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

Change
489.64
to:
489.65
AND
Change
(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(E)-(3S)-3-hydroxy-3-methyl-1-octenyl]cyclopentyl]-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1);
to:
(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(E)-(3S)-3-hydroxy-3-methyloct-1-enyl]cyclopentyl]-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1);

Change
pH 6.0 buffer, Mobile phase, Diluent, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Carteolol Hydrochloride.
to:
Buffer, Mobile phase, Standard stock solution, Standard solution, System suitability stock solution, System suitability solution, Chromatographic system, and System suitability—
Proceed as directed in the Assay under Carteolol Hydrochloride.
AND
Add
Diluent—Prepare a mixture of Buffer and methanol (1:1).
AND
In all instances in Procedure: Change
Standard preparation
to:
Standard solution

In USP Carvedilol Related Compound A RS: Change
629.74
to:
629.75
AND
In USP Carvedilol Related Compound B RS: Change
645.74
to:
645.76
AND
In USP Carvedilol Related Compound C RS: Change
496.60
to:
496.61
AND
In USP Carvedilol Related Compound E RS: Change
2-(2-Methoxyphenoxy)ethyl amine.
C₉H₁₃NO₂ 167.21
to:
[Note—This material may be available in the free base or salt form.]
2-(2-Methoxyphenoxy)ethyl amine.
C₉H₁₃NO₂ 167.21
2-(2-Methoxyphenoxy)ethyl amine hydrochloride monohydrate.
C₉H₁₃NO₂ ∙ HCl ∙ H₂O 221.68
AND
In USP Carvedilol System Suitability Mixture RS: Change
Mixture of approximately 0.1% carvedilol related compound F (1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol) in a matrix of carvedilol drug substance.
to:
Contains a mixture of carvedilol related compound F in a matrix of carvedilol drug substance:
Carvedilol.
Carvedilol related compound F.
[Note—This material may be available in the free base or salt form.]
1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol.
C₂₄H₃₀N₂O₄ 410.51
1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol acetate.
C₂₄H₃₀N₂O₄ ∙ C₂H₄O₂ 470.57

Line 2 of Sample solution: Change
Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution.
to:
Initially add Diluent to fill about 80% of the total volume. Sonicate briefly to facilitate dissolution. Cool, and dilute with Diluent to volume.

Line 2 of USP Cefadroxil Related Compound I RS: Change
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
to:
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid.

Line 7 of Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × P × F × 100
to:
Result = (R_U/R_S) × (C_S/C_U) × P × 100
AND
Line 17 of Analysis: Change
P = potency of cefadroxil in USP Cefadroxil RS (µg/mg)
to:
P = potency of cefazolin in USP Cefazolin RS (mg/mg)
AND
Line 19 of Analysis: Delete
F = conversion factor, 0.001 mg/µg

Change
pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefazolin.
to:
pH 3.6 Buffer—Dissolve 0.900 g of anhydrous dibasic sodium phosphate and 1.298 g of citric acid monohydrate in water to make 1000 mL.
pH 7.0 Buffer—Dissolve 5.68 g of anhydrous dibasic sodium phosphate and 3.63 g of monobasic potassium phosphate in water to make 1000 mL.
Mobile phase—Prepare a suitable mixture of pH 3.6 Buffer and acetonitrile (9:1). Pass through a membrane filter having a 10-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution—Transfer 750 mg of salicylic acid to a 100-mL volumetric flask, dissolve in 10 mL of methanol, dilute with pH 7.0 Buffer to volume, and mix.
Standard preparation—Transfer about 25 mg of USP Cefazolin RS, accurately weighed, to a 25-mL volumetric flask, dissolve in and dilute with pH 7.0 Buffer to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.0-mm × 30-cm column that contains 10-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure. The relative retention times are about 0.7 for salicylic acid and 1.0 for cefazolin; the resolution, R, between the analyte and internal standard peaks is not less than 4.0; the column efficiency is not less than 1500 theoretical plates; the tailing factor is not more than 1.5; 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 Cefazolin. Calculate the quantity, in mg, of cefazolin (C₁₄H₁₄N₈O₄S₃) in each mL of the Injection taken by the formula:
(1000C / V)(R_U / R_S)
in which 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 responses for the major peaks. Calculate the quantity, in mg, of cefazolin (C₁₄H₁₄N₈O₄S₃) in each mL of Injection taken by the formula:
(1000C / V)(R_U / R_S)
in which C is the concentration, in mg per mL, of USP Cefazolin RS, calculated on the anhydrous basis, in the Standard preparation; V is the volume, in mL, of Injection taken; and R_U and R_S are the peak response ratios of cefazolin to the internal standard obtained from the Assay preparation and the Standard preparation, respectively.

