Monograph Status/Commentary

Monograph Status/Commentary

Monograph status

(New) Proposed for Comment: Comment period from May 21, to August 19, 2021

  • Santalum album Oil (v 0.2)

Proposed for Comment: Comment period from January 26, to April 26, 2021

  • Mangifera indica Bark (v 0.3)
  • Mangifera indica Bark Powder (v 0.3)
  • Mangifera indica Bark Dry Extract (v 0.3)

Proposed for Comment: Comment period from May 29, to August 27, 2020

  • Azadirachta indica Seed
  • Azadirachta indica Seed Powder
  • Azadirachta indica Seed Oil

Proposed for Comment: Comment period from March 31, to June 29, 2020

  • Scutellaria baicalensis Root
  • Scutellaria baicalensis Root Powder
  • Scutellaria baicalensis Root Dry Extract

Final Authorized (as of February 27, 2020)

  • Terminalia chebula Fruit
  • Terminalia chebula Fruit Powder
  • Terminalia chebula Fruit Dry Extract
  • Cullen corylifolium Fruit
  • Cullen corylifolium Fruit Powder
  • Cullen corylifolium Fruit Dry Extract

Commentary (February 27, 2020)

Monographs: Terminalia chebula Fruit, Terminalia chebula Fruit Powder, Terminalia chebula Fruit Dry Extract/Multiple Sections

  • No. of Commenters: 1

Comment Summary #1: Why is arjungenin a compound of interest in Terminalia chebula? It's not used in any of the assays?

Response: For informative purpose, “Constituents of Interest” includes more compounds than the ones used in the monograph.

  • Expert Committee Initiated Comments - 4

Comment #1: Expert Committee commented that the Definition should be changed from “Terminalia chebula Fruit consists of the dried fruit” to “Terminalia chebula Fruit consists of the pericarp of the dried ripe fruit” in Definition.

Response: Change incorporated

Comment #2: Expert Committee requested that the family name of the Family Combretaceae be italicized in the Definition.

Response: Change incorporated

Comment #3: The expert committee requested that the column temperature be changed from 25° to 35° in the Chromatographic system in the Composition.

Response: Change incorporated

Comment #4: Expert Committee suggested changing the phrase “NLT 2.0 between the chebulagic acid peak and the peak after” to “NLT 2.0 between the chebulagic acid peak and the following peak” in the System suitability in the Composition.

Response: Change incorporated