Errata - English

In paragraph five: Change
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉¹
to:
Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉
AND
In footnote 1: Change
This chapter will appear in a future Pharmacopeial Forum (PF) issue.
to:
This chapter appeared in issue 46(3) of the Pharmacopeial Forum (PF).

Line 1 of paragraph 3: Change
general information chapter Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers <601>),
to:
general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>),

Change
Apparatus 5 (see general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests 〈601〉), a cascade impactor, has been calibrated at 15 L/min specifically to meet the recommendation of the CEN Standard and is therefore used for this test.³
to:
The Next Generation Impactor without pre-separator used with inhalation aerosols, inhalation sprays, and nasal aerosols is described in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests 〈601〉. An archival version of this cascade impactor has been calibrated at 15 L/min specifically to meet the recommendation of the CEN Standard and this configuration is therefore used for this test.³
AND
In Apparatus: Change
A detailed description of Apparatus 5 and the induction port is contained in 〈601〉, and includes details of
to:
Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, C.4 Next Generation Impactor without Pre-separator for Inhalation Aerosols, Inhalation Sprays, and Nasal Aerosols includes details of
AND
In Procedure: Change
Figure 2. Apparatus 5 for Measuring the Size Distribution of Products for Nebulization.
to:
Figure 2. Next Generation Impactor without Pre-separator for Measuring the Size Distribution of Products for Nebulization.
AND
In Procedure: Change
on the back-up filter as described for Apparatus 5 (see 〈601〉).
to:
on the back-up filter as described in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, C.4 Next Generation Impactor without Pre-separator for Inhalation Aerosols, Inhalation Sprays, and Nasal Aerosols.
AND
In Procedure: Change
Determine the cumulative mass-weighted particle-size distribution of the aerosol size-fractionated by the impactor in accordance with the procedure given in 〈601〉.
to:
Determine the cumulative mass-weighted particle-size distribution of the aerosol size-fractionated by the impactor in accordance with the procedure given in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests <601>, C.4 Next Generation Impactor without Pre-separator for Inhalation Aerosols, Inhalation Sprays, and Nasal Aerosols.
AND
In Table 2: Change
Table 2. Cut-off Sizes for Apparatus 5 at 15 L/min
to:
Table 2. Cut-off Sizes for Next Generation Impactor without Pre-separator at 15 L/min

Line 3 of Application/4.: Change
proscribed
to:
prescribed
AND
Line 3 of Description of Polymers Contained in <661.1>/Polyethylenes: Change
Low-density polypropylene (LDPE)
to:
Low-density polyethylene (LDPE)
AND
Line 6 of Description of Polymers Contained in <661.1>/Polypropylene: Change
0.3% polypropylene
to:
0.3%. Polypropylene
AND
Line 3 of Description of Polymers Contained in <661.1>/Polyethylene Terephthalate and Polyethylene Terephthalate G: Change
1,4-cyclohexaemimethanol
to:
1,4-cyclohexanedimethanol

In Overview: Change
The test is also sensitive to size accuracy at 15 μm, since small errors in size will translate into large errors in count at the midpoint of the PS distribution.
to:
The test is also sensitive to size accuracy at 15 μm, since small errors in size will translate into large errors in count at the midpoint of the particle size distribution.

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).

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).

Change
(see Near-Infrared Spectroscopy—Theory and Practice 〈1856〉),
to:
(see 〈856〉),
AND
Change
(see Chemometrics 〈1039〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and Raman Spectroscopy—Theory and Practice 〈1858〉, and the following chapters to be published at a later date: Near-Infrared Spectroscopy—Theory and Practice 〈1856〉 and Raman Spectroscopy—Theory and Practice 〈1858〉).
to:
(see Chemometrics 〈1039〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and Raman Spectroscopy—Theory and Practice 〈1858〉).

Change
(see Mass Spectrometry 〈736〉, Nuclear Magnetic Resonance Spectroscopy 〈761〉, 〈854〉, 〈857〉, 〈941〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and 〈858〉.
to:
(see Mass Spectrometry 〈736〉, Nuclear Magnetic Resonance Spectroscopy 〈761〉, 〈854〉, 〈856〉, 〈857〉, 〈858〉, and 〈941〉).

Change
Anti-Factor Xa Activity for Low Molecular Weight Heparin
to:
The following procedure is used where specified in the individual monographs. This assay can be performed manually in plastic tubes utilizing heated block stations or water bath. Microtiter plate equipment with a reader and automated coagulometer can improve reproducibility and throughput. Acetic acid solution (stopping solution) is used for manual and microtiter plate assay. Automated coagulometers measure initial kinetic rate, and because of that, stopping of the reaction is not needed.
Anti-Factor Xa Activity for Low Molecular Weight Heparin

In footnote 1 in Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography/Chromatographic system/Columns/Analytical: Change
guard column TSK SWXL 6-mm × 4-mm;
to:
guard column TSK SWXL 6-mm × 4-cm;

Rows 11 and 15 of Column 2 of Table 2: Change
100
to:
10
AND
Rows 11 and 15 of Column 3 of Table 2: Change
10
to:
1.0
AND
Row 11 of Column 4 of Table 2: Change
1.5
to:
0.15
AND
Row 15 of Column 4 of Table 2: Change
30
to:
3.0

In Analysis: Change
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonia cyanide solution,
to:
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonium cyanide solution,