Errata - English

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 1 of Standard solution: Change
1.2 µg/mL each of USP Miconazole Nitrate RS, USP Econazole Nitrate RS, USP Doxazosin Related Compound C RSUSP Doxazosin Related Compound C RS, USP Miconazole Related Compound F RS, and USP Miconazole Related Compound I RS in Diluent
to:
1.2 µg/mL each of USP Miconazole Nitrate RS, USP Econazole Nitrate RS, USP Miconazole Related Compound C RS, USP Miconazole Related Compound F RS, and USP Miconazole Related Compound I RS in Diluent
AND
In the first variable definition list in Analysis: Change
C_S = concentration of USP Doxazosin Related Compound C RS, USP Doxazosin Related Compound F RS, USP Miconazole Related Compound I RS, or USP Miconazole Nitrate RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Miconazole Related Compound C RS, USP Miconazole Related Compound F RS, USP Miconazole Related Compound I RS, or USP Econazole Nitrate RS in the Standard solution (µg/mL)

Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 2: Change
Samples: Standard solution and Sample solution
to:
Samples: Standard solution A and Sample solution
AND
In the variable definition list: Change
r_S = peak response of erythritol from the Standard solution
C_S = concentration of USP Erythritol RS in the Standard solution (mg/mL)
to:
r_S = peak response of erythritol from Standard solution A
C_S = concentration of USP Erythritol RS in Standard solution A (mg/mL)

This erratum applies to the new USP-NF ONLINE platform only.
Line 1 of System suitability solution: Change
20 mUSP Glyceryl Monocaprylate RSUSP Glyceryl Monocaprylate RSg/mL each of 1-monooctanoyl-rac-glycerol and 1-monodecanoyl-rac-glycerol in tetrahydrofuran
to:
20 mg/mL each of 1-monooctanoyl-rac-glycerol and 1-monodecanoyl-rac-glycerol in tetrahydrofuran

Change
Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.
to:
Buffer solution—Dissolve 15.4 g of ammonium acetate in water, add 11.5 mL of glacial acetic acid, dilute with water to 1000 mL, and mix to obtain a solution having a pH of about 4.7.
Mobile phase—Mix 350 mL of water, 100 mL of Buffer solution, and 550 mL of methanol. Cool to room temperature, dilute with water to 1000 mL, mix, degas, and filter. Make adjustments if necessary (see System Suitability under Chromatography <621>.)
Internal standard solution—Transfer a quantity of diluted nitroglycerin to a suitable volumetric flask, add about 60% of the flask volume of methanol, sonicate for 5 minutes, and shake for 30 minutes. Dilute with methanol to volume to obtain a solution having a concentration of about 3 mg of nitroglycerin per mL, and mix. Allow any undissolved material to settle, filter, and store the filtrate in an airtight container.
Standard preparation—Transfer about 125 mg of recently mixed USP Diluted Isosorbide Dinitrate RS, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of Mobile phase, shake for 30 minutes, dilute with Mobile phase to volume, and mix. Pipet 10 mL of the resulting solution into a 25-mL volumetric flask, and add 4.0 mL of Internal standard solution and 4 mL of dilute Buffer solution (1 in 10). Cool to room temperature, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.25 mg of isosorbide dinitrate per mL, based on the quantity of USP Diluted Isosorbide Dinitrate RS weighed and the labeled content of isosorbide dinitrate. Pass a portion of this solution through a 0.45-µm filter.
AND
Add
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 220-nm detector and a 4-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between isosorbide dinitrate and nitroglycerin is not less than 2.0; and the relative standard deviation for replicate injections determined from the peak response ratios is not more than 2%. [Note—The relative retention times are about 0.75 for isosorbide dinitrate and 1.0 for nitroglycerin. The relative retention times for isosorbide mononitrates, if present, are about 0.38.]
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diluted Isosorbide Dinitrate.
to:
Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

