Errata - English

In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution
AND
In Limit of Benzene/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution

In Analysis: Change
M_W(Salt) = molecular weight of ammonium glycyrrhizate, 840.08 g/mol
M_W(Acid) = molecular weight of glycyrrhizic acid, 821.59 g/mol
to:
M_W(Salt) = molecular weight of ammonium glycyrrhizate, 839.97 g/mol
M_W(Acid) = molecular weight of glycyrrhizic acid, 822.94 g/mol

In System suitability: Change
Samples: System suitability solution, Standard solution A, and Standard solution B
to:
Samples: System suitability solution and Standard solution A
AND
In Analysis: Change
Samples: Mobile phase, Standard solution A, and Sample solution
Chromatograph the Standard solution and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.
to:
Samples: Mobile phase, Standard solution A, Standard solution B, and Sample solution
Chromatograph Standard solution B and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.

In Test 1: Change
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions)
to:
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions); 900 mL

In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 10.0% for the tributyl phosphine oxide and osteltamivir phosphate peaks
to:
NMT 10.0% for the tributyl phosphine oxide and oseltamivir phosphate peaks

In Chromatographic system and Procedure: Change
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS, on the anhydrous basis, in the Standard preparation;
to:
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS in the Standard preparation;

Line 2 of USP Eszopiclone Related Compound A RS:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoic salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO 561.38
to:
[Note – This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoate salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO₂ 561.38

In USP Atorvastatin Related Compound B RS: Change
(3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as (3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.

In Dissolution 〈711〉/Standard solution: Change
USP Dapsone RS of a known concentration in Medium
to:
(L/1000) mg/mL of USP Dapsone RS in Medium, where L is the label claim in mg/Tablet. Transfer a portion of this solution containing 0.2 mg of dapsone to a 25-mL volumetric flask, add 5 mL of 1 N sodium hydroxide, and dilute with water to volume.

In Analysis: Change
[Note—The relative retention times for naloxone and 2,2′-bisnaloxone (4,5′:4′,5″-diepoxy-3,3′,14,14′-tetrahydroxy-17,17′-bis(prop-2-enyl)-2,2′-bimorphinanyl-6,6′-dione) are 1.0 and 2.8, respectively.]
to:
[Note—The relative retention times for naloxone and 2,2′-bisnaloxone (4,5ɑ:4′,5′ɑ-diepoxy-3,3′,14,14′-tetrahydroxy-17,17′-bis(prop-2-enyl)-2,2′-bimorphinanyl-6,6′-dione) are 1.0 and 2.8, respectively.]

Change
Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that contains 95% alcohol by weight or 92.42% alcohol v/v.
to:
Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that contains 95% alcohol v/v or 92.42% alcohol by weight.

In footnote f of Table 2: Change
1,1-Bis{2-chloro-[4-(3-{1,2,4-triazolo[4,3-a]pyridin-3-(2H)-on-2-yl}propyl)piperazine-1-yl]phenyl}ethane trihydrochloride.
to:
2,2'-{[Ethane-1,1-diylbis(3-chloro-4,1-phenylene)bis(piperazine-4,1-diyl)]bis(propane-3,1-diyl)}bis([1,2,4]triazolo[4,3-a]pyridin-3(2H)-one).

In General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)
to:
where L is the limit in the original article as listed in Table 5 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)

In Test 1, Test 3, Test 4, Test 5, and Test 6/Analysis: Change
M_r1 = molecular weight of atorvastatin, 558.64
M_r2 = molecular weight of atorvastatin calcium, 1155.34
to:
M_r1 = molecular weight of atorvastatin, 558.65
M_r2 = molecular weight of atorvastatin calcium, 1155.36

In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
to:
Acid stage standard solution: (L/10000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
AND
In Dissolution <711>/Test 2/Buffer stage: Change
Buffer stage standard solution: (L/1000) of USP Pantoprazole Sodium RS where L is the label claim in mg/Tablet
to:
Buffer stage standard solution: (L/1000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Buffer stage medium, where L is the label claim in mg/Tablet

In the definition list in Particle Size Distribution by Cascade Impaction/Analysis: Change
M_r1 = molecular weight of salmeterol free base, 415.75
to:
M_r1 = molecular weight of salmeterol free base, 415.57
AND
In the definition list in Delivered-Dose Uniformity <601>/Analysis: Change
M_r1 = molecular weight of salmeterol free base, 415.75
to:
M_r1 = molecular weight of salmeterol free base, 415.57

In Column: Change
4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B ^▲(90:10)_▲ (ERR 1-Mar-2019) for about 30 min is recommended prior to use.]
to:
4.6-mm × 15-cm; 5-µm packing L7

In paragraph 3: Change
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to room temperature before weighing.
to:
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to room temperature before weighing accurately.

In USP Benazepril Related Compound B RS: Change
(3S) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride.
to:
2-[(S)-3-{[(R)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3S) 3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.

In Analysis: Change
Result = {[(V_S − V_B) × N × F]/W} × 100
to:
Result = {[(V_S − V_B) × M × F]/W} × 100
AND
Change
N = actual normality of the Titrant (mEq/mL)
F = equivalency factor, 320.2 mg/mEq
to:
M = actual molarity of the Titrant (mmol/mL)
F = equivalency factor, 320.26 mg/mmol

In Analysis: Change
Titrate the Blank with 1 N sodium hydroxide VS, and record the volume of 1 N sodium hydroxide VS consumed. Titrate the excess acid in the Sample solution with 1 N sodium hydroxide VS to the inflection point at pH 4, and record the buret reading.
to:
Titrate the Blank potentiometrically with 1 N sodium hydroxide VS, and record the volume of 1 N sodium hydroxide VS consumed. Titrate the excess acid in the Sample solution potentiometrically with 1 N sodium hydroxide VS to the inflection point at pH 4, and record the buret reading.

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

Change
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay, and use 40 µL injection volume for the Sensitivity solution.