Errata - English

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 1 of Sample: Change
6 mg/mL of phenytoin sodium in water from a suitable number of Capsules prepared as follows. Nominally transfer 300 mg of the powder into 50 mL of water in a separator.
to:
300 mg of phenytoin sodium from the contents of Capsules in 50 mL of water in a separator.

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 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 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)

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)

Line 16 of Analysis: Change
C_U = nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (units/mL)
to:
C_U = nominal concentration of citric acid monohydrate in the Assay preparation for citric acid/citrate assay (µg/mL)

Line 13 of Analysis in Test 1: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 12 of Analysis in Test 2: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 13 of Analysis in Test 3: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

Line 16 of Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 14 of the second Calculate statement in Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

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.

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.

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.

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)