Errata - English

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 all instances in Table 4: Change
<
to:
≤
AND
In Control of Photometric Response/Acidic Nicotinic Acid Solutions in 0.1 N Hydrochloric Acid/paragraph 1: Change
Using nicotinic acid solutions, the absorbance accuracy must be ± 0.01 A_λ.
to:
Using nicotinic acid solutions, the absorbance accuracy must be ± 0.010 A_λ (for values below 1.00 A_λ).

In Standard solution: Change
USP Simvastatin RS in Medium
to:
USP Simvastatin RS in Medium. Transfer a portion of the solution to a centrifuge tube containing about 10 mg of Prewashed manganese dioxide per milliliter of transferred solution under test, and mix. Allow the mixture to stand for 30 min with occasional shaking, centrifuge, and use a portion of the clear supernatant.

Change
Solution A, Mobile phase, Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay, making any necessary volumetric adjustments.
to:
Solution A, Mobile phase, Standard solution, Chromatographic system, and System suitability: Proceed as directed in the Assay, making any necessary volumetric adjustments.
Sample solution: Take a portion of the solution under test, and dilute if necessary.

Change
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N potassium hydroxide VS. Titrate with 0.1 N hydrochloric acid VS until a permanent pale-pink color is produced.
to:
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N hydrochloric acid VS. Titrate with the potassium hydroxide solution until a permanent pale-pink color is produced.

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 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 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 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 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.