Errata - English

Change
Standard solution: Transfer 2.0 mg/mL of USP Latanoprost RS into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
Sample solution: Transfer 2.0 mg/mL of Latanoprost into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
to:
Standard solution: 2.0 mg/mL of USP Latanoprost RS prepared as follows. Transfer USP Latanoprost RS into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
Sample solution: 2.0 mg/mL of Latanoprost prepared as follows. Transfer Latanoprost into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.

In Sample solution: Change
Transfer about 100 mg of chloroprocaine hydrochloride to a 100-mL volumetric flask, dissolve in 40 mL of methanol, and dilute with water to volume.
to:
Transfer a volume of Injection, equivalent to about 100 mg of chloroprocaine hydrochloride to a 100-mL volumetric flask, add 40 mL of methanol, and dilute with water to volume.

In Standard solution: Change
7.5 µg/mL of USP 2-Methylbenzhydrol RS in methanol
to:
7.5 µg/mL of USP Methylbenzhydrol RS in methanol
AND
In Analysis: Change
C_S = concentration of USP 2-Methylbenzhydrol RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Methylbenzhydrol RS in the Standard solution (mg/mL)

In Buffer stage/Analysis: Change
Calculate the percentage of the labeled amount of risedronate sodium (C₇H₁₀NNaO₇P₇) dissolved:
to:
Calculate the percentage of the labeled amount of risedronate sodium (C₇H₁₀NNaO₇P₂) dissolved:

In Dissolution 〈711〉/Test 1/Tier 1/Phosphate buffer, pH 7.5: Change
sodium hydroxide
to:
sodium hydroxide solution
AND
In Dissolution 〈711〉/Test 1/Tier 1/Analysis: Change
449.40
to:
449.39
AND
In Dissolution 〈711〉/Test 1/Tier 2/Solution A and Solution B: Change
sodium hydroxide
to:
sodium hydroxide solution
AND
In Dissolution 〈711〉/Test 2/Tier 2/Analysis: Change
449.40
to:
449.39
AND
In Dissolution 〈711〉/Test 3/Tier 2/Analysis: Change
449.40
to:
449.39

In USP Tioconazole Related Compound A RS: Change
389.73
to:
389.72
AND
In USP Tioconazole Related Compound B RS: Change
458.62
to:
458.60
AND
In USP Tioconazole Related Compound C RS: Change
C₁₆H₁₃BrCl₂N₂OS · HCl 468.63
to:
C₁₆H₁₂BrCl₃N₂OS · HCl 503.06

In Organic Impurities/Standard solution: Change
isosorbide related compound A
to:
isosorbide mononitrate related compound A
AND
In System suitability/Suitability requirements/Relative standard deviation: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In four instances in Analysis: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In Table 1: Change
Isosorbide related compound A
to:
Isosorbide mononitrate related compound A

In Table 2, footnote b: Change
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-4a,5a,6,12a-tetrahydro-3,5,10,12,12a-pentahydroxy-6-methyl-tetracene-1,11-dioxo-2-naphthacenecarboxamide.
to:
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,11(4H,5H)-dione.

In Organic Impurities/Solution B: Change
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide TS to a pH of 6.0.
to:
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide solution to a pH of 6.0.
AND
In both equations in Organic Impurities/Analysis: Change
449.40
to:
449.39

In Organic Impurities/Standard solution: Change
isosorbide related compound A
to:
isosorbide mononitrate related compound A
AND
In System suitability/Suitability requirements/Relative standard deviation: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In four instances in Analysis: Change
isosorbide related compound A,
to:
isosorbide mononitrate related compound A,
AND
In Table 1: Change
Isosorbide related compound A
to:
Isosorbide mononitrate related compound A

In Analysis: Change
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonia cyanide solution,
to:
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonium cyanide solution,

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

In Analysis: Change
Result = (R_U/R_S) x C_S x V x (D/W_U) x (1/L) x 100
R_U = peak area ratio of ibuprofen to benzophenone from the Sample solution
R_S = peak area ratio of ibuprofen to benzophenone from the Standard solution
C_S = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
D = density of Oral Suspension (g/mL)
W_U = weight of the portion of Oral Suspension added to the Medium (g)
L = label claim (mg/mL)
to:
Result = (R_U/R_S) x C_S x V x (d/W_U) x D x (1/L) x 100
R_U = peak area ratio of ibuprofen to benzophenone from the Sample solution
R_S = peak area ratio of ibuprofen to benzophenone from the Standard solution
C_S = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
d = density of Oral Suspension (g/mL)
W_U = weight of the portion of Oral Suspension added to the Medium (g)
D = dilution factor of the Sample solution, 2
L = label claim (mg/mL)

Change
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester
to:
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester

In Analysis: Change
C_S = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
to:
C_S = concentration of the corresponding USP Reference Standard or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

In Analysis: Change
r_S = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution
to:
r_T = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution

In Standard solution B: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,
AND
In Sample solution: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,

In Organic Impurities/Table 2: Change:
3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycin^m
to:
3’-N-Demethyl-3’-N-[(4-methylphenyl)sulfonyl]azithromycin^m
AND
In Organic Impurities/Table 2/footnote m: 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 Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

Change
C₄₈H₇₄O₁₄(Component H₂B_1a) 875.09
C₄₇H₇₂O₁₄(Component H₂B_1b) 861.07
Component H₂B_1a:
Avermectin A_1a, 5-O-demethyl-22,23-dihydro-.
(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6′-(S)-sec-Butyl-3′,4′,5′,6,6′,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70161-11-4.
Component H₂B_1b:
Avermectin A_1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-.
(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3′,4′,5′,6,6′,7,10,11,-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU.
to:
C₄₈H₇₄O₁₄(Component H₂B_1a) 875.11
C₄₇H₇₂O₁₄(Component H₂B_1b) 861.08
Component H₂B_1a:
Avermectin A_1a, 5-O-demethyl-22,23-dihydro-.
(2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6’-(S)-sec-Butyl-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 71827-03-7; UNII: 91Y2202OUW.
Component H₂B_1b:
Avermectin A_1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-.
(2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-Tetradecahydro-20,20b-dihydroxy-6’-isopropyl-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU.

In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of 0.5 N hydrochloric acid VS to a 500-mL volumetric flask, dilute with water to volume, and mix well.

In Analysis: Change
M_r1 = molecular weight of atorvastatin, 558.64
M_r2 = molecular weight of atorvastatin calcium, 1155.34
to:
M_r1 = molecular weight of atorvastatin, 558.65
M_r2 = molecular weight of atorvastatin calcium, 1155.36