Errata - English

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.

Line 1 of Sample solution: Change
1 mg/mL of Oral Suspension in Diluent
to:
Nominally 1 mg/mL of phenytoin prepared as follows. Weigh and transfer a suitable volume of Oral Suspension to an appropriate volumetric flask. Add methanol to about 20% of the final flask volume and dissolve. Dilute with Diluent to volume. Dissolve with the aid of sonication, if necessary.

Change
Buffer, Mobile phase, Diluent, and Sample solution: Prepare as directed in the Assay.
to:
Buffer, Mobile phase, and Diluent: Prepare as directed in the Assay.
AND
Add
Sample solution: Use the Sample stock solution as directed in the Assay.

Line 1 of Standard solution: Change
Standard solution: 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase. Pass a portion of the solution
to:
Standard solutions: Prepare 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase separately in five individual flasks. Pass a portion of each solution
AND
Line 1 of Analysis/Samples: Change
Standard solution and Sample solution
to:
Standard solutions and Sample solution
AND
Line 3 of Analysis: Change
Separately inject equal volumes of the Standard solution
to:
Separately inject equal volumes of the Standard solutions

Line 1 of Type IA: Change
225–600
to:
225–600mPa · s
AND
Line 1 of Type IB: Change
150–450
to:
150–450 mPa · s
AND
Line 1 of Type IC: Change
800–2200
to:
800–2200 mPa · s
AND
Line 1 of Type IIA: Change
100–300
to:
100–300 mPa · s

In the System suitability solution: Change
0.5 mg/mL of USP Naproxen Sodium RS and 0.5 µg/mL of USP Naproxen Related Compound A RS in Diluent, from Standard stock solution 1 and Standard stock solution 2, respectively
to:
0.5 µg/mL of USP Naproxen Related Compound A RS from Standard stock solution 2 and 0.5 mg/mL of USP Naproxen Sodium RS in Diluent

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 new USP-NF ONLINE platform only.
Line 2 of Standard solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,
AND
Line 2 of Sample solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,

Line 1 of USP 2-Propanol System Suitability RS: Change
It contains 0.1% of each of the following: ethyl ether, acetone, isopropyl alcohol, diisopropyl ether, 1-propanol, and 2-butanol.
to:
It is a mixture of the following: ethyl ether (0.1%), acetone (0.1%), diisopropyl ether (0.1%), 1-propanol (0.1%), 2-butanol (0.1%), and isopropyl alcohol (99.5%).

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.]

Line 4: Change
(±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol l-(+)-tartrate (2:1) (salt);
1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt
to:
(±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (+)-tartrate (2:1) (salt);
1-(Isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol L-tartrate

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 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C₃₆H₄₃NO₆ 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.
C₃₆H₄₃NO₆ · H₂O 603.76

In the Analysis: Change
Result = (r_U/r_S) × C_S × (M_r1/M_r2) × V × (100/L)
to:
Result = (r_U/r_S) × C_S × (M_r1/M_r2) × V × (100/L) × D
AND
In the variable definition list in Analysis: Add
D = dilution factor for the Sample solution, 2

Line 2 of USP Salmeterol Related Compound H RS: Change
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.
C₃₆H₄₃NO₆ 585.73
to:
1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.
C₃₆H₄₃NO₆ · H₂O 603.76

In the variable definition list of Ciprofloxacin Related Compounds/Analysis: Change
C_U = nominal concentration of ciprofloxacin in the Otic Suspension (mg/mL)
to:
C_U = nominal concentration of ciprofloxacin in the Sample solution (mg/mL)
AND
In the variable definition list of Dexamethasone Related Compounds/Analysis: Change
C_U = nominal concentration of dexamethasone in the Otic Suspension (mg/mL)
to:
C_U = nominal concentration of dexamethasone in the Sample solution (mg/mL)

In the second Calculate statement in Analysis: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)
AND
In Tolerances: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)

In the variable definition list in Analysis: Change
C_S = concentration of USP Acamprosate Calcium Related Compound A RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Acamprosate Related Compound A RS in the Standard solution (µg/mL)

In USP Econazole Related Compound C RS: Change
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium nitrate (salt).
C₂₅H₂₁Cl₁₄N₃O₄ 569.26
to:
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium chloride.
C₂₅H₂₁Cl₅N₂O 542.71

In USP Reference Standards 〈11〉/USP Azaerythromycin A RS: Change
734.96
to:
734.97
AND
In USP Azithromycin N-oxide RS: Change
764.98
to:
765.00
AND
In USP N-Demethylazithromycin RS: Change
734.96
to:
734.97
AND
In USP Desosaminylazithromycin RS: Change
590.79
to:
590.80

In footnote m in Table 2: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.