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 Vitamins B3 (as Niacinamide), B6, and Folic Acid, Method 1/System suitability: Change
[Note—The relative retention times for niacinamide, pyridoxine, and folic acid are about 1.0, 1.6, 2.0, and 3.0 respectively.]
to:
[Note—The relative retention times for niacinamide, pyridoxine, and folic acid are about 1.0, 2.0, and 3.0, respectively.]
AND
In Vitamins B1 (as Thiamine Ion) and B2 (as Riboflavin), Method 1; Vitamin C (as Ascorbic Acid), Vitamins B3 (as Niacinamide), B6 (as Pyridoxine), and Folic Acid, Method 2/Analysis: Change
Calculate the percentage of the labeled amount of vitamin B1 as thiamine ion (C₁₂H₁₇N₄OS⁺), vitamin B2 as riboflavin (C₁₇H₂₀N₄O₆), vitamin B3 as niacinamide (C₆H₆N₂O), vitamin B6 as pyridoxine (C₈H₁₁NO₃), and folic acid (C₁₉H₁₉N₇O₆), in the portion of Chewable Gels taken:
to:
Calculate the percentage of the labeled amount of vitamin C as ascorbic acid (C₆H₈O₆), vitamin B1 as thiamine ion (C₁₂H₁₇N₄OS⁺), vitamin B2 as riboflavin (C₁₇H₂₀N₄O₆), vitamin B3 as niacinamide (C₆H₆N₂O), vitamin B6 as pyridoxine (C₈H₁₁NO₃), and folic acid (C₁₉H₁₉N₇O₆), in the portion of Chewable Gels taken:
AND
In Vitamins B1 (as Thiamine Ion) and B2 (as Riboflavin), Method 1; Vitamin C (as Ascorbic Acid), Vitamins B3 (as Niacinamide), B6 (as Pyridoxine), and Folic Acid, Method 2/Acceptance criteria: Change
90.0%–150.0% of the labeled amounts of vitamin B3 as niacinamide, vitamin B6 as pyridoxine, riboflavin, and thiamine as thiamine ion (C₁₂H₁₇N₄OS⁺); and NLT 90.0% and NMT 245.0% of the labeled amount of folic acid
to:
90.0%–250.0% of the labeled amount of vitamin C as ascorbic acid; 90.0%–150.0% of the labeled amounts of vitamin B3 as niacinamide, vitamin B6 as pyridoxine, riboflavin, and thiamine as thiamine ion (C₁₂H₁₇N₄OS⁺); and NLT 90.0% and NMT 245.0% of the labeled amount of folic acid

In Medium: Change
Sodium phosphate buffer, pH of 6.0 (14.2 g/L of disodium hydrogen orthophosphate anhydrous in water, adjusted with dilute hydrochloric acid to a pH of 6.0)
to:
Sodium phosphate buffer, pH 6.0 (14.2 g/L of sodium phosphate, dibasic, anhydrous in water, adjusted with dilute hydrochloric acid to pH 6.0)
AND
In Solution A: Change
orthophosphoric acid
to:
phosphoric acid

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);

In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt form.] 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hydrochloride.

In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems.

In USP Amoxicillin Related Compound A RS: Change
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C₁₆H₁₄N₂O₂ 266.29
to:
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C₈H₁₂N₂O₃S 216.26

In USP Riluzole Related Compound A RS: Change
4-Trifluoromethoxyphenylamine; 4-trifluoromethoxyanaline.
C₇H₆F₃NO 177.12
to:
4-(Trifluoromethoxy)aniline.
C₇H₆F₃NO 177.13

In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt form.] 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hydrochloride.

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