Edetate Calcium Disodium

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 21–Nov–2014

Targeted Official Date: 01–Dec–2015

Expert Committee: Monographs—Excipients

Coordinating Pharmacopoeia: Japanese Pharmacopoeia

The harmonized standard for Edetate Calcium Disodium has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the Edetate Calcium Disodium 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.

On December 27, 2013, USP announced the approval of General Notices section 5.60.30 “Elemental Impurities in USP Drug Products and Dietary Supplements” with an official date of December 1, 2015. This General Notices section will make applicable General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements. The implementation of General Chapters <232> and <2232> also will include removal of all references to General Chapter <231> Heavy Metals from monographs and General Chapters in the USP–NF. In order to fully implement the omission of <231>, the test of Heavy Metals in this monograph is deleted with the official date of December 1, 2015, according to the General Notices in USP38–NF33.

In order to be consistent with current USP style and the current General Notices 5.60.30, changes from the existing USP–NF monograph include:

  • In the beginning of the monograph,
    • Removed the harmonization attributes table and notes. The information is presented in the attached Edetate Calcium Disodium PDG sign-off document.
    • Added a statement of “Portions of this monograph that are national USP text, and are not part of the harmonized text, are marked with symbols to specify this fact.”
  • Added symbols to the non-harmonized sections: Identification by IR absorption, Limit of Nitrilotriacetic Acid, Packaging and Storage.
  • Heavy Metals
    • Deleted the test according to section 5.60.30 in General Notices. The official date will be Dec. 1, 2015.

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

The Edetate Calcium Disodium monograph will be incorporated into and become official with the Second Supplement to USP 38–NF 33.

Should you have any questions about the Edetate Calcium Disodium monograph, please contact Kevin Moore (301-816-8369 or ktm@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization website or contact Emily Meyer (301-230-7438 or eam@usp.org).