Errata - English

In Table 2, footnote b: Change
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-4a,5a,6,12a-tetrahydro-3,5,10,12,12a-pentahydroxy-6-methyl-tetracene-1,11-dioxo-2-naphthacenecarboxamide.
to:
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,11(4H,5H)-dione.

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 Limit of Methanol (Methyl Alcohol) and Methyl Acetate/Analysis: Change
C_U = concentration of methanol (methyl alcohol) or methyl acetate in the Sample solution (mg/mL)
to:
C_U = concentration of Polyvinyl Alcohol in the Sample solution (mg/mL)

Change
A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
to:
A: Triturate a quantity of the contents of Capsules, equivalent to about 500 mg of theophylline, with 10-mL and 5-mL portions of solvent hexane, and discard the solvent hexane. Triturate the residue with two 10-mL portions of a mixture of equal volumes of 6 N ammonium hydroxide and water, and filter each time. Evaporate the combined filtrates to about 5 mL, neutralize, if necessary, with 6 N acetic acid, using litmus, and then cool to about 15°, with stirring. Collect the precipitate on a filter, wash it with cold water, and dry at 105° for 2 hours: the theophylline so obtained melts between 270° and 274° (see Melting Range or Temperature 〈741〉, Procedures, Procedure for Class I). Retain the remaining portion of the theophylline for use in Identification test B.
B: The IR absorption spectrum of a potassium bromide dispersion of the residue obtained in Identification test A exhibits maxima only at the same wavenumbers as that of a potassium bromide dispersion of USP Theophylline RS.
C: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Line 1: Change
Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask:it meets the requirements of the test for Specific rotation under Mannitol.
to:
+137° to +145°.Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask. Add 40 mL of a 1-in-10 ammonium molybdate solution, previously filtered if necessary. Add 20 mL of 1 N sulfuric acid, and dilute with water to volume.

Line 2: Change
Sample: System suitability solution
to:
Samples: System suitability solution and Standard solution
AND
Line 2 of Suitability requirements: Change
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections
to:
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks, System suitability solution
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections, Standard solution

Line 6 of Analysis: Change
Result = (r_U/r_S) × (C_U/C_S) × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100

In Analysis: Change
^▲Add 1 mL of silver nitrate TS to the Standard solution and then add a 50-mL portion of the Sample solution. Mix and allow to stand for 5 min protected from direct sunlight. Compare the turbidity of the solutions._{▲(NF 1-May-2019)}
to:
Add 1 mL of silver nitrate TS to the Standard solution. Add 1 mL of silver nitrate TS to a 50-mL portion of the Sample solution. After mixing, allow each solution to stand for 5 min protected from direct sunlight. Compare the turbidity of the solutions.

In paragraph 2 of 2.4 Study Design/2.4.1 Time Points: Change
Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution 〈1090〉.
to:
Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution 〈1090〉.

In USP Pyrantel Related Compound A RS: Change
(Z)-1-Methyl-2-(2-(thiophen-2-yl)vinyl)-1,4,5,6-tetrahydropyrimidine.
C₃₄H₃₀N₂O₆S 594.69
to:
(Z)-1-Methyl-2-[2-(2-thiophenyl)vinyl]-1,4,5,6-tetrahydropyrimidine 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1).
C₁₁H₁₄N₂S · C₂₃H₁₆O₆ 594.68

In Acceptance criteria: Change
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the dried basis
to:
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the anhydrous basis

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.

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:

In Organic Impurities/Table 2: Change
3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycin^m
to:
3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycin^m
AND
In Table 2/footnote m: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.

Change
Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Sterile Preparations <797>).
to:
Prepare Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel containing 40 mg/mL of lidocaine hydrochloride, 1 mg/mL of racepinephrine hydrochloride, and 10 mg/mL of tetracaine hydrochloride as follows (see Pharmaceutical Compounding—Nonsterile Preparations <795>).

Line 16 of Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 14 of the second Calculate statement in Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

In Qualitative and Quantitative Analysis of Pesticide Residues: Change
[Note—Current version Document No. SANTE/11813/2017, https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_wrkdoc_2017-11813.pdf]
to:
[Note—Current version Document No. SANTE/12682/2019, https://ec.europa.eu/food/system/files/2020-01/pesticides_mrl_guidelines_wrkdoc_2019-12682.pdf]

In Chromatographic system: Change
Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the standard deviation for replicate injections is not more than 2.0%.
to:
Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

In Liquid Chromatography: Isocratic Elution/Injection volume: Change
Result = (V_inj2 = V_inj1 (L₂ d_c2² )/(L₁ d_c1²)
to:
V_inj2 = V_inj1 (L₂ d_c2² )/(L₁ d_c1²)
AND
In Liquid Chromatography: Gradient Elution/Column parameters and flow rate: Change
F₂ = F₂ × [(dc₂² × dp₁)/(dc₁² × dp₂)]
to:
F₂ = F₁ × [(dc₂² × dp₁)/(dc₁² × dp₂)]

In USP Melengestrol Acetate Related Compound A RS: Change
16-Methylene-17α-hydroxy-4-pregnene-3,20-dione 17-acetate.
to:
16-Methylene-3,20-dioxopregn-4-en-17-yl acetate.
AND
In USP Melengestrol Acetate Related Compound B RS: Change
17α-Hydroxy-6,16-dimethyleneprogna-4-ene-3,20-dione 17-acetate.
to:
6,16-Dimethylene-3,20-dioxopregn-4-en-17-yl acetate.

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

This erratum applies to the new USP-NF ONLINE platform only.
In the variable definition in Analysis: Change
C_S = concentration of USP Sumatriptan Succinate Related Compound A RS
to:
C_S = concentration of USP Sumatriptan Succinate RS

In Analysis: Change
Result = {r_U/[r_S + (Σr_U/F)]} × (1/F) × 100
to:
Result = {r_U/[r_S + Σ(r_U/F)]} × (1/F) × 100