Errata - English

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)

In Test 1/Analysis: Change
dissolved at time point (i):
Result_i = (r_U/r_S) × C_S × V × D × (1/L) × 100
to:
dissolved:
Result = (r_U/r_S) × C_S × V × D × (1/L) × 100
AND
In Test 3/Analytical procedure 1/Analysis: Change
V = volume of Medium, 900 mL
to:
V = volume of Medium 1, 900 mL
AND
In Test 3/Analytical procedure 2/Analysis: Change
V_M = volume of Medium, 900 mL
to:
V_M = volume of Medium 1, 900 mL
AND
In Test 3/Analytical procedure 3/Blank: Change
Medium
to:
Medium 2
AND
In Test 3/Analytical procedure 3/Analysis: Change
V_M = volume of Medium, 900 mL
to:
V_M = volume of Medium 2, 900 mL

Change
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Assay.
to:
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Content of Calcium.

Line 1 of Identification test A: Change
A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
to:
Dissolve a quantity of it in water to obtain a test solution containing 10 mg per mL, heating in a water bath at 60° if necessary. Similarly, prepare a Standard solution of USP Potassium Gluconate RS in water containing 10 mg per mL. Apply separate 5-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel, and allow to dry.Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50: 30: 10: 10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 minutes. Allow to cool, spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110° for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and R_F value to that obtained from the Standard solution.

In System suitability solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In System suitability/Samples: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

In Analysis: Change
Result = {[(V_S − V_B) × N × F]/W} × 100
to:
Result = {[(V_S − V_B) × M × F]/W} × 100
AND
Change
N = actual normality of the Titrant (mEq/mL)
F = equivalency factor, 320.2 mg/mEq
to:
M = actual molarity of the Titrant (mmol/mL)
F = equivalency factor, 320.26 mg/mmol

Line 14 of Analysis: Change
Result = [(V × N × F)/W] × 100
to:
Result = [(V × M × F)/W] × 100
AND
Line 15 of Analysis: Change
V = volume of titrant consumed by the Sample (mL)
N = actual normality of the titrant (mEq/mL)
F = equivalency factor, 136.14 mg/mEq
to:
V = volume of Titrant consumed by the Sample (mL)
M = actual molarity of the Titrant (mM/mL)
F = equivalency factor, 136.14 mg/mM

Line 5 of Titrimetric system: Delete the subsection
Blank: 100 mL of water and 4 mL of 3 N hydrochloric acid
AND
Line 11 of Analysis: Delete the sentence
Perform a blank determination.
AND
Line 13 of Analysis: Change
Result = [(V − B) × N × F × 100]/W
to:
Result = [(V × N × F)/W] × 100
AND
Line 15 of Analysis: Delete
B = volume of titrant consumed by the Blank (mL)

In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of 0.5 N hydrochloric acid VS to a 500-mL volumetric flask, dilute with water to volume, and mix well.

In Column: Change
4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B ^▲(90:10)_▲ (ERR 1-Mar-2019) for about 30 min is recommended prior to use.]
to:
4.6-mm × 15-cm; 5-µm packing L7

In Row 2 of Column 3 of Table 4: Change
0.014^▲/0.028_{▲2S (USP41)}
to:
0.014
AND
In Row 3 of Column 3 of Table 4: Change
0.014
to:
0.014/0.028
AND
In Chromatographic system/Column: Change
4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B (80:20) for NLT 20 min is recommended prior to use.]
to:
4.6-mm × 15-cm; 5-µm packing L7

Line 2 of USP Candesartan Cilexetil Related Compound D RS: Change
1-{[(Cyclohexyloxycarbonyloxy)carbonyl]oxy}ethyl 3-{[2’-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.
to:
1-{[(Cyclohexyloxy)carbonyl]oxy}ethyl 3-({2’-(2-ethyl-2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl}methyl)-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.

Line 1 of Mode in Titrimetric system: Change
Direct titration
to:
Residual titration
AND
Line 10 of Analysis: Change
(V_T − V_B)
to:
(V_B − V_S)
AND
Line 11 of Analysis: Change
V_T = 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 3: Change
Mobile phase: Alcohol and 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7 (5:95)
to:
Buffer: 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7
Mobile phase: Alcohol and Buffer (5:95)

In Standard stock solution: Change
(equivalent to 0.05 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS free base
to:
(equivalent to 0.05 mg/mL of carbinoxamine) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS (as the free base)
AND
In the Standard solution: Change
(equivalent to 0.001 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.001 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS free base
to:
(equivalent to 0.001 mg/mL of carbinoxamine) and 0.001 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS (as the free base)
AND
In the Analysis: Change
C_S = concentration of USP Carbinoxamine Maleate RS free base
to:
C_S = concentration of USP Carbinoxamine Maleate RS (as the free base)

In the Standard stock solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In the Standard solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In the Analysis: Change
C_S = concentration of USP Carbinoxamine Maleate RS free base
to:
C_S = concentration of USP Carbinoxamine Maleate RS (as the free base)

In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution
AND
In Limit of Benzene/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution

In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution
AND
In Limit of Benzene/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution