Errata - English

Line 2 of USP Candesartan Cilexetil Related Compound D RS: Change
1-{[(Cyclohexyloxycarbonyloxy)carbonyl]oxy}ethyl 3-{[2’-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.
to:
1-{[(Cyclohexyloxy)carbonyl]oxy}ethyl 3-({2’-(2-ethyl-2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl}methyl)-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.

Lines 3 and 6: Change
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
to:
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
C₁₂H₉N₃O₂S 259.28
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
C₁₂H₁₀N₂OS 230.29

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 Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C₁₇H₂₀N₂S · HCl 320.88

Line 4 of USP Almotriptan Related Compound B RS: Change
C₁₅H₂₂N₃O₂S
to:
C₁₅H₂₁N₃O₂S
AND
Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C₁₇H₂₅N₃O₃S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride.
C₁₇H₂₅N₃O₃S · HCl 387.92

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

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 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C₁₇H₂₀N₂S · HCl 320.88

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C₁₅H₁₆FN₃O₃ 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C₁₅H₁₆FN₃O₃ · HCl 341.77

Line 2 of USP Irinotecan Related Compound C RS: Change
(S)-9-[(1,4′-Bipiperidine)-1′-carbonyloxy]-4-methyl-11-ethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinoline hydrochloride.
to:
11-Ethyl-4-hydroxy-4-methyl-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinolin-9-yl (1,4′-bipiperidine)-1′-carboxylate hydrochloride.

Line 2 of USP Levofloxacin Related Compound A RS: Change
(S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid.
to:
(S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid.
AND
Line 2 of USP Levofloxacin Related Compound B RS: Change
(S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid.
to:
(S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid.

Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 282.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C₁₇H₂₀N₂S · HCl 320.88

Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change
7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
C₁₅H₁₆FN₃O₃ 305.30
to:
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C₁₅H₁₆FN₃O₃ · HCl 341.77

Line 2 of USP Mycophenolate Mofetil Related Compound B RS: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-one.

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 Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C₁₇H₂₀N₂S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine hydrochloride.
C₁₇H₂₀N₂S · HCl 320.88

Line 2 of USP Mycophenolate Mofetil Related Compound B RS: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-one.

Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.

Line 2 of USP Travoprost Related Compound A RS: Change
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid.
to:
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid
or
(Z)-7-((1R,2R,3R,5S)-3,5-Dihydroxy-2-{(R,E)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]but-1-enyl}cyclopentyl)hept-5-enoic acid.

Line 2 of USP Mycophenolate Mofetil Related Compound B RS: Change
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuranyl-1-one.
to:
(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-one.

Line 2 of USP Brinzolamide Related Compound B RS: Change
(R-4-Amino)-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno[3,2,-e]-thiazine-6-sulfonamide-1,1-dioxide ethandioate 1:1.
to:
(R)-4-Amino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide oxalate.

Line 2 of USP Desloratadine Related Compound B RS: Change
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine.
C₁₉H₁₉ClN₂ 310.82
to:
8-Chloro-11-(1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine hydrochloride.
C₁₉H₂₀Cl₂N₂ 347.28

Line 11 of USP Tacrolimus System Suitability Mixture RS: Change
and tacrolimus 8-propyl analog
(3S,4R,5S,8S,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21-(4H,23H)-tetrone.
to:
and tacrolimus 8-propyl analog
(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-pro-pyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21-(4H,23H)-tetrone.

Line 2 of USP Valsartan Related Compound A RS: Change
(R)-N-Valeryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)valine.
to:
N-Valeryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-D-valine.
AND
Line 2 of USP Valsartan Related Compound B RS: Change
(S)-N-Butyryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine.
to:
N-Butyryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine.
AND
Line 2 of USP Valsartan Related Compound C RS: Change
(S)-N-Valeryl-N-([2'-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine benzyl ester.
to:
N-Valeryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine benzyl ester.

Line 2 of USP Chlorpheniramine Related Compound C RS: Change
3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine.
C₁₅H₁₇CIN₂ 260.76
to:
3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.
C₁₅H₁₇CIN₂ · C₄H₄O₄ 376.83

Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a 98.9/0.5/0.3/0.3 (area %) mixture of the following four compounds:
Risperidone (98.9%)
Risperidone cis-N-oxide (0.5%): cis-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one, N-oxide monohydrate.
C₂₃H₂₉FN₄O₄ 444.50
Bicyclorisperidone (0.3%): 3-(4-fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-2-aza-1-azoniabicyclo[2.2.2]oct-2-ene iodide.
C₂₃H₂₈FIN₄O₄ 538.40
Z-oxime (0.3%): (Z)-3-[2-[4-(2,4-Difluorophenyl)(hydroxyimino)methyl]-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.
C₂₃H₂₈F₂N₄O₂ 430.29
to:
Contains a mixture of four compounds:
98.9% of Risperidone.
0.5% of Risperidonecis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one-N-oxide.
0.3% of Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-1-aza-2-azoniabicyclo[2.2.2]oct-2-ene iodide.
0.3% of Z-Oxime: (Z)-3-[2-[4-(2,4-Difluorophenyl)(hydroxyimino)methyl]-1-piperidinyl]ethyl-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.

Line 2 of USP Risperidone Related Compounds Mixture RS: Change
Contains a 98.9: 0.5: 0.30: 0.3 (area %) mixture of four compounds:
98.9% of Risperidone.
0.5% of Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one].
0.3% of Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-1-aza-2-azoniabicyclo[2.2.2]oct-2-ene iodide.
0.3% of Z-Oxime: (Z)-3-[2-[4-(2,4-Difluorophenyl) (hydroxyimino)methyl]-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.
to:
Contains a mixture of the following four compounds:
98.9% of Risperidone.
0.5% of Risperidone cis-N-oxide: cis-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one-N-oxide.
0.3% of Bicyclorisperidone: 3-(4-Fluoro-2-hydroxyphenyl)-1-[2-(6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido-[1,2-a]pyrimidin-3-yl)ethyl]-1-aza-2-azoniabicyclo[2.2.2]oct-2-ene iodide.
0.3% of Z-Oxime: (Z)-3-[2-[4-(2,4-Difluorophenyl) (hydroxyimino)methyl]-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.

Line 2 of Venlafaxine Related Compound A RS: Change
1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol.
C₁₆H₂₅NO₂
263.38
to:
1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride.
C₁₆H₂₅NO₂ · HCl
299.84

Line 3 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C₁₇H₂₅N₃O₃S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride.
C₁₇H₂₅N₃O₃S · HCl 387.92

Line 2 of USP Chlorpheniramine Related Compound C RS: Change
3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine.
C₁₅H₁₇CIN₂ 260.76
to:
3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.
C₁₅H₁₇CIN₂ · C₄H₄O₄ 376.83