Tetracycline Hydrochloride Ophthalmic Ointment
»Tetracycline Hydrochloride Ophthalmic Ointment contains not less than 90.0percent and not more than 125.0percent of the labeled amount of C
22
H
24
N
2
O
8
·HCl.
Packaging and storage—
Preserve in collapsible ophthalmic ointment tubes.
USP Reference standards
á
11
ñ
—
USP Tetracycline Hydrochloride RS
.
USP4-Epianhydrotetracycline Hydrochloride RS
.
Sterility
á
71
ñ
:
meets the requirements.
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.
Metal particles—
It meets the requirements of the test for
Metal Particles in Ophthalmic Ointments
á
751
ñ
.
Assay—
Proceed with Ophthalmic Ointment as directed in the
Assay
under
Tetracycline Hydrochloride Ointment
.
Auxiliary Information—
Staff Liaison
:
William W.Wright,Ph.D.,Scientific Fellow
Expert Committee
:(PA7)Pharmaceutical Analysis 7
USP28–NF23
Page 1888
Phone Number
:1-301-816-8335
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