Errata - English

Line 1 of USP 2-Propanol System Suitability RS: Change
It contains 0.1% of each of the following: ethyl ether, acetone, isopropyl alcohol, diisopropyl ether, 1-propanol, and 2-butanol.
to:
It is a mixture of the following: ethyl ether (0.1%), acetone (0.1%), diisopropyl ether (0.1%), 1-propanol (0.1%), 2-butanol (0.1%), and isopropyl alcohol (99.5%).

Line 4: Change
(±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol l-(+)-tartrate (2:1) (salt);
1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt
to:
(±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (+)-tartrate (2:1) (salt);
1-(Isopropylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol L-tartrate

In the second Calculate statement in Analysis: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)
AND
In Tolerances: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)

In the variable definition list in Analysis: Change
C_S = concentration of USP Acamprosate Calcium Related Compound A RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Acamprosate Related Compound A RS in the Standard solution (µg/mL)

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

This erratum applies to the Revision Bulletin posted on www.uspnf.com only.
In the variable definition list in Analysis: Change
C_U = nominal concentration of the Sample solution (mg/mL)
to:
C_U = nominal concentration of the Sample solution (mg/mL)
[Note—Disregard any peak less than 0.1%.]

In the variable definition list in Analysis: Change
C_S = concentration of oxybutynin chloride in the Standard solution (mg/mL)
to:
C_S = concentration of USP Oxybutynin Chloride RS in the Standard solution (mg/mL)

This erratum applies to the new USP-NF ONLINE platform only.
Line 2 of Standard solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,
AND
Line 2 of Sample solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,

This erratum applies to the Revision Bulletin posted on www.uspnf.com only.
In System suitability: Add
[Note—The relative retention times for oxybutynin and oxybutynin related compound A are about 1.0 and 1.6, respectively.]

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

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 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 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

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 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

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 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.
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

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
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