Errata - English

In the Analysis: Change
Result = (r_U/r_S) × C_S × (M_r1/M_r2) × V × (100/L)
to:
Result = (r_U/r_S) × C_S × (M_r1/M_r2) × V × (100/L) × D
AND
In the variable definition list in Analysis: Add
D = dilution factor for the Sample solution, 2

In the System suitability solution: Change
0.5 mg/mL of USP Naproxen Sodium 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 Sodium RS in Diluent

Line 2 of USP Ethinyl Estradiol Related Compound B RS: Change
19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol.
C₂₀H₂₂O₂ 294.39
to:
19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol monohydrate.
C₂₀H₂₂O₂ · H₂O 312.40

Line 1: Change
Proceed with Ophthalmic Suspension as directed in the Assay under Hydrocortisone Acetate Injectable Suspension.
to:
Standard preparation—Prepare as directed for Assay for Steroids <351>, Standard Preparation, using USP Hydrocortisone Acetate RS.
Assay preparation—Transfer to a separator an accurately measured volume of Ophthalmic Suspension, equivalent to about 50 mg of hydrocortisone acetate, and dilute with water to about 15 mL. Extract with four 25-mL portions of chloroform, filtering each portion through chloroform-washed cotton into a 250-mL volumetric flask. Add chloroform to volume, and mix. Pipet 10 mL of this solution into a 100-mL volumetric flask, add chloroform to volume, and mix. Pipet 10 mL of the resulting solution into a glass-stoppered, 50-mL conical flask, evaporate the chloroform on a steam bath just to dryness, cool, and dissolve the residue in 20.0 mL of alcohol.
Procedure—Proceed as directed for Assay for Steroids <351>, Procedure. Calculate the quantity, in mg, of hydrocortisone acetate (C₂₃H₃₂O₆) in each mL of Ophthalmic Suspension taken by the formula:
5(C/V)(A_U/A_S)
in which V is the volume, in mL, of Ophthalmic Suspension taken; and the other terms are defined therein.

In the equation in Analysis: Change
Result = (r_U/r_S) × (1/F) × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × (1/F) × 100
AND
Add to the variable list:
C_S = concentration of guaifenesin in the Diluted sample solution
C_U = concentration of guaifenesin in the Sample solution

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)

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

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: