USP 35Official Monographs / Neomycin4021
Ophthalmic Solution and Bacitracin Ophthalmic Ointment
» Neomycin and Polymyxin B Sulfates Ophthal-» Neomycin and Polymyxin B Sulfates and Baci-mic Solution contains the equivalent of not less tracin Ophthalmic Ointment is a sterile ointment than 90.0 percent and not more than 130.0 per-containing Neomycin Sulfate, Polymyxin B Sul-cent of the labeled amounts of neomycin and fate, and Bacitracin. It contains the equivalent of polymyxin B. It may contain one or more suita-not less than 90.0 percent and not more than ble buffers, dispersants, irrigants, and140.0 percent of the labeled amounts of neomy-prervatives.cin, polymyxin B, and bacitracin.
2022年清明节Packaging and storage—Prerve in tight containers, and Packaging and storage—Prerve in collapsible ophthalmic avoid exposure to excessive heat.ointment tubes.
USP Reference standards 〈11〉—USP Reference standards 〈11〉—
USP Neomycin Sulfate RS USP Bacitracin Zinc RS
USP Polymyxin B Sulfate RS USP Neomycin Sulfate RS
USP Polymyxin B Sulfate RS
Thin-layer chromatographic identification test 〈201BNP〉:
meets the requirements.Thin-layer chromatographic identification test 〈201BNP〉:
meets the requirements.
Sterility 〈71〉—It meets the requirements when tested as di-
rected for Membrane Filtration under Test for Sterility of the Prod-Sterility 〈71〉—It meets the requirements when tested as di-uct to d for Membrane Filtration under Test for Sterility of the Prod-
uct to be Examined.
pH 〈791〉: between 5.0 and 7.0.
Minimum fill 〈755〉: meets the requirements.
Assay for neomycin and Assay for polymyxin B—Proceed
with Ophthalmic Solution as directed in the Assay for neomycin Water, Method I 〈921〉: not more tha
n 0.5%, 20 mL of a mix-and in the Assay for polymyxin B under Neomycin and Polymyxin ture of toluene and methanol (7:3) being ud in place of
B Sulfates and Hydrocortisone hanol in the titration vesl.
Metal particles—It meets the requirements of the test for
Metal Particles in Ophthalmic Ointments 〈751〉.
Assay for neomycin and Assay for polymyxin B—Proceed
with Ophthalmic Ointment as directed in the Assay for neomycin Neomycin and Polymyxin B Sulfates
and in the Assay for polymyxin B under Neomycin and Polymyxin and Bacitracin Ointment B Sulfates and Bacitracin Zinc Ophthalmic Ointment.
Assay for bacitracin—Proceed with Ophthalmic Ointment as » Neomycin and Polymyxin B Sulfates and Baci-directed in the Assay for bacitracin under Bacitracin Ointment.
tracin Ointment contains the equivalent of not
less than 90.0 percent and not more than 130.0
percent of the labeled amounts of neomycin,
polymyxin B, and bacitracin. It may contain a Neomycin and Polymyxin B Sulfates, suitable local anesthetic.Bacitracin, and Hydrocortisone Acetate
救救我吧Ointment
Packaging and storage—Prerve in tight, light-resistant
containers, preferably at controlled room temperature.
» Neomycin and Polymyxin B Sulfates, Bacitracin, USP Reference standards 〈11〉—and Hydrocortisone Acetate Ointment contains USP Bacitracin Zinc RS the equivalent of not less than 90.0 percent and USP Neomycin Sulfate RS not more than 130.0 percent of the labeled
USP Polymyxin B Sulfate RS
amounts of neomycin, polymyxin B, and bacitra-Thin-layer chromatographic identification test 〈201BNP〉:
meets the requirements.cin, and not less than 90.0 percent and not more Minimum fill 〈755〉: meets the requirements.than 110.0 percent of the labeled amount of hy-Water, Method I 〈921〉: not more than 0.5%, 20 mL of a mix-drocortisone acetate in a suitable ointment ba. ture of toluene and methanol (7:3) being ud in place of
Packaging and storage—Prerve in collapsible tubes or in methanol in the titration vesl.
well-clod containers.
Assay for neomycin and Assay for polymyxin B—Proceed
with Ointment as directed in the Assay for neomycin and in the USP Reference standards 〈11〉—
Assay for polymyxin B under Neomycin and Polymyxin B Sulfates USP Bacitracin Zinc RS
and Bacitracin Zinc Ophthalmic Ointment.USP Hydrocortisone Acetate RS
Assay for bacitracin—Proceed with Ointment as directed in USP Neomycin Sulfate RS
the Assay under Bacitracin Ointment.USP Polymyxin B Sulfate RS
m1l
Identification—
A: It meets the requirements under Thin-Layer Chromato-
graphic Identification Test 〈201BNP〉.
B: The retention time of the major peak for hydrocortisone
acetate in the chromatogram of the Assay preparation corre-
sponds to that in the chromatogram of the Standard prepara-
tion, as obtained in the Assay for hydrocortisone acetate.
4022Neomycin / Official Monographs
USP 35
Minimum fill 〈755〉: meets the requirements.
Water, Method I 〈921〉: not more than 0.5%, 20 mL of a mix-ture of toluene and methanol (7:3) being ud in place of Bacitracin, and Lidocaine Ointment
methanol in the titration vesl.
