COMMENTARY - US Pharmacopeial Convention

COMMENTARY– USP 32-NF 27 Second Supplement
Response: Comment not incorporated. The relative response factors are different
between the drug substance monograph and the drug product monograph because the
methods are different between the two monographs.
Comment Summary #3: The commenter suggested adding a Reference Standard
containing a mixture of related compounds for peak identification to the Related
compounds test.
Response: Comment not incorporated because no supporting data was provided. The
Expert Committee is willing to consider future changes upon receipt of supporting data.
Comment Summary #4: The commenter indicated providing a relative response factor
for 3'-N-{[4-(Acetylamino)phenyl]sulfonyl}-3'-demethylazithromycin to prevent the
overestimation of this impurity in the Related compounds test.
Response: Comment not incorporated because the current requirements reflect the
approved marketed product.
Comment Summary #5: The commenter suggested providing a combined specification
for 14-demethyl-14-(hydroxymethyl) azithromycin and desosaminylazithromycin in the
Related compounds test.
Response: Comment not incorporated the current Related compounds test reflect the
approved marketed product.
Comment Summary #6: The commenter suggested revising the acceptance criteria in
the Related compounds test to harmonize this monograph with the limits stated in the
European Pharmacopoeia monograph for this drug.
Response: Comment not incorporated because the current limits reflect the acceptance
criteria in the approved marketed product.
Comment Summary #7: The commenter submitted an ‘Intent to Comment’ letter.
Response: Comment not incorporated because no supporting data was provided. The
Expert Committee is willing to consider future changes upon receipt of supporting data.
Monograph/Section(s): Behenoyl Polyoxylglycerides/Water
Expert Committee(s): Excipient Monographs 2
No. of Commenters: 1
Comment Summary #1: The commenter indicated the Water should be increased from
“0.5%” to “1.0%” for all the polyoxylglyceride monographs because polyoxyglycerides
are highly hydroscopic.
Response: Comment incorporated.
Monograph/Section(s): Citalopram Hydrobromide/Related Compounds Test 2
Expert Committee(s): Monograph Development–Psychiatrics and Psychoactives
No. of Commenters: 2
Comment Summary #1: The commenter suggested including a Note to indicate the
location of the bromide peak and the clear instructions to disregard this peak.
Response: Comment incorporated.
Comment Summary #2: The commenter suggested three revisions: 1) increase the
limit of Citalopram Related Compounds A, C, D, G, and H from “0.10%” each to “0.15%”
each, 2) revise the limit of any individual unspecified impurity from “0.10%” to “0.1%,”
and 3) increase the limit for total specified and unspecified impurities from “0.50%” to
“0.75%.”
- 11 -