Errata - English

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 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 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

Change
847.00
to:
847.02
AND
Change
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d]imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate
to:
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,18,20-Trihydroxy-1’-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-5,10,26-trioxo-3,5,9,10-tetrahydrospiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2’,3’:7,8]naphtho[1,2-d]imidazole-2,4’-piperidin]-16-yl acetate

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 Analysis: Change
Calculate the percentage of Nandrolone Decanoate (C₂₈H₄₄O₃) in the portion of Nandrolone Decanoate taken:
to:
Calculate the percentage of nandrolone decanoate (C₂₈H₄₄O₃) in the portion of Nandrolone Decanoate taken:

In Analysis: Change
Result = (R_U/R_S) x C_S x V x (D/W_U) x (1/L) x 100
R_U = peak area ratio of ibuprofen to benzophenone from the Sample solution
R_S = peak area ratio of ibuprofen to benzophenone from the Standard solution
C_S = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
D = density of Oral Suspension (g/mL)
W_U = weight of the portion of Oral Suspension added to the Medium (g)
L = label claim (mg/mL)
to:
Result = (R_U/R_S) x C_S x V x (d/W_U) x D x (1/L) x 100
R_U = peak area ratio of ibuprofen to benzophenone from the Sample solution
R_S = peak area ratio of ibuprofen to benzophenone from the Standard solution
C_S = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
d = density of Oral Suspension (g/mL)
W_U = weight of the portion of Oral Suspension added to the Medium (g)
D = dilution factor of the Sample solution, 2
L = label claim (mg/mL)

In Table 2, footnote b: Change
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-4a,5a,6,12a-tetrahydro-3,5,10,12,12a-pentahydroxy-6-methyl-tetracene-1,11-dioxo-2-naphthacenecarboxamide.
to:
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,11(4H,5H)-dione.

In Analysis: Change
C_U = nominal concentration of dimenhydrinate in the Sample solution (mg/mL)
to:
C_U = determined concentration of dimenhydrinate in the Sample solution, as obtained in the Assay (mg/mL)

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 General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)
to:
where L is the limit in the original article as listed in Table 5 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)

In footnote 2: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.

In footnote b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.

In USP Mecamylamine Related Compound A RS: Change
N,1,7,7-Tetramethyl bicyclo [2.2.1]heptan-2-amine.
C₁₁H₂₁N 167.29
to:
N,1,7,7-Tetramethylbicyclo[2.2.1]heptan-2-amine hydrochloride.
C₁₁H₂₁N · HCl 203.75

In footnote 2: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.

In Analysis: Change
bromocriptine mesylate (C₃₂H₄₀BrN₅O₅ · CH₄SO₃)
to:
bromocriptine (C₃₂H₄₀BrN₅O₅)
AND
In Tolerances: Change
bromocriptine mesylate (C₃₂H₄₀BrN₅O₅ · CH₄SO₃)
to:
bromocriptine (C₃₂H₄₀BrN₅O₅)

In footnote b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.

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

In Standard solution A: Change
0.5 μg/mL of Acyclovir standard solution in Solution A
to:
0.5 μg/mL of USP Acyclovir RS from Acyclovir standard solution in Solution A
AND
In Standard solution B: Change
5 μg/mL of Guanine solution in Solution A
to:
5 μg/mL of guanine from Guanine solution in Solution A
AND
In Analysis 1: Change
r_S = peak response of guanine in the Standard solution
C_S = concentration of guanine in the Standard solution
to:
r_S = peak response of guanine in Standard solution B
C_S = concentration of guanine in Standard solution B
AND
In Analysis 2: Change
r_S = peak response of acyclovir in the Standard solution
C_S = concentration of USP Acyclovir RS in the Standard solution (mg/mL)
to:
r_S = peak response of acyclovir in Standard solution A
C_S = concentration of USP Acyclovir RS in Standard solution A (mg/mL)

In Analysis: Change
Titrate the Blank with 1 N sodium hydroxide VS, and record the volume of 1 N sodium hydroxide VS consumed. Titrate the excess acid in the Sample solution with 1 N sodium hydroxide VS to the inflection point at pH 4, and record the buret reading.
to:
Titrate the Blank potentiometrically with 1 N sodium hydroxide VS, and record the volume of 1 N sodium hydroxide VS consumed. Titrate the excess acid in the Sample solution potentiometrically with 1 N sodium hydroxide VS to the inflection point at pH 4, and record the buret reading.

In Table 1/footnotes: Change
^b1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
^c1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
^d3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one.
^e1,2,3,9-Tetrahydro-9-methyl-3-[1H-imidazol-1-yl)methyl]-4H-carbazol-4-one.
to:
^b9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
^c9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one.
^d3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
^e3-[(1H-Imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.

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
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 Acceptance criteria: Change
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the dried basis
to:
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the anhydrous basis

In Standard stock solution: Change
0.005 mg/mL of methanol and 0.01 mg each of isopropyl alcohol, secondary butyl alcohol, and 2-methoxyethanol in Internal standard solution
to:
0.005 mg/mL of methanol and 0.01 mg/mL each of isopropyl alcohol, secondary butyl alcohol, and 2-methoxyethanol in Internal standard solution

In Analysis: Change
r_S = sum of all the peak areas, excluding the solvent peaks from the Standard solution
to:
r_S = sum of all the peak areas, excluding the solvent peaks from the Sample solution

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

In footnote f of Table 2: Change
1,1-Bis{2-chloro-[4-(3-{1,2,4-triazolo[4,3-a]pyridin-3-(2H)-on-2-yl}propyl)piperazine-1-yl]phenyl}ethane trihydrochloride.
to:
2,2'-{[Ethane-1,1-diylbis(3-chloro-4,1-phenylene)bis(piperazine-4,1-diyl)]bis(propane-3,1-diyl)}bis([1,2,4]triazolo[4,3-a]pyridin-3(2H)-one).

In USP Ondansetron Related Compound A RS: Change
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
C₁₆H₂₀N₂O · HCl 292.80
to:
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.
C₁₆H₂₀N₂O · HCl 292.81
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.

Change
Solution A, Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

In footnote 1 of table: Change
Estra-1,3,5(10)-triene-6-one-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7α,17β)
to:
7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-6-one-3,17β-diol
AND
In footnote 2: Change
Estra-1,3,5(10),6-tetraene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7α,17β)
to:
7-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10),6-tetraene-3,17β-diol
AND
In footnote 3: Change
Estra-1,3,5(10)-triene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfonyl]nonyl]-(7α,17β)
to:
7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfonyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol
AND
In footnote 4: Change
Estra-1,3,5(10)-triene-3,17-diol,7-{9-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonylsulfinyl]nonyl}-(7α,17β)
to:
7α-{9-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonylsulfinyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol
AND
In footnote 5: Change
7,7-Nonamethylene-bis(estra-1,3,5(10)-triene-3,17-diol-(7α,17β)
to:
7α,7α-Nonamethylenebis[estra-1,3,5(10)-triene-3,17β-diol]
AND
In footnote 6: Change
Estra-1,3,5(10)-triene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7β,17β)
to:
7β-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol

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.