Carboxymethylcellulose Calcium

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 17-Nov-2023 (Item had an incorrect original posting date of September 26, 2023, and was corrected to November 17, 2023)

Official Date: 01-Aug-2024

Expert Committee: Complex Excipients

Coordinating Pharmacopeia: United States Pharmacopeia

A revision to the harmonized standard for Carboxymethylcellulose Calcium 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 Carboxymethylcellulose Calcium 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:

  1. In the beginning of the monograph, added the statement: "Portions of this chapter that are national USP text, and are not part of the harmonized text, are marked with symbols (⧫⧫) to specify this fact."
  2. Identification D. Described the test procedure to align with the PDG sign-off document.
  3. Loss on Drying. Specified sample amount: 1.0 g according to the PDG sign-off document.
  4. Limit of Sulfate. Added a note - “[Note: This test is only necessary if sulfuric acid is utilized in the manufacturing process, as indicated on the Labeling.]”
  5. Labeling. Added a Labeling requirement - "Label to indicate if sulfuric acid is utilized in the manufacturing process” in the monograph and list it as a harmonized attribute on the PDG sign-off coversheet.
  6. Packaging and Storage. Added symbols (⧫⧫) to specify this is a non-harmonized attribute in the monograph.
  7. Definition, Identification A, Identification B, Identification C, Residue on Ignition, Limit of Chloride, Alkalinity. No changes to these harmonized attributes.

Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Carboxymethylcellulose Calcium monograph will be incorporated into and become official with the USP-NF 2024 Issue 2 (August 1, 2024).

Should you have any questions about the Carboxymethylcellulose Calcium monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please contact Richard Lew at (240-221-2060 or rll@usp.org).