Errata - English

Line 5 of paragraph 1 of Robust Design During Development: Change
lamellae (46,47)
to:
lamellae as discussed in Evaluation of the Inner Surface Durability of Glass Containers <1660> and by the FDA (45)
AND
Line 2 of paragraph 4 of Robust Design During Development: Change
(ICH)-relevant trials.
to:
(ICH)-relevant trials (46).

Line 1 of Sample solution: Change
Polydextrose, calculated on the anhydrous and ash-free basis, in Mobile phase
to:
Polydextrose in Mobile phase
AND
Line 1 of Acceptance criteria: Change
NLT 90.0%
to:
NLT 90.0% on the anhydrous and ash-free basis

Line 1 of Medium B: Change
Kreb's salt solution containing 0.3% (v/v) human serum albumen
to:
Krebs' salt solution containing 0.3% (v/v) human serum albumin
AND
Line 1 of Medium C: change
Kreb's salt solution containing 0.3% (v/v) human serum albumen
to:
Krebs' salt solution containing 0.3% (v/v) human serum albumin

Line 1 of Standard stock solution: Change
50 mg of USP Nifedipine RS in Diluent A and water (50:50)
to:
0.50 mg/mL of USP Nifedipine RS prepared as follows. Transfer a suitable amount of USP Nifedipine RS to an appropriate volumetric flask. Dissolve in 50% of the flask volume of Diluent A. Dilute with water to volume.
AND
Line 1 of Instrumental conditions/Analytical wavelength: Change
238 nm
to:
338 nm

In the definition list in Particle Size Distribution by Cascade Impaction/Analysis: Change
M_r1 = molecular weight of salmeterol free base, 415.75
to:
M_r1 = molecular weight of salmeterol free base, 415.57
AND
In the definition list in Delivered-Dose Uniformity <601>/Analysis: Change
M_r1 = molecular weight of salmeterol free base, 415.75
to:
M_r1 = molecular weight of salmeterol free base, 415.57

This erratum applies to the new USP-NF ONLINE platform only.
In the first variable definition list in Analysis: Change
C_S = concentration of USP Doxazosin Related Compound D RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Dorzolamide Related Compound D RS in the Standard solution (mg/mL)
AND
In the second variable definition list in Analysis: Change
C_S = concentration of USP Doxazosin Related Compound B RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Dorzolamide Related Compound B RS in the Standard solution (mg/mL)

This erratum applies to the new USP-NF ONLINE platform only.
In the variable definition in Analysis: Change
C_S = concentration of USP Sumatriptan Succinate Related Compound A RS
to:
C_S = concentration of USP Sumatriptan Succinate RS

This erratum applies to the new USP-NF ONLINE platform only.
Change
Mobile phase: Methanol and Buffer (30:70)
Diluent: Methanol, water, and 0.05 N sulfuric acid ^▲VS_{▲1S (USP41)} (20:60:20)
to:
Mobile phase: Methanol and Buffer (30:70)
^▲_{▲(ERR 1-Oct-2018)}
Diluent: Methanol, water, and 0.05 N sulfuric acid ^▲VS_{▲1S (USP41)} (20:60:20)

This erratum applies to the new USP-NF ONLINE platform only.
Change
System suitability
^▲_{▲1S (USP41)}
Sample: Standard solution
Suitability requirements
Tailing factor: NMT 2.0
to:
System suitability
Sample: Standard solution
Suitability requirements
^▲_{▲1S (USP41)}
Tailing factor: NMT 2.0

Line 1 of Sample solution: Change
1.1 µg/mL of sodium fluoride
to:
0.5 µg/mL of fluoride ion
AND
In the variable definition list in Analysis: Change
C_U = nominal concentration of sodium fluoride in the Sample solution (µg/mL)
to:
C_U = nominal concentration of fluoride ion in the Sample solution (µg/mL)

This erratum applies to the new USP-NF ONLINE platform only.
Line 1 of Standard stock solution 2: Change
0.1 mg/mL of in Diluent.
to:
0.1 mg/mL of USP Triamterene Related Compound A RS in Diluent.
AND
Line 1 of Standard stock solution 3: Change
0.1 mg/mL of USP Tranylcypromine Related Compound B RS in Diluent.
to:
0.1 mg/mL of USP Triamterene Related Compound B RS in Diluent.

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 1 of System suitability solution: Change
0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Econazole Nitrate RS in Diluent.
to:
0.1 mg/mL of USP Miconazole Nitrate RS and 6 µg/mL of USP Miconazole Related Compound F RS in Diluent.

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 1 of Standard solution: Change
1.2 µg/mL each of USP Miconazole Nitrate RS, USP Econazole Nitrate RS, USP Doxazosin Related Compound C RSUSP Doxazosin Related Compound C RS, USP Miconazole Related Compound F RS, and USP Miconazole Related Compound I RS in Diluent
to:
1.2 µg/mL each of USP Miconazole Nitrate RS, USP Econazole Nitrate RS, USP Miconazole Related Compound C RS, USP Miconazole Related Compound F RS, and USP Miconazole Related Compound I RS in Diluent
AND
In the first variable definition list in Analysis: Change
C_S = concentration of USP Doxazosin Related Compound C RS, USP Doxazosin Related Compound F RS, USP Miconazole Related Compound I RS, or USP Miconazole Nitrate RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Miconazole Related Compound C RS, USP Miconazole Related Compound F RS, USP Miconazole Related Compound I RS, or USP Econazole Nitrate RS in the Standard solution (µg/mL)

This erratum applies to the new USP-NF ONLINE platform only.
Line 1 of System suitability solution: Change
20 mUSP Glyceryl Monocaprylate RSUSP Glyceryl Monocaprylate RSg/mL each of 1-monooctanoyl-rac-glycerol and 1-monodecanoyl-rac-glycerol in tetrahydrofuran
to:
20 mg/mL each of 1-monooctanoyl-rac-glycerol and 1-monodecanoyl-rac-glycerol in tetrahydrofuran

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 4 of USP Reference Standards <11>: Change
USP Doxazosin Related Compound C RS
to:
USP Miconazole Related Compound C RS
AND
Line 7 of USP Reference Standards <11>: Change
USP Econazole Nitrate RS
to:
USP Miconazole Related Compound F RS

In the second Calculate statement in Analysis: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)
AND
In Tolerances: Change
(C₃₃H₃₄FN₂O₅)
to:
(C₃₃H₃₅FN₂O₅)

In the variable definition list in Analysis: Change
C_S = concentration of USP Acamprosate Calcium Related Compound A RS in the Standard solution (µg/mL)
to:
C_S = concentration of USP Acamprosate Related Compound A RS in the Standard solution (µg/mL)

In the System suitability solution: Change
0.5 mg/mL of USP Naproxen Sodium RS and 0.5 µg/mL of USP Naproxen Related Compound A RS in Diluent, from Standard stock solution 1 and Standard stock solution 2, respectively
to:
0.5 µg/mL of USP Naproxen Related Compound A RS from Standard stock solution 2 and 0.5 mg/mL of USP Naproxen Sodium RS in Diluent

Line 2 of USP Miconazole Related Compound C RS: Change
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine.
C₁₅H₁₃Cl₄NO 365.08
to:
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine hydrochloride.
C₁₅H₁₃Cl₄NO · HCl 401.53

This erratum applies to the new USP-NF ONLINE platform only.
Line 2 of Standard solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,
AND
Line 2 of Sample solution: Change
1 N sodium hydroxide,
to:
1 N hydrochloric acid,