Errata - English

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 Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

In Analysis: Change
C_U = nominal concentration of dimenhydrinate in the Sample solution (mg/mL)
to:
C_U = determined concentration of dimenhydrinate in the Sample solution, as obtained in the Assay (mg/mL)

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.

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 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.

In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
to:
Acid stage standard solution: (L/10000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
AND
In Dissolution <711>/Test 2/Buffer stage: Change
Buffer stage standard solution: (L/1000) of USP Pantoprazole Sodium RS where L is the label claim in mg/Tablet
to:
Buffer stage standard solution: (L/1000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Buffer stage medium, where L is the label claim in mg/Tablet

In Dissolution 〈711〉/Standard solution: Change
USP Dapsone RS of a known concentration in Medium
to:
(L/1000) mg/mL of USP Dapsone RS in Medium, where L is the label claim in mg/Tablet. Transfer a portion of this solution containing 0.2 mg of dapsone to a 25-mL volumetric flask, add 5 mL of 1 N sodium hydroxide, and dilute with water to volume.

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 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 Dissolution 〈711〉/Test 1/Analysis: Change
Result = (r_U/r_S) × C_S × V × (1/L) × 100
r_U = peak response of linezolid from the Sample solution
r_S = peak response of linezolid from the Standard solution
C_S = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
to:
Result = (r_U/r_S) × C_S × V × (1/L) × D × 100
r_U = peak response of linezolid from the Sample solution
r_S = peak response of linezolid from the Standard solution
C_S = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
D = dilution factor of the Sample solution, as needed

In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change
10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL
to:
Dissolve 10 g of cetyltrimethylammonium bromide and 1.6 g of pepsin, purified in 1000 mL of 0.1 N hydrochloric acid; 900 mL

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

In Dissolution 〈711〉/Test 1/Analysis: Change
Determine the percentage of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U × C_S × V × 100)/(A_S × D × L)
to:
Calculate the percentage of the labeled amount of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U/A_S) × C_S × V × D × (1/L) × 100
AND
Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)
AND
In Dissolution 〈711〉/Test 2/Analysis: Change
r_U = peak response from the Sample solution
r_S = peak response from the Standard solution
to:
r_U = peak response of telmisartan from the Sample solution
r_S = peak response of telmisartan from the Standard solution
AND
In Dissolution 〈711〉/Test 3/Analysis: Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)

In Dissolution 〈711〉/Medium: Change
26.7 g/L of sodium acetate trihydrate in water. Add 133 mL of glacial acetic acid to this solution, and then dilute with water to 10 L; 900 mL.
to:
0.02 M sodium acetate buffer, pH 3.5, prepared as follows. Dissolve 2.67 g of sodium acetate in 100 mL of water. Add 13.3 mL of glacial acetic acid and then dilute with water to 1000 mL; 900 mL.

In Test 6: Change
Times: 0.5, 1, and 4 h—for strengths 540 and 1080 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strength 1620 mg as potassium citrate monohydrate.
to:
Times: 0.5, 1, and 4 h—for strength 540 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strengths 1080 and 1620 mg as potassium citrate monohydrate.

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)

In Analysis: Change
Results = (A_U/A_S) × C_S × D × (1/L) × V × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
D = dilution factor for Sample solution, if needed
L = label claim (mg/Tablet)
V = volume of Medium, 500 mL
to:
Result = (A_U/A_S) × C_S × V × D × (M_r1/M_r2) × (1/L) × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
V = volume of Medium, 500 mL
D = dilution factor for the Sample solution, if needed
M_r1 = molecular weight of prochlorperazine, 373.94
M_r2 = molecular weight of prochlorperazine maleate, 606.09
L = label claim (mg/Tablet)

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

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 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 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 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

In General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)
to:
where L is the limit in the original article as listed in Table 5 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)

In footnote 1 in Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography/Chromatographic system/Columns/Analytical: Change
guard column TSK SWXL 6-mm × 4-mm;
to:
guard column TSK SWXL 6-mm × 4-cm;

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 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)