Errata - English

Line 6 of 6.50.20. Solutions: Change
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.
to:
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with, or 1 part by weight of a solid shall be dissolved in, a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2)” means that the respective numbers of parts, by volume, of the designated liquids shall be mixed, unless otherwise indicated.

Footnotes b, c, and d of Table 2: Change
^btrans-Isoterbinafine or (E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
^ccis-Terbinafine or (Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
^d4-Methylterbinafine or (E)-N,6,6-trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.
to:
^btrans-Isoterbinafine or (2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
^ccis-Terbinafine or (2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
^d4-Methylterbinafine or (2E)-N,6,6-Trimethyl-N-((4-methylnaphthalen-1-yl)methyl)hept-2-en-4-yn-1-amine.

Line 2 of USP Terbinafine Related Compound A RS: Change
N-Methyl-C-(naphthalen-1-yl)methanamine.
to:
N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound B RS: Change
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound C: Change
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride.
AND
Line 2 of Terbinafine Related Compound D RS: Change
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine.
to:
(2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn-1-amine hydrochloride.

Line 3 of the variable definition list: Change
r_S = peak response of each impurity from the Standard solution
to:
r_S= peak response of each impurity or doxazosin mesylate (for calculating unspecified impurities) from the Standard solution
AND
Line 5 of the variable definition list: Change
C_S = concentration of USP Doxazosin Mesylate RS in the Standard solution (mg/mL)
to:
C_S= concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

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)

Line 2 of Buffer, Mobile phase, Chromatographic system, and System suitability: Change
Proceed as directed in the Assay.
to:
Proceed as directed in the Assay, except use 270 nm for analysis.
AND
Line 10 of Analysis: Change
V = volume of the Medium, 750 mL
to:
V = volume of the Medium, 900 mL

Line 6 of Analysis: Change
37 ± 0.5° at each time point.
to:
37 ± 0.5°.
AND
Line of 40 of Analysis:Delete the equation
Result₅ = ({C₅ × [V − (4 × V_s)]} + [(C₄ + C₃ + C₂ + C₁) × V_s]) × (1/L) × 100
AND
Row 5 of Column 2 of Table 11: Change
4
to:
5

Row 2 of Column 1 of Table 1:Change
Isoniacin
to
Isoniacin^a
AND
Row 5 of Column 1 of Table 1: Change
Picolinohydrazide
to
Picolinohydrazide^b
AND
Row 6 of Column 1 of Table 1: Change
Isonicotinonitrile
to:
Isonicotinonitrile^c
AND
Add footnotes to Table 1:
^a Isonicotinic acid.
^b 2-Isoniazid.
^c 4-Cyanopyridine.

Line 2 of first reference: Delete
http://www.acoem.org/Reproductive_Developmental_Hazard_Management.aspx.
AND
Line 2 of second reference: Delete
http://www.asco.org/advocacy/worker-safety-when-handling-hazardous-drugs-focus-statement-oncology-societies.

Line 5 of Type A1 (formerly, Type A): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type A2 (formerly, Type B3): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B1: Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B2 (total exhaust): Change
radionucleotides
to:
radionuclides

USP Oxymetazoline Related Compound A RS: Change
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide.
C₁₆H₂₆N₂O₂ 278.39
to:
N-(2-Aminoethyl)-2-[4-(tert-butyl)-3-hydroxy-2,6-dimethylphenyl]acetamide hydrochloride.
C₁₆H₂₆N₂O₂ · HCl 314.85

Line 2 of USP Perindopril Related Compound A RS: Change
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid hydrochloride.
C₁₇H₂₈N₂O₅ · HCl 205.68
to:
(2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid.
C₉H₁₅NO₂ 169.22

Line 2 of USP Bisoctrizole Resolution Mixture RS: Change
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.
to:
A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.

