Errata - English

In Test 2/Analysis: Change
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
AND
Change
M_r2 = molecular weight of prazosin hydrochloride, 419.86
to:
M_r2 = molecular weight of prazosin hydrochloride, 419.87

In USP Ropivacaine Related Compound A RS: Change
2,6-Dimethylaniline hydrochloride.
C₈H₁₂ClN 157.64
[CAS-21436-98-6].
to:
2,6-Dimethylaniline hydrochloride.
C₈H₁₁N · HCl 157.64
AND
In USP Ropivacaine Related Compound B RS: Change
(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.
C₁₇H₂₆N₂O 328.89
to:
(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate; (R)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate.
C₁₇H₂₆N₂O · HCl · H₂O 328.88

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 footnote 1 of table: Change
Estra-1,3,5(10)-triene-6-one-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7α,17β)
to:
7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-6-one-3,17β-diol
AND
In footnote 2: Change
Estra-1,3,5(10),6-tetraene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7α,17β)
to:
7-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10),6-tetraene-3,17β-diol
AND
In footnote 3: Change
Estra-1,3,5(10)-triene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfonyl]nonyl]-(7α,17β)
to:
7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfonyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol
AND
In footnote 4: Change
Estra-1,3,5(10)-triene-3,17-diol,7-{9-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonylsulfinyl]nonyl}-(7α,17β)
to:
7α-{9-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonylsulfinyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol
AND
In footnote 5: Change
7,7-Nonamethylene-bis(estra-1,3,5(10)-triene-3,17-diol-(7α,17β)
to:
7α,7α-Nonamethylenebis[estra-1,3,5(10)-triene-3,17β-diol]
AND
In footnote 6: Change
Estra-1,3,5(10)-triene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7β,17β)
to:
7β-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol

In Peptone diluent: Change
Dispense into sterile containers as needed for preparing samples. Trace mineral solution. Prepare a solution containing
to:
Dispense into sterile containers as needed for preparing samples.
Trace mineral solution: Prepare a solution containing

In Content of Methoxy and 2-Hydroxypropoxy Groups/Analysis: Change
Result = (r_UM/r_SM) × (C_S/C_U) × (M_r1/M_r2)
to:
Result = (r_UM/r_SM) × (C_S/C_U) × (M_r1/M_r2) × 100
AND
Change
Result = (r_UI/r_SI) × (C_S/C_U) × (M_r1/M_r2)
to:
Result = (r_UI/r_SI) × (C_S/C_U) × (M_r1/M_r2) × 100

Change
Mobile phase, Internal standard solution, and Standard preparation—Prepare as directed in the Assay under Theophylline.
to:
Buffer solution—Transfer 2.72 g of sodium acetate trihydrate to a 2000-mL volumetric flask, add about 200 mL of water, and shake until dissolution is complete. Add 10.0 mL of glacial acetic acid, dilute with water to volume, and mix.
Mobile phase—Transfer 70.0 mL of acetonitrile to a 1000-mL volumetric flask, dilute with Buffer solution to volume, and mix. Degas, and filter before using. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution—Transfer about 50 mg of theobromine, accurately weighed, to a 100-mL volumetric flask, dissolve in 10.0 mL of 6 N ammonium hydroxide, dilute with Mobile phase to volume, and mix.
Standard preparation—Dissolve an accurately weighed quantity of USP Theophylline RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.1 mg of USP Theophylline RS per mL.
AND
Change
Chromatographic system—Proceed as directed in the Assay under Theophylline.
to:
(see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 1.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the theophylline and theobromine peaks is not less than 2.0, the tailing factor for the theophylline peak is not more than 2.0, and the relative standard deviation for replicate injections is not more than 1.5%.
AND
Change
Procedure—Proceed as directed for Procedure in the Assay under Theophylline.
to:
Procedure—Separately inject equal volumes (between 10 µL and 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, and measure the peak responses for the major peaks. The retention time of theophylline relative to that of theobromine is about 1.6.

Change
847.00
to:
847.02
AND
Change
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d]imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate
to:
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,18,20-Trihydroxy-1’-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-5,10,26-trioxo-3,5,9,10-tetrahydrospiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2’,3’:7,8]naphtho[1,2-d]imidazole-2,4’-piperidin]-16-yl acetate

