Errata - English

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.]

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 Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × ^▲(M_r1/M_r2) ×_{▲ (USP 1-Aug-2019)} 100
to:
Result = (R_U/R_S) × (C_S/C_U) × 100
AND
Delete
^▲M_r1 = molecular weight of tiagabine hydrochloride, 412.00
M_r2 = molecular weight of tiagabine hydrochloride monohydrate, 430.02_{▲ (USP 1-Aug-2019)}

In USP Galantamine Hydrobromide Related Compounds Mixture RS: Change
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂
to:
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂ 269.34

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 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 USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C₄H₈O₄S₂ 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.
C₄H₇KO₄S₂ ∙ KCl 296.86
AND
In USP Mesna Related Compound B RS: Change
2,2′-Disulfanediylbis(ethane-1-sulfonic acid).
C₄H₁₀O₆S₄ 282.36
to:
2,2′-Disulfanediylbis(ethane-1-sulfonic acid), dipotassium salt, crystal adduct with sodium chloride.
C₄H₈K₂O₆S₄ ∙ NaCl 416.98

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

In USP Metaraminol Enantiomer RS: Change
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol.
C₉H₁₃NO₂ 167.21
to:
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol D-tartrate.
C₉H₁₃NO₂ ∙ C₄H₆O₆ 317.29

Change
Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution by shaking a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 1 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 〈621〉). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the R_F value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.

In USP Fexofenadine Related Compound B RS: Change
3-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl benzeneacetic acid hydrochloride.
C₃₂H₃₉NO₄ · HCl 538.12
to:
3-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl benzeneacetic acid hydrochloride monohydrate;
Also known as 2-(3-{1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanoic acid hydrochloride monohydrate.
C₃₂H₃₉NO₄ · HCl · H₂O 556.14

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 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
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.

In Chromatographic system/Column: Change
4-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
AND
In System suitability: Change
[Note—The relative retention times for bupivacaine hydrochloride and dibutyl phthalate are about 1.0 and 1.2, respectively.]
to:
[Note—The relative retention times for bupivacaine and dibutyl phthalate are about 1.0 and 1.2, respectively.]
AND
In System suitability/Suitability requirements: Change
Resolution: NLT 2.0 between bupivacaine hydrochloride and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the ratio of bupivacaine to the internal standard from three replicate injections
to:
Resolution: NLT 2.0 between bupivacaine and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the peak response ratio of bupivacaine to the internal standard from three replicate injections

In Organic Impurities/System suitability: Change
Sample: Standard solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0
Relative standard deviation: NMT 5.0%
Signal-to-noise ratio: NLT 10
to:
Samples: Standard solution and Sensitivity solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 5.0%, Standard solution
Signal-to-noise ratio: NLT 10, Sensitivity solution

Change
Standard solution: 0.5 µg/mL of USP Leflunomide RS, from the Standard solution in Mobile phase
to:
Standard stock solution: Proceed as directed in the Standard solution in the Assay.
Standard solution: 0.5 µg/mL of USP Leflunomide RS from the Standard stock solution in Mobile phase

In Detection solution: Change
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate), and heat at 105° for 5 min.
to:
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate).

In USP Reference Standards 〈11〉: Change
USP Rivastigmine Tartrate R-Isomer RS
to:
USP Rivastigmine Tartrate R-Isomer RS
(R)-3-[1-(Dimethylamino)ethyl]phenyl ethylmethylcarbamate, hydrogen tartrate.
C₁₄H₂₂N₂O₂ · C₄H₆O₆ 400.42

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 Reference Standards <11>/USP Mirtazapine Resolution Mixture RS: Change
This resolution mixture contains approximately 0.1% w/w each of the following:
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.
to:
Mirtazapine.
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.