Errata - English

Line 2: Change
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride.
to:
Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621> ).
Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL.
AND
After the Assay preparation subsection: Add
System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diphenhydramine Hydrochloride.
to:
Separately inject equal volumes, about 10 μL, of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 1: Change
A volume of Ophthalmic Solution, equivalent to about 2.5 mg of oxymetazoline hydrochloride, responds to the Identification test under Oxymetazoline Hydrochloride Nasal Solution.
to:
Place a volume of Ophthalmic Solution, equivalent to about 2.5 mg of oxymetazoline hydrochloride, in a 60-mL separator, and add water to make about 10 mL. Add 2 mL of sodium carbonate solution (1 in 10), extract with 10 mL of chloroform, and transfer the chloroform extract to a second 60-mL separator. Extract the chloroform solution with 10 mL of 0.1 N hydrochloric acid, allow to separate, and discard the chloroform layer. Transfer 8 mL of the acidic aqueous layer to a test tube, neutralize by the dropwise addition of 1 N sodium hydroxide, add 1 drop of 1 N sodium hydroxide in excess, and mix. Add a few drops of sodium nitroferricyanide TS and 2 drops of sodium hydroxide solution (15 in 100), mix, and allow to stand for 10 minutes. Add 0.1 N hydrochloric acid dropwise until the pH is between 8 and 9, and allow to stand for 10 minutes. A violet color develops.

Line 2: Change
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride.
to:
Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL.
AND
After the Assay preparation subsection: Add
System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diphenhydramine Hydrochloride.
to:
Separately inject equal volumes, about 10 μL, of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Footnote d: Change
((5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(1-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
to:
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.

Line 3: Change the section head
Isosorbide mononitrate related compound A stock solution:
to:
Isosorbide mononitrate related compound A standard stock solution:
AND
Line 7: Change the section head
Isosorbide dinitrate stock solution:
to:
Isosorbide dinitrate standard stock solution:
AND
Line 3 of Standard stock solution: Change
Isosorbide mononitrate related compound A stock solution and Isosorbide dinitrate stock solution,
to:
Isosorbide mononitrate related compound A standard stock solution and Isosorbide dinitrate standard stock solution,

Line 2: Change
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride.
to:
Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL.
AND
After the Assay preparation subsection: Add
System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diphenhydramine Hydrochloride.
to:
Separately inject equal volumes, about 10 μL, of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 1 of Sample solution C in Limit of Lead (Pb): Change
Sample solution
to:
Sample stock solution
AND
Line 1 of Sample solution D in Limit of Lead (Pb): Change
Sample solution
to:
Sample stock solution
AND
Line 1 of Sample solution A in Limit of Mercury (Hg) and Nickel (Ni): Change
Sample solution
to:
Sample stock solution
AND
Line 1 of Sample solution B in Limit of Mercury (Hg) and Nickel (Ni): Change
Sample solution
to:
Sample stock solution
AND
Line 1 of Sample solution C in Limit of Mercury (Hg) and Nickel (Ni): Change
Sample solution
to:
Sample stock solution

Footnote c: Change
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-1-ene hydrochloride (identified and reported as an individual unspecified impurity if present).
to:
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-6-ene hydrochloride (identified and reported as an individual unspecified impurity if present).
AND
Footnote d: Change
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-6-ene hydrochloride (identified and reported as an individual unspecified impurity if present).
to:
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-1-ene hydrochloride (identified and reported as an individual unspecified impurity if present).

Line 2 of Venlafaxine Related Compound A RS: Change
1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol.
C₁₆H₂₅NO₂
263.38
to:
1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride.
C₁₆H₂₅NO₂ · HCl
299.84

Line 16 of Analysis: Change
Calculate the percentage of edetate disodium
to:
Calculate the weight of edetate disodium
AND
Line 19 of Analysis: Change
Result = (V_T/V_U) × W × (M_r1/M_r2) × 100
to:
Result = (V_T/V_U) × W × (M_r1/M_r2)

Line 2 of Venlafaxine Related Compound A RS: Change
1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol.
C₁₆H₂₅NO₂
263.38
to:
1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride.
C₁₆H₂₅NO₂ · HCl
299.84

Change
pH 7.0 Buffer, pH 5.0 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Prepare as directed in the Assay under Ceftriaxone Sodium.
to:
pH 7.0 Buffer—Dissolve 13.6 g of dibasic potassium phosphate and 4.0 g of monobasic potassium phosphate in water to obtain 1000 mL of solution. Adjust this solution with phosphoric acid or 10 N potassium hydroxide to a pH of 7.0 ± 0.1.
pH 5.0 Buffer—Dissolve 25.8 g of sodium citrate in 500 mL of water, adjust with citric acid solution (1 in 5) to a pH of 5.0 ± 0.1, and dilute with water to a volume of 1000 mL.
Mobile phase—Dissolve 3.2 g of tetraheptylammonium bromide in 400 mL of acetonitrile, add 44 mL of pH 7.0 Buffer and 4 mL of pH 5.0 Buffer, and add water to make 1000 mL. Pass through a membrane filter of 0.5-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Ceftriaxone Sodium RS in Mobile phase to obtain a solution having a known concentration of about 0.2 mg per mL. Use this solution promptly after preparation.
Resolution solution—Dissolve a suitable quantity of USP Ceftriaxone Sodium E-Isomer RS in Standard preparation, and dilute with Mobile phase to obtain a solution containing about 160 µg of USP Ceftriaxone Sodium E-Isomer RSper mL and 160 µg of USP Ceftriaxone Sodium RSper mL. Use this solution promptly after preparation.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 270-nm detector and a 4.0-mm × 15-cm column that contains 5-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure. The resolution, R, between the ceftriaxone E-isomer and ceftriaxone peaks is not less than 3. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure. The column efficiency determined from the analyte peak is not less than 1500 theoretical plates, the tailing factor for the analyte is not more than 2, and the relative standard deviation for replicate injections is not more than 2%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Ceftriaxone Sodium. Calculate the quantity, in mg, of ceftriaxone (C₁₈H₁₈N₈O₇S₃) in each mL of the Injection taken by the formula:
200(C / V)(r_U / r_S)
in which V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
to:
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 responses for the major peaks. Calculate the quantity, in mg, of ceftriaxone (C₁₈H₁₈N₈O₇S₃) in each mL of Injection taken by the formula:
200(C / V)(r_U / r_S)
in which C is the concentration, in mg per mL, of USP Ceftriaxone Sodium RS in the Standard preparation; V is the volume, in mL, of Injection taken; and r_U and r_S are the ceftriaxone peak responses obtained from the Assay preparation and the Standard preparation, respectively.