Errata - English

In Dissolution <711>/Test 3/For Tablets labeled to contain 60 mg of nifedipine: Phase 2/Tolerances: Change
The cumulative percentages of the labeled amount of nifedipine (C₁₇H₁₈N₂O₆), released in vivo and dissolved at the times specified, conform to Dissolution 〈711〉, Acceptance Table 2.
to:
The cumulative percentages of the labeled amount of nifedipine (C₁₇H₁₈N₂O₆), dissolved at the times specified, conform to Dissolution 〈711〉, Acceptance Table 2.

In B: Identity by Fatty Acid Composition/Chromatographic system/Column: Change
0.25-mm × 15-cm fused silica capillary;
to:
0.25-mm × 15-m fused silica capillary;
AND
In C. Limit of Ethylene Glycol and Diethylene Glycol/System suitability: Change
butane 1,4-diol,
to:
butane 1,3-diol,

In Dissolution <711>/Test 3/Analysis: Change
A_S = absorbance from the Acid stage standard solution or Buffer stage standard solution at time point i
to:
A_S = absorbance from the Acid stage standard solution or Buffer stage standard solution

Change
C. Identification Tests—General <191>, Chemical Identification Tests, Sodium: A solution (1 in 100) meets the requirements of the flame test.
to:
C. A solution (1 in 100) imparts an intense yellow color to a nonluminous flame.

Correct the chemical structure
AND
Change
The ratio of OH group to the sum of C₁₅H₃₁COO and C₁₇H₃₅COO groups is mainly 3:1.
Polyethylene glycol 20 sorbitan ether monostearate;
to:
Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.;

Change
Penicillin G Procaine, Dihydrostreptomycin Sulfate, Chlorpheniramine Maleate, and Dexamethasone Suspension.
to:
Penicillin G Procaine, Dihydrostreptomycin Sulfate, Chlorpheniramine Maleate, and Dexamethasone Injectable Suspension.

In Limit of Free Iodide/Analysis: Change
N = Titrant normality (meq/mL)
F = equivalent weight of iodide, 0.1269 mg/meq
to:
N = Titrant normality (mEq/mL)
F = equivalent weight of iodide, 126.9 mg/mEq

In Dissolution <711>/Test 2/Tier 2: Change
Stock standard solution: 0.60 mg/mL of USP Cyclophosphamide RS in Medium. Add Medium to about 70% of the flask volume, and sonicate to dissolve. Dilute with Medium to volume. [Note—Medium in Tier 1 or Tier 2 should be used respectively.]
Standard solution: (L/900) mg/mL of USP Cyclophosphamide RS from Stock standard solution in Medium. Store solution at 10°. [Note—Medium in Tier 1 or Tier 2 should be used respectively.]
to:
Standard stock solution: 0.60 mg/mL of USP Cyclophosphamide RS in Medium. Add Medium to about 70% of the flask volume, and sonicate to dissolve. Dilute with Medium to volume. [Note—Medium in Tier 1 or Tier 2 should be used respectively.]
Standard solution: (L/900) mg/mL of USP Cyclophosphamide RS from Standard stock solution in Medium. Store solution at 10°. [Note—Medium in Tier 1 or Tier 2 should be used respectively.]

In Limit of Oxalate/Acceptance criteria: Change
The absorbance of the Sample solution is no less than that of the Standard solution (NMT 0.35% of oxalate).
to:
The absorbance of the Sample solution is not less than that of the Standard solution (NMT 0.35% of oxalate).

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

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 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.

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 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 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 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 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

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.