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

Line 5 of Analysis: Change
Result = (A_U/A_S) × C_S × d × V × D × (1/L) × 100
to:
Result = (A_U/A_S) × C_S × (d/W_U) × V × D × (1/L) × 100
AND
Add to the variable definition list
W_U = weight of reconstituted Cefdinir for Oral Suspension taken (mg)

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

Line 10 of the Calculate statement in the Analysis: Change
C_U = nominal concentration of cefotaxime sodium in Sample solution 1, 2, 3, or 4 (mg/mL)
to:
C_U = nominal concentration of cefotaxime in Sample solution 1, 2, 3, or 4 (mg/mL)

In Analysis: Change
Calculate the percentage of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P × 100
to:
Calculate the quantity, in µg/mg, of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P

In Analysis: Change
r_C = peak response of ceftiofur from the Sample solution (mg/mL)
r_A = sum of the responses of all peaks that elute after ceftiofur from the Sample solution (mg/mL)
to:
r_C = peak response of ceftiofur from the Sample solution
r_A = sum of the responses of all peaks that elute after ceftiofur from the Sample solution

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

In Analysis: Change
r_C = peak response of ceftiofur from the Sample solution (mg/mL)
r_A = sum of the responses of all peaks that elute after ceftiofur from the Sample solution (mg/mL)
to:
r_C = peak response of ceftiofur from the Sample solution
r_A = sum of the responses of all peaks that elute after ceftiofur from the Sample solution

Change
pH 7.0 Buffer, pH 5.0 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Prepare as directed in the Assay under Ceftriaxone Sodium.
to:
pH 7.0 Buffer—Dissolve 13.6 g of dibasic potassium phosphate and 4.0 g of monobasic potassium phosphate in water to obtain 1000 mL of solution. Adjust this solution with phosphoric acid or 10 N potassium hydroxide to a pH of 7.0 ± 0.1.
pH 5.0 Buffer—Dissolve 25.8 g of sodium citrate in 500 mL of water, adjust with citric acid solution (1 in 5) to a pH of 5.0 ± 0.1, and dilute with water to a volume of 1000 mL.
Mobile phase—Dissolve 3.2 g of tetraheptylammonium bromide in 400 mL of acetonitrile, add 44 mL of pH 7.0 Buffer and 4 mL of pH 5.0 Buffer, and add water to make 1000 mL. Pass through a membrane filter of 0.5-μm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Ceftriaxone Sodium RS in Mobile phase to obtain a solution having a known concentration of about 0.2 mg per mL. Use this solution promptly after preparation.
Resolution solution—Dissolve a suitable quantity of USP Ceftriaxone Sodium E-Isomer RS in Standard preparation, and dilute with Mobile phase to obtain a solution containing about 160 µg of USP Ceftriaxone Sodium E-Isomer RSper mL and 160 µg of USP Ceftriaxone Sodium RSper mL. Use this solution promptly after preparation.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 270-nm detector and a 4.0-mm × 15-cm column that contains 5-μm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure. The resolution, R, between the ceftriaxone E-isomer and ceftriaxone peaks is not less than 3. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure. The column efficiency determined from the analyte peak is not less than 1500 theoretical plates, the tailing factor for the analyte is not more than 2, and the relative standard deviation for replicate injections is not more than 2%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Ceftriaxone Sodium. Calculate the quantity, in mg, of ceftriaxone (C₁₈H₁₈N₈O₇S₃) in each mL of the Injection taken by the formula:
200(C / V)(r_U / r_S)
in which V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
to:
Procedure—Separately inject equal volumes (about 20 μL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of ceftriaxone (C₁₈H₁₈N₈O₇S₃) in each mL of Injection taken by the formula:
200(C / V)(r_U / r_S)
in which C is the concentration, in mg per mL, of USP Ceftriaxone Sodium RS in the Standard preparation; V is the volume, in mL, of Injection taken; and r_U and r_S are the ceftriaxone peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Change
Buffer: 23 mg/mL of monobasic ammonium phosphate in water
to:
Solution A: 23 g/L of monobasic ammonium phosphate in water
AND
Line 4 of System suitability solution: Change
Dilute with Buffer to volume.
to:
Dilute with Solution A to volume.
AND
Line 3 of Standard solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.
AND
Line 3 of Sample solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.

In USP Cetirizine Related Compound A RS: Change
2-(2-{4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetic acid, ethyl ester dihydrochloride.
C₂₃H₂₉ClN₂O₃ · 2HCl 489.86
to:
(RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester oxalate.
C₂₃H₂₉ClN₂O₃ · C₂H₂O₄ 506.98

Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 16 of Analysis: Change
Result = [(V_S − V_B) × F]/W
to:
Result = [(V_B − V_S) × N × M_r]/W
AND
Line 17 of Analysis: Change
V_S = Titrant volume consumed by the Sample (mL)
V_B = Titrant volume consumed by the Blank (mL)
F = calculation factor, 56.1
to:
V_B = Titrant volume consumed by the Blank (mL)
V_S = Titrant volume consumed by the Sample (mL)
N = actual normality of 1 N sodium hydroxide (mEq/mL)
M_r = molecular weight of potassium hydroxide, 56.11

Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 9 of Analysis: Change
Result = [(V_S − V_B) × F]/W
to:
Result = [(V_B − V_S) × N × M_r]/W
AND
Line 10 of Analysis: Change
V_S = Titrant volume consumed by the Sample (mL)
V_B = Titrant volume consumed by the Blank (mL)
F = factor, 56.1
to:
V_B = Titrant volume consumed by the Blank (mL)
V_S = Titrant volume consumed by the Sample (mL)
N = actual normality of 1 N sodium hydroxide (mEq/mL)
M_r = molecular weight of potassium hydroxide, 56.11