Errata - English

In 4.2.1 Appearance (Turbidity/Opalescence): Change
The determination of turbidity may be performed using either a visual (Procedure A) or instrumental (Procedure B) comparison.
to:
The determination of turbidity may be performed using either a visual (Procedure A) or instrumental comparison (Procedure B).

In Limit of Sulfites: Add
Sample: 0.5 mL of Formic Acid
AND
In Analysis: Change
Add 12 mL of a 42-g/L solution of sodium hydroxide in carbon dioxide-free water to 0.5 mL of the Sample solution.
to:
Add 12 mL of a 42-g/L solution of sodium hydroxide in carbon dioxide-free water to the Sample.

In Enantiomeric Purity Test/Sample stock solution: Change
Equivalent to 500 µg/mL of Naproxen in tetrahydrofuran prepared as follows. Dissolve 25 mg of naproxen sodium
to:
Equivalent to 500 µg/mL of Naproxen Sodium in tetrahydrofuran prepared as follows. Dissolve 25 mg of Naproxen Sodium
AND
In Enantiomeric Purity Test/Sample solution: Change
Equivalent to 50 µg/mL of Naproxen in Mobile phase from Sample stock solution
to:
Equivalent to 50 µg/mL of Naproxen Sodium in Mobile phase from Sample stock solution

In Organic Impurities: Change
Diluent, Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed
to:
Diluent, Buffer, Mobile phase, System suitability solution, Standard solution, and Sample solution: Prepare
AND
Change
Sensitivity solution: 0.0005 mg/mL of USP Bupropion Hydrochloride RS in Diluent
Mode: LC
to:
Sensitivity solution: 0.0005 mg/mL of USP Bupropion Hydrochloride RS in Diluent
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC

Delete
Assemble an apparatus similar to that illustrated,
AND
Change
Congealing Temperature Apparatus
to:
Figure 1. Congealing Temperature Apparatus
AND
Change
in which the container for the substance is a 25- × 100-mm test tube.
to:
Assemble an apparatus similar to that in Figure 1, in which the container for the substance is a 25- × 100-mm test tube.

In USP Reference Standards <11>: Change
USP Pramipexole Dihydrochloride RS
[Note—Supplied in monohydrate form.]
to:
USP Pramipexole Dihydrochloride Monohydrate RS
AND
In USP Reference Standards <11>/USP Pramipexole Related Compound D RS: Change
284.25
to:
284.24

In Limit of Pramipexole Related Compound D/System suitability stock solution and Limit of Pramipexole Related Compound D/System suitability solution: Change
USP Pramipexole Dihydrochloride RS
to:
USP Pramipexole Dihydrochloride Monohydrate RS
AND
In Organic Impurities/System suitability solution, Organic Impurities/Standard solution, and Organic Impurities/Analysis: Change
USP Pramipexole Dihydrochloride RS
to:
USP Pramipexole Dihydrochloride Monohydrate RS

In Dissolution <711>/Test 17/Medium/For Tablets labeled to contain 30 mg or 60 mg of nifedipine: Change
To this add 5 mL of sodium dodecyl sulfate; 900 mL.
to:
Add 5 g of sodium dodecyl sulfate to 1 L of this solution; 900 mL.
AND
In Dissolution <711>/Test 17/Medium/For Tablets labeled to contain 90 mg of nifedipine: Change
To this add 1 mL of sodium dodecyl sulfate; 900 mL.
to:
Add 10 g of sodium dodecyl sulfate to 1 L of this solution; 900 mL.
AND
In Dissolution <711>/Test 18/Medium: Change
To this add 5 mL of sodium dodecyl sulfate; 900 mL,
to:
Add 5 g of sodium dodecyl sulfate to 1 L of this solution; 900 mL,

In Procedure/Standard solution: Change
0.25 mg/mL of USP Diphenhydramine Hydrochloride RS from the Standard stock solution
to:
0.25 mg/mL of USP Diphenhydramine Hydrochloride RS from the Standard stock solution in Diluent

