USPUSP-NF
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Potassium Lactate Solution
2-Hydroxypropanoic Acid, Monopotassium Salt C3H5KO3 Formula wt: 128.17
 326 [996-31-6] 276897E67U potassium lactate, dl-

BRIEFING

 Potassium Lactate Solution, FCC 14. Based on data and information received, the following revisions are proposed:

  1. Revise the Acceptance criteria for the pH test from 5.0–9.0 to 5.0–9.5.

  2. Revise the Acceptance criteria for the Sodium test from NMT 0.1% to NMT 0.2%.

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

 The proposal is targeted for publication in FCC 15.

 (FI: G. Clapper)

 Case ID—SUB-2058

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