Assay for neomycin and Assay for polymyxin B—Proceed » Neomycin and Polymyxin B Sulfates, Bacitracin,with Ointment as directed in the Assay for neomycin and in the and Lidocaine Ointment contains the equivalent Assay for polymyxin B under Neomycin and Polymyxin B Sulfates of not less than 90.0 percent and not more than and Bacitracin Zinc Ophthalmic Ointment .
130.0 percent of the labeled amounts of neomy-Assay for bacitracin—Proceed with Ointment as directed in cin, polymyxin B, and bacitracin, and not less the Assay under Bacitracin Ointment .
than 90.0 percent and not more than 110.0 per-Assay for hydrocortisone acetate—Proceed with Ointment as directed in the Assay under Hydrocortisone Acetate Lotion .
蒸螃蟹做法cent of the labeled amount of lidocaine (C 14H 22N 2O).
Packaging and storage—Prerve in well-clod containers,preferably at controlled room temperature.
USP Reference standards 〈11〉—Bacitracin, and Hydrocortisone Acetate USP Bacitracin Zinc RS Ophthalmic Ointment
USP Lidocaine RS
USP Neomycin Sulfate RS » Neomycin and Polymyxin B Sulfates, Bacitracin,USP Polymyxin B Sulfate RS and Hydrocortisone Acetate Ophthalmic Oint-Identification—
ment contains the equivalent of not less than A: It meets the requirements under Thin-Layer Chromato-90.0 percent and not more than 140.0 percent graphic Identification Test 〈201BNP 〉.
of the labeled amounts of neomycin, polymyxin B: The retention time of the major peak for lidocaine in the B, and bacitracin, and not less than 90.0 percent chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation , as obtained in and not more than 110.0 percent of the labeled the Assay for lidocaine .
amount of hydrocortisone acetate, in a suitable Minimum fill 〈755〉: meets the requirements.
ointment ba.
Water, Method I 〈921〉: not more than 0.5%, 20 mL of a mix-Packaging and storage—Prerve in collapsible ophthalmic ture of toluene and methanol (7:3) being ud in place of ointment tubes.
石锅拌饭怎么做methanol in the titration vesl.
Assay for neomycin and Assay for polymyxin B—Proceed USP Reference standards 〈11〉—with Ointment as directed in the Assay for neomycin and in the USP Bacitracin Zinc RS
Assay for polymyxin B under Neomycin and Polymyxin B Sulfates USP Hydrocortisone Acetate RS and Bacitracin Zinc Ophthalmic Ointment .
回不去的过去
USP Neomycin Sulfate RS Assay for bacitracin—Proceed with Ointment as directed in USP Polymyxin B Sulfate RS the Assay under Bacitracin Ointment .Identification—
Assay for lidocaine—
A: It meets the requirements under Thin-Layer Chromato-Mobile pha—Dissolve 4.44 g of docusate sodium in 1000graphic Identification Test 〈201BNP 〉.
怎样学数学mL of a mixture of methanol and water (4:1), add 1 mL of 0.1B: The retention time of the major peak for hydrocortisone N sulfuric acid, and mix. Make adjustments if necessary (e acetate in the chromatogram of the Assay preparation corre-System Suitability under Chromatography 〈621〉).
sponds to that in the chromatogram of the Standard prepara-Standard preparation—Dissolve a suitable quantity of USP tion , as obtained in the Assay for hydrocortisone acetate .
Lidocaine RS, accurately weighed, in Mobile pha to obtain a Sterility 〈71〉—It meets the requirements when tested as di-solution having a known concentration of about 0.4 mg per rected for Membrane Filtration under Test for Sterility of the Prod-mL.
uct to be Examined.neighbourhood
Assay preparation—Transfer an accurately weighed quantity Minimum fill 〈755〉: meets the requirements.
of Ointment, equivalent to about 40 mg of lidocaine, to a Water, Method I 〈921〉: not more than 0.5%, 20 mL of a mix-parator, add 50 mL of n -hexane, and shake until the speci-ture of toluene and methanol (7:3) being ud in place of men is in solution. Add 30 mL of Mobile pha , shake for 1methanol in the titration vesl.
minute, and allow the layers to parate. Drain the lower layer into a 100-mL volumetric flask, and extract the n -hexane layer Metal particles—It meets the requirements of the test for remaining in the parator with two 30-mL portions of Mobile Metal Particles in Ophthalmic Ointments 〈751〉.
pha , combining the lower layers in the volumetric flask. Dilute Assay for neomycin and Assay for p
olymyxin B—Proceed the combined extracts in the 100-mL volumetric flask with Mo-with Ophthalmic Ointment as directed in the Assay for neomycin bile pha to volume, and mix.
and in the Assay for polymyxin B under Neomycin and Polymyxin Chromatographic system (e Chromatography 〈621〉)—The B Sulfates and Bacitracin Zinc Ophthalmic Ointment .
liquid chromatograph is equipped with a 230-nm detector and Assay for bacitracin—Proceed with Ophthalmic Ointment as a 4-mm × 25-cm column that contains packing L1. The flow directed in the Assay under Bacitracin Ointment .
rate is about 1 mL per minute. Chromatograph the Standard Assay for hydrocortisone acetate—Proceed with
preparation , and record the peak respon as directed for Proce-Ophthalmic Ointment as directed in the Assay under Hydrocorti-dure: the column efficiency determined from the analyte peak is sone Acetate Lotion .
not less than 500 theoretical plates, and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure—Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the respons for the major peaks. Calculate the quantity, in mg, of
