Sodium Starch Glycolate

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 28–Feb–2014 (updated 28–Feb–2017*)

Official Date: 01–Dec–2014

Expert Committee: Monographs—Excipients

*Coordinating Pharmacopeia: USP

A revision to the harmonized standard for Sodium Starch Glycolate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 sign-off Rev. 3 cover sheet. This revision to the Sodium Starch Glycolate monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF monograph include revisions to existing tests:

  • Identification:
    • Identification B
      1. Minor verbiage changes to align with the PDG Stage 6 sign-off document
      2. Identification C
  • Changed description of procedure to align with the PDG Stage 6 sign-off document, including “add 2mL of 15% potassium carbonate, and heat to boiling. No precipitate is formed.” and “heat to boiling. Allow to cool in ice water”. This was the original procedure published in PF 30(4). There are also other minor verbiage changes to align with PDG Stage 6 sign-off document.
  • Limit of Sodium Glycolate:
    • Minor verbiage changes to align with the PDG Stage 6 sign-off document

In addition, the monograph has been edited to be consistent with the current USP style guide.

The Sodium Starch Glycolate monograph will be incorporated into and become official with the Second Supplement to USP 37–NF 32.

*Should you have any questions about the Sodium Starch Glycolate monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or

*The previous sign-offs and Stage 6 postings are included as below: