Errata - English

Change
Solution A, Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

In Chromatographic system: Change
Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the standard deviation for replicate injections is not more than 2.0%.
to:
Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

In Chromatographic system: Change
Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the standard deviation for replicate injections is not more than 10.0%.
to:
Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 10.0%.

In Tolerances: Change
NLT 75 (Q) of the labeled amount of sorafenib (C₂₁H₁₆ClF₃N₄O₃) is dissolved.
to:
NLT 75% (Q) of the labeled amount of sorafenib (C₂₁H₁₆ClF₃N₄O₃) is dissolved.

In footnote 1 of table: Change
Estra-1,3,5(10)-triene-6-one-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7α,17β)
to:
7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-6-one-3,17β-diol
AND
In footnote 2: Change
Estra-1,3,5(10),6-tetraene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7α,17β)
to:
7-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10),6-tetraene-3,17β-diol
AND
In footnote 3: Change
Estra-1,3,5(10)-triene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfonyl]nonyl]-(7α,17β)
to:
7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfonyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol
AND
In footnote 4: Change
Estra-1,3,5(10)-triene-3,17-diol,7-{9-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonylsulfinyl]nonyl}-(7α,17β)
to:
7α-{9-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonylsulfinyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol
AND
In footnote 5: Change
7,7-Nonamethylene-bis(estra-1,3,5(10)-triene-3,17-diol-(7α,17β)
to:
7α,7α-Nonamethylenebis[estra-1,3,5(10)-triene-3,17β-diol]
AND
In footnote 6: Change
Estra-1,3,5(10)-triene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7β,17β)
to:
7β-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol

In USP Atorvastatin Related Compound C RS: Change
C₆₆H₆₆F₄N₄O₁₀
to:
C₆₆H₆₆CaF₄N₄O₁₀
AND
In USP Atorvastatin Related Compound E RS: Change
1155.38
to:
1155.36

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 Sample solution: Change
Nominally 0.6 mg/mL of phenytoin
to:
Nominally 0.6 mg/mL of phenytoin sodium
AND
In Analysis: Change
C_U = nominal concentration of phenytoin in the Sample solution (mg/mL)
to:
C_U = nominal concentration of phenytoin sodium in the Sample solution (mg/mL)

Change
USP Ondansetron RS
USP Ondansetron Related Compound C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
USP Ondansetron Related Compound D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
to:
USP Ondansetron RS
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.
USP Ondansetron Related Compound C RS
9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
USP Ondansetron Related Compound D RS
9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one.

In USP Succinylmonocholine Chloride RS: Change
Ethanaminium, 2-(carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride.
to:
Ethanaminium, 2-(3-carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride;
Also known as 2-[(3-Carboxypropanoyl)oxy]-N,N,N-trimethylethan-1-aminium chloride.

Change
Using the Injection as the Test solution, proceed as directed for Color and clarity under Isoproterenol Inhalation Solution.
to:
Standard solution—Transfer 2.0 mL of 0.100 N iodine VS to a 500-mL volumetric flask, dilute with water to volume, and mix.
Procedure—Visually examine a portion of the Injection (Test solution) in a suitable clear glass test tube against a white background: it is not pinkish and it contains no precipitate. If any yellow color is observed in the Test solution, concomitantly determine the absorbances of the Test solution and the Standard solution in 1-cm cells with a suitable spectrophotometer set at 460 nm: the absorbance of the Test solution does not exceed that of the Standard solution.

In Test 2: Change
Determine the amount of isosorbide dinitrate (C₆H₉NO₆) dissolved by employing the following method.
to:
Determine the amount of isosorbide dinitrate (C₆H₈N₂O₈) dissolved by employing the following method.

Change
USP Eleutheroside B RS
β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl.
C₁₇H₂₄O₉ 372.37
USP Eleutheroside E RS
β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-diyl)bis(2,6-dimethoxy-4,1-phenylene)bis-.
C₃₄H₄₆O₁₈ 742.70
to:
USP Eleutheroside B RS
USP Eleutheroside E RS

Change
USP Eleutheroside B RS
β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl.
C₁₇H₂₄O₉ 372.37
USP Eleutheroside E RS
β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-diyl)bis(2,6-dimethoxy-4,1-phenylene)bis-.
C₃₄H₄₆O₁₈ 742.70
to:
USP Eleutheroside B RS
USP Eleutheroside E RS

In Test 1/Apparatus 2: Change
[Note—A suitable sinker is available from VanKel, www.chem.agilent.com, catalog number 12-3050. Proper placement of the Capsules is in the sinkers with the cap facing the fixed prong end.]
to:
[Note—A suitable sinker is available from www.agilent.com, catalog number 12-3050. Proper placement of the Capsules is in the sinkers with the cap facing the fixed prong end.]

In Analysis: Change
Result = {r_U/[r_S + (Σr_U/F)]} × (1/F) × 100
to:
Result = {r_U/[r_S + Σ(r_U/F)]} × (1/F) × 100

Change
USP Eleutheroside B RS
β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl.
C₁₇H₂₄O₉ 372.37
USP Eleutheroside E RS
β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-diyl)bis(2,6-dimethoxy-4,1-phenylene)bis-.
C₃₄H₄₆O₁₈ 742.70
to:
USP Eleutheroside B RS
USP Eleutheroside E RS

In Qualitative and Quantitative Analysis of Pesticide Residues: Change
[Note—Current version Document No. SANTE/11813/2017, https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_wrkdoc_2017-11813.pdf]
to:
[Note—Current version Document No. SANTE/12682/2019, https://ec.europa.eu/food/system/files/2020-01/pesticides_mrl_guidelines_wrkdoc_2019-12682.pdf]

Change
Ammonium bicarbonate solution, Diluent, Solution A, Solution B, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Proceed as directed in the Assay under Dimenhydrinate Tablets.
to:
Ammonium bicarbonate solution—Dissolve 4 g of ammonium bicarbonate in 250 mL of water.
Diluent—Dissolve 4 g of ammonium bicarbonate in 200 mL of water. Add 50 mL of methanol, and mix.
Solution A—Dissolve 0.8 g of ammonium bicarbonate in 800 mL of water. Add 200 mL of methanol, filter, and degas.
Solution B—Dissolve 0.8 g of ammonium bicarbonate in 150 mL of water. Add 850 mL of methanol, filter, and degas.
Mobile phase—Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 〈621〉).
Internal standard solution—Prepare a solution in methanol containing 2.0 mg of 2-hydroxybenzyl alcohol per mL.
Standard preparation—Accurately weigh about 50 mg of USP Dimenhydrinate RS, add about 5 mL of Ammonium bicarbonate solution and 20.0 mL of Internal standard solution, and mix. To 1 mL of this solution add about 9 mL of Diluent, and mix.
AND
Add
Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equipped with a 229-nm detector and a 4.6-mm × 25-cm column that contains packing L7. The flow rate is about 1.5 mL per minute. The chromatograph is programmed as follows.

Time (minutes), 0, 0–7.0, 7.0–7.1, 7.1–15, 15–15.1, 15.1–22.0
Solution A (%), 100, 100, 100→0, 0, 0→100, 100
Solution B (%), 0, 0, 0→100, 100, 100→0, 0
Elution, equilibration, isocratic, linear gradient, isocratic, linear gradient, isocratic

Chromatograph the Standard preparation, and record the peak areas as directed for Procedure: the relative retention times are about 0.3 for 8-chlorotheophylline, 0.5 for the internal standard, and 1.0 for diphenhydramine; the resolution, R, between 8-chlorotheophylline and the internal standard is not less than 4.5; and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Dimenhydrinate Tablets.
to:
Procedure—Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks.

Change
Ammonium bicarbonate solution, Diluent, Solution A, Solution B, Mobile phase, Internal standard solution, and Chromatographic system—Proceed as directed in the Assay under Dimenhydrinate Tablets.
to:
Ammonium bicarbonate solution—Dissolve 4 g of ammonium bicarbonate in 250 mL of water.
Diluent—Dissolve 4 g of ammonium bicarbonate in 200 mL of water. Add 50 mL of methanol, and mix.
Solution A—Dissolve 0.8 g of ammonium bicarbonate in 800 mL of water. Add 200 mL of methanol, filter, and degas.
Solution B—Dissolve 0.8 g of ammonium bicarbonate in 150 mL of water. Add 850 mL of methanol, filter, and degas.
Mobile phase—Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 〈621〉).
Internal standard solution—Prepare a solution in methanol containing 2.0 mg of 2-hydroxybenzyl alcohol per mL.
AND
Change
Standard solution—Prepare as directed for Standard preparation in the Assay under Dimenhydrinate Tablets.
to:
Standard solution—Accurately weigh about 50 mg of USP Dimenhydrinate RS, add about 5 mL of Ammonium bicarbonate solution and 20.0 mL of Internal standard solution, and mix. To 1 mL of this solution add about 9 mL of Diluent, and mix.
AND
Add
Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equipped with a 229-nm detector and a 4.6-mm × 25-cm column that contains packing L7. The flow rate is about 1.5 mL per minute. The chromatograph is programmed as follows.

Time (minutes), 0, 0–7.0, 7.0–7.1, 7.1–15, 15–15.1, 15.1–22.0
Solution A (%), 100, 100, 100→0, 0, 0→100, 100
Solution B (%), 0, 0, 0→100, 100, 100→0, 0
Elution, equilibration, isocratic, linear gradient, isocratic, linear gradient, isocratic

Chromatograph the Standard solution, and record the peak areas as directed for Procedure: the relative retention times are about 0.3 for 8-chlorotheophylline, 0.5 for the internal standard, and 1.0 for diphenhydramine; the resolution, R, between 8-chlorotheophylline and the internal standard is not less than 4.5; and the relative standard deviation for replicate injections is not more than 2.0%.

Change
(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-l-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid
to:
(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid

In paragraph five: Change
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉¹
to:
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉
AND
In footnote 1: Change
This chapter will appear in a future Pharmacopeial Forum (PF) issue.
to:
This chapter appeared in issue 46(3) of the Pharmacopeial Forum (PF).

In Analysis: Change
To 2.0 mL of the Sample solution, add 5.0 mL of a 4-g/L solution of methylbenzothiazolone hydrazone hydrochloride to an 80% (v/v) solution of glacial acetic acid in water.
to:
To 2.0 mL of the Sample solution, add 5.0 mL of a 4-g/L solution of methylbenzothiazolone hydrazone hydrochloride in an 80% (v/v) solution of glacial acetic acid in water.

In Overview: Change
The test is also sensitive to size accuracy at 15 μm, since small errors in size will translate into large errors in count at the midpoint of the PS distribution.
to:
The test is also sensitive to size accuracy at 15 μm, since small errors in size will translate into large errors in count at the midpoint of the particle size distribution.

In USP Pyrantel Related Compound A RS: Change
(Z)-1-Methyl-2-(2-(thiophen-2-yl)vinyl)-1,4,5,6-tetrahydropyrimidine.
C₃₄H₃₀N₂O₆S 594.69
to:
(Z)-1-Methyl-2-[2-(2-thiophenyl)vinyl]-1,4,5,6-tetrahydropyrimidine 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1).
C₁₁H₁₄N₂S · C₂₃H₁₆O₆ 594.68

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.

Change
Solution A, Solution B, Mobile phase, Internal standard solution, and Chromatographic system—Prepare as directed in the Assay under Dimenhydrinate Tablets.
to:
Solution A—Dissolve 0.8 g of ammonium bicarbonate in 800 mL of water. Add 200 mL of methanol, filter, and degas.
Solution B—Dissolve 0.8 g of ammonium bicarbonate in 150 mL of water. Add 850 mL of methanol, filter, and degas.
Mobile phase—Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 〈621〉).
Internal standard solution—Prepare a solution in methanol containing 2.0 mg of 2-hydroxybenzyl alcohol per mL.
AND
Add
Chromatographic system (see Chromatography 〈621〉)—
The liquid chromatograph is equipped with a 229-nm detector and a 4.6-mm × 25-cm column that contains packing L7. The flow rate is about 1.5 mL per minute. The chromatograph is programmed as follows.

Time (minutes), 0, 0–7.0, 7.0–7.1, 7.1–15, 15–15.1, 15.1–22.0
Solution A (%), 100, 100, 100→0, 0, 0→100, 100
Solution B (%), 0, 0, 0→100, 100, 100→0, 0
Elution, equilibration, isocratic, linear gradient, isocratic, linear gradient, isocratic

Chromatograph the Standard preparation, and record the peak areas as directed for Procedure: the relative retention times are about 0.3 for 8-chlorotheophylline, 0.5 for the internal standard, and 1.0 for diphenhydramine; the resolution, R, between 8-chlorotheophylline and the internal standard is not less than 4.5; and the relative standard deviation for replicate injections is not more than 2.0%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Dimenhydrinate Tablets. Calculate the quantity, in mg, of dimenhydrinate (C₁₇H₂₁NO · C₇H₇ClN₄O₂) in each mL of the Injection taken by the formula:
(200C/V)(R_U/R_S)
in which C is the concentration of USP Dimenhydrinate RS in the Standard preparation; V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
to:
Procedure— Separately inject equal volumes (about 10 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity, in mg, of dimenhydrinate (C₁₇H₂₁NO · C₇H₇ClN₄O₂) in each mL of the Injection taken by the formula:
(200C/V)(R_U/R_S)
in which C is the concentration of USP Dimenhydrinate RS in the Standard preparation; V is the volume, in mL, of Injection taken; and R_U and R_S are the peak area ratios of diphenhydramine to the internal standard obtained from the Assay preparation and the Standard preparation, respectively.