications and relative molecular weight, if applicable, shall be described.
For peptides, characterization shall include data on the amino acid sequence, and, when relevant, peptide map. For DNA products, characterization shall include nucleic acid sequence, DNA melting point, and side chain modifications when applicable.
- General Properties
For chemical raw materials, a list of physicochemical and other relevant properties of the drug substance shall be provided.
It is recommended that the country of origin be described for botanical and zoological raw materials, and for naturally occurring chemical raw materials if applicable or relevant.
The natural habitat and geographical distribution of the plant, alga, macroscopic fungi, or animal shall be provided.
It is recommended that information be included about the current sources of the substance, including its geographical location and whether it is cultivated or harvested from the wild.
It is recommended that information be included if the critical habitat of the species has been determined to be endangered or threatened.
It is recommended that information be included if the species is an endangered or threatened species under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Fauna and Flora.
It is recommended that information be included if the species is entitled to special protection under some other Federal law or international treaty to which the United States is a party.
For botanical raw materials, the part of plant and stage of development shall be provided.
Sponsor shall describe whether fresh or dried Botanical material was used.
The morphological, histological and anatomical description (including gender, if applicable) shall be provided for zoological raw materials.
These guidelines do not address Genetically Modified Organisms (GMO) as starting raw materials. Sponsors are invited to discuss starting raw materials originating from genetically modified organisms directly with the MRC as necessary.
For zoological raw materials, the age, health status, method of breeding and feeding of animals, immunization techniques (immune sera) with description of antigens, culture media (microbial strains) shall be described, if applicable.
For zoological raw materials, the conditions of slaughter and dissection of animals, shall be described, if applicable.
For zoological raw materials, an assessment of the risk of infectivity including viral, bacterial and prionic diseases, shall be provided.
For raw materials of viral origin: the method of inactivation shall be described.
For chemical raw materials, any biological activity, if applicable, shall be described.
Any Distribution controls on the starting material imposed by any regulatory authority shall be described.
It is recommended that the sponsor make reasonable attempts to identify any addictive properties of the drug substance including literature review and abuse liability studies.
It is recommended that Safe Handling Practices be included when such information can help protect laboratory personnel from unusual or unnecessary danger.