5,12-Naphthacenedione, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-α-l-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S-cis)-, hydrochloride;
(1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl-3-amino-2,3,6-trideoxy-α-l-lyxo-hexopyranoside hydrochloride [23541-50-6]
BRIEFING
Daunorubicin Hydrochloride. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:
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Update Identification A to reference 197K and add the use of 197A for flexibility.
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Add Identification C for chloride detection to strengthen the monograph.
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Replace the current HPLC procedure in the Assay with the similar procedure that is proposed for the Organic Impurities test.
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Add a test for Organic Impurities based on a validated procedure. The procedure was validated using the Kromasil C18 brand of column with L1 packing in which daunorubicin elutes at about 12 min.
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Add USP Daunorubicinone RS and USP Doxorubicin Hydrochloride RS to the USP Reference Standards section to support the proposed Organic Impurities test.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM1: P. Pabba)
Correspondence Number—C233316
USP REFERENCE STANDARDS FOR PURCHASE
USP Daunorubicin Hydrochloride RSUSP Daunorubicinone RS
USP Doxorubicin Hydrochloride RS