Errata - English

In Column: Change
4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B ^▲(90:10)_▲ (ERR 1-Mar-2019) for about 30 min is recommended prior to use.]
to:
4.6-mm × 15-cm; 5-µm packing L7

In USP Atorvastatin Related Compound A RS: Change
Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2-isopropyl-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2);
Also known as Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.

Change
3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol;
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside [250249-75-3].
to:
3-Rhamnoglucoside of 5,7,3',4'-tetrahydroxyflavonol trihydrate;
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside trihydrate [250249-75-3].

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

Change
Sample solution: 0.12 mg/mL of Mercaptopurine in Solution A. [NOTE—Inject the Sample solution within 1 h of preparation.]
to:
Sample stock solution: 0.5 mg/mL of mercaptopurine in a mixture of methanol and Solution A (1:9) prepared as follows. Transfer a suitable quantity of Mercaptopurine to an appropriate volumetric flask, add methanol equivalent to 10% of the final volume, and shake to dissolve. Dilute with Solution A to volume.
Sample solution: 0.12 mg/mL of mercaptopurine in Solution A from the Sample stock solution. [NOTE—Inject the Sample solution within 1 h of preparation.]

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 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)

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 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
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

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.

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.

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

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 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)