Errata - English

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 Detection solution: Change
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate), and heat at 105° for 5 min.
to:
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate).

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.

In Procedure: Change
(694.83/676.83)(25)C_A(r_U/r_S)
in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively;
to:
(694.84/676.82)(25)C_A(r_U/r_S)
in which 694.84 and 676.82 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively;

In USP Metoprolol Related Compound C RS: Change
(±)4-[2-Hydroxy-3-(1-methylethyl)aminopropoxy]benzaldehyde.
C₁₃H₁₉NO₃ 237.29
to:
4-[2-Hydroxy-3-(isopropylamino)propoxy]benzaldehyde hydrochloride.
C₁₃H₁₉NO₃ · HCl 273.76
AND
In USP Metoprolol Related Compound D RS: Change
(±) N,N-Bis[2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]propyl](1-methylethyl)amine.
C₂₇H₄₁NO₆ 475.62
to:
N,N-Bis{2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]propyl}isopropylamine hydrochloride; also known as (±) N,N-Bis[2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]propyl](1-methylethyl)amine hydrochloride.
C₂₇H₄₁NO₆ · HCl 512.08

In Standard solution: Change
0.5 ng/mL of in Medium B.
to:
0.5 ng/mL of USP Filgrastim RS in Medium B.
AND
In Positive control solution: Change
10 ng/mL of in Medium B
to:
10 ng/mL of USP Filgrastim RS in Medium B

In USP Ropivacaine Related Compound A RS: Change
2,6-Dimethylaniline hydrochloride.
C₈H₁₂ClN 157.64
[CAS-21436-98-6].
to:
2,6-Dimethylaniline hydrochloride.
C₈H₁₁N · HCl 157.64
AND
In USP Ropivacaine Related Compound B RS: Change
(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.
C₁₇H₂₆N₂O 328.89
to:
(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate; (R)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate.
C₁₇H₂₆N₂O · HCl · H₂O 328.88

Change
Mobile phase: Acetonitrile, water, and 1 M ammonium formate (450:440:110), adding 0.19 mL of triethylamine to the acetonitrile portion
to:
Solution A: Add 0.19 mL of triethylamine to each 450 mL of acetonitrile.
Mobile phase: Solution A, water, and 1 M ammonium formate (450:440:110)

In Related Compounds/Standard solution: Change
0.75 mg/mL of in water
to:
0.75 mg/mL of USP Filgrastim RS in water
AND
In Impurities with Charges Different from Filgrastim/Reference solution A: Change
1 mg/mL of in water
to:
1 mg/mL of USP Filgrastim RS in water
AND
In Impurities with Charges Different from Filgrastim/Reference solution B: Change
Dilute Reference solution A with water to obtain a concentration of 20 µg/mL of .
to:
Dilute Reference solution A with water to obtain a concentration of 20 µg/mL of USP Filgrastim RS.
AND
In Impurities with Charges Different from Filgrastim/Reference solution C: Change
3 mg/mL of in water
to:
3 mg/mL of USP Filgrastim RS in water
AND
In Impurities with Molecular Weight Different from That of Filgrastim/Reference solution A: Change
Dilute 25 µg of with 25 µL of 4X SDS sample buffer and sufficient water to obtain 100 µL of a solution containing a 250-µg/mL preparation of in 1X SDS sample buffer.
to:
Dilute 25 µg of USP Filgrastim RS with 25 µL of 4X SDS sample buffer and sufficient water to obtain 100 µL of a solution containing a 250-µg/mL preparation of USP Filgrastim RS in 1X SDS sample buffer.
AND
In Impurities with Molecular Weight Different from That of Filgrastim/Reference solution B: Change
Prepare both a reduced and a nonreduced Reference solution B by diluting Reference solution A (1:100) with the appropriate 1X SDS sample buffer to obtain a 2.5-µg/mL preparation of .
to:
Prepare both a reduced and a nonreduced Reference solution B by diluting Reference solution A (1:100) with the appropriate 1X SDS sample buffer to obtain a 2.5-µg/mL preparation of USP Filgrastim RS.
AND
In Impurities with Molecular Weight Different from That of Filgrastim/Reference solution C: Change
Dilute 75 µg of with 25 µL of 4X SDS sample buffer and sufficient water to obtain 100 µL of a solution containing a 750-µg/mL preparation of in 1X SDS sample buffer.
to:
Dilute 75 µg of USP Filgrastim RS with 25 µL of 4X SDS sample buffer and sufficient water to obtain 100 µL of a solution containing a 750-µg/mL preparation of USP Filgrastim RS in 1X SDS sample buffer.
AND
In Limit of High Molecular Weight Proteins/Resolution solution: Change
Dissolve about 1 mg of in 0.33 mL of 0.25 M sucrose,
to:
Dissolve about 1 mg of USP Filgrastim RS in 0.33 mL of 0.25 M sucrose,
AND
In Limit of High Molecular Weight Proteins/Standard solution: Change
0.3 mg/mL of in water
to:
0.3 mg/mL of USP Filgrastim RS in water

In Standard solution: Change
Prepare a solution containing 80 µg of and 200 µL of Digestion solution
to:
Prepare a solution containing 80 µg of USP Filgrastim RS and 200 µL of Digestion solution
AND
In System suitability requirements: Change
Eight major peaks should be present in each chromatogram as illustrated in the reference chromatogram provided with .
to:
Eight major peaks should be present in each chromatogram as illustrated in the reference chromatogram provided with USP Filgrastim RS.