Line 1 of System suitability/Relative standard deviation: Change
NMT 2.0% for any peak
to:
NMT 2.0% for sulindac, sulindac related compound B, and sulindac related compound C
AND
Line 3 of Analysis: Change
Calculate the percentage of the labeled amount of sulindac related compound A, sulindac related compound B, or sulindac related compound C in the portion of Tablets taken:
to:
Calculate the percentage of sulindac related compound B or sulindac related compound C in the portion of Tablets taken:
AND
Line 8 of Analysis: Change
r_U = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Sample solution
to:
r_U = peak response of sulindac related compound B or sulindac related compound C from the Sample solution
AND
Line 12 of Analysis: Change
r_S = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Standard solution
to:
r_S = peak response of sulindac related compound B or sulindac related compound C from the Standard solution

Line 5 of Standard solution: Change
Mix 10.0 mL of this solution
to:
Mix 5.0 mL of this solution
AND
Line 7 of Standard solution: Change
about 0.67 µg/mL
to:
about 0.5 µg/mL
Line 4 of Sample solution: Change
10.0 mL of this solution
to:
5.0 mL of this solution
AND
In the variable definition list in Analysis: Change
V_F = final volume of the Sample solution, 15 mL
D = dilution factor for preparation of the Sample solution, 5
to:
V_F = final volume of the Sample solution, 10 mL
D = dilution factor for preparation of the Sample solution, 10

Change
Buffer, Mobile phase, Diluent, and Sample solution: Prepare as directed in the Assay.
to:
Buffer, Mobile phase, and Diluent: Prepare as directed in the Assay.
AND
Add
Sample solution: Use the Sample stock solution as directed in the Assay.

Footnote c: Change
(4R,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.
to:
(4S,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.

Line 16 of Analysis: Change
Calculate the percentage of any individual unspecified impurity
to:
Calculate the percentage of any other individual impurity
AND
Line 20 of Analysis: Change
r_U = peak response of any individual unspecified impurity
to:
r_U = peak response of any other individual impurity

Line 2 of USP Timolol Related Compound A RS: Change
(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol.
C₁₃H₂₄N₄O₃S 316.42
to:
(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol maleate.
C₁₃H₂₄N₄O₃S · C₄H₄O₄ 432.49
AND
Line 2 of USP Timolol Related Compound C RS: Change
N-(tert-Butyl)-2,3-bis(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-1-amine.
C₁₉H₃₁N₇O₄S₂ 485.19
to:
N-(tert-Butyl)-2,3-bis(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-1-amine maleate.
C₁₉H₃₁N₇O₄S₂ ∙ C₄H₄O₄ 601.69
AND
Line 3 of USP Timolol Related Compound D RS: Change
C₆H₉N₇O₄S
to:
C₆H₉N₃O₂S
AND
Line 2 of USP Timolol Related Compound E RS: Change
(S)-3-(tert-Butylamino)-1-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-yl hydrogen maleate.
C₁₇H₂₆N₄O₆S 414.48
to:
(S,Z)-4-({1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]propan-2-yl}oxy)-4-oxobut-2-enoic acid maleate salt (1:1)
C₁₇H₂₆N₄O₆S ∙ C₄H₄O₄ 530.55

Line 2 of paragraph 1 of Operational Qualification: Change
OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.
to:
OQ demonstrates fitness for the selected use, and should reflect URS.
AND
Line 2 of paragraph 3 of Operational Qualification/Instrument Function Tests: Change
Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.
to:
Holistic tests, which involve the entire system, demonstrate that the whole system complies with URS.

Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the Calculate statement of Uniformity of Dosage Units <905>/Procedure for content uniformity/Analysis: Change
Calculate the quantity, in mg, of the labeled amount of codeine phosphate
to:
Calculate the quantity, in mg, of codeine phosphate

Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the second Calculate statement in Uniformity of Dosage Units <905>/Procedure for content uniformity/Analysis: Change
Calculate the quantity, in mg/mL, of the labeled amount of codeine phosphate
to:
Calculate the quantity, in mg, of codeine phosphate