In Dissolution <711>/Test 3/Acid stage/Analysis: Change
Result = A – [(r_U/r_S) x C_S x (M_r1/M_r2) x (1/L) x 100]
to:
Result = A – [(r_U/r_S) x C_S x V x (M_r1/M_r2) x (1/L) x 100]
AND
In Dissolution <711>/Test 3/Acid stage/Analysis: Change
C_S = concentration of USP Pantoprazole Sodium RS in the Acid stage standard solution (mg/mL)
M_r1 = molecular weight of pantoprazole, 383.37
to:
C_S = concentration of USP Pantoprazole Sodium RS in the Acid stage standard solution (mg/mL)
V = volume of the flask used to prepare the Sample solution (mL)
M_r1 = molecular weight of pantoprazole, 383.37
AND
In Dissolution <711>/Test 4/Acid stage/Analysis: Change
Result = A – [(r_U/r_S) x C_S x (1/L) x (M_r1/M_r2) x 100]
to:
Result = A – [(r_U/r_S) x C_S x V x (M_r1/M_r2) x (1/L) x 100]
AND
In Dissolution <711>/Test 4/Acid stage/Analysis: Change
C_S = concentration of USP Pantoprazole Sodium RS in the Acid stage standard solution (mg/mL)
L = label claim (mg/Tablet)
M_r1 = molecular weight of pantoprazole, 383.37
M_r2 = molecular weight of pantoprazole sodium, 405.35
to:
C_S = concentration of USP Pantoprazole Sodium RS in the Acid stage standard solution (mg/mL)
V = volume of the flask used to prepare the Sample solution (mL)
M_r1 = molecular weight of pantoprazole, 383.37
M_r2 = molecular weight of pantoprazole sodium, 405.35
L = label claim (mg/Tablet)
AND
In Dissolution <711>/Test 5/Acid stage/Analysis: Change
Result = A – (r_U/r_S) x C_S x (M_r1/M_r2) x (1/L) x 100
to:
Result = A – [(r_U/r_S) x C_S x V x (M_r1/M_r2) x (1/L) x 100]
AND
In Dissolution <711>/Test 5/Acid stage/Analysis: Change
C_S = concentration of USP Pantoprazole Sodium RS in the Acid stage standard solution (mg/mL)
M_r1 = molecular weight of pantoprazole, 383.37
to:
C_S = concentration of USP Pantoprazole Sodium RS in the Acid stage standard solution (mg/mL)
V = volume of the flask used to prepare the Sample solution (mL)
M_r1 = molecular weight of pantoprazole, 383.37

In Organic Impurities/Impurity Table: Change
^c(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-4-(prop-1-en-2-yl)-2propyl-1H-imidazole-5-carboxylate.
to:
^c(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-4-(prop-1-en-2-yl)-2-propyl-1H-imidazole-5-carboxylate.

Change
2-Propanol, 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-, (±)-, (E)-2butenedioate (2:1) (salt).
to:
2-Propanol, 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-, (±)-, (E)-2-butenedioate (2:1) (salt).

In Content of Sennosides A and B/Analysis: Change
F = conversion factor for the molecular weights of sennoside A and B to the corresponding calcium salt (Table 2), 1.044
to:
F = conversion factor for the molecular weights of sennoside A and B to the corresponding calcium salt, 1.044

Change
863.34
to:
863.37
AND
Change
2-[(all-E)-3,7,11,15,19,23,27,31,35,39-Decamethyl-2,6,10,14,18,22,26,30,34,38-tetracontadecaenyl)-5,6-dimethoxy-3-methyl-p-benzoquinone
to:
2-[(all-E)-3,7,11,15,19,23,27,31,35,39-Decamethyl-2,6,10,14,18,22,26,30,34,38-tetracontadecaenyl]-5,6-dimethoxy-3-methyl-p-benzoquinone;
2-[(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-Decamethyltetraconta-2,6,10,14,18,22,26,30,34,38-decaenyl]-5,6-dimethoxy-3-methyl-1,4-benzoquinone

In UV Absorbance Limit for Polycyclic Aromatic Hydrocarbons/Analysis: Change
Measure the absorbance over the range 265 nm,
to:
Measure the absorbance over the range 265–420 nm,
AND
In UV Absorbance Limit for Polycyclic Aromatic Hydrocarbons/Acceptance criteria: Change
At no wavelength in the range of 265 nm
to:
At no wavelength in the range of 265–420 nm

In Packaging and Storage: Delete
Dosage forms prepared with this article should bear the following statement: Do not use if you have a liver problem; discontinue use and consult a healthcare practitioner if you develop symptoms such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).
AND
In Labeling: Add
Dosage forms prepared with this article should bear the following statement: Do not use if you have a liver problem; discontinue use and consult a healthcare practitioner if you develop symptoms such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).