In USP Reference Standards <11>/USP Ropivacaine Related Compound A RS: Change
2,6-Dimethylaniline hydrochloride.
C₈H₁₂ClN 157.64 [CAS-21436-98-6].
to:
2,6-Dimethylaniline hydrochloride.
C₈H₁₁N · HCl 157.64
AND
In USP Ropivacaine Related Compound B RS: Change
(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.
C₁₇H₂₆N₂O 328.89
to:
(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1-propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate; (R)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate.
C₁₇H₂₆N₂O · HCl · H₂O 328.88

In Analysis: Change
M = actual molarity of the Back-titrant (mM/mL)
to:
M = actual molarity of the Back-titrant (mmol/mL)
AND
Change
F = equivalency factor, 136.06 mg/mM
to:
F = equivalency factor, 136.06 mg/mmol

In Biotin, Method 3/Solid-phase extraction: Change
anion-xchange
to:
anion-exchange
AND
In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
, calcium pantothenate (C₁₈H₃₂CaN₂O₁₀), and folic acid (C₁₉H₁₉N₇O₆),
AND
In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 3/Analysis: Delete
, calcium pantothenate (C₁₈H₃₂CaN₂O₁₀), and folic acid (C₁₉H₁₉N₇O₆),
AND
In the Calculate statement in Folic Acid, Method 3; Ascorbic Acid, Niacin or Niacinamide, Pyridoxine Hydrochloride, Calcium Pantothenate, Riboflavin, and Thiamine, Method 4/Analysis: Add
ascorbic acid (C₆H₈O₆),

In Bicarbonate/B.: Change
(1:20)
to:
(1 in 20)
AND
In Borate/A.: Change
(1:50):
to:
(1 in 50):
AND
In Calcium/A.: Change
(1:20)
to:
(1 in 20)
AND
In Carbonate/B.: Change
(1:20)
to:
(1 in 20)
AND
In Chloride/B.: Change
(1:100),
to:
(1 in 100),
AND
In Cobalt/A.: Change
(1:20)
to:
(1 in 20)
AND
Change
(1:10)
to:
(1 in 10)
AND
In Tartrate/A.: Change
(1:20).
to:
(1 in 20).

In Table 3: Delete
Propofol related compound B^b 0.8 1.0 0.05
AND
Change
Propofol related compound A^c
to:
Propofol related compound A^b
AND
Change
^b2,6-Diisopropylbenzoquinone.
^c3,3′-5,5′-Tetraisopropyldiphenol.
to:
^b3,3′-5,5′-Tetraisopropyldiphenol.

In the variable definition for F in Vitamin E, Method 2/Analysis: Change
1/2 for products labeled to contain all-rac vitamin E sources)
to:
1/2 (for products labeled to contain all-rac vitamin E sources)
AND
In Biotin, Method 2/Basal medium stock solution: Change
Dissolve the anhydrous dextrose and anhydrous Sodium acetate
to:
Dissolve the anhydrous dextrose and anhydrous sodium acetate
AND
In Cyanocobalamin, Method 2/Basal medium stock solution: Change
thedextros,
to:
the dextrose,
AND
In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
, calcium pantothenate (C₁₈H₃₂CaN₂O₁₀), and folic acid (C₁₉H₁₉N₇O₆),
AND
In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 3/Analysis: Delete
, calcium pantothenate (C₁₈H₃₂CaN₂O₁₀), and folic acid (C₁₉H₁₉N₇O₆),
AND
In the Calculate statement in Folic Acid, Method 3; Ascorbic Acid, Niacin or Niacinamide, Pyridoxine Hydrochloride, Calcium Pantothenate, Riboflavin, and Thiamine, Method 4/Analysis: Add
ascorbic acid (C₆H₈O₆)

Change
Diluent 1—Prepare a solution of 0.1 mL of phosphoric acid in 1000 mL of water.
Diluent 2—Prepare a mixture of Diluent 1 and acetonitrile (60:40).
to:
Diluent 1—Prepare a solution of 0.1 mL of phosphoric acid in 1000 mL of water.

In Standard solution 3: Change
USP Methyl Caproate RS, USP Methyl Caprylate RS, USP Methyl Caprate RS, USP Methyl Laurate RS, and USP Methyl Laurate RS.
to:
USP Methyl Caproate RS, USP Methyl Caprylate RS, USP Methyl Caprate RS, USP Methyl Laurate RS, and USP Methyl Myristate RS.