1,3-Benzenediol, 5-[1-hydroxy-2-(1-methylethyl)amino]ethyl-, (±)-, sulfate (2:1) (salt);
(±)-3,5-Dihydroxy-α-[(isopropylamino)methyl]benzyl alcohol sulfate (2:1);
5-[1-Hydroxy-2-(isopropylamino)ethyl]benzene-1,3-diol sulfate (2:1) [5874-97-5]
BRIEFING
Metaproterenol Sulfate. This proposal is based on the version of the monograph official as of June 1, 2023. It is proposed to revise the monograph with the following changes:
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Update the Chemical Information section to include an additional chemical name.
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Update the Definition from "calculated on the anhydrous, isopropyl alcohol-free, and methanol-free basis" to "calculated on the anhydrous and solvent-free basis" to be consistent with the testing procedures.
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Revise Identification A to allow the flexibility of using either 197A or 197K, and add a Note describing the procedure to be followed if a difference in the IR spectra of the analyte and standard is observed.
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Replace the colorimetric test in Identification B with a chromatographic retention time agreement as obtained in the proposed Assay.
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Replace the HPLC-based Assay with a liquid chromatography (LC) procedure similar to the proposed Organic Impurities test. The liquid chromatographic procedure was validated using the ACE C18 brand of column with L1 packing. The typical retention time for metaproterenol is about 13 min.
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In the Assay, update the basis for the Acceptance criteria to align with the revised Definition.
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Delete the Limit of Metaproterenone Sulfate test, since it is analyzed in the proposed Organic Impurities procedure.
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Delete the Isopropyl Alcohol and Methanol limit test, as the relevant control of residual solvents must be followed based on General Notices, 5.60.20 Residual Solvents in USP and NF Articles.
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Add an Organic Impurities test based on a validated LC procedure. The liquid chromatographic procedure was validated using the ACE C18 brand of column with L1 packing. The typical retention time for metaproterenol is about 13 min.
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Add USP Metaproterenol Related Compound A RS and USP Metaproterenol Related Compound C RS to the USP Reference Standards section to support the proposed procedures.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM5: R. Radhakrishnan)
Case ID—SUB-1147
USP REFERENCE STANDARDS FOR PURCHASE
USP Metaproterenol Related Compound A RSUSP Metaproterenol Related Compound C RS
USP Metaproterenol Sulfate RS