Errata - English

In USP Ondansetron Related Compound A RS: Change
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
C₁₆H₂₀N₂O · HCl 292.80
to:
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.
C₁₆H₂₀N₂O · HCl 292.81
AND
In USP Ondansetron Related Compound D RS: Change
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
to:
9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one.

In footnote 2: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.

Change
Uniformity of Dosage Units 〈905〉
Procedure for content uniformity
to:
Uniformity of Dosage Units 〈905〉: Meets the requirements
Procedure for content uniformity, chewable tablets only
AND
In Uniformity of Dosage Units: Delete
Acceptance criteria: Meet the requirements for chewable tablets

In Dissolution 〈711〉/Test 1/Analysis: Change
Determine the percentage of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U × C_S × V × 100)/(A_S × D × L)
to:
Calculate the percentage of the labeled amount of telmisartan (C₃₃H₃₀N₄O₂) dissolved:
Result = (A_U/A_S) × C_S × V × D × (1/L) × 100
AND
Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)
AND
In Dissolution 〈711〉/Test 2/Analysis: Change
r_U = peak response from the Sample solution
r_S = peak response from the Standard solution
to:
r_U = peak response of telmisartan from the Sample solution
r_S = peak response of telmisartan from the Standard solution
AND
In Dissolution 〈711〉/Test 3/Analysis: Change
C_S = concentration of the Standard solution (mg/mL)
to:
C_S = concentration of USP Telmisartan RS in the Standard solution (mg/mL)

Change
Sample: Standard solution
to:
Samples: System suitability solution and Standard solution
AND
Change
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound B, System suitability solution
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 2.0%, Standard solution

Line 1 of Standard solution A: Change
USP Ganoderic Acid RS
to:
USP Ganoderic Acid A RS
AND
Line 3 of variable definition list in Analysis: Change
r_S = peak area of ganoderic acid in Standard solution A
to:
r_S = peak area of ganoderic acid A in Standard solution A
AND
Line 11 of variable definition list in Analysis: Change
F = relative response factor, with respect to ganoderic acid A (see Table 3)
to:
F = relative response factor, with respect to ganoderic acid A (see Table 2)

In Test 2: Change
Determine the amount of isosorbide dinitrate (C₆H₉NO₆) dissolved by employing the following method.
to:
Determine the amount of isosorbide dinitrate (C₆H₈N₂O₈) dissolved by employing the following method.

In Analysis: Change
r_S = sum of all the peak areas, excluding the solvent peaks from the Standard solution
to:
r_S = sum of all the peak areas, excluding the solvent peaks from the Sample solution

In System suitability: Change
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
to:
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
AND
In System suitability/Suitability requirements/Resolution: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Analysis: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Acceptance criteria: Change
(3R,3′S-meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin

In Analysis: Change
M_r1 = molecular weight of atorvastatin, 558.64
M_r2 = molecular weight of atorvastatin calcium, 1155.34
to:
M_r1 = molecular weight of atorvastatin, 558.65
M_r2 = molecular weight of atorvastatin calcium, 1155.36

In Dissolution 〈711〉/Medium: Change
26.7 g/L of sodium acetate trihydrate in water. Add 133 mL of glacial acetic acid to this solution, and then dilute with water to 10 L; 900 mL.
to:
0.02 M sodium acetate buffer, pH 3.5, prepared as follows. Dissolve 2.67 g of sodium acetate in 100 mL of water. Add 13.3 mL of glacial acetic acid and then dilute with water to 1000 mL; 900 mL.

Line 1 of Sample solution: Change
Transfer 3.0 mL of the clear filtrate, reserved from the Assay, to a 100-mL volumetric flask.
to:
Sample stock solution: Dilute the clear filtrate, reserved from the Assay, with water to obtain a solution containing about 160 µg/mL of potassium citrate monohydrate.
Sample solution: Transfer 3.0 mL of the Sample stock solution to a 100-mL volumetric flask.

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 1 of System suitability solution: Change
0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Econazole Nitrate RS in Diluent.
to:
0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Miconazole Related Compound F RS in Diluent.

In 4.1 Documentation and Procedures/4.1.3 Labels: Change
The use of symbols that are recognized by international organizations is strongly recommended.
to:
The use of symbols that are recognized by international organizations is strongly recommended. See General Notices, 10.20. Labeling.

In USP Benazepril Related Compound B RS: Change
(3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride.
to:
2-[(S)-3-{[(R)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]acetic acid hydrochloride;
Also known as (3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.

In paragraph five: Change
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉¹
to:
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉
AND
In footnote 1: Change
This chapter will appear in a future Pharmacopeial Forum (PF) issue.
to:
This chapter appeared in issue 46(3) of the Pharmacopeial Forum (PF).

Change
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
to:
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

In Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity solution,
AND
In System suitability/Suitability requirements: Delete
Signal-to-noise ratio: NLT 10, Sensitivity solution

In Analysis: Change
Result = (r_U/r_S) × C_S × (1/F)
to:
Result = (r_U/r_S) × C_F × (1/F)
AND
Change
C_S = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)
to:
C_F = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)

In Dissolution 〈711〉/Test 8/Tolerances: Change
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 1.
to:
The percentage of the labeled amount of valproic acid (C₈H₁₆O₂) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 2.

Change
Where the label states that Seco barbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and for Bacterial endotoxins under Secobarbital Sodium for Injection. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Secobarbital Sodium for Injection.
to:
Where the label states that Secobarbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>.