Errata - English

Line 11 of Analysis: Change
(V_S − V_B)
to:
(V_B − V_S)
AND
Line 12 of Analysis: Change
V_S = Titrant volume consumed by the Sample (mL)
V_B = Titrant volume consumed by the Blank (mL)
to:
V_B = Titrant volume consumed by the Blank (mL)
V_S = Titrant volume consumed by the Sample (mL)

Line 14 of Analysis: Change
[(V_S − V_B) × N × F]/W
to:
[(V_B − V_S) × N × M_r]/W
AND
Line 15 of Analysis: Change
V_S = volume of 1 N sodium hydroxide consumed by the sample (mL)
V_B = volume of 1 N sodium hydroxide consumed by the blank test (mL)
to:
V_B = volume of 1 N sodium hydroxide consumed by the blank test (mL)
V_S = volume of 1 N sodium hydroxide consumed by the sample (mL)
AND
Line 21 of Analysis: Change
F = molecular weight of potassium hydroxide, 56.11
to:
M_r = molecular weight of potassium hydroxide, 56.11

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 15 of Procedure: Change
431.94 is the molecular weight of zinc undecylenate;
to:
M_r is the molecular weight of zinc undecylenate, 431.94;
AND
Line 16 of Procedure: Change
65.39 is the atomic weight of zinc;
to:
A_r is the atomic weight of zinc, 65.39;
AND
Line 19 of Procedure: Change
C_H and C_L are the concentrations, in µg per mL,
to:
C_s1 and C_s2 are the concentrations, in µg per mL,

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
Buffer, Mobile phase, Diluent, Sensitivity solution,
to:
Buffer, Mobile phase, Diluent, Standard solution, Sensitivity solution,
AND
Line 1 of Samples in Analysis: Change
Standard solution, Sample solution, and Sensitivity solution
to:
Sample solution

Change the subsection head
Buffer:
to:
Buffer A:
AND
After the Buffer A subsection: Add
Buffer B: 0.067 M dibasic potassium phosphate
AND
Line 1 of Mobile phase: Change
Methanol and Buffer
to:
Methanol and Buffer A
AND
Line 4 of Sample stock solution: Change
with the aid of 330 mL of Buffer, to a 1000-mL volumetric flask containing 50 mL of Buffer.
to:
with the aid of 330 mL of Buffer B, to a 1000-mL volumetric flask containing 50 mL of Buffer B.

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 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 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 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)