Errata - English

Line 1 of B. Thin-Layer Chromatographic Identification Test <201>: Change
The R_F value of the principal spot from Sample solution A corresponds to that from Standard solution A, as described in the test for Organic Impurities.
to:
The R_F value of the principal spot from Sample solution B corresponds to that from Standard solution A, as described in the test for Organic Impurities.

Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C₁₇H₂₅N₃O₃S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride.
C₁₇H₂₅N₃O₃S · HCl 387.92

Line 4 of USP Almotriptan Related Compound B RS: Change
C₁₅H₂₂N₃O₂S
to:
C₁₅H₂₁N₃O₂S
AND
Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C₁₇H₂₅N₃O₃S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride.
C₁₇H₂₅N₃O₃S · HCl 387.92

Variable definition list of second equation in Test 2/Analysis: Change
V_S = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
V_S = volume of the Sample solution withdrawn at each time point (mL)
AND
Variable definition list of second equation in Test 3/Analysis: Change
V_S = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)
to:
V_S = volume of the Sample solution withdrawn at each time point (mL)

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

Line 5 of Magnesium stock solution: Change
Transfer 2.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 20 μg/mL of magnesium (Mg)
to:
Transfer 1.0 mL of this solution to a 100-mL volumetric flask to obtain a solution containing 10 μg/mL of magnesium (Mg)

In A.: Change
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S
Procedure for 197S

Line 3 of System suitability: Change
[Note—The relative retention times of aniline and p-toluidine are about 4.1 and 5.1 min, respectively.]
to:
[Note—The relative retention times of aniline and p-toluidine are 0.8 and 1.0, respectively.]

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C₆H₁₀N₄O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate.
C₆H₁₀N₄O · HCl · H₂O 208.65

Line 1 of Test preparation: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Transfer about 69 mg of Aminosalicylate Sodium, accurately weighed, to a 100-mL low-actinic volumetric flask, add 50 mL of Mobile phase, and swirl to dissolve. Add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 690 mg of aminosalicylate sodium, to a 100-mL low-actinic volumetric flask. Add 50 mL of Mobile phase, and shake for about 5 minutes. Dilute with Mobile phase to volume, and mix. Filter, and transfer 10.0 mL of the clear filtrate to a low-actinic, 100-mL volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

Change the subsection:
Mobile phase and Internal standard solution—Prepare as directed in the Assay under Aminosalicylic Acid.
to:
Mobile phase—Prepare as directed in the Assay under Aminosalicylic Acid.
Internal standard solution—Prepare a solution of sulfanilamide in Mobile phase having a concentration of about 5 µg per mL.

Line 1 of Test solution: Change
Use the Assay preparation, prepared as directed in the Assay.
to:
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 500 mg of aminosalicylic acid, to a 100-mL low-actinic volumetric flask. Add 50 mL of Mobile phase, and shake for about 5 minutes. Dilute with Mobile phase to volume, and mix. Filter, and transfer 10.0 mL of the clear filtrate to a 100-mL low-actinic volumetric flask containing 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.

In System suitability solution: Change
0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP Nortriptyline Hydrochloride RS from suitable volumes of Standard solution, System suitability stock solution A, and System suitability stock solution B in Mobile phase
to:
0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP Nortriptyline Hydrochloride RS from suitable volumes of System suitability stock solution A and System suitability stock solution B in Mobile phase

Line 2: Change
Sample solution: Nominally 0.01 mg/mL of amitriptyline hydrochloride in methanol from a suitable amount of finely powdered Tablets. Filter a portion of the solution, and use the filtrate for analysis.
to:
Sample stock solution: Nominally 0.1 mg/mL of amitriptyline hydrochloride in methanol from a suitable amount of finely powdered Tablets. Filter a portion of the solution, and use the filtrate.
Sample solution: Nominally 0.01 mg/mL of amitriptyline hydrochloride from Sample stock solution in methanol

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