Errata - English

In Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity solution,
AND
In System suitability/Suitability requirements: Delete
Signal-to-noise ratio: NLT 10, Sensitivity solution

In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

Change
523.32
to:
523.33
AND
Change
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate
to:
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate

In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of 0.5 N hydrochloric acid VS to a 500-mL volumetric flask, dilute with water to volume, and mix well.

Change
Where the label states tetracycline hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which tetracycline hydrochloride is used can be met.
to:
Where the label states Tetracycline Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Tetracycline Hydrochloride is used can be met.

In System suitability solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In System suitability/Samples: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

Change
Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.
to:
Where Tetracycline Hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.

In Analysis: Change
C_S = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
to:
C_S = concentration of the corresponding USP Reference Standard or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

In Analysis: Change
Calculate the percentage of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P × 100
to:
Calculate the quantity, in µg/mg, of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P

In Liquid Chromatography: Isocratic Elution/Injection volume: Change
L₂ = internal diameter of the column used (mm)
dc₁ = particle size indicated in the monograph (µm)
dc₂ = particle size of the column used (µm)
to:
L₂ = new column length (mm)
dc₁ = column internal diameter indicated in the monograph (mm)
dc₂ = new column internal diameter (mm)

In Standardization with visual end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄
AND
In Standardization with potentiometric end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄

Change
Standard solution: Transfer 2.0 mg/mL of USP Latanoprost RS into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
Sample solution: Transfer 2.0 mg/mL of Latanoprost into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
to:
Standard solution: 2.0 mg/mL of USP Latanoprost RS prepared as follows. Transfer USP Latanoprost RS into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
Sample solution: 2.0 mg/mL of Latanoprost prepared as follows. Transfer Latanoprost into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.

In Liquid Chromatography: Isocratic Elution/Injection volume: Change
Result = (V_inj2 = V_inj1 (L₂ d_c2² )/(L₁ d_c1²)
to:
V_inj2 = V_inj1 (L₂ d_c2² )/(L₁ d_c1²)
AND
In Liquid Chromatography: Gradient Elution/Column parameters and flow rate: Change
F₂ = F₂ × [(dc₂² × dp₁)/(dc₁² × dp₂)]
to:
F₂ = F₁ × [(dc₂² × dp₁)/(dc₁² × dp₂)]

In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems.