Errata - English

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

In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.

Line 1 of Diluent: Change
Dimethyl sulfoxide and 1 N sodium hydroxide solution (4:1)
to:
Dimethyl sulfoxide
AND
Line 1 of Standard solution: Change
3.2 μg/mL of USP Triethylamine RS in Diluent
to:
4.0 μg/mL of USP Triethylamine RS in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.
AND
Line 1 of Sample solution: Change
40 mg/mL of Adapalene in Diluent
to:
50 mg/mL of Adapalene in Diluent. Transfer 4.0 mL of this solution to a 20-mL headspace vial, and add 1.0 mL of 1 N NaOH solution.

Change
Test preparation: Into a 50-mL color-comparison tube place 10.0 mL of Solution S.
to:
Test preparation: Into a 50-mL color-comparison tube pipet 10.0 mL of Solution S and dilute with water to 25 mL. Using a pH meter or short-range pH indicator paper as external indicator, adjust with 1 N acetic acid or 6 N ammonium hydroxide to a pH of between 3.0 and 4.0, dilute with water to 40 mL, and mix.

In Test 1/Analysis: Change
dissolved at time point (i):
Result_i = (r_U/r_S) × C_S × V × D × (1/L) × 100
to:
dissolved:
Result = (r_U/r_S) × C_S × V × D × (1/L) × 100
AND
In Test 3/Analytical procedure 1/Analysis: Change
V = volume of Medium, 900 mL
to:
V = volume of Medium 1, 900 mL
AND
In Test 3/Analytical procedure 2/Analysis: Change
V_M = volume of Medium, 900 mL
to:
V_M = volume of Medium 1, 900 mL
AND
In Test 3/Analytical procedure 3/Blank: Change
Medium
to:
Medium 2
AND
In Test 3/Analytical procedure 3/Analysis: Change
V_M = volume of Medium, 900 mL
to:
V_M = volume of Medium 2, 900 mL

Lines 3 and 6: Change
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
to:
USP Olanzapine Related Compound A RS
5-Methyl-2-((2-nitrophenyl)amino)-3-thiophenecarbonitrile.
C₁₂H₉N₃O₂S 259.28
USP Olanzapine Related Compound B RS
2-Methyl-10H-thieno-[2,3-b][1,5]benzodiazepin-4[5H]-one.
C₁₂H₁₀N₂OS 230.29

In Test 2 and Test 3 in Analysis: Change
Result₁ = C₁ × (1/L) × (M_r1/M_r2) × 100
to:
Result₁ = C₁ × V × (1/L) × (M_r1/M_r2) × 100

In Procedure for a pooled sample/Analysis: Change
Result = (A_U/A_S) × (C_S/C_U) × V × (1/L) × 100
to:
Result = (A_U/A_S) × C_S × V × (1/L) × 100
AND
Change
C_S = concentration of USP Penicillamine RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Penicillamine RS in the Standard solution (mg/mL)
AND
Delete
C_U = nominal concentration of penicillamine in the Sample solution (µg/mL)
AND
In Procedure for a unit sample/Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × V × (1/L) × 100
to:
Result = (r_U/r_S) × C_S × V × (1/L) × 100
AND
Delete
C_U = nominal concentration of in the Sample solution (mg/mL)

In Sample solution: Change
Nominally 0.6 mg/mL of phenytoin
to:
Nominally 0.6 mg/mL of phenytoin sodium
AND
In Analysis: Change
C_U = nominal concentration of phenytoin in the Sample solution (mg/mL)
to:
C_U = nominal concentration of phenytoin sodium in the Sample solution (mg/mL)

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.

In Standard stock solution: Change
of USP Insulin RS of the appropriate species
to:
of the USP Insulin Reference Standard of the appropriate species
AND
In Sample stock solution: Change
of USP Insulin RS of the appropriate species.
to:
of the USP Insulin Reference Standard of the appropriate species.

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 USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.

In Test 1/Tolerances and Test 3/Tolerances: Change
[(C₁₇H₁₉NO₃)₂ · H₂SO₄ · 5H₂O)]
to:
[(C₁₇H₁₉NO₃)₂ · H₂SO₄ · 5H₂O]

In Analysis: Change
r_U = peak response of abiratrone acetate from the Sample solution
r_S = peak response of abiratrone acetate from the Standard solution
to:
r_U = peak response of abiraterone acetate from the Sample solution
r_S = peak response of abiraterone acetate from the Standard solution

In USP Atorvastatin Related Compound B RS: Change
(3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as (3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.

Line 13 of Analysis in Test 1: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 12 of Analysis in Test 2: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 13 of Analysis in Test 3: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

Line 16 of Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81
AND
Line 14 of the second Calculate statement in Analysis: Change
M_r2 = molecular weight of ciprofloxacin hydrochloride, 367.81
to:
M_r2 = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81

Line 3 of Analysis: Change
of USP Memantine Related Compound E RS or
to:
of memantine related compound E or
AND
In the variable definition list: Change
r_U = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solution
to:
r_U = peak response of memantine related compound E or any individual degradation product from the Sample solution