Nystatin Ointment
»Nystatin Ointment contains not less than 90.0percent and not more than 130.0percent of the labeled amount of USP Nystatin Units.
Packaging and storage—
Preserve in well-closed containers,preferably at controlled room temperature.
USP Reference standards
á
11
ñ
—
USP Nystatin RS
.
Minimum fill
á
755
ñ
:
meets the requirements.
Water,
Method I
á
921
ñ
:
not more than 0.5%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Assay—
Proceed with Ointment as directed in the
Assay
under
Nystatin Cream
.
Auxiliary Information—
Staff Liaison
:
William W.Wright,Ph.D.,Scientific Fellow
Expert Committee
:(PA7)Pharmaceutical Analysis 7
USP28–NF23
Page 1407
Pharmacopeial Forum
:Volume No.28(1)Page 135
Phone Number
:1-301-816-8335
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