Errata - English

This erratum applies to the new USP-NF ONLINE platform only.
Change
System suitability
^▲_{▲1S (USP41)}
Sample: Standard solution
Suitability requirements
Tailing factor: NMT 2.0
to:
System suitability
Sample: Standard solution
Suitability requirements
^▲_{▲1S (USP41)}
Tailing factor: NMT 2.0

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 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

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

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

This erratum applies to the new USP-NF ONLINE platform only.
Line 1 of Standard stock solution 2: Change
0.1 mg/mL of in Diluent.
to:
0.1 mg/mL of USP Triamterene Related Compound A RS in Diluent.
AND
Line 1 of Standard stock solution 3: Change
0.1 mg/mL of USP Tranylcypromine Related Compound B RS in Diluent.
to:
0.1 mg/mL of USP Triamterene Related Compound B RS in Diluent.

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

This erratum applies to the new USP-NF ONLINE platform only.
Change
Mobile phase: Methanol and Buffer (30:70)
Diluent: Methanol, water, and 0.05 N sulfuric acid ^▲VS_{▲1S (USP41)} (20:60:20)
to:
Mobile phase: Methanol and Buffer (30:70)
^▲_{▲(ERR 1-Oct-2018)}
Diluent: Methanol, water, and 0.05 N sulfuric acid ^▲VS_{▲1S (USP41)} (20:60:20)

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

Line 1 of Standard stock solution: Change
50 mg of USP Nifedipine RS in Diluent A and water (50:50)
to:
0.50 mg/mL of USP Nifedipine RS prepared as follows. Transfer a suitable amount of USP Nifedipine RS to an appropriate volumetric flask. Dissolve in 50% of the flask volume of Diluent A. Dilute with water to volume.
AND
Line 1 of Instrumental conditions/Analytical wavelength: Change
238 nm
to:
338 nm

This erratum applies to the new USP-NF ONLINE platform only.
Change
3. Solution A–Mix 850 mg of bismuth subnitrate with 40 mL of water and 10 mL of glacial acetic acid.
4. Solution B–Dissolve 8 g of potassium iodide in 20 mL of water. Mix A and B together to obtain a Stock Solution which can be stored for several months in a dark bottle. Mix 10 mL of the Stock Solution with 20 mL of glacial acetic acid, and dilute with water to make 100 mL, to prepare the spray reagent.
to:
3. Solution A–Mix 850 mg of bismuth subnitrate with 40 mL of water and 10 mL of glacial acetic acid.
Solution B–Dissolve 8 g of potassium iodide in 20 mL of water. Mix A and B together to obtain a Stock Solution which can be stored for several months in a dark bottle. Mix 10 mL of the Stock Solution with 20 mL of glacial acetic acid, and dilute with water to make 100 mL, to prepare the spray reagent.
AND
Update list numbers
5–23
to:
4–22

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)

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

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.

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 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.

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)

(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 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