Errata - English

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

In Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × ^▲(M_r1/M_r2) ×_{▲ (USP 1-Aug-2019)} 100
to:
Result = (R_U/R_S) × (C_S/C_U) × 100
AND
Delete
^▲M_r1 = molecular weight of tiagabine hydrochloride, 412.00
M_r2 = molecular weight of tiagabine hydrochloride monohydrate, 430.02_{▲ (USP 1-Aug-2019)}

In all instances in paragraph 2: Change
s_r
to:
s
AND
In paragraph 2: Change
is found to be 0.0015, then M_min must be ≥ 0.3000 g or 300 mg.
to:
is found to be 0.00015, then M_min must be ≥ 0.30000 g or 300.00 mg.

Change
Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, chloride;
3,7-Bis(dimethylamino)phenothiazin-5-ium chloride;
to:
Phenothiazin‐5‐ium, 3,7‐bis(dimethylamino)‐, chloride, hydrate (1:1:x);
3,7‐Bis(dimethylamino)phenothiazin‐5‐ium chloride hydrate;
[122965‐43‐9].
AND
Change
Monohydrate [122965-43-9].
to:
Monohydrate [67183‐68‐0].

Change
If light protection is necessary^c
to:
If light protection is necessary
AND
Change Row 11
Chemical Suitability for Use Assessment Risk-based testing Risk-based testing
to:
Chemical Suitability for Use
Assessment Risk-based testing Risk-based testing
Functionality

In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Extracting media: Change
50 percent alcohol: Dilute 125 mL of alcohol with water to 238 mL, and mix.
25 percent alcohol: Dilute 125 mL of 50 percent alcohol with water to 250 mL, and mix.
General procedure: [Note— Use an Extracting medium of 50 percent alcohol for PET bottles and 25 percent alcohol for PETG bottles.]
to:
Purified Water: See monograph.
50 percent alcohol: Dilute 125 mL of alcohol with water to 238 mL, and mix.
25 percent alcohol: Dilute 125 mL of 50 percent alcohol with water to 250 mL, and mix.
n-Heptane
General procedure: [Note— Use an Extracting medium of 50 percent alcohol for PET bottles and 25 percent alcohol for PETG bottles.]
AND
In four instances in Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Heavy Metals: Change
Extracting media
to:
Purified Water Extracting medium
AND
In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Ethylene Glycol/Test solution: Change
Extracting media
to:
Purified Water Extracting medium
AND
In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Ethylene Glycol/Procedure/paragraph 1: Change
Extracting media extract Extracting medium
to:
Purified Water Extracting medium
AND
In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Ethylene Glycol/Procedure/paragraph 2: Change
using as the blank the solution from the Extracting media: the absorbance of the solution
to:
using Purified Water Extracting medium as the blank: the absorbance of the solution

In Acceptance criteria/Chromatographic similarity: Change
[Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of being used.]
to:
[Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of USP Anise Oil RS being used.]

In USP Galantamine Hydrobromide Related Compounds Mixture RS: Change
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂
to:
Anhydrogalantamine;
(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.
C₁₇H₁₉NO₂ 269.34

A paragraph before the Introduction was deleted:
This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by the symbol ♦. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis <1052>, Biotechnology-Derived Articles—Capillary Electrophoresis <1053>, Biotechnology-Derived Articles—Isoelectric Focusing <1054>, Biotechnology-Derived Articles—Peptide Mapping <1055>, and Biotechnology-Derived Articles—Total Protein Assay <1057>.

In Analysis: Change
M = actual molarity of the Back-titrant (mM/mL)
to:
M = actual molarity of the Back-titrant (mmol/mL)
AND
Change
F = equivalency factor, 136.06 mg/mM
to:
F = equivalency factor, 136.06 mg/mmol

In Analysis: Change
^▲Add 1 mL of silver nitrate TS to the Standard solution and then add a 50-mL portion of the Sample solution. Mix and allow to stand for 5 min protected from direct sunlight. Compare the turbidity of the solutions._{▲(NF 1-May-2019)}
to:
Add 1 mL of silver nitrate TS to the Standard solution. Add 1 mL of silver nitrate TS to a 50-mL portion of the Sample solution. After mixing, allow each solution to stand for 5 min protected from direct sunlight. Compare the turbidity of the solutions.

In three instances in Analysis: Change
0.1 M sodium hydroxide
to:
Titrant
AND
In the equation: Change
M
to:
N
AND
In the variable definition list: Change
M = actual molarity of the Titrant (mol/L)
to:
N = actual normality of the Titrant

In Standard solution: Change
0.25 μg/mL of 1-vinyl-2-pyrrolidone and 5 μg/mL of vinyl acetate, respectively, diluted from the Standard stock solution in Mobile phase
to:
0.25 μg/mL of 1-vinyl-2-pyrrolidone and 0.25 μg/mL of vinyl acetate, respectively, diluted from the Standard stock solution in Mobile phase

Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C₁₇H₂₅N₃O₃S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride.
C₁₇H₂₅N₃O₃S · HCl 387.92

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 1 of Chromatographic system/Column: Change
10-µm
to:
5-µm
AND
In the variable definition list in Analysis: Change
r_U = citrate peak area from the Sample solution
r_S = citrate peak area from the Standard solution
to:
r_U = citric acid peak area from the Sample solution
r_S = citric acid peak area from the Standard solution
AND
Change
M_r2 = molecular weight of citrate (C₆H₅O₇), 189.10
to:
M_r2 = molecular weight of citric acid (C₆H₈O₇), 192.13

Line 1 of Sample solution: Change
Transfer 3.0 mL of the clear filtrate, reserved from the Assay, to a 100-mL volumetric flask.
to:
Sample stock solution: Dilute the clear filtrate, reserved from the Assay, with water to obtain a solution containing about 160 µg/mL of potassium citrate monohydrate.
Sample solution: Transfer 3.0 mL of the Sample stock solution to a 100-mL volumetric flask.

In the variable definition list in Analysis: Change
C_S = concentration of oxybutynin chloride in the Standard solution (mg/mL)
to:
C_S = concentration of USP Oxybutynin Chloride RS in the Standard solution (mg/mL)

This erratum applies to the Revision Bulletin posted on www.uspnf.com only.
In System suitability: Add
[Note—The relative retention times for oxybutynin and oxybutynin related compound A are about 1.0 and 1.6, respectively.]

This erratum applies to the Revision Bulletin posted on www.uspnf.com only.
In the variable definition list in Analysis: Change
C_U = nominal concentration of the Sample solution (mg/mL)
to:
C_U = nominal concentration of the Sample solution (mg/mL)
[Note—Disregard any peak less than 0.1%.]

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)

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)

Footnote c of Table 2: Change
(2aR,4R,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-formyl-3-phenylisoserine.
to:
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)‐12b‐Acetoxy‐9‐(((2R,3S)‐3‐formamido‐2‐hydroxy‐3‐phenylpropanoyl)oxy)‐4,6,11‐trihydroxy‐4a,8,13,13‐tetramethyl‐5‐oxo‐2a,3,4,4a,5,6,9,10,11,12,12a,12b‐dodecahydro‐1H‐7,11‐methanocyclodeca[3,4]benzo[1,2‐b]oxet-12‐yl benzoate.
AND
Footnote d of Table 2: Change
(2aR,4R,4aS,6R,9S,11S,12S,12aR,12bS)-6-{[(2,2-Dichloroethoxy)carbonyl]oxy}-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b)oxet-5-one 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-tert-butoxycarbonyl-e-phenylisoserine.
to:
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)‐6‐{[(2,2‐Dichloroethoxy)carbonyl]oxy}‐1,2a,3,4,4a,6,9,10,11,12,12a,12b‐dodecahydro‐4,9,11,12,12b‐pentahydroxy‐4a,8,13,13‐tetramethyl‐7,11‐methano‐5H‐cyclodeca[3,4]benz[1,2‐b]oxet‐5‐one 12b‐acetate, 12‐benzoate, 9‐ester with (2R,3S)‐N‐tert-butoxycarbonyl‐3‐phenylisoserine.