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Morphine Sulfate Injection

Type of Posting: Revision Bulletin

Posting Date: 30–Nov–2012

Official Date: 01–Dec–2012

Archive Date: 09–Feb–2015

Expert Committee: Monographs—Small Molecules 2

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Morphine Sulfate Injection Monograph that appears in the Second Supplement to USP 35–NF 30 (page 5972). The Revision Bulletin is necessitated by an error that occurred during the finalization of the Second Supplement. The Expert Committee did not intend to adopt the proposed revisions to the Bacterial endotoxin and Labeling sections that appeared in Pharmacopeial Forum 37(3) [March–April 2011] but these were inadvertently included in the monograph as published in the Second Supplement. The Expert Committee is now correcting this error by restoring, through the Revision Bulletin, the Bacterial endotoxin and Labeling sections verbatim as previously published in USP 35–NF 30 (page 3957).

The restored text in the monograph will read as follows:

  • In Bacterial endotoxins <85>—“It contains not more than 17.0 USP Endotoxin Units per mg of morphine sulfate; if labeled for intrathecal use, it contains NMT 14.29 USP Endotoxin Units/mg of morphine sulfate.”
  • In Labeling—“It meets the requirements for Labeling under Injections <1>. Label it also to state that the Injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. Injection containing no antioxidant or antimicrobial agents prominently bears on its label the words “Preservative-free,” and includes, in its labeling, its routes of administration and the statement that it is not to be heat-sterilized. Injection containing antioxidant or antimicrobial agents includes in its labeling its routes of administration and the statement that it is not for intrathecal or epidural use.”

Two other changes that were proposed in PF 37(3) will remain in this version of the monograph:

  • The replacement of the Thin Layer Chromatography Identification A method with the HPLC method also used as the Assay.
  • The change of the molecular weight of morphine sulfate pentahydrate from 758.85 to 758.83.

The Morphine Sulfate Injection Monograph Revision Bulletin supersedes the monograph as published in the Second Supplement to USP 35–NF 30 that was scheduled to become official on December 1, 2012. This Revision Bulletin will be incorporated into the Second Supplement to USP 36–NF 31.

Should you have any questions, please contact Clydewyn M. Anthony, Ph.D. (301-816-8139 or cma@usp.org).