Errata - English

In Test A: Change
It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in R_F value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.
to:
Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in R_F value to that obtained from the Standard solution. The spot obtained from the test solution, corresponding in R_F value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.

In test A: Change
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

In System suitability: Change
Samples: System suitability solution, Standard solution A, and Standard solution B
to:
Samples: System suitability solution and Standard solution A
AND
In Analysis: Change
Samples: Mobile phase, Standard solution A, and Sample solution
Chromatograph the Standard solution and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.
to:
Samples: Mobile phase, Standard solution A, Standard solution B, and Sample solution
Chromatograph Standard solution B and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.

In Limit of Unspecified Impurities: Change
Mobile phase and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase, Standard stock solution, and Chromatographic system: Proceed as directed in the Assay.

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 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 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 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 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 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 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 Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r22) × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100

In Analysis: Change
Calculate the percentage of any unspecified impurities in the portion of Sotalol Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × 100
r_U= sum of all the peak responses of all unspecified impurities from the Sample solution
to:
Calculate the percentage of any unspecified impurity in the portion of Sotalol Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × 100
r_U = peak response of each unspecified impurity from the Sample solution
AND
In Table 1: Change
Any unspecified impurities
to:
Any unspecified impurity

Change
Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”:
to:
Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light:

Change
Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”:
to:
Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light:

Change
Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection.
to:
Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine Hydrochloride and Epinephrine Injection.

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

Change
Proceed as directed in the Identification test under Erythromycin Ethylsuccinate Oral Suspension, beginning with “Prepare a Standard solution.”
to:
Prepare a Standard solution of USP Erythromycin Ethylsuccinate RS in methanol containing about 3 mg per mL. Apply separately 10 µL each of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel mixture, and allow to dry. Place the plate in an unlined chromatographic chamber, and develop the chromatograms in a solvent system consisting of a mixture of methanol and chloroform (85:15) until the solvent front has moved about 9 cm. Remove the plate from the chamber, mark the solvent front, and allow the solvent to evaporate. Spray the plate with a mixture of dehydrated alcohol, p-methoxybenzaldehyde, and sulfuric acid (90:5:5). Heat the plate at 100° for 10 minutes, and examine the chromatograms, in which the erythromycin and succinic acid moieties appear as black-to-purple spots: the R_F values of the principal spots obtained from the test solution correspond to those obtained from the Standard solution.

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 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
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 Analysis: Change
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
C_U = nominal concentration of prazosin in the Sample solution (µg/mL)
M_r1 = molecular weight of prazosin, 383.41
M_r2 = molecular weight of prazosin hydrochloride, 419.86
to:
C_S = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
C_U = nominal concentration of prazosin in the Sample solution (mg/mL)
M_r1 = molecular weight of prazosin, 383.41
M_r2 = molecular weight of prazosin hydrochloride, 419.87

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 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 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)