Errata - English

In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

Change
523.32
to:
523.33
AND
Change
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate
to:
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate

In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of 0.5 N hydrochloric acid VS to a 500-mL volumetric flask, dilute with water to volume, and mix well.

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 System suitability solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In System suitability/Samples: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

Change
Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.
to:
Where Tetracycline Hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.

In Analysis: Change
Calculate the percentage of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P × 100
to:
Calculate the quantity, in µg/mg, of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P

In USP Econazole Related Compound C RS: Change
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium nitrate (salt).
C₂₅H₂₁Cl₁₄N₃O₄ 569.26
to:
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium chloride.
C₂₅H₂₁Cl₅N₂O 542.71

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

In Analysis: Change
Results = (A_U/A_S) × C_S × D × (1/L) × V × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
D = dilution factor for Sample solution, if needed
L = label claim (mg/Tablet)
V = volume of Medium, 500 mL
to:
Result = (A_U/A_S) × C_S × V × D × (M_r1/M_r2) × (1/L) × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
V = volume of Medium, 500 mL
D = dilution factor for the Sample solution, if needed
M_r1 = molecular weight of prochlorperazine, 373.94
M_r2 = molecular weight of prochlorperazine maleate, 606.09
L = label claim (mg/Tablet)

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
C₄₈H₇₄O₁₄(Component H₂B_1a) 875.09
C₄₇H₇₂O₁₄(Component H₂B_1b) 861.07
Component H₂B_1a:
Avermectin A_1a, 5-O-demethyl-22,23-dihydro-.
(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6′-(S)-sec-Butyl-3′,4′,5′,6,6′,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70161-11-4.
Component H₂B_1b:
Avermectin A_1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-.
(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3′,4′,5′,6,6′,7,10,11,-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU.
to:
C₄₈H₇₄O₁₄(Component H₂B_1a) 875.11
C₄₇H₇₂O₁₄(Component H₂B_1b) 861.08
Component H₂B_1a:
Avermectin A_1a, 5-O-demethyl-22,23-dihydro-.
(2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6’-(S)-sec-Butyl-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 71827-03-7; UNII: 91Y2202OUW.
Component H₂B_1b:
Avermectin A_1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-.
(2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-Tetradecahydro-20,20b-dihydroxy-6’-isopropyl-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU.

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