In USP Benazepril Related Compound A RS: Change
(3R) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
to:
2-[(R)-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 (3R) 3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
AND
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.
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.
AND
In USP Benazepril Related Compound C RS: Change
3-(1-Carboxy-3-phenyl-1(S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
to:
(S)-2-{[(S)-1-(Carboxymethyl)-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-3-yl]amino}-4-phenylbutanoic acid;
Also known as 3-(1-Carboxy-3-phenyl-1(S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
AND
In USP Benazepril Related Compound D RS: Change
(3-(1-Ethoxycarbonyl-3-cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid, monohydrochloride.
to:
2-[(S)-3-{[(S)-4-Cyclohexyl-1-ethoxy-1-oxobutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3-(1-Ethoxycarbonyl-3-cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid, monohydrochloride.
AND
In USP Benazepril Related Compound E RS: Change
3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
to:
(S)-2-(3-Amino-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetic acid hydrochloride;
Also known as 3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride.
C₁₂H₁₄N₂O₃ · HCl 270.71
AND
In USP Benazepril Related Compound F RS: Change
tert-Butyl-3-amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
to:
tert-Butyl (S)-2-(3-amino-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetate;
Also known as tert-Butyl-3-amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid.
C₁₆H₂₂N₂O₃ 290.36
AND
In USP Benazepril Related Compound G RS: Change
(3-(1-Ethoxycarbonyl-3-phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid ethyl ester.
to:
Ethyl (S)-2-{[(S)-1-(2-ethoxy-2-oxoethyl)-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-3-yl]amino}-4-phenylbutanoate;
Also known as (3-(1-Ethoxycarbonyl-3-phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine)-1-acetic acid ethyl ester.
C₂₆H₃₂N₂O₅ 452.55

Change
Delete the following
^▲•USP Reference Standards <11>
USP Retinyl Acetate RS
USP Retinyl Palmitate RS
_{▲(CN 1-May-2018)}
to:
•USP Reference Standards <11>
USP Retinyl Acetate RS
USP Retinyl Palmitate RS

In Sample solution: Change
Nominally 0.6 mg/mL of phenytoin
to:
Nominally 0.6 mg/mL of phenytoin sodium
AND
In Analysis: Change
C_U = nominal concentration of phenytoin in the Sample solution (mg/mL)
to:
C_U = nominal concentration of phenytoin sodium in the Sample solution (mg/mL)

In Absorptivity: Change
The absorptivity of the Sample solution at 445 nm is NLT 95.0% and NMT 103.0% that of the Standard solution.
to:
The absorptivity, calculated on the dried basis, of the Sample solution at 445 nm is NLT 95.0% and NMT 103.0% that of the Standard solution.

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 USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.

In B.: Change
The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

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 Medium: Change
Sodium phosphate buffer, pH of 6.0 (14.2 g/L of disodium hydrogen orthophosphate anhydrous in water, adjusted with dilute hydrochloric acid to a pH of 6.0)
to:
Sodium phosphate buffer, pH 6.0 (14.2 g/L of sodium phosphate, dibasic, anhydrous in water, adjusted with dilute hydrochloric acid to pH 6.0)
AND
In Solution A: Change
orthophosphoric acid
to:
phosphoric acid

In Table 1/footnotes: Change
^b1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
^c1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
^d3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one.
^e1,2,3,9-Tetrahydro-9-methyl-3-[1H-imidazol-1-yl)methyl]-4H-carbazol-4-one.
to:
^b9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
^c9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one.
^d3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
^e3-[(1H-Imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.

In Analysis: Change
Results = (A_U/A_S) × C_S × D × (1/L) × V × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
D = dilution factor for Sample solution, if needed
L = label claim (mg/Tablet)
V = volume of Medium, 500 mL
to:
Result = (A_U/A_S) × C_S × V × D × (M_r1/M_r2) × (1/L) × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
V = volume of Medium, 500 mL
D = dilution factor for the Sample solution, if needed
M_r1 = molecular weight of prochlorperazine, 373.94
M_r2 = molecular weight of prochlorperazine maleate, 606.09
L = label claim (mg/Tablet)

Change
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N potassium hydroxide VS. Titrate with 0.1 N hydrochloric acid VS until a permanent pale-pink color is produced.
to:
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N hydrochloric acid VS. Titrate with the potassium hydroxide solution until a permanent pale-pink color is produced.

In Leachable Arsenic/Analysis: Change
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure.
to:
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure 1.

In Acetic Acid in Peptides/Analysis: Change
C_SPA = concentration of potassium acetate in each of the Standard solutions (mg/mL)
to:
C_SPA = concentration of potassium acetate in each of the Standard solutions (µg/mL)
AND
In Ammonium/Analysis: Change
C_SAC = concentration of ammonium chloride in each of the Standard solutions (mg/mL)
to:
C_SAC = concentration of ammonium chloride in each of the Standard solutions (µg/mL)

In USP Ziprasidone Related Compound F RS: Change
2-(2-Amino-5-{2-[4-(benzo[d]isothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetic acid.
C₂₁H₂₃ClN₄O₂S 430.95
to:
Sodium 2-(2-amino-5-{2-[4-(benzisothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetate monohydrate;
Also known as Sodium 2-(2-amino-5-{2-[4-(benzo[d]isothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetate monohydrate.
C₂₁H₂₂ClN₄NaO₂S · H₂O 470.95