In the variable definition in Analysis: Change
C_S = concentration of USP Cyclophosphamide RS in the Standard solution (mg/mL). [Note—Concentration is calculated on the anhydrous basis.]
C_U = concentration of Cyclophosphamide in the Sample solution (mg/mL). [Note—Nominal concentration is calculated on the anhydrous basis.]
to:
C_S = concentration of USP Cyclophosphamide RS in the Standard solution (mg/mL)
C_U = concentration of Cyclophosphamide in the Sample solution (mg/mL)

Line 3 of Analysis: Change
Calculate the percentage of each specified impurity
to:
Calculate the percentage of each specified impurity, other than chloroquine related compound G,
AND
In Analysis/second equation/variable definition list: Change
r_U=peak response of chloroquine N-oxide or any other impurity from the Sample solution
r_U=peak response of chloroquine related compound G or any other impurity from the Sample solution

Line 1 of Sample solution: Change
25 mg/mL of Norepinephrine Bitartrate in glacial acetic acid. If necessary warm slightly to effect solution.
to:
Dissolve 500 mg of Norepinephrine Bitartrate in 20 mL of glacial acetic acid, warming slightly if necessary to effect solution.

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Line 3 of C.: Change
Standard solution B,
to:
Standard solution C,

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 4 of USP Reference Standards <11>: Change
USP Doxazosin Related Compound C RS
to:
USP Miconazole Related Compound C RS
AND
Line 7 of USP Reference Standards <11>: Change
USP Econazole Nitrate RS
to:
USP Miconazole Related Compound F RS

Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Tablets containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 2 of USP Chlorpheniramine Related Compound C RS: Change
3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine.
C₁₅H₁₇CIN₂ 260.76
to:
3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.
C₁₅H₁₇CIN₂ · C₄H₄O₄ 376.83

Footnote m: Change
(2S,5R,6R)-Ethyl 6-((R)-2-{(2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxamido}-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.
to:
2-(((3-Acetyl-4-(ethoxycarbonyl)-5,5-dimethylthiazolidin-2-yl)methyl)amino)-2-oxo-1-phenylethyl 6-(2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.

Change
Standard solution: 4.0 mg/mL of USP Polydextrose RS, calculated on the anhydrous and ash-free basis, in Mobile phase
Sample solution: 4.0 mg/mL of Hydrogenated Polydextrose, calculated on the anhydrous and ash-free basis, in Mobile phase
to:
Standard solution: 4.0 mg/mL of USP Polydextrose RS in Mobile phase
Sample solution: 4.0 mg/mL of Hydrogenated Polydextrose in Mobile phase

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Line 3 of C.: Change
Standard solution B;
to:
Standard solution C;

In the equation in Standardization: Change
N = mg K₂Cr₂O₇/49.04 x mL Na₂S₂O₃
to:
M = mg K₂Cr₂O₇/49.04 x mL Na₂S₂O₃

This erratum applies to the new USP-NF ONLINE platform only.
In the first variable definition list in Analysis: Change
C_S = concentration of USP Doxazosin Related Compound D RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Dorzolamide Related Compound D RS in the Standard solution (mg/mL)
AND
In the second variable definition list in Analysis: Change
C_S = concentration of USP Doxazosin Related Compound B RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Dorzolamide Related Compound B RS in the Standard solution (mg/mL)

Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia powder prepared from dried rhizome and roots/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 2 of USP Cilostazol Related Compound C RS: Change
1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.
C₃₁H₄₃N₉O₃ 589.73
to:
1-(4-(1-Cyclohexyl-1H-tetrazol-5-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.
C₃₁H₄₅N₉O₂ 575.75

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Lines 3 and 6 of C.: Change
Standard solution B,
to:
Standard solution C,
AND
Change
Standard solution C)
to:
Standard solution D)

Line 4 of paragraph 3 of 3.2 Combined Validation of Accuracy and Precision: Change
validate evaluate
to:
validate
AND
Variable definition in paragraph 6 of 3.2 Combined Validation of Accuracy and Precision: Change
Z²(1 + P)/2 = standard normal
to:
Z²(1 + P)/2 = the square of the standard normal