BRIEFING
〈785〉 Osmolality and Osmolarity. This proposal is based on the version of the chapter official as of December 1, 2020. On the basis of comments received, the following changes are being proposed:
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Types of Osmolality Instruments: Include a cross-reference to the new general chapter, Osmolality and Osmolarity—Practical Considerations 〈1785〉, which contains additional information on the use of different osmometers on the same sample.
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Procedure for Calibration Check: Clarify the use of single solution or bracketing solutions and include an example.
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Test Solutions: Add a discussion on the impact of sample dilution.
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Method 1: Freezing-Point Osmometry: Under Procedure, remove the rinsing step as it is not consistent with modern instruments that use disposable test cells. Under Troubleshooting, remove the sentence related to sample viscosity.
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Tonicity: Add a cross-reference to 〈1785〉.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCPA: M. Marques)
Case ID—SUB-482