Errata - English

Change
Table 3
to:
Table 4
AND
Change
Table 4
to:
Table 5
AND
Line 1 of Mobile phase: Change
Table 3
to:
Table 4
AND
In the variable definition list in Analysis: Change
F = relative response factor for each impurity (see Table 4)
to:
F = relative response factor for each impurity (see Table 5)
AND
Line 1 of Acceptance criteria: Change
Table 4
to:
Table 5

Line 3 of System suitability solution: Change
0.5 mg/mL of USP Naproxen RS and 0.5 µg/mL of USP Naproxen Related Compound A RS in Diluent, from Standard stock solution 1 and Standard stock solution 2, respectively
to:
0.5 µg/mL of USP Naproxen Related Compound A RS from Standard stock solution 2 and 0.5 mg/mL of USP Naproxen RS in Diluent

Line 2 of Bupivacaine Related Compound B: Change
N-(2,6-Dimethylphenyl)piperidine-2-carboxamide.
C₁₄H₂₀N₂O 232.32
to:
N-(2,6-Dimethylphenyl)piperidine-2-carboxamide hydrochloride.
C₁₄H₂₀N₂O · HCl 268.79

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)

Change
Test preparation: Into a 50-mL color-comparison tube place 10.0 mL of Solution S.
to:
Test preparation: Into a 50-mL color-comparison tube pipet 10.0 mL of Solution S and dilute with water to 25 mL. Using a pH meter or short-range pH indicator paper as external indicator, adjust with 1 N acetic acid or 6 N ammonium hydroxide to a pH of between 3.0 and 4.0, dilute with water to 40 mL, and mix.

Equation in Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × (Mr₁/Mr₂) × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100
AND
In the variable definition list: Delete
Mr₁ = molecular weight of milrinone free base, 211.22
Mr₂ = molecular weight of milrinone lactate, 151.16

Line 3 of Analysis: Change
Calculate the percentage of insulin lispro, A-21 desamido insulin lispro, and other impurities in the portion of Insulin Lispro taken:
to:
Calculate the percentage of insulin lispro, A-21 desamido insulin lispro, and other impurities in the portion of Injection taken:

Line 3 of System suitability: Change
[Note—The relative retention times of aniline and p-toluidine are about 4.1 and 5.1 min, respectively.]
to:
[Note—The relative retention times of aniline and p-toluidine are 0.8 and 1.0, respectively.]

(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

(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)

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 1 of System suitability solution: Change
0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Econazole Nitrate RS in Diluent.
to:
0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Miconazole Related Compound F RS in Diluent.

In the second variable definition in Analysis: Change
r_U = peak response of chloroindolinone or ziprasidone related compound F from the Sample solution
to:
r_U = peak response of chloroindolinone, ziprasidone related compound F, or any unspecified impurity from the Sample solution

Line 1 of Sample solution: Change
1.1 µg/mL of sodium fluoride
to:
0.5 µg/mL of fluoride ion
AND
In the variable definition list in Analysis: Change
C_U = nominal concentration of sodium fluoride in the Sample solution (µg/mL)
to:
C_U = nominal concentration of fluoride ion in the Sample solution (µg/mL)

Line 1 of Medium B: Change
Kreb's salt solution containing 0.3% (v/v) human serum albumen
to:
Krebs' salt solution containing 0.3% (v/v) human serum albumin
AND
Line 1 of Medium C: change
Kreb's salt solution containing 0.3% (v/v) human serum albumen
to:
Krebs' salt solution containing 0.3% (v/v) human serum albumin

Line 1 of Plastic Additives/Reference solutions/Reference solution I: Change
0.24 mg/mL of USP Plastic Additive 4 RS prepared in the Solvent mixture
to:
0.24 mg/mL of USP Plastic Additive 4 RS prepared in methylene chloride
AND
Line 1 of Reference solution J: Change
0.24 mg/mL of USP Plastic Additive 5 RS prepared in the Solvent mixture
to:
0.24 mg/mL of USP Plastic Additive 5 RS prepared in methylene chloride
AND
Line 1 of Poly(ethylene-vinyl acetate)/Polyvinyl chloride, plasticized/Reference solutions U, V, W: Change
0.1-mg/mL solutions
to:
10.0-mg/mL solutions

Line 1 of Sample solution: Change
Polydextrose, calculated on the anhydrous and ash-free basis, in Mobile phase
to:
Polydextrose in Mobile phase
AND
Line 1 of Acceptance criteria: Change
NLT 90.0%
to:
NLT 90.0% on the anhydrous and ash-free basis

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 2 of USP Doxepin Related Compound C RS: Change
(E,Z)-3-(Dibenzo[b,e]oxepin-11(6H-ylidene)-N-methyl-propoan-1-amine.
to:
(E,Z)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride.

In the second variable definition list: Change
C_S2 = concentration of USP Cholesterol RS in the Standard solution (mg/mL)
to:
C_S2 = concentration of USP Cholesterol RS in the System suitability solution (mg/mL)

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)

Line 2 of USP Eszopiclone Related Compound A RS:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoic salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO 561.38
to:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoate salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO₂ 561.38