Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 30-Apr-2021
Official Date: 01-May-2022
Expert Committee: Complex Excipients
Coordinating Pharmacopeia: USP
A revision to the harmonized standard for Croscarmellose Sodium has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 of the PDG process, the Croscarmellose Sodium monograph has been formally approved by the USP Complex Excipients Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.
Changes from the existing USP–NF monograph include:
- Identification A. Added a new identification test using Infrared Spectroscopy. Renamed the original Identification A as Identification B.
- Deleted the original Identification B as it is a non-specific, general identification test for cellulosic polymers.
- Identification C. Replace the original flame test for sodium identification with a wet chemistry test using potassium pyroantimonate. In addition, this identification test becomes a harmonized attribute in the PDG sign-off document.
- Packaging and Storage. Add the diamond symbols (⧫⧫) to this test because it is a non-harmonized attribute. In addition, due to hygroscopicity of Croscarmellose Sodium, a tight container is more suitable for packaging and storage of this material according to USP general chapter <659>. Since the packaging and storage are tied together, the description was changed to “Packaging and Storage— Preserve in tight containers.”
- USP Reference Standards <11>. Added the new USP Croscarmellose Sodium RS.
- Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Croscarmellose Sodium monograph will be incorporated into and become official with the USP-NF 2022 Issue 1 (May 1, 2022).
Should you have any questions about the Croscarmellose Sodium monograph, please contact
The previous PDG sign-off Documents and Stage 4 postings are included as below:
- Download the Croscarmellose Sodium monograph–Stage 4
- Download the Croscarmellose Sodium PDG Sign-Off Documents:
- Previous Stage 6 posting in PF 30 (4), 2004
- Previous Stage 6 posting in PF 30 (2), 2004
- Previous Stage 6 posting in PF 28 (5), 2002