Errata - English

Line 2 of USP Hyoscyamine Related Compound A RS: Change
Norhyoscyamine sulfate; (1R,3r,5S)-8-azabicyclo [3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate.C₁₆H₂₁NO₃ 275.34
to:
Norhyoscyamine sulfate; (1R,3r,5S)-8-Azabicyclo[3.2.1]octan-3-yl (S)-3-hydroxy-2-phenylpropanoate sulfate (2:1).(C₁₆H₂₁NO₃)₂ · H₂SO₄ 648.77

Line 1 of Medium: Change
pH 6.8 phosphate buffer; 1000 mL, degassed
to:
pH 6.8 phosphate buffer prepared as follows. Dissolve 6.805 g of monobasic potassium phosphate and 0.896 g of sodium hydroxide in and dilute with water to 1000 mL. Adjust with 0.2 M sodium hydroxide or 1 M phosphoric acid as required to a pH of 6.8; 1000 mL degassed.

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

Line 5 of Analysis: Change
Result = (r_U/r_S) × C_S × (M_r1/M_r2) × 100
to:
Result = (r_U/r_S) × C_S × (M_r1/M_r2)

Change
Buffer: 23 mg/mL of monobasic ammonium phosphate in water
to:
Solution A: 23 g/L of monobasic ammonium phosphate in water
AND
Line 4 of System suitability solution: Change
Dilute with Buffer to volume.
to:
Dilute with Solution A to volume.
AND
Line 3 of Standard solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.
AND
Line 3 of Sample solution: Change
and dilute with Buffer to volume.
to:
and dilute with Solution A to volume.

Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
r_S = peak area of ganoderic acid in Standard solution A
to:
r_S = peak area of ganoderic acid A in Standard solution A
AND
Line 11 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response factor, with respect to ganoderic acid A (see Table 2)

Change:
Mobile phase, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Mannitol.
to:
Mobile phase—Use degassed water.
Resolution solution—Dissolve sorbitol and USP Mannitol RS in water to obtain a solution having concentrations of about 4.8 mg per mL of each.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a refractive index detector that is maintained at a constant temperature and a 4-mm × 25-cm column that contains packing L19. The column temperature is maintained at a temperature between 30° and 85° controlled within ±2° of the selected temperature, and the flow rate is about 0.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%. In a similar manner, chromatograph the Resolution solution: the resolution, R, between the sorbitol and mannitol peaks is not less than 2.0.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Mannitol.
to:
Separately inject equal volumes (about 20 µL) of the Assay preparation and the Standard preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
r_S = peak area of ganoderic acid in Standard solution A
to:
r_S = peak area of ganoderic acid A in Standard solution A
AND
Line 10 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response factor, with respect to ganoderic acid A (see Table 2)

Delete the subsection
Blank: Proceed as directed in the Analysis, omitting the test specimen.
AND
Equation in Analysis: Change
Result = {[V_S − V_B) × M × F]/W} × 100
to:
Result = [(V_S × M × F)/W] × 100
AND
Line 2 of the variable definition list in Analysis: Delete
V_B = Titrant volume consumed by the Blank (mL)

Equation in Test 1: Change
Result = [(A_U/A_S) × C_S × (V − V_S) + (C₆₀ ×V_S) + (C₁₈₀ ×V_S) ×100]/L
to:
Result = [(A_U/A_S) × C_S × (V − V_S) + (C₆₀ ×V_S) + (C₁₈₀ ×V_S)] ×(100/L)
AND
Equation 3 in Test 2: Change
Result = [C₂ × (V − SV₁) + C₁ ×SV₁ ×100]/L
to:
Result = [C₂ × (V − SV₁) + C₁ ×SV₁] ×(100/L)
AND
Equation 4 in Test 2: Change
Result = {C_n ×[V − (n − 1)V_S] + (C₁ + C₂ + ... + C_n-1) × V_S ×100}/L
to:
Result = {C_n ×[V − (n − 1)V_S] + (C₁ + C₂ + ... + C_n-1) × V_S} ×(100/L)

Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
to:
A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.