Errata - English

In USP Levalbuterol Related Compound D RS: Change
5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde;
Also known as 5-[2-{(1,1-Dimethylethyl)amino}methyl]-4-hydroxy-3-(methoxymethyl)-benzenemethanol.
C₁₃H₁₉NO₃ 237.29
[NOTE: This Reference Standard is available as the benzesulfonic acid salt.]
to:
5-[2-(tert-Butylamino)-1-hydroxyethyl]-2-hydroxybenzaldehyde sulfate (2:1) (salt);
Also known as 5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde sulfate (2:1).
(C₁₃H₁₉NO₃)₂ · H₂SO₄ 572.67

In Mobile phase: Change
^▲Acetonitrile, methanol, and acetic acid (50:50). To each liter of the solution add 3 mL of acetic acid and 1 mL of triethylamine._{▲ (USP 1-May-2019)}
to:
Acetonitrile and methanol (50:50). To each liter of the solution add 3 mL of acetic acid and 1 mL of triethylamine.

In USP Levalbuterol Related Compound D RS: Change
5-{2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl}-2-hydroxy-benzaldehyde.
C₁₃H₁₉NO₃ 237.29
^▲[NOTE—This may be available as the sulfate salt (2:1).]_{▲ (USP 1-May-2019)}
to:
5-[2-(tert-Butylamino)-1-hydroxyethyl]-2-hydroxybenzaldehyde sulfate (2:1) (salt);
Also known as 5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde sulfate (2:1).
(C₁₃H₁₉NO₃)₂ · H₂SO₄ 572.67

In the second variable definition list in Analysis: Change
V_S = volume of the Sample solution withdrawn at each time point, i
to:
V_S = volume of the Sample solution withdrawn at each time point, i (mL)

In Row 2 of Column 3 of Table 4: Change
0.014^▲/0.028_{▲2S (USP41)}
to:
0.014
AND
In Row 3 of Column 3 of Table 4: Change
0.014
to:
0.014/0.028
AND
In Chromatographic system/Column: Change
4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B (80:20) for NLT 20 min is recommended prior to use.]
to:
4.6-mm × 15-cm; 5-µm packing L7

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
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.]

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].

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
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.)

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 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

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
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.)

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.