Errata - English

Line 1 of Sample solution: Change
25 mg/mL of Norepinephrine Bitartrate in glacial acetic acid. If necessary warm slightly to effect solution.
to:
Dissolve 500 mg of Norepinephrine Bitartrate in 20 mL of glacial acetic acid, warming slightly if necessary to effect solution.

Line 1 of C: Change
Undiluted Oral Rinse used as the test solution meets the requirements for Identification test B under Calcium Gluconate, except that a Standard solution containing about 0.6 mg of USP Potassium Gluconate RS per mL is used and 15 μL of the test solution and the Standard solution are applied to the thin-layer chromatographic plate.
to:
Use undiluted Oral Rinse as the test solution and prepare a Standard solution of USP Potassium Gluconate RS in water containing 0.6 mg/mL. Apply separate 15-μL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel, and allow to dry. Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50:30:10:10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 minutes. Allow to cool and spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110° for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and R_F value to that obtained from the Standard solution.

Footnote m: Change
(2S,5R,6R)-Ethyl 6-((R)-2-{(2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxamido}-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.
to:
2-(((3-Acetyl-4-(ethoxycarbonyl)-5,5-dimethylthiazolidin-2-yl)methyl)amino)-2-oxo-1-phenylethyl 6-(2-(4-ethyl-2,3-dioxopiperazine-1-carboxamido)-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Line 3 of C.: Change
Standard solution B;
to:
Standard solution C;

Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Tablets containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Line 3 of C.: Change
Standard solution B;
to:
Standard solution C;

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Lines 3 and 6 of C.: Change
Standard solution B,
to:
Standard solution C,
AND
Change
Standard solution C)
to:
Standard solution D)

Line 2 of USP Eszopiclone Related Compound A RS: Change
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
to:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoic salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO 561.38

Line 3 of Standard solution A: Change
lead acetate,
to:
lead acetate TS,
AND
Line 11 of Analysis: Change
Locate the two prominent bands from Standard solution A corresponding in R_F value to the two bands from Standard solution B.
to:
Locate the prominent bands from Standard solution A corresponding in R_F value to the band from Standard solution B.

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Lines 3 and 6 of C.: Change
Standard solution B,
to:
Standard solution C,
AND
Change
Standard solution C)
to:
Standard solution D)

Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia powder prepared from dried rhizome and roots/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 2 of USP Timolol Related Compound A RS: Change
(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol.
C₁₃H₂₄N₄O₃S 316.42
to:
(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol maleate.
C₁₃H₂₄N₄O₃S · C₄H₄O₄ 432.49
AND
Line 2 of USP Timolol Related Compound C RS: Change
N-(tert-Butyl)-2,3-bis(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-1-amine.
C₁₉H₃₁N₇O₄S₂ 485.19
to:
N-(tert-Butyl)-2,3-bis(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-1-amine maleate.
C₁₉H₃₁N₇O₄S₂ ∙ C₄H₄O₄ 601.69
AND
Line 3 of USP Timolol Related Compound D RS: Change
C₆H₉N₇O₄S
to:
C₆H₉N₃O₂S
AND
Line 2 of USP Timolol Related Compound E RS: Change
(S)-3-(tert-Butylamino)-1-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-yl hydrogen maleate.
C₁₇H₂₆N₄O₆S 414.48
to:
(S,Z)-4-({1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]propan-2-yl}oxy)-4-oxobut-2-enoic acid maleate salt (1:1)
C₁₇H₂₆N₄O₆S ∙ C₄H₄O₄ 530.55

Line 2 of USP Eszopiclone Related Compound A RS: Change
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
to:
[Note—This material may be available in the free base or salt form.]
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide.
C₁₇H₁₇ClN₆O₄ 404.81
6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3-chlorobenzoic salt (1:1).
C₁₇H₁₇ClN₆O₄ · C₇H₅ClO 561.38

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Line 3 of C.: Change
Standard solution B,
to:
Standard solution C,

Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia Dry Extract/System suitability: Change
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,
AND
Lines 3 and 6 of C.: Change
Standard solution B,
to:
Standard solution C,
AND
Change
Standard solution C)
to:
Standard solution D)

Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower R_F) and chlorogenic acid (higher R_F) that are clearly separated,
to:
Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher R_F) and chlorogenic acid (lower R_F) that are clearly separated,

Footnote e and f: Change
^e Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-ethylpyrrolidine-2-carboxamido]-1-thio-L-threo-α-D-galacto-octopyranoside 3-phosphate.
^f Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-D-threo-α-D-galacto-octopyranoside.
to:
^e Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-L-threo-α-D-galacto-octopyranoside 3-phosphate.
^f Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-L-threo-α-D-galacto-octopyranoside.

Line 2 of USP Cilostazol Related Compound C RS: Change
1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.
C₃₁H₄₃N₉O₃ 589.73
to:
1-(4-(1-Cyclohexyl-1H-tetrazol-5-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.
C₃₁H₄₅N₉O₂ 575.75