Errata - English

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 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 USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
C₃₂H₃₇NO₄ 538.12
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.
C₃₂H₃₇NO₄ 499.65

In USP Sildenafil Related Compound A RS: Change
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-(2-methylpropyl)-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one.
C₂₃H₃₂N₆O₄S 488.60
to:
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-(2-methylpropyl)-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one;
Also known as 1-{[3-(6,7-Dihydro-1-methyl-7-oxo-3-isobutyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl}-4-methylpiperazine.
C₂₃H₃₂N₆O₄S 488.61

Change
Diluent, Solution A, System suitability solution, Chromatographic system, and Sample solution: Proceed as directed in the Assay.
to:
Diluent, Buffer solution, Solution A, Solution B, Mobile phase, System suitability solution, Chromatographic system, and Sample solution: Proceed as directed in the Assay.

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 19.4 Example Calculations of MKT for CRT Storage Evaluation/Example 3—Calculation of Annual MKTStep 3: Change
3.354
to:
3.340
AND
In Step 4: Change
2.795
to:
2.783
AND
In Step 5: Change
−33.511
to:
−33.515
AND
In Step 6: Change
298.410
to:
298.372

In all instances in paragraph 2: Change
s_r
to:
s
AND
In paragraph 2: Change
is found to be 0.0015, then M_min must be ≥ 0.3000 g or 300 mg.
to:
is found to be 0.00015, then M_min must be ≥ 0.30000 g or 300.00 mg.

In Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × ^▲(M_r1/M_r2) ×_{▲ (USP 1-Aug-2019)} 100
to:
Result = (R_U/R_S) × (C_S/C_U) × 100
AND
Delete
^▲M_r1 = molecular weight of tiagabine hydrochloride, 412.00
M_r2 = molecular weight of tiagabine hydrochloride monohydrate, 430.02_{▲ (USP 1-Aug-2019)}

In System suitability stock solution B: Change
2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS, and 0.37 mg/mL of stigmastanol
to:
0.37 mg/mL of stigmastanol and 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS in chloroform

In B: Change
It meets the requirements in the test Viscosity—Capillary Methods <911>, Viscosity—Rotational Methods <912>, and Viscosity—Rolling Ball Method <913>.
to:
It meets the requirements in the test Viscosity—Capillary Methods <911>, Viscosity—Rotational Methods <912>, or Viscosity—Rolling Ball Method <913>.

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

In System suitability stock solution B: Change
2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS and 0.37 mg/mL of stigmastanol
to:
0.37 mg/mL of stigmastanol and 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS in chloroform

In Analysis: Change
r_C = peak response of ceftiofur from the Sample solution (mg/mL)
r_A = sum of the responses of all peaks that elute after ceftiofur from the Sample solution (mg/mL)
to:
r_C = peak response of ceftiofur from the Sample solution
r_A = sum of the responses of all peaks that elute after ceftiofur from the Sample solution

In the second equation in Analysis: Change
Result = (R_L − P_B)/(P_A − P_B)
to:
Result = (R_L − P_B)/(P_A − P_B) × 100

In USP Telmisartan Related Compound A RS: Change
1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole.
C₁₉H₂₀N₄ 304.39
to:
1,7’-Dimethyl-2’-propyl-1H,3’H-2,5’-bibenzo[d]imidazole monohydrate.
C₁₉H₂₀N₄ ∙ H₂O 322.41