Errata - English

In Analysis: Change
Calculate the percentage of Nandrolone Decanoate (C₂₈H₄₄O₃) in the portion of Nandrolone Decanoate taken:
to:
Calculate the percentage of nandrolone decanoate (C₂₈H₄₄O₃) in the portion of Nandrolone Decanoate taken:

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 USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

In Standardization with visual end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄
AND
In Standardization with potentiometric end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄

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.

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 b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.

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.

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:

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 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 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)

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 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 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 USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

Change
Standard solution: 1.0 µg/mL of USP p-Chloroaniline RS in Diluent
to:
Standard solution: 0.001 mg/mL of USP p-Chloroaniline RS in Diluent
AND
In Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × D × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100
AND
Delete
D = dilution factor for the Sample solution, 2.5

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

Change:
B. Test for Hydroxyl Group:
to:
B. Hydroxyl Value:
AND
In D./Analysis: Change
Dissolve or disperse the Sample in alcohol.
to:
Dissolve or disperse the Sample in 5 mL alcohol.

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 Procedure/Analysis: Change
Calculate the percentage of methylbenzethonium chloride (C₂₈H₄₄ClNO₂ · H₂O) in the portion of Methylbenzethonium Chloride taken:
to:
Calculate the percentage of methylbenzethonium chloride (C₂₈H₄₄ClNO₂) in the portion of Methylbenzethonium Chloride taken:

In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change
Meets the requirements when tested as specified in test B.
to:
Meets the requirements of the test for amine hydrochlorides

In Analysis: Change
bromocriptine mesylate (C₃₂H₄₀BrN₅O₅ · CH₄SO₃)
to:
bromocriptine (C₃₂H₄₀BrN₅O₅)
AND
In Tolerances: Change
bromocriptine mesylate (C₃₂H₄₀BrN₅O₅ · CH₄SO₃)
to:
bromocriptine (C₃₂H₄₀BrN₅O₅)

In System suitability solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In System suitability/Samples: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
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)

Change
Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets.
to:
Application volume—5 µL.
Developing solvent system—a mixture of methanol, chloroform, water, and pyridine (90:80:30:10).
Procedure—Proceed as directed in Thin-Layer Chromatographic Identification Test <201>. Dry the plate with the aid of a current of warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes.