Methenamine Mandelate Delayed-Release Tablets
»Methenamine Mandelate Delayed-Release Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of methenamine mandelate (C
6
H
12
N
4
·C
8
H
8
O
3
).
Packaging and storage—
Preserve in well-closed containers.
USP Reference standards
á
11
ñ
—
USP Methenamine Mandelate RS
.
Disintegration
á
701
ñ
:
2hours and 30minutes,determined as directed under
Delayed-release (enteric coated)Tablets.
Other requirements—
Delayed-release Tablets respond to the
Identification
test and meet the requirements for
Uniformity of dosage units
and
Assay
under
Methenamine Mandelate Tablets
.
Auxiliary Information—
Staff Liaison
:
Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee
:(PA7)Pharmaceutical Analysis 7
USP28–NF23
Page 1244
Phone Number
:1-301-816-8394
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