Errata - English

Line 1 of System suitability solution:Change
USP Diphenhydramine Hydrochloride Related Compound A RS
to:
USP Diphenhydramine Related Compound A RS
AND
Line 4 of System suitability: Change
for diphenhydramine hydrochloride related compound A and diphenhydramine hydrochloride are
to:
for diphenhydramine related compound A and diphenhydramine are

Line 5 of Standard solution: Change
Mix 10.0 mL of this solution
to:
Mix 5.0 mL of this solution
AND
Line 7 of Standard solution: Change
about 0.67 µg/mL
to:
about 0.5 µg/mL
Line 4 of Sample solution: Change
10.0 mL of this solution
to:
5.0 mL of this solution
AND
In the variable definition list in Analysis: Change
V_F = final volume of the Sample solution, 15 mL
D = dilution factor for preparation of the Sample solution, 5
to:
V_F = final volume of the Sample solution, 10 mL
D = dilution factor for preparation of the Sample solution, 10

Line 2: Change
Sample: System suitability solution
to:
Samples: System suitability solution and Standard solution
AND
Line 2 of Suitability requirements: Change
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections
to:
Resolution: NLT 1.5 between the digoxin and lanatoside C peaks, System suitability solution
Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections, Standard solution

Line 3 of Analysis: Change
of USP Memantine Related Compound E RS or
to:
of memantine related compound E or
AND
In the variable definition list: Change
r_U = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solution
to:
r_U = peak response of memantine related compound E or any individual degradation product from the Sample solution

Line 1 of System suitability solution: Change
0.02 µg/mL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS in Standard solution
to:
Transfer about 40 mL of the Standard solution to a 50-mL volumetric flask. Using a microliter syringe, add 1 µL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS. Dilute with Standard solution to volume.

Line 8 of Analysis: Change
Result = (r_U/r_S) × (C_S/C_U) × (1/F) × (100/100 − L)
to:
Result = (r_U/r_S) × (C_S/C_U) × (1/F) × (100/[100 − L])

Line 6 of Analysis in Test 1: Change
Result = (A_U/A_S) × (C_S/L) × (M_r1/M_r2) × 100
to:
Result = (A_U/A_S) × (C_S/L) × (M_r1/M_r2) × V × 100
AND
Add to the variable definition list in Test 1
V = volume of Medium, 500 mL
AND
Equation in Test 3: Change
Result = (r_U/r_S) × (C_S/L) × (M_r1/M_r2) × 100
to:
Result = (r_U/r_S) × (C_S/L) × (M_r1/M_r2) × V × 100
AND
Add to the variable definition list in Test 3
V = volume of Medium, 500 mL

Line 1 of Standard solution: Change
Prepare a solution containing 1.0 mg/mL of USP Tamsulosin Hydrochloride RS in methanol.
to:
Prepare a solution containing 0.1 mg/mL of USP Tamsulosin Hydrochloride RS in methanol.
AND
Line 6 of Sample solution: Change
Add 30 mL of Mobile phase, and shake by mechanical means for 30 min.
to:
Add 30 mL of Mobile phase, shake by mechanical means for 30 min, and dilute with Mobile phase to volume.

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

Line 1 of Human thrombin solution: Change
33 Units in terms of the U.S. Standard Thrombin/mL in Buffer
to:
33 U.S. Units in terms of the U.S. Standard Thrombin/mL in Buffer
AND
Line 5 of Analysis: Change
Standard solution and Sample solution,
to:
Standard solution or Sample solution,

Line 13 of paragraph 2 of C.3 Apparatus 2 for Inhalation Powders—Marple Miller Impactor/C.3.1 Design—Apparatus 2: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration of T seconds as determined during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.
AND
Line 3 of paragraph 2 of C.4 Apparatus 3 for Inhalation Powders—Andersen Impactor (with pre-separator)/C.4.1 Design—Apparatus 3: Change
Once the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration, T ± 5%, as determined during testing for Delivered-Dose Uniformity.
to:
Once the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration such that the total volume sampled is at least 4 L.
AND
Line 19 of paragraph 2 of C.5 Apparatus 4 for Inhalation Powders—Multistage Liquid Impinger/C.5.1 Design—Apparatus 4: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the duration such that the total volume sampled is at least 4 L.
AND
Line 9 of paragraph 4 of C.6 Apparatus 5 for Inhalation Powders—Next Generation Impactor (with pre-separator)/C.6.2 Procedure—Apparatus 5: Change
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.
to:
Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.

Line 3: Change
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements).
to:
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any combination of at least two of the conditions previously mentioned (totaling 12 measurements).

Line 3: Change
Calculate the percentage of any individual unspecified degradation product
to:
Calculate the percentage of any individual degradation product
AND
Line 6: Change
r_U = peak response of any individual unspecified degradation product from the Sample solution
to:
r_U = peak response of any individual degradation product from the Sample solution

Footnote d of Impurity Table: Change
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
to:
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2′-(2-trityl-2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.

Line 1 of Acceptance criteria: Change
The Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution.
to:
The oil portion of the Sample may turn hazy, but it remains colorless or shows a slight pink or yellow color, and the acid portion of the Sample does not become darker than the Standard solution.

Line 5 of Analysis: Change
Result = (A_U/A_S) × C_S × d × V × D × (1/L) × 100
to:
Result = (A_U/A_S) × C_S × (d/W_U) × V × D × (1/L) × 100
AND
Add to the variable definition list
W_U = weight of reconstituted Cefdinir for Oral Suspension taken (mg)

Line 2 of Buffer, Mobile phase, Chromatographic system, and System suitability: Change
Proceed as directed in the Assay.
to:
Proceed as directed in the Assay, except use 270 nm for analysis.
AND
Line 10 of Analysis: Change
V = volume of the Medium, 750 mL
to:
V = volume of the Medium, 900 mL

Line 3 of Sample stock solution: Change
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,
to:
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of solvent hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the solvent hexane. Dry the extraction thimble to remove residual solvent hexane,

Line 3 of Sample stock solution: Change
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,
to:
Transfer the thimble to a continuous-extraction apparatus fitted with a 250-mL round-bottom flask containing 150 mL of solvent hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the solvent hexane. Dry the extraction thimble to remove residual solvent hexane,

Line 1: Change
Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask:it meets the requirements of the test for Specific rotation under Mannitol.
to:
+137° to +145°.Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask. Add 40 mL of a 1-in-10 ammonium molybdate solution, previously filtered if necessary. Add 20 mL of 1 N sulfuric acid, and dilute with water to volume.

Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change
A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
to:
A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.

Line 1 of footnote 2: Change
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2_Guideline.pdf.
to:
http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.

Line 2 of bullet 1 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003684.pdf
AND
Line 2 of bullet 2 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/179302en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/WC500003675.pdf
AND
Line 3 of bullet 3 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/vet/iwp/074300en.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004575.pdf
AND
Delete bullet 4 of International Regulations and Guidance Documents in second paragraph
AND
Line 2 of bullet 5 of International