Errata - English

In Liquid Chromatography: Isocratic Elution/Injection volume: Change
L₂ = internal diameter of the column used (mm)
dc₁ = particle size indicated in the monograph (µm)
dc₂ = particle size of the column used (µm)
to:
L₂ = new column length (mm)
dc₁ = column internal diameter indicated in the monograph (mm)
dc₂ = new column internal diameter (mm)

In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems.

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 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 Organic Impurities: Change
Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase and Chromatographic system: Proceed as directed in the Assay.
AND
Change
Standard solution: 1 µg/mL of metronidazole from USP Metronidazole RS and 2 µg/mL of tinidazole related compound A from USP Tinidazole Related Compound A RS in Mobile phase
to:
Standard solution: 1 µg/mL of metronidazole from USP Metronidazole RS and 2 µg/mL of tinidazole related compound A from USP Tinidazole Related Compound A RS in Mobile phase
Sample solution: Nominally 1 mg/mL of metronidazole prepared as follows. Mix the contents of Capsules (NLT 20). Transfer an amount equivalent to 100 mg of metronidazole to a 100-mL volumetric flask, add 80 mL of Mobile phase, and sonicate with intermittent shaking for 10 min. Shake for 30 min, and dilute with Mobile phase to volume. Centrifuge a portion of the solution.

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 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 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

In Organic Impurities, Procedure 1: Change
System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

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.

Change
The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm^–1.
to:
The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm^–1.

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 Procedure/System suitability: Change
[Note—The relative retention times for acetanilide, cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.4, 0.8, 0.9, and 1.0, respectively.]
to:
[Note—The relative retention times for cefuroxime axetil diastereoisomer B, cefuroxime axetil diastereoisomer A, and cefuroxime axetil delta-3 isomers are 0.8, 0.9, and 1.0, respectively.]

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 Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity solution,
AND
In System suitability/Suitability requirements: Delete
Signal-to-noise ratio: NLT 10, Sensitivity solution

In Analysis: Change
Result = (r_U/r_S) × C_S × (1/F)
to:
Result = (r_U/r_S) × C_F × (1/F)
AND
Change
C_S = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)
to:
C_F = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)

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)

Change
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay, and use 40 µL injection volume for the Sensitivity solution.

In USP Metaraminol Enantiomer RS: Change
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol.
C₉H₁₃NO₂ 167.21
to:
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol D-tartrate.
C₉H₁₃NO₂ ∙ C₄H₆O₆ 317.29

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

In Dissolution 〈711〉/Test 8/Tolerances: Change
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 1.
to:
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 2.

Change
Where the label states that Seco barbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and for Bacterial endotoxins under Secobarbital Sodium for Injection. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Secobarbital Sodium for Injection.
to:
Where the label states that Secobarbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>.

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 to a 500-mL volumetric flask, dilute with water to volume, and mix well.

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.