Monograph Status/Commentary

Monograph Status/Commentary

Monograph status

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

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