In USP Reference Standards <11>/USP Olmesartan Medoxomil Related Compound A RS: Change
1-{[2′-(1H-Tetrazol-5-yl)biphenyl-4-yl]methyl}-4,4-dimethyl-2-propyl-1H-furo[3,4-d]imidazol-6(4H)-one.
C₂₄H₂₄N₆O₂ 428.49
to:
1-{[2'-(1H-Tetrazol-5-yl)biphenyl-4-yl]methyl}-6,6-dimethyl-2-propyl-3,6-dihydro-4H-furo[3,4-d]imidazol-4-one.
C₂₄H₂₄N₆O₂ 428.50

In Organic Impurities/Procedure/Impurity Table: Change
Olefinic impurity^c
N-alkyl impurity^d
to:
Olmesartan medoxomil olefinic impurity^c
Olmesartan medoxomil N-alkyl impurity^d
AND
In Organic Impurities/Procedure/Impurity Table: Change
^b 1-{[2′-(1H-Tetrazol-5-yl)biphenyl-4-yl]methyl}-4,4-dimethyl-2-propyl-1H-furo[3,4-d]imidazol-6(4H)-one.
^c (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2′-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(prop-1-en-2-yl)-2-propyl-1H-imidazole-5-carboxylate.
^d (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
to:
^b 1-{[2'-(1H-Tetrazol-5-yl)biphenyl-4-yl]methyl}-6,6-dimethyl-2-propyl-3,6-dihydro-4H-furo[3,4-d]imidazol-4-one.
^c (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-4-(prop-1-en-2-yl)-2propyl-1H-imidazole-5-carboxylate.
^d (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(2-trityl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazole-5-carboxylate.

Change
558.59
1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl ethyl)-2-propyl-1-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester;
to:
558.60
1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester;

In Dissolution <711>/Test 4/Acid resistance stage/Analysis: Change
M_r2 = molecular weight of esomeprazole magnesium trihydrate, 767.17
to:
M_r2 = molecular weight of esomeprazole magnesium, 713.12

Change
766.96
to:
766.97
AND
Change
2-Propanol, 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phen oxy]-3-[(1-methylethyl)amino]-, (±)-, (E)-2-butenedioate (2:1) (salt).
to:
2-Propanol, 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-, (±)-, (E)-2-butenedioate (2:1) (salt).

Change
Benzamide, 4-amino-5-chloro-N-[1-[3-(4-fluorophen oxy)propyl]-3-methoxy-4-piperidinyl]-2-methoxy-, cis-.
cis-4-Amino-5-chloro-N-[1-[3-(p-fluorophenoxy)propyl]-3-methoxy-4-piperidyl]-o-anisamide
to:
Benzamide, 4-amino-5-chloro-N-[1-[3-(4-fluorophenoxy)propyl]-3-methoxy-4-piperidinyl]-2-methoxy-, cis-.
cis-4-Amino-5-chloro-N-[1-[3-(p-fluorophenoxy)propyl]-3-methoxy-4-piperidyl]-2-anisamide
AND
Change
484.0
to:
483.97

In Dissolution <711>/Test 1/Analysis: Change
C_S = concentration of USP Oseltamivir Phosphate RS in the Standard solution
to:
C_S = concentration of USP Oseltamivir Phosphate RS in the Standard solution (mg/mL)
AND
In Dissolution <711>/Test 2/Analysis: Change
L = label claim (mg/Tablet)
to:
L = label claim for oseltamivir (mg/Capsule)

In USP Iopamidol Related Compound B RS: Change
5-Glycolamido-N,N′-bis[2-hydroxy-1-(hydroxymeth yl)ethyl]-2,4,6-triiodoisophthalamide.
C₁₆H₂₀I₃N₃O₇ 747.07
to:
N¹,N³-Bis(1,3-dihydroxypropan-2-yl)-5-(2-hydroxyacetamido)-2,4,6-triiodoisophthalamide.
C₁₆H₂₀I₃N₃O₈ 763.06