Errata - English

In Standard stock solution: Change
(equivalent to 0.05 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS free base
to:
(equivalent to 0.05 mg/mL of carbinoxamine) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS (as the free base)
AND
In the Standard solution: Change
(equivalent to 0.001 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.001 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS free base
to:
(equivalent to 0.001 mg/mL of carbinoxamine) and 0.001 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS (as the free base)
AND
In the Analysis: Change
C_S = concentration of USP Carbinoxamine Maleate RS free base
to:
C_S = concentration of USP Carbinoxamine Maleate RS (as the free base)

In Analysis: Change
r_U = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline hydrochloride from the Sample solution
r_S = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline hydrochloride from the Standard solution
to:
r_U = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline from the Sample solution
r_S = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline from the Standard solution

In USP Mesna Related Compound A RS: Change
2-(Acetylthio)ethane-1-sulfonic acid.
C₄H₈O₄S₂ 184.22
to:
2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride.
C₄H₇KO₄S₂ ∙ KCl 296.86
AND
In USP Mesna Related Compound B RS: Change
2,2′-Disulfanediylbis(ethane-1-sulfonic acid).
C₄H₁₀O₆S₄ 282.36
to:
2,2′-Disulfanediylbis(ethane-1-sulfonic acid), dipotassium salt, crystal adduct with sodium chloride.
C₄H₈K₂O₆S₄ ∙ NaCl 416.98

In the Standard stock solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In the Standard solution: Change
USP Carbinoxamine Maleate RS free base)
to:
carbinoxamine)
AND
In the Analysis: Change
C_S = concentration of USP Carbinoxamine Maleate RS free base
to:
C_S = concentration of USP Carbinoxamine Maleate RS (as the free base)

Change
Standard solution: 0.5 µg/mL of USP Leflunomide RS, from the Standard solution in Mobile phase
to:
Standard stock solution: Proceed as directed in the Standard solution in the Assay.
Standard solution: 0.5 µg/mL of USP Leflunomide RS from the Standard stock solution in Mobile phase

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 the definition list in Particle Size Distribution by Cascade Impaction/Analysis: Change
M_r1 = molecular weight of salmeterol free base, 415.75
to:
M_r1 = molecular weight of salmeterol free base, 415.57
AND
In the definition list in Delivered-Dose Uniformity <601>/Analysis: Change
M_r1 = molecular weight of salmeterol free base, 415.75
to:
M_r1 = molecular weight of salmeterol free base, 415.57

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 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.

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)