Accessed from 10.6.1.
1 by ebsc0sa on Sun Nov 15 22:07:48 EST 2015
USP 39
concentration assumed to be equal to the median dose level
of the Standard.
Neomycin Sulfate
.
Neomycin sulfate.
Neomycins sulfate [1405-10-3].
» Neomycin Sulfate is the sulfate salt of a kind of
neomycin, an antibacterial substance produced
by the growth of Streptomyces fradiae Waksman
(Fam. Streptomycetaceae), or a mixture of two
or more such salts. It has a potency equivalent to
not less than 600 µg of neomycin per mg, calcu-
lated on the dried basis.
Packaging and storage—Preserve in tight, light-resistant
containers.
Labeling—Where it is intended for use in preparing inject-
able or other sterile dosage forms, the label states that it is
sterile or must be subjected to further processing during the
preparation of injectable or other sterile dosage forms.
USP Reference standards 〈11〉—
USP Endotoxin RS
USP Neomycin Sulfate RS
Identification—
A: It meets the requirements for neomycin under Thin-
Layer Chromatographic Identification Test 〈201BNP〉.
B: Dissolve about 10 mg in 1 mL of water, add 5 mL of
15 N sulfuric acid, and heat at 100° for 100 minutes. Allow
to cool, add 10 mL of xylene, and shake for 10 minutes.
Allow to separate, and decant the xylene layer. To the xy-
lene layer add 10 mL of p-bromoaniline TS, and shake: a
vivid pink-red color develops upon standing.
C: A solution (1 in 20) responds to the tests for Sulfate
〈191〉.
pH 〈791〉: between 5.0 and 7.5, in a solution containing
33 mg of neomycin per mL.
Loss on drying 〈731〉—Dry about 100 mg in vacuum at a
pressure not exceeding 5 mm of mercury at 60° for 3 hours:
it loses not more than 8.0% of its weight.
Other requirements—Where the label states that Neomy-
cin Sulfate is sterile, it meets the requirements for Sterility
and Bacterial endotoxins under Neomycin for Injection. Where
the label states that Neomycin Sulfate must be subjected to
further processing during the preparation of injectable dos-
age forms, it meets the requirements for Bacterial endotoxins
under Neomycin for Injection. Where it is intended for use in
preparing nonparenteral sterile dosage forms, it is exempt
from the requirements for Bacterial endotoxins.
Assay—Proceed with Neomycin Sulfate as directed under
Antibiotics—Microbial Assays 〈81〉.
Neomycin Sulfate Cream
.
» Neomycin Sulfate Cream contains the equiva-
lent of not less than 90.0 percent and not more
than 135.0 percent of the labeled amount of
neomycin.
Packaging and storage—Preserve in well-closed contain-
ers, preferably at controlled room temperature.
USP Reference standards 〈11〉—
USP Neomycin Sulfate RS
Official from May 1, 2016
Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
Official Monographs / Neomycin 5011
Thin-layer chromatographic identification test
〈201BNP〉: meets the requirements.
Minimum fill 〈755〉: meets the requirements.
Assay—Proceed as directed under Antibiotics—Microbial As-
says 〈81〉, using an accurately weighed portion of Cream,
equivalent to about 1.75 mg of neomycin, shaken in a
separator with about 50 mL of ether, and extracted with
four 20-mL portions of Buffer No. 3. Combine the aqueous
extracts, and dilute with Buffer No. 3 to an appropriate vol-
ume to obtain a stock solution of convenient concentration.
Dilute this stock solution quantitatively and stepwise with
Buffer No. 3 to obtain a Test Dilution having a concentration
assumed to be equal to the median dose level of the Stan-
dard.
Neomycin Sulfate Ointment
.
» Neomycin Sulfate Ointment contains the equiv-
alent of not less than 90.0 percent and not more
than 135.0 percent of the labeled amount of
neomycin.
Packaging and storage—Preserve in well-closed contain-
ers, preferably at controlled room temperature.
USP Reference standards 〈11〉—
USP Neomycin Sulfate RS
Thin-layer chromatographic identification test
〈201BNP〉: meets the requirements.
Minimum fill 〈755〉: meets the requirements.
Change to read:
USP Monographs
•Water Determination, Method I 〈921〉• (CN 1-May-2016):
.
not more than 1.0%, 20 mL of a mixture of toluene and
methanol (7:3) being used in place of methanol in the titra-
tion vessel.
Assay—Proceed as directed under Antibiotics—Microbial As-
says 〈81〉, using an accurately weighed portion of Ointment,
equivalent to about 3.5 mg of neomycin, shaken in a
separator with about 50 mL of ether, and extracted with
four 20-mL portions of Buffer No. 3. Combine the aqueous
extracts, and dilute with Buffer No. 3 to an appropriate vol-
ume to obtain a stock solution of convenient concentration.
Dilute this stock solution quantitatively and stepwise with
Buffer No. 3 to obtain a Test Dilution having a concentration
assumed to be equal to the median dose level of the Stan-
dard.
.
Neomycin Sulfate Ophthalmic
Ointment
DEFINITION
Neomycin Sulfate Ophthalmic Ointment is a sterile prepara-
tion of Neomycin Sulfate in a suitable ointment base. It
contains the equivalent of NLT 90.0% and NMT 135.0%
of the labeled amount of neomycin.
