Errata - English

In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.

In B.: Change
The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

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 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 Acceptance criteria/Total impurities: Change
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Standard solution.
to:
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Sample solution.

In USP Tryptophan Related Compound A RS: Change
3,3′-[Ethylidenebis(1H-indole-1,3-diyl)]bis[2S)-2-aminopropanoic]acid.
C₂₄H₂₆N₄O₄ 432.49
to:
(2S,2'S)-3,3'-[Ethane-1,1-diylbis(1H-indole-1,3-diyl)]bis(2-aminopropanoic acid).
C₂₄H₂₆N₄O₄ 434.50

Change
Where the label states tetracycline hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which tetracycline hydrochloride is used can be met.
to:
Where the label states Tetracycline Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Tetracycline Hydrochloride is used can be met.

In Analysis: Change
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_U.)
to:
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_A.)

Change
USP Atorvastatin Related Compound H RS (lactone impurity)
to:
USP Atorvastatin Related Compound H RS
Also known as Lactone impurity;
AND
Change
USP Atorvastatin Related Compound I RS (acetonide impurity)
to:
USP Atorvastatin Related Compound I RS
Also known as Acetonide impurity;

In A./Standard solution B: Change
USP Procyanidin A₂ RS
to:
USP Procyanidin A2 RS
AND
In A./System suitability/Suitability requirements/Derivatization reagent B/White light: Change
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A₂ and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A₂ and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A₂ in the lower-half section.
to:
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section.
AND
In A./Acceptance criteria/Derivatization reagent B/White light: Change
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A₂ and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B₂, or procyanidin B₁ appear below procyanidin A₂.
to:
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2.
AND
In C./Acceptance criteria/Profile at 520 nm: Change
cyanidin-3-O-arabinose,
to:
cyanidin-3-O-arabinoside,
AND
In C./Acceptance criteria/Profile at 520 nm: Change
peonidin-3-O-arabinose
to:
peonidin-3-O-arabinoside

In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change
10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL
to:
Dissolve 10 g of cetyltrimethylammonium bromide and 1.6 g of pepsin, purified in 1000 mL of 0.1 N hydrochloric acid; 900 mL

This erratum applies to the new USP-NF ONLINE platform only.
Change
System suitability
^▲_{▲1S (USP41)}
Sample: Standard solution
Suitability requirements
Tailing factor: NMT 2.0
to:
System suitability
Sample: Standard solution
Suitability requirements
^▲_{▲1S (USP41)}
Tailing factor: NMT 2.0

In Mobile phase: Change
^▲Acetonitrile, methanol, and acetic acid (50:50). To each liter of the solution add 3 mL of acetic acid and 1 mL of triethylamine._{▲ (USP 1-May-2019)}
to:
Acetonitrile and methanol (50:50). To each liter of the solution add 3 mL of acetic acid and 1 mL of triethylamine.

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 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 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.

In USP Pantoprazole Related Compound E RS: Change
A mixture of the stereoisomers of 6,6′-bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazolyl.
to:
6,6′-Bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazole.

Change
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester
to:
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester

In Analysis: Change
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)
to:
C_S = concentration of the corresponding USP Reference Standard or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

In Analysis: Change
r_S = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution
to:
r_T = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution

In Analysis: Change
M_r1 = molecular weight of atorvastatin, 558.64
M_r2 = molecular weight of atorvastatin calcium, 1155.34
to:
M_r1 = molecular weight of atorvastatin, 558.65
M_r2 = molecular weight of atorvastatin calcium, 1155.36

Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
r_S = peak area of ganoderic acid in Standard solution A
to:
r_S = peak area of ganoderic acid A in Standard solution A
AND
Line 10 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response factor, with respect to ganoderic acid A (see Table 2)

This erratum applies to the new USP-NF ONLINE platform only.
Line 2 of Standard solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,
AND
Line 2 of Sample solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,

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

In test A: Change
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.