C14H4N2Na2O8·H2O 392.19
C14H4N2Na2O8·2 H2O 410.20
C14H4N2Na2O8·3 H2O 428.22
1H-Pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid, 4,5-dihydro-4,5-dioxo-, sodium salt (1:2);
Sodium 9-carboxy-4,5-dioxo-4,5-dihydro-1H-pyrrolo[2,3-f]quinoline-2,7-dicarboxylate
[122628-50-6] 1H-Pyrrolo[2,3-f]quinoline-2,7,9-tricarboxylic acid, 4,5-dihydro-4,5-dioxo-, sodium salt (1:2) trihydrate [1519046-70-8]
BRIEFING
Pyrroloquinoline Quinone Disodium. This proposal is based on the version of the monograph official as of December 1, 2021. On the basis of comments received, the following changes are being proposed:
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Revise Identification A to move the retention time agreement requirement for sodium to a new Identification B, and renumber the original Identification B as Identification C.
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Revise the System suitability requirement for Relative standard deviation in the Assay.
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Revise the Organic Impurities test to add a requirement for Relative standard deviation in System suitability.
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Revise the procedure for the Water Determination test.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(NBDS: F. Tadjimukhamedov)
Case ID—SUB-2810