Errata - English

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.

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 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)

Line 8 of the variable definition list of the first equation: Change
C_U = nominal concentration of ropinirole related compound B free base in the Sample solution (µg/mL)
to:
C_U = nominal concentration of ropinirole in the Sample solution (µg/mL)

Line 2: Change
proceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>,
to:
proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, A. Delivered-Dose Uniformity/A.2 Inhalation Aerosols and Inhalation Sprays and A.4 Inhalation Powders,
AND
Line 4: Delete
Unless otherwise stated in the individual monograph, apply the acceptance criteria for Metered-Dose Inhalers and Dry Powder Inhalers as described in <601>.

The version of the Timolol Maleate monograph which appeared in the Second Supplement to USP 40–NF 35 did not include the revisions approved in the version appearing in the First Supplement to USP 40–NF 35. The version appearing in the First Supplement should be used. The file as it should have appeared in the Second Supplement is attached to the compendial notice found at http://www.uspnf.com/notices/second-supplement-usp-40-nf-35-online-timolol-maleate.

Line 7 of the variable definition list for the first equation: Change
C_U = concentration of Penicillin G Procaine in the Sample solution (mg)
to:
C_U = concentration of Penicillin G Procaine in the Sample solution (mg/mL)
AND
Line 7 of the variable definition list for the second equation: Change
C_U = concentration of Penicillin G Procaine in the Sample solution (mg)
to:
C_U = concentration of Penicillin G Procaine in the Sample solution (mg/mL)