Errata - English

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

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

Line 1 of USP 2-Propanol System Suitability RS: Change
It contains 0.1% of each of the following: ethyl ether, acetone, isopropyl alcohol, diisopropyl ether, 1-propanol, and 2-butanol.
to:
It is a mixture of the following: ethyl ether (0.1%), acetone (0.1%), diisopropyl ether (0.1%), 1-propanol (0.1%), 2-butanol (0.1%), and isopropyl alcohol (99.5%).

In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C₄H₈O₄S₂ 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.
C₄H₇KO₄S₂ ∙ KCl 296.86
AND
In USP Mesna Related Compound B RS: Change
2,2′-Disulfanediylbis(ethane-1-sulfonic acid).
C₄H₁₀O₆S₄ 282.36
to:
2,2′-Disulfanediylbis(ethane-1-sulfonic acid), dipotassium salt, crystal adduct with sodium chloride.
C₄H₈K₂O₆S₄ ∙ NaCl 416.98

In USP Galantamine Hydrobromide Related Compounds Mixture RS: Change
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂
to:
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂ 269.34

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

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 USP Levalbuterol Related Compound D RS: Change
5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde;
Also known as 5-[2-{(1,1-Dimethylethyl)amino}methyl]-4-hydroxy-3-(methoxymethyl)-benzenemethanol.
C₁₃H₁₉NO₃ 237.29
[NOTE: This Reference Standard is available as the benzesulfonic acid salt.]
to:
5-[2-(tert-Butylamino)-1-hydroxyethyl]-2-hydroxybenzaldehyde sulfate (2:1) (salt);
Also known as 5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde sulfate (2:1).
(C₁₃H₁₉NO₃)₂ · H₂SO₄ 572.67

In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C₄H₈O₄S₂ 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.
C₄H₇KO₄S₂ ∙ KCl 296.86
AND
In USP Mesna Related Compound B RS: Change
2,2′-Disulfanediylbis(ethane-1-sulfonic acid).
C₄H₁₀O₆S₄ 282.36
to:
2,2′-Disulfanediylbis(ethane-1-sulfonic acid), dipotassium salt, crystal adduct with sodium chloride.
C₄H₈K₂O₆S₄ ∙ NaCl 416.98

Change
USP Eleutheroside B RS
β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl.
C₁₇H₂₄O₉ 372.37
USP Eleutheroside E RS
β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-diyl)bis(2,6-dimethoxy-4,1-phenylene)bis-.
C₃₄H₄₆O₁₈ 742.70
to:
USP Eleutheroside B RS
USP Eleutheroside E RS

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

In USP Sildenafil Related Compound A RS: Change
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-(2-methylpropyl)-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one.
C₂₃H₃₂N₆O₄S 488.60
to:
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-(2-methylpropyl)-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one;
Also known as 1-{[3-(6,7-Dihydro-1-methyl-7-oxo-3-isobutyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl}-4-methylpiperazine.
C₂₃H₃₂N₆O₄S 488.61

In USP Atorvastatin Related Compound A RS: Change
Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2-isopropyl-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2);
Also known as Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.

Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C₃₆H₄₃NO₆ 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.
C₃₆H₄₃NO₆ · H₂O 603.76

In USP Atorvastatin Related Compound C RS: Change
C₆₆H₆₆F₄N₄O₁₀
to:
C₆₆H₆₆CaF₄N₄O₁₀
AND
In USP Atorvastatin Related Compound E RS: Change
1155.38
to:
1155.36

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

In USP Econazole Related Compound B RS: Change
Econazole amine;
2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine.
C₁₅H₁₄Cl₃NO 330.64
to:
Econazole amine;
2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine nitrate.
C₁₅H₁₄Cl₃NO · HNO₃ 393.65

Change
USP Eleutheroside B RS
β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl.
C₁₇H₂₄O₉ 372.37
USP Eleutheroside E RS
β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-diyl)bis(2,6-dimethoxy-4,1-phenylene)bis-.
C₃₄H₄₆O₁₈ 742.70
to:
USP Eleutheroside B RS
USP Eleutheroside E RS

In USP Atorvastatin Related Compound B RS: Change
(3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as (3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

In USP Sumatriptan Succinate Related Impurities RS: Change
Mixture of sumatriptan succinate, [3-[2-(methylamino) ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide maleate salt, sumatriptan succinate related compound C, [3-[2-(dimethylamino-N-oxide)ethyl]-1H-indol- 5-yl]-N-methylmethanesulfonamide, and [3-[2-(aminoethyl)]-1H-indol-5-yl]-N-methyl methanesulfonamide.
to:
Mixture of sumatriptan succinate, [3-[2-(methylamino)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide, sumatriptan succinate related compound C, [3-[2-(dimethylamino-N-oxide)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide, and [3-[2-(aminoethyl)]-1H-indol-5-yl]-N-methyl methanesulfonamide.

Change
USP Eleutheroside B RS
β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl.
C₁₇H₂₄O₉ 372.37
USP Eleutheroside E RS
β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-diyl)bis(2,6-dimethoxy-4,1-phenylene)bis-.
C₃₄H₄₆O₁₈ 742.70
to:
USP Eleutheroside B RS
USP Eleutheroside E RS

In USP Atorvastatin Related Compound B RS: Change
3S,5R Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as 3S,5R Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C₃₆H₄₃NO₆ 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.
C₃₆H₄₃NO₆ · H₂O 603.76

In USP Sumatriptan Succinate Related Impurities RS: Change
Mixture of sumatriptan succinate, [3-[2-(methylamino) ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide maleate salt, sumatriptan succinate related compound C, [3-[2-(dimethylamino-N-oxide)ethyl]-1H-indol- 5-yl]-N-methylmethanesulfonamide, and [3-[2-(aminoethyl)]-1H-indol-5-yl]-N-methyl methanesulfonamide.
to:
Mixture of sumatriptan succinate, [3-[2-(methylamino)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide, sumatriptan succinate related compound C, [3-[2-(dimethylamino-N-oxide)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide, and [3-[2-(aminoethyl)]-1H-indol-5-yl]-N-methyl methanesulfonamide.

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 Pyrantel Related Compound A RS: Change
(Z)-1-Methyl-2-(2-(thiophen-2-yl)vinyl)-1,4,5,6-tetrahydropyrimidine.
C₃₄H₃₀N₂O₆S 594.69
to:
(Z)-1-Methyl-2-[2-(2-thiophenyl)vinyl]-1,4,5,6-tetrahydropyrimidine 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1).
C₁₁H₁₄N₂S · C₂₃H₁₆O₆ 594.68

In USP Telmisartan Related Compound A RS: Change
1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole.
C₁₉H₂₀N₄ 304.39
to:
1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole monohydrate.
C₁₉H₂₀N₄ ∙ H₂O 322.41