Errata - English

In Content of Methoxy and 2-Hydroxypropoxy Groups/Analysis: Change
Result = (r_UM/r_SM) × (C_S/C_U) × (M_r1/M_r2)
to:
Result = (r_UM/r_SM) × (C_S/C_U) × (M_r1/M_r2) × 100
AND
Change
Result = (r_UI/r_SI) × (C_S/C_U) × (M_r1/M_r2)
to:
Result = (r_UI/r_SI) × (C_S/C_U) × (M_r1/M_r2) × 100

In the first equation in Analysis: Change
C_S = concentration of USP Withanoside IV RS in Standard solution A (mg/mL)
to:
C_S = concentration of USP Withanolide A RS in Standard solution A (mg/mL)

In Table 2: Change
Bendamustine related compound B
to:
Bendamustine related compound B^a
AND
Change
Bendamustine related compound C^a
to:
Bendamustine related compound C^b
AND
Change
Bendamustine related compound G^a
to:
Bendamustine related compound G^b
AND
Change
Bendamustine related compound I^a
to:
Bendamustine related compound I^b
AND
Change
^a This process impurity is controlled in the drug substance monograph. It is included in the table for identification only, and it is not to be reported in the total impurities.
to:
^a It is a free base of USP Bendamustine Related Compound B RS: 4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)butanoic acid.
^b This process impurity is controlled in the drug substance monograph. It is included in the table for identification only, and it is not to be reported in the total impurities.

In USP Bendamustine Related Compound B RS: Change
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)butanoic acid.
C₁₆H₂₁N₃O₃ 303.36
to:
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)butanoic acid hydrochloride.
C₁₆H₂₁N₃O₃ · xHCl

Change
Result = (r_U/r_S) x (C_S/C_U) x (M_r1/M_r2) x (V/L) x 100
to:
Result = (r_U/r_S) x C_S x (M_r1/M_r2) x (V/L) x 100
AND
Delete
C_U = nominal concentration of anagrelide in the Sample solution (mg/mL)

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 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 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 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.