Errata - English

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 7 of USP Risperidone System Suitability Mixture RS: Change
9-Hydroxyrisperidone-(6RS)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6-dimethyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
to:
9-Hydroxyrisperidone: (9RS)-3-{2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.

Line 2 of Sample solution: Change
Use about 1.9 mL of Diluent per mg of the Carvedilol, and sonicate briefly to facilitate dissolution.
to:
Initially add Diluent to fill about 80% of the total volume. Sonicate briefly to facilitate dissolution. Cool, and dilute with Diluent to volume.

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 10 of Procedure: Change
100(312.41 / 348.87)(C/L)(r_U / r_S)
to:
100(312.41 / 348.87)(C/C_U)(r_U / r_S)
AND
Line of 14 of Procedure: Change
L is as defined above;
to:
C_U is the nominal concentration, in mg per mL, of granisetron in the Assay preparation;

Line 1: Change
A volume of Ophthalmic Solution, equivalent to about 2.5 mg of oxymetazoline hydrochloride, responds to the Identification test under Oxymetazoline Hydrochloride Nasal Solution.
to:
Place a volume of Ophthalmic Solution, equivalent to about 2.5 mg of oxymetazoline hydrochloride, in a 60-mL separator, and add water to make about 10 mL. Add 2 mL of sodium carbonate solution (1 in 10), extract with 10 mL of chloroform, and transfer the chloroform extract to a second 60-mL separator. Extract the chloroform solution with 10 mL of 0.1 N hydrochloric acid, allow to separate, and discard the chloroform layer. Transfer 8 mL of the acidic aqueous layer to a test tube, neutralize by the dropwise addition of 1 N sodium hydroxide, add 1 drop of 1 N sodium hydroxide in excess, and mix. Add a few drops of sodium nitroferricyanide TS and 2 drops of sodium hydroxide solution (15 in 100), mix, and allow to stand for 10 minutes. Add 0.1 N hydrochloric acid dropwise until the pH is between 8 and 9, and allow to stand for 10 minutes. A violet color develops.

Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(V_S − V_B)
to:
(V_B − V_S)
AND
Line 11 of Analysis: Change
V_S = Titrant volume consumed by the Sample (mL)
V_B = Titrant volume consumed by the Blank (mL)
to:
V_B = Titrant volume consumed by the Blank (mL)
V_S = Titrant volume consumed by the Sample (mL)

Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 9 of Analysis: Change
Result = [(V_S − V_B) × F]/W
to:
Result = [(V_B − V_S) × N × M_r]/W
AND
Line 10 of Analysis: Change
V_S = Titrant volume consumed by the Sample (mL)
V_B = Titrant volume consumed by the Blank (mL)
F = factor, 56.1
to:
V_B = Titrant volume consumed by the Blank (mL)
V_S = Titrant volume consumed by the Sample (mL)
N = actual normality of 1 N sodium hydroxide (mEq/mL)
M_r = molecular weight of potassium hydroxide, 56.11

Line 15 of Procedure: Change
431.94 is the molecular weight of zinc undecylenate;
to:
M_r is the molecular weight of zinc undecylenate, 431.94;
AND
Line 16 of Procedure: Change
65.39 is the atomic weight of zinc;
to:
A_r is the atomic weight of zinc, 65.39;
AND
Line 19 of Procedure: Change
C_H and C_L are the concentrations, in µg per mL,
to:
C_s1 and C_s2 are the concentrations, in µg per mL,