Errata - English

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

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 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

In System suitability: Change
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
to:
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
AND
In System suitability/Suitability requirements/Resolution: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Analysis: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Acceptance criteria: Change
(3R,3′S-meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin

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,

Change
Uniformity of Dosage Units 〈905〉
Procedure for content uniformity
to:
Uniformity of Dosage Units 〈905〉: Meets the requirements
Procedure for content uniformity, chewable tablets only
AND
In Uniformity of Dosage Units: Delete
Acceptance criteria: Meet the requirements for chewable tablets

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 Analysis: Change
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_U.)
to:
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_A.)

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 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.

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 Sample solution: Change
Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min until the supernatant is clear. Use the clear supernatant for analysis.
to:
Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min. Dilute with Diluent to volume, and shake. Allow to stand for 10 min until the supernatant is clear. Use the clear supernatant for analysis.

In Test 2/Analysis: Change
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
AND
Change
M_r2 = molecular weight of prazosin hydrochloride, 419.86
to:
M_r2 = molecular weight of prazosin hydrochloride, 419.87

Change
Constitute Erythromycin Ethylsuccinate for Oral Suspension as directed in the labeling, and proceed as directed in the Assay under Erythromycin Ethylsuccinate Oral Suspension.
to:
Constitute Erythromycin Ethylsuccinate for Oral Suspension as directed in the labeling, and proceed as directed for erythromycin under Antibiotics—Microbial Assays 〈81〉, using an accurately measured volume of the reconstituted suspension, freshly mixed and free from air bubbles, blended for 4 ± 1 minutes in a high-speed glass blender jar with sufficient methanol to give a stock solution containing the equivalent of about 1 mg of erythromycin per mL. Dilute this stock solution quantitatively with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.

In Test 2/Analysis: Change
C_S = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (ug/mL) in the Standard solution
to:
C_S = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (µg/mL) in the Standard solution

In Test 1: Change
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions)
to:
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions); 900 mL