Errata - English

Line 5 of Titrimetric system: Delete the subsection
Blank: 100 mL of water and 4 mL of 3 N hydrochloric acid
AND
Line 11 of Analysis: Delete the sentence
Perform a blank determination.
AND
Line 13 of Analysis: Change
Result = [(V − B) × N × F × 100]/W
to:
Result = [(V × N × F)/W] × 100
AND
Line 15 of Analysis: Delete
B = volume of titrant consumed by the Blank (mL)

Line 3 of Flow Rate (HPLC): Change

in which F₁ is the flow rate indicated in the monograph, in mL/min; F₂ is the adjusted flow rate, in mL/min; l₁ is the length of the column indicated in the monograph; l₂ is the length of the column used; d₁ is the column inner diameter indicated in the monograph; and d₂ is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.
to:

in which F₁ is the flow rate indicated in the monograph, in mL/min; F₂ is the adjusted flow rate, in mL/min; d₁ is the column inner diameter indicated in the monograph; and d₂ is the internal diameter of the column used. Additionally, the flow rate can be adjusted by ±50%.

Line 10 of Analysis: Change
Result = {[(V_S1 − V_B) × N × F₁]/W} × 100
to:
Result = {[(V_S2 − V_B) × N × F₁]/W} × 100
AND
Line 11 of Analysis: Change
V_S1
to:
V_S2

Line 34 of Content of 1-Monoglycerides/Analysis: Change
F = equivalency factor of glyceryl monobehenate, 207.3 mg/mEq
to:
F = equivalency factor of glyceryl monobehenate, 0.2073 g/mEq
AND
Line 19 of Limit of Free Glycerin/Analysis: Change
F = equivalency factor of glycerin, 23.0 mg/mEq
to:
F = equivalency factor of glycerin, 0.023 g/mEq

Column 3 of Table 1: Change in Row 1
Percentage, NMT (%)
to:
Percentage (%)
Change in Row 2
12.0
to:
NMT 12.0
Change in Row 3
6.0
to:
NMT 6.0
Change in Row 4
60.0
to:
NLT 60.0
Change in Row 5
35.0
to:
NMT 35.0
Change in Row 6
2.0
to:
NMT 2.0
Change in Row 7
2.0
to:
NMT 2.0
Change in Row 8
2.0
to:
NMT 2.0

Line 4 of Analysis: Change
Determine the alcohol content of the sample thus prepared by the Gas–Liquid Chromatographic Method (see Method II in Alcohol Determination <611>, using methyl ethyl ketone as the internal standard in place of acetone.
to:
Determine the alcohol content of the sample thus prepared by the Gas Chromatographic Method (see Method II in Alcohol Determination <611>), using methyl ethyl ketone as the internal standard in place of acetonitrile.

Line 7 of Procedure: Change
(293.36/329.82)10,000(1 / F)(1 / V)(C_S / C_A)(r_i / r_S)
to:
(293.36 / 329.83)10,000(1 / F)(1 / V)(C_S / C_A)(r_i / r_S)
AND
Line 8 of Procedure: Change
329.82
to:
329.83

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.

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 1 of Sample solution: Change
Equivalent to 600 mg/mL of anhydrous sodium acetate
to:
Dissolve the equivalent of 3 g of anhydrous sodium acetate in 5 mL of water.
AND
Line 1 of Analysis: Change
To 5 mL of Sample solution add
to:
To the Sample solution add

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 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 19 of Analysis: Change
Result = [(F_MC × P_FA1 × A_MC)/(P_MC × A_FA1)] × 100
to:
Result = (F_MC × P_FA1 × A_MC)/(P_MC × A_FA1)

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 1: Change
It meets the requirements of the test for Chromatographic purity under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Test solution.
to:
It meets the requirements of the test for Organic Impurities under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Sample solution.