Errata - English

In Organic Impurities/Table 3/footnote c: Change
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-2-hydroxypropyl methyl-L-valinate hydrochloride.
to:
3-[(2-Amino-6-oxo-1,6-dihydropurin-9-yl)methoxy]-2-hydroxypropyl L-valinate hydrochloride.

In Dissolution <711>/Test 1/Procedure/Chromatographic procedure/Analysis: Change
Result = (R_U/R_S) × C_S × V × (1/L) × 100
to:
Result = (R_U/R_S) × C_S × V × D × (1/L) × 100
AND
Add
D = dilution factor of the Sample solution, 2

In A./Standard solution B: Change
USP Procyanidin A₂ RS
to:
USP Procyanidin A2 RS
AND
In A./System suitability/Suitability requirements/Derivatization reagent B/White light: Change
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A₂ and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A₂ and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A₂ in the lower-half section.
to:
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section.
AND
In A./Acceptance criteria/Derivatization reagent B/White light: Change
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A₂ and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B₂, or procyanidin B₁ appear below procyanidin A₂.
to:
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2.
AND
In C./Acceptance criteria/Profile at 520 nm: Change
cyanidin-3-O-arabinose,
to:
cyanidin-3-O-arabinoside,
AND
In C./Acceptance criteria/Profile at 520 nm: Change
peonidin-3-O-arabinose
to:
peonidin-3-O-arabinoside

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 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.

Change
7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride
to:
(4S,4aS,5aS,6S,12aS)-7-Chloro-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide monohydrochloride

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 Limit of Methanol (Methyl Alcohol) and Methyl Acetate/Analysis: Change
C_U = concentration of methanol (methyl alcohol) or methyl acetate in the Sample solution (mg/mL)
to:
C_U = concentration of Polyvinyl Alcohol in the Sample solution (mg/mL)

In Release Liner Peel Test: Change
The product fails the test if the mean peel force is outside the acceptable range determined during product development.
to:
The product fails the test if the overall mean peel force is outside the acceptable range determined during product development.

In Sterility Tests 〈71〉: Change
Where the label states that Piperacillin is sterile or that it must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration.
to:
Where the label states that Piperacillin is sterile, it meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration.

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 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

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 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

In Test 1, Test 3, Test 4, Test 5, and Test 6/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

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 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

Change
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Assay.
to:
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Content of Calcium.

Change
541.68
Milbemycin B, 5-O-demethyl-28-deoxy-25-methyl-6,28-epoxy-23-hydroxyimino-, [6R,23S,25S(E)]-; (2αE,4E,5′S,6R,6′S,8E,11R,13R,15S,17αR,20αR,20βS)-3′,4′,5′,6,6′,7,10,11,14,15,17α,20,20α,20β-tetradecahydro-20β-hydroxy-5′,6′,6,8,19-pentamethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-17-one 20-oxime.
to:
541.69
Milbemycin B, 5-demethoxy-28-deoxy-6,28-epoxy-5-(hydroxyamino)-25-methyl-, (6R,25R)-; (2R,2a′E,2a1′S,4′E,5S,6R,6′R,8′E,11′R,15′S,17a′R,20′Z,20a′R)-2a1′-Hydroxy-20′-(hydroxyimino)-5,6,6′,8′,19′-pentamethyl-2a1′,3,4,5,6,6′,7′,10′,11′,14′,15′,17a′,20′,20a′-tetradecahydro-2′H,17′H-spiro[pyran-2,13′-[11,15]methano[1,5]dioxacyclooctadecino[9,8,7-cd]benzofuran]-17′-one.
AND
Change
555.70
Milbemycin B, 5-O-demethyl-28-deoxy-25-ethyl-6,28-epoxy-23-hydroxyimino-, [6R,23S,25S(E)]-; (2αE,4E,5′S,6R,6′S,8E,11R,13R,15S,17αR,20αR,20βS)-6′-ethyl-3′,4′,5′,6,6′,7,10,11,14,15,17α,20,20α,20β-tetradecahydro-20β-hydroxy-5′,6,8,19-tetramethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-17-one 20-oxime.
to:
555.71
Milbemycin B, 5-demethoxy-28-deoxy-6,28-epoxy-25-ethyl-5-(hydroxyamino)-, [6R,25R]-; (2R,2a′E,2a1′S,4′E,5S,6R,6′R,8′E,11′R,15′S,17a′R,20′Z,20a′R)-6-Ethyl-2a1′-hydroxy-20′-(hydroxyimino)-5,6′,8′,19′-tetramethyl-2a1′,3,4,5,6,6′,7′,10′,11′,14′,15′,17a′,20′,20a′-tetradecahydro-2′H,17′H-spiro[pyran-2,13′-[11,15]methano[1,5]dioxacyclooctadecino[9,8,7-cd]benzofuran]-17′-one.

Change
Related Compounds
System suitability solution and Sample solution: Prepare as directed in the Assay.
Analysis
Samples: System suitability solution and Sample solution
Using the chromatograms of the Sample solution and the System suitability solution, calculate the percentage of atovaquone related compounds in the portion of Atovaquone taken:
to:
Organic Impurities
Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, Chromatographic system and System suitability: Proceed as directed in the Assay.
Analysis
Sample: Sample solution
Calculate the percentage of atovaquone related compounds in the portion of Atovaquone taken:

Change
USP Atorvastatin Related Compound H RS (lactone impurity)
to:
USP Atorvastatin Related Compound H RS
Also known as Lactone impurity;
AND
Change
USP Atorvastatin Related Compound I RS (acetonide impurity)
to:
USP Atorvastatin Related Compound I RS
Also known as Acetonide impurity;

In Chromatographic system/Column: Change
4-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
AND
In System suitability: Change
[Note—The relative retention times for bupivacaine hydrochloride and dibutyl phthalate are about 1.0 and 1.2, respectively.]
to:
[Note—The relative retention times for bupivacaine and dibutyl phthalate are about 1.0 and 1.2, respectively.]
AND
In System suitability/Suitability requirements: Change
Resolution: NLT 2.0 between bupivacaine hydrochloride and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the ratio of bupivacaine to the internal standard from three replicate injections
to:
Resolution: NLT 2.0 between bupivacaine and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the peak response ratio of bupivacaine to the internal standard from three replicate injections

Change
A. The UV-Vis spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
to:
A. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

In Standard stock solution: Change
1 mg/mL of USP Pindolol RS in Mobile phase prepared as follows. To a suitable amount of USP Pindolol RS add Mobile phase to fill about 90% of the total volume, and sonicate for about 5 min to dissolve.
to:
1 mg/mL of USP Pindolol RS in Mobile phase prepared as follows. To a suitable amount of USP Pindolol RS add Mobile phase to fill about 90% of the total volume, and sonicate for about 5 min to dissolve. Dilute with Mobile phase to volume.