Errata - English

In Labeling: Change
The label states the Latin binomial(s) of one or several Salix species included in the article.
to:
The label states the Latin binomial(s) of one or several Salix species included in the article. Dosage forms prepared with this article should bear the following statement: Not for use in children, women who are pregnant or nursing, or by persons with known sensitivity to aspirin.
AND
In USP Reference Standards <11>: Delete
(This monograph is postponed indefinitely.)

In Labeling: Change
It meets the labeling requirements of Botanical Extracts <565>.
to:
It meets the labeling requirements of Botanical Extracts <565>. Dosage forms prepared with this article should bear the following statement: Not for use in children, women who are pregnant or nursing, or by persons with known sensitivity to aspirin.
AND
In USP Reference Standards <11> : Delete
(This monograph is postponed indefinitely.)

In Labeling: Change
The label states the Latin binomial(s) of one or several Salix species included in the article.
to:
The label states the Latin binomial(s) of one or several Salix species included in the article. Dosage forms prepared with this article should bear the following statement: Not for use in children, women who are pregnant or nursing, or by persons with known sensitivity to aspirin.
AND
In USP Reference Standards <11>: Delete
(This monograph is postponed indefinitely.)

In Mobile phase and Chromatographic system: Change
Proceed as directed in the Assay under Triazolam.
to:
Proceed as directed in the Assay.
AND
In Procedure: Change
Proceed as directed for Procedure in the Assay under Triazolam.
to:
Proceed as directed in the Assay.

Change
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
to:
The retention time of the metacresol peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Change
Delete the following
^▲•USP Reference Standards <11>
USP Retinyl Acetate RS
USP Retinyl Palmitate RS
_{▲(CN 1-May-2018)}
to:
•USP Reference Standards <11>
USP Retinyl Acetate RS
USP Retinyl Palmitate RS

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)

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

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%.]

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%).

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

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,

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 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)

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 variable definition list of Ciprofloxacin Related Compounds/Analysis: Change
C_U = nominal concentration of ciprofloxacin in the Otic Suspension (mg/mL)
to:
C_U = nominal concentration of ciprofloxacin in the Sample solution (mg/mL)
AND
In the variable definition list of Dexamethasone Related Compounds/Analysis: Change
C_U = nominal concentration of dexamethasone in the Otic Suspension (mg/mL)
to:
C_U = nominal concentration of dexamethasone in the Sample solution (mg/mL)

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 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.