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Edetate Calcium Disodium
C10H12CaN2Na2O8·xH2O 374.27
 Calciate (2-), [[N,N′-1,2-ethanediylbis[N-(carboxymethyl)glycinato]](4-)-N,N′,O,O′,ON,ON′]-, disodium, hydrate, (OC-6-21)-;
 Disodium[(ethylenedinitrilo)tetraacetato]calciate(2-) hydrate
 [23411-34-9] ⧫Anhydrous [62-33-9⧫]

BRIEFING

 Edetate Calcium Disodium. This proposal is based on the version of the monograph official as of May 1, 2020 and on PF 43(2) [Mar.–Apr. 2017]. The Japanese Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the Edetate Calcium Disodium monograph, as part of the process of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The first Stage 2 (former Stage 4) proposal was published in PF 43(2) [Mar.–Apr. 2017]. Based on discussion of comments received, the following monograph, which is the second publication of Revision 1, OFFICIAL INQUIRY STAGE 2 to the current Edetate Calcium Disodium monograph, includes the following changes:

  1. Chemical Information. Add the symbols (⧫⧫) to "Anhydrous CAS RN®: 62-33-9" because only USP will keep this as a local requirement.

  2. Identification A. Remove the diamond symbols because this test is proposed to be a harmonized attribute in the PDG Stage 2 proposal.

  3. Identification B. Remove the original Procedure since it is redundant. Add a new Identification test for Calcium.

  4. Identification C. Change “potassium pyroantimonate TS” to “Potassium pyroantimonate solution” to reflect the modified solution preparation procedure to align with the PDG Stage 2 proposal.

  5. Organic Impurities, Procedure 2: Limit of Nitrilotriacetic Acid. Replace the test with the PDG Stage 2 proposed procedure and remove the symbols (⧫⧫) from this test, because it is proposed to become a harmonized attribute.The liquid chromatographic procedures are based on analyses performed with the Phenomenex Hypercarb brand of column with L109 packing, packed with graphitized carbon. The typical retention time for nitrilotriacetic acid is about 5 min.

  6. Definition, Assay, Chloride and Sulfate, Organic Impurities, Procedure 1: Disodium Edetate, pH, and Water Determination. No changes for these harmonized attributes.

  7. Packaging and Storage. No changes from existing USP–NF text. This attribute is not part of the Stage 2 PDG global text. A future decision on inclusion as a non-harmonized attribute or a local requirement will be made at Stage 4.

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

 (SE: J. Liu)

 Correspondence Number—C222194

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USP Edetate Calcium Disodium RS
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