Synthetic Camphor (racemic Camphor);
Bicyclo[2.2.1]heptane-2-one, 1,7,7-trimethyl-;
Camphor;
2-Bornanone;
1,7,7-Trimethylbicyclo[2.2.1]heptan-2-one
[76-22-2] Natural Camphor (d-Camphor);
(1R,4R)-1,7,7-Trimethylbicyclo[2.2.1]heptan-2-one [464-49-3]
BRIEFING
Camphor. This proposal is based on the version of the monograph official prior to 2013. On the basis of comments received, it is proposed to make the following changes:
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Clarify the two grades of Camphor in the Chemical Information section as synthetic Camphor (racemic Camphor) and natural Camphor (d-Camphor).
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Add natural Camphor and its corresponding chemical information to the Chemical Information section to align with the Definition and the proposed changes to the tests for Melting Range or Temperature 〈741〉 and Optical Rotation 〈781S〉, Procedures, Specific Rotation.
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Clarify the Acceptance criteria in the Limit of Nonvolatile Residue test.
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Clarify the Acceptance criteria in the test for Halogens.
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Revise the Melting Range or Temperature 〈741〉 test to include separate acceptance criteria for natural Camphor and synthetic Camphor, based on the European Pharmacopoeia monographs for d-Camphor and Camphor, Racemic.
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Update the Acceptance criteria in the test for Optical Rotation 〈781S〉, Procedures, Specific Rotation to include separate Acceptance criteria for natural Camphor and synthetic Camphor, based on the European Pharmacopoeia monographs for d-Camphor and Camphor, Racemic.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM1: A. Adekoya)
Case ID—SUB-1383