Errata - English

In USP Zileuton Related Compound A RS: Change
N-(1-Benzo-[b]thien-2-ylethyl)urea.
C₁₁H₁₂N₂OS 220.30
to:
N-(1-Benzo-[b]thien-2-ylethyl)urea;
Also known as 1-[1-(Benzo[b]thiophen-2-yl)ethyl]urea.
C₁₁H₁₂N₂OS 220.29
AND
In USP Zileuton Related Compound B RS: Change
2-(Benzo[b]thien-2-oyl)benzo[b]thiopene.
C₁₇H₁₀OS₂ 294.40
to:
2-(Benzo[b]thien-2-oyl)benzo[b]thiophene;
Also known as Bis(benzo[b]thiophen-2-yl)methanone.
C₁₇H₁₀OS₂ 294.39
AND
In USP Zileuton Related Compound C RS: Change
1-Benzo-[b]thien-2-ylethanone.
C₁₀H₈OS 176.24
to:
1-Benzo-[b]thien-2-ylethanone;
Also known as 1-(Benzo[b]thiophen-2-yl)ethan-1-one.
C₁₀H₈OS 176.23

In Standard solution: Change
0.25 μg/mL of 1-vinyl-2-pyrrolidone and 5 μg/mL of vinyl acetate, respectively, diluted from the Standard stock solution in Mobile phase
to:
0.25 μg/mL of 1-vinyl-2-pyrrolidone and 0.25 μg/mL of vinyl acetate, respectively, diluted from the Standard stock solution in Mobile phase

In System suitability solution: Change
0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP Nortriptyline Hydrochloride RS from suitable volumes of Standard solution, System suitability stock solution A, and System suitability stock solution B in Mobile phase
to:
0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP Nortriptyline Hydrochloride RS from suitable volumes of System suitability stock solution A and System suitability stock solution B in Mobile phase

In Test 2/Analysis: Change
Result_i = (r_U/r_S) × C_S × (M_r1/M_r2)
to:
Result_i = (A_U/A_S) × C_S × (M_r1/M_r2)
AND
Change
r_U = peak response from the Sample solution
r_S = peak response from the Standard solution
to:
A_U = absorbance from the Sample solution
A_S = absorbance from the Standard solution

In both variable definition lists in Analysis: Change
M_r1 = molecular weight of fentanyl citrate, 528.59
M_r2 = molecular weight of fentanyl, 336.47
to:
M_r1 = molecular weight of fentanyl citrate, 528.60
M_r2 = molecular weight of fentanyl, 336.48

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 4.1 Documentation and Procedures/4.1.3 Labels: Change
The use of symbols that are recognized by international organizations is strongly recommended.
to:
The use of symbols that are recognized by international organizations is strongly recommended. See General Notices, 10.20. Labeling.

In Cation-exchange column: Change
Proceed as directed under Column Partition Chromatography (see Chromatography 〈621〉),
to:
Proceed as directed under Chromatography 〈621〉, General Procedures, Column Chromatography,

In Analysis: Change
Result = [(100 × a) × (l/α)] × (1/C_U) × (M_r1/M_r2) × 100
to:
Result = [(100 × a)/(l × α)] × (1/C_U) × (M_r1/M_r2) × 100

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

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 Procedure: Change
(336.48/528.59)CD(r_U/r_S)
in which 336.48 and 528.59 are the molecular weights
to:
(336.48/528.60)CD(r_U/r_S)
in which 336.48 and 528.60 are the molecular weights

In the Standard solution: Change
Transfer suitable volumes of the Standard stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.
to:
0.1 mg/mL of USP Tiagabine Hydrochloride RS and 0.04 mg/mL of butylparaben in Diluent prepared as follows. Transfer suitable volumes of the Standard stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.
AND
In the Sample solution: Change
Transfer suitable volumes of the Sample stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.
to:
0.1 mg/mL of Tiagabine Hydrochloride and 0.04 mg/mL of butylparaben in Diluent prepared as follows. Transfer suitable volumes of the Sample stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume.

In Procedure: Change
20,000(C_S)(r_i/r_S)(1/F)
in which C_S is the concentration, in mg per mL, of orbifloxacin in the Standard solution; r_i is the peak area response for each impurity obtained from the Test solution; r_S is the peak area response for the orbifloxacin peak obtained from the Standard solution; and F is the relative response factor for each impurity, as presented in Table 1.
to:
20,000(C_S)(r_i/r_S)(1/F)(1/W)
in which C_S is the concentration, in mg per mL, of orbifloxacin in the Standard solution; r_i is the peak area response for each impurity obtained from the Test solution; r_S is the peak area response for the orbifloxacin peak obtained from the Standard solution; F is the relative response factor for each impurity, as presented in Table 1; and W is the sample weight taken to prepare the Test solution (mg).

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.

In the footnotes in Table 2: Change
^d(S,E)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
^e(S,Z)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
to:
^d(S,Z)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
^e(S,E)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.

In USP Atorvastatin Related Compound C RS: Change
Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2,3-Bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
AND
In USP Atorvastatin Related Compound D RS: Change
Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
to:
3-(4-Fluorobenzoyl)-2-isobutyryl-N,3-diphenyloxirane-2-carboxamide; Also known as Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
AND
In USP Atorvastatin Related Compound E RS: Change
3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.34
to:
Calcium (3S,5S)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as 3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.38
AND
In USP Atorvastatin Related Compound H RS: Change
540.62
to:
540.64
AND
In Atorvastatin Related Compound I RS: Change
654.81
to:
654.82

Change
If light protection is necessary^c
to:
If light protection is necessary
AND
Change Row 11
Chemical Suitability for Use Assessment Risk-based testing Risk-based testing
to:
Chemical Suitability for Use
Assessment Risk-based testing Risk-based testing
Functionality

Change
Mix a quantity of Oral Suspension, equivalent to about 200 mg of mebendazole, with 20 mL of a mixture of chloroform and 96 percent formic acid (19:1). Proceed as directed for Identification under Mebendazole Tablets, beginning with “Warm the suspension on a water bath for a few minutes.” The specified result is obtained.
to:
Mix a quantity of Oral Suspension, equivalent to about 200 mg of mebendazole, with 20 mL of a mixture of chloroform and 96 percent formic acid (19:1). Warm the suspension on a water bath for a few minutes, cool, and filter through a medium-porosity, sintered-glass filter. Apply 10 μL of this solution and 10 μL of a Standard solution of USP Mebendazole RS in a mixture of chloroform and 96 percent formic acid (19:1) containing 10 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform, methanol, and 96 percent formic acid (90:5:5) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, allow the solvent to evaporate, and examine the plate under short-wavelength UV light: the R_F value of the principal spot obtained from the Test solution corresponds to that obtained from the Standard solution.

In the equation in Analysis: Change
Result = (r_U/r_T) x 100
to:
Result = (r_U/r_T) x D x 100
AND
Add
D = dilution factor for the Sample solution, 0.01