Errata - English

Line 5 of Standard solution: Change
Mix 10.0 mL of this solution
to:
Mix 5.0 mL of this solution
AND
Line 7 of Standard solution: Change
about 0.67 µg/mL
to:
about 0.5 µg/mL
Line 4 of Sample solution: Change
10.0 mL of this solution
to:
5.0 mL of this solution
AND
In the variable definition list in Analysis: Change
V_F = final volume of the Sample solution, 15 mL
D = dilution factor for preparation of the Sample solution, 5
to:
V_F = final volume of the Sample solution, 10 mL
D = dilution factor for preparation of the Sample solution, 10

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

Product column: Change
10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16
to:
10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625
AND
Sample 1/HCP ratio column: Change
4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6
to:
4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6
AND
Sample 2/HCP ratio column: Change
2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6
to:
2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6
AND
Sample 3/HCP ratio column: Change
0.3, 0.5, 0.6, 0.9, 1.4, <6, <6
to:
0.32, 0.50, 0.60, 0.88, 1.44, <6, <6
AND
Sample 3/% max ratio value column: Change
83%
to:
61%

Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Myristyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of Myristyl Alcohol in Internal standard solution

Line 2: Change
Sample: System suitability solution
to:
Samples: System suitability solution and Standard solution
AND
Line 2 of Suitability requirements: Change
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections
to:
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks, System suitability solution
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections, Standard solution

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

Line 1 of Standard solution: Change
Prepare 1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution
AND
Line 1 of Sample solution: Change
Prepare 1.0 mg/mL of Oleyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.
to:
1.0 mg/mL of Oleyl Alcohol in Internal standard solution

Line 3 of Analysis: Change
of USP Memantine Related Compound E RS or
to:
of memantine related compound E or
AND
In the variable definition list: Change
r_U = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solution
to:
r_U = peak response of memantine related compound E or any individual degradation product from the Sample solution

Line 2 of USP Ranitidine Related Compound C RS: Change
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.
to:
N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N′-methyl-2-nitro-1,1-ethenediamine.

In the numerator of the equation: Change
2.8
to:
14
AND
Add
× f
AND
Line 10: Change
where %LOD is the percentage of loss on drying.
to:
where f is the correction factor obtained in the standardization of 0.2 N sodium hydroxide and %LOD is the percentage of loss on drying.

Variable definition list of second equation in Test 2/Analysis: Change
V_S = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
V_S = volume of the Sample solution withdrawn at each time point (mL)
AND
Variable definition list of second equation in Test 3/Analysis: Change
V_S = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
V_S = volume of the Sample solution withdrawn at each time point (mL)

Line 2 of Procedure 2: Change
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, and Chromatographic system:
to:
Buffer, Solution A, Solution B, Mobile phase, System suitability solution, Chromatographic system, and System suitability:

Line 6 of Analysis: Change
37 ± 0.5° at each time point.
to:
37 ± 0.5°.
AND
Line of 40 of Analysis:Delete the equation
Result₅ = ({C₅ × [V − (4 × V_s)]} + [(C₄ + C₃ + C₂ + C₁) × V_s]) × (1/L) × 100
AND
Row 5 of Column 2 of Table 11: Change
4
to:
5