IDENTIFICATION
• A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST
〈201BNP〉: Meets the requirements
ASSAY
• PROCEDURE
(See Antibiotics—Microbial Assays 〈81〉.)
 Accessed from 10.6.1.1 by ebsc0sa on Sun Nov 15 22:07:48 EST 2015
5012 Neomycin / Official Monographs
Sample solution: Shake a portion of the Ophthalmic
Ointment containing nominally 3.5 mg of neomycin in
a separator with 50 mL of ether. Extract with four
20-mL portions of Buffer B.3. Combine the aqueous ex-
tracts, and dilute with Buffer B.3 to a suitable volume.
Analysis: Proceed as directed in the chapter. Dilute the
Sample solution with Buffer B.3 to obtain a Test Dilution
having a neomycin concentration that is nominally
equivalent to the median level of the standard.
Acceptance criteria: 90.0%–135.0%
PERFORMANCE TESTS
Delete the following:
▲ • MINIMUM FILL 〈755〉: Meets the requirements▲USP39
.
SPECIFIC TESTS
• STERILITY TESTS 〈71〉: Meets the requirements
Delete the following:
▲ • WATER DETERMINATION, Method I 〈921〉
. Test solution—Shake a portion of ground Tablet powder,
Analysis: Use 20 mL of a mixture of toluene and meth-
anol (7:3) in place of methanol in the titration vessel.
Acceptance criteria: NMT 1.0%▲USP39
Delete the following:
▲ • METAL PARTICLES IN OPHTHALMIC OINTMENTS 〈751〉:
.
Meets the requirements▲USP39
Add the following:
▲ • OTHER REQUIREMENTS: It meets the requirements in
USP Monographs
Ophthalmic Products—Quality Tests 〈771〉.▲USP39
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in collapsible
ophthalmic ointment tubes.
• USP REFERENCE STANDARDS 〈11〉
USP Neomycin Sulfate RS
Neomycin Sulfate Oral Solution
.
» Neomycin Sulfate Oral Solution contains the
equivalent of not less than 90.0 percent and not
more than 125.0 percent of the labeled amount
of neomycin. It may contain one or more suita-
ble colors, flavors, and preservatives.
Packaging and storage—Preserve in tight, light-resistant
containers, preferably at controlled room temperature.
USP Reference standards 〈11〉—
USP Neomycin Sulfate RS
Thin-layer chromatographic identification test
〈201BNP〉: meets the requirements.
Uniformity of dosage units 〈905〉—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS:
meets the requirements.
Deliverable volume 〈698〉—
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS:
meets the requirements.
pH 〈791〉: between 5.0 and 7.5.
Assay—Proceed as directed under Antibiotics—Microbial As-
says 〈81〉, using an accurately measured volume of Oral So-
Official from May 1, 2016
Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
USP 39
lution quantitatively diluted with Buffer No. 3 to yield a solu-
tion having a convenient concentration of neomycin.
Quantitatively dilute this stock solution with Buffer No. 3 to
obtain a Test Dilution having a concentration assumed to be
equal to the median dose level of the Standard.
Neomycin Sulfate Tablets
.
» Neomycin Sulfate Tablets contain the equiva-
lent of not less than 90.0 percent and not more
than 125.0 percent of the labeled amount of
neomycin.
Packaging and storage—Preserve in tight containers.
USP Reference standards 〈11〉—
USP Neomycin Sulfate RS
Thin-layer chromatographic identification test
〈201BNP〉—
equivalent to about 70 mg of neomycin (base), with 5 mL
of water, and filter. Dilute a portion of this solution with 0.1
N hydrochloric acid to obtain a solution containing the
equivalent of 3.5 mg of neomycin (base) per mL. It meets
the requirements.
Disintegration 〈701〉: 60 minutes.
Uniformity of dosage units 〈905〉: meet the require-
ments.
Loss on drying 〈731〉—Dry about 100 mg of powdered
Tablets, accurately weighed, in a capillary-stoppered bottle
in vacuum at a pressure not exceeding 5 mm of mercury at
60° for 3 hours: it loses not more than 10.0% of its weight.
Assay—Proceed as directed under Antibiotics—Microbial As-
says 〈81〉, using not less than 5 Tablets blended at high-
speed in a blender jar for 3 to 5 minutes with a sufficient
accurately measured volume of Buffer No. 3 to obtain a
stock solution having a convenient concentration. Dilute this
stock solution quantitatively and stepwise with Buffer No. 3
to obtain a Test Dilution having a concentration assumed to
be equal to the median dose level of the Standard.
Neomycin Sulfate and Bacitracin
.
Ointment
» Neomycin Sulfate and Bacitracin Ointment
contains the equivalent of not less than 90.0 per-
cent and not more than 130.0 percent of the la-
beled amounts of neomycin and bacitracin.
Packaging and storage—Preserve in tight, light-resistant
containers, preferably at controlled room temperature.
USP Reference standards 〈11〉—
USP Bacitracin Zinc RS
USP Neomycin Sulfate RS
Thin-layer chromatographic identification test
〈201BNP〉: meets the requirements.
Minimum fill 〈755〉: meets the requirements.
Change to read:
•Water Determination, Method I 〈921〉• (CN 1-May-2016):
.
not more than 0.5%, 20 mL of a mixture of toluene and
methanol (7:3) being used in place of methanol in the titra-
tion vessel.