Errata - English

In Detection solution: Change
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate), and heat at 105° for 5 min.
to:
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate).

In Analysis: Change
[Note—The relative retention times for naloxone and 2,2′-bisnaloxone (4,5′:4′,5″-diepoxy-3,3′,14,14′-tetrahydroxy-17,17′-bis(prop-2-enyl)-2,2′-bimorphinanyl-6,6′-dione) are 1.0 and 2.8, respectively.]
to:
[Note—The relative retention times for naloxone and 2,2′-bisnaloxone (4,5ɑ:4′,5′ɑ-diepoxy-3,3′,14,14′-tetrahydroxy-17,17′-bis(prop-2-enyl)-2,2′-bimorphinanyl-6,6′-dione) are 1.0 and 2.8, respectively.]

Line 5 of Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × P × F × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × P × 100

Footnote b: Change
cis isomer of the hydroxy compound.
to:
trans isomer of the hydroxy compound.
AND
Footnote c: Change
trans isomer of the hydroxy compound.
to:
cis isomer of the hydroxy compound.
AND
Footnote d: Change
cis isomer of the monoacrylate.
to:
trans isomer of the monoacrylate.
AND
Footnote e: Change
trans isomer of the monoacrylate.
to:
cis isomer of the monoacrylate.

Rows 11 and 15 of Column 2 of Table 2: Change
100
to:
10
AND
Rows 11 and 15 of Column 3 of Table 2: Change
10
to:
1.0
AND
Row 11 of Column 4 of Table 2: Change
1.5
to:
0.15
AND
Row 15 of Column 4 of Table 2: Change
30
to:
3.0

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: Change
Buffer, Mobile phase, Diluent, Sensitivity solution,
to:
Buffer, Mobile phase, Diluent, Standard solution, Sensitivity solution,
AND
Line 1 of Samples in Analysis: Change
Standard solution, Sample solution, and Sensitivity solution
to:
Sample solution

Line 1 of Acceptance criteria: Change
The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution.
to:
The oil portion of the Sample may turn hazy, but it remains colorless or shows a slight pink or yellow color, and the acid portion of the Sample does not become darker than the Standard solution.

Line 2 of USP Risperidone Related Compound G RS: Change
3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
C₂₃H₂₈FN₃O₃ 413.49
to:
3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one hydrochloride.
C₂₃H₂₈FN₃O₃·HCl 448.94