Errata - English

Change
3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol;
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside [250249-75-3].
to:
3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol trihydrate;
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside trihydrate [250249-75-3].

In 4.1 Documentation and Procedures/4.1.3 Labels: Change
The use of symbols that are recognized by international organizations is strongly recommended.
to:
The use of symbols that are recognized by international organizations is strongly recommended. See General Notices, 10.20. Labeling.

In USP Benazepril Related Compound B RS: Change
(3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride.
to:
2-[(S)-3-{[(R)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

In Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity solution,
AND
In System suitability/Suitability requirements: Delete
Signal-to-noise ratio: NLT 10, Sensitivity solution

In Analysis: Change
Result = (r_U/r_S) × C_S × (1/F)
to:
Result = (r_U/r_S) × C_F × (1/F)
AND
Change
C_S = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)
to:
C_F = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)

In Dissolution 〈711〉/Test 8/Tolerances: Change
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 1.
to:
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 2.

In paragraph five: Change
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉¹
to:
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉
AND
In footnote 1: Change
This chapter will appear in a future Pharmacopeial Forum (PF) issue.
to:
This chapter appeared in issue 46(3) of the Pharmacopeial Forum (PF).

Change
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
to:
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.

In the second equation in Analysis: Change
Result = (R_L − P_B)/(P_A − P_B)
to:
Result = (R_L − P_B)/(P_A − P_B) × 100

In USP Reference Standards <11>/USP Mirtazapine Resolution Mixture RS: Change
This resolution mixture contains approximately 0.1% w/w each of the following:
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.
to:
Mirtazapine.
Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide.

Change:
Mobile phase, Diluting solution, System suitability solution, and Chromatographic system—Prepare as directed in the test for Related compounds under Furosemide.
to:
Mobile phase—Prepare a filtered and degassed mixture of water, tetrahydrofuran, and glacial acetic acid (70:30:1). Make adjustments if necessary (see System Suitability under Chromatography <621>).
Diluting solution—Dilute 22 mL of glacial acetic acid with a mixture of acetonitrile and water (50:50) to 1000 mL, and mix.
System suitability solution—Dissolve suitable quantities of USP Furosemide RS and USP Furosemide Related Compound A RS in Diluting solution to obtain a solution containing about 20 µg per mL and 12 µg per mL, respectively.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a detector capable of recording at both 254 nm and 272 nm and a 4.6-mm x 25-cm column that contains packing L1. [NOTE—The 2,4-dichloro-5-sulfamoylbenzoic acid impurity does not respond at 272 nm and the 2,4-bis(furfurylamino)-5-sulfamoylbenzoic acid impurity has a very intense absorbance at 254 nm.] The flow rate is about 1.0 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the resolution, R, between furosemide and furosemide related compound A is not less than 2.5; and the relative standard deviation determined from furosemide is not more than 2.0%. [NOTE—The response for furosemide is at 254 nm.]

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 Test 1: Change
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions)
to:
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions); 900 mL

In Chromatographic system and Procedure: Change
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS, on the anhydrous basis, in the Standard preparation;
to:
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS in the Standard preparation;

In System suitability solution: Change
0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP Nortriptyline Hydrochloride RS from suitable volumes of Standard solution, System suitability stock solution A, and System suitability stock solution B in Mobile phase
to:
0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP Nortriptyline Hydrochloride RS from suitable volumes of System suitability stock solution A and System suitability stock solution B in Mobile phase

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 Analysis: Change
M_W(Salt) = molecular weight of ammonium glycyrrhizate, 840.08 g/mol
M_W(Acid) = molecular weight of glycyrrhizic acid, 821.59 g/mol
to:
M_W(Salt) = molecular weight of ammonium glycyrrhizate, 839.97 g/mol
M_W(Acid) = molecular weight of glycyrrhizic acid, 822.94 g/mol

In System suitability: Change
Samples: System suitability solution, Standard solution A, and Standard solution B
to:
Samples: System suitability solution and Standard solution A
AND
In Analysis: Change
Samples: Mobile phase, Standard solution A, and Sample solution
Chromatograph the Standard solution and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.
to:
Samples: Mobile phase, Standard solution A, Standard solution B, and Sample solution
Chromatograph Standard solution B and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.

In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 10.0% for the tributyl phosphine oxide and osteltamivir phosphate peaks
to:
NMT 10.0% for the tributyl phosphine oxide and oseltamivir phosphate peaks

In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C₄H₈O₄S₂ 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.
C₄H₇KO₄S₂ ∙ KCl 296.86
AND
In USP Mesna Related Compound B RS: Change
2,2′-Disulfanediylbis(ethane-1-sulfonic acid).
C₄H₁₀O₆S₄ 282.36
to:
2,2′-Disulfanediylbis(ethane-1-sulfonic acid), dipotassium salt, crystal adduct with sodium chloride.
C₄H₈K₂O₆S₄ ∙ NaCl 416.98