BRIEFING
Croscarmellose Sodium. The United States Pharmacopeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the Croscarmellose Sodium monograph, as part of the process of international harmonization of monographs and general analytical methods of the European, Indian, Japanese, and United States pharmacopeias under the Pharmacopeial Discussion Group (PDG). The following monograph, which represents the revised OFFICIAL INQUIRY STAGE 2 (former STAGE 4) document, is based on the comments from all PDG Pharmacopoeias. Differences between the Official Inquiry Stage 2 document and the current NF monograph include the following:
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Water-Soluble Substances. Remove the diamond symbols (◆◆) from the test because this test is proposed to become a new harmonized attribute in the Croscarmellose Sodium monograph. Change the title from "Content of Water-Soluble Material" to "Water-Soluble Substances". Additionally, the testing procedures and calculation formula are modified to align with the PDG Stage 2 proposal for harmonization.
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Degree of Substitution. Add clarification and a calculation formula for net number of milliequivalents, M, based on stakeholders' needs.
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Loss on Drying. Add a sample amount of 1.0 g to align with the PDG Stage 2 proposal.
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Settling Volume. Adjust the significant figures in the Acceptance criteria based on the precision of the measurement, since 100-mL graduated cylinders typically have 1-mL graduations.
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Sodium Chloride and Sodium Glycolate, Sodium Glycolate. This is a non-harmonized attribute. Propose to shift the calibration curve range to the lower range because low levels of sodium glycolate are commonly observed in the product.
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Definition; Identification A, B, and C; pH; and Residue on Ignition. No changes for these harmonized attributes.
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Microbial Enumeration Tests and Tests for Specified Microorganisms and Packaging and Storage. No changes from the existing USP–NF text. These attributes are not part of the Stage 2 PDG global text. A future decision on inclusion as non-harmonized attributes or local requirements will be made at Stage 4.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(EXC: J. Liu)
Correspondence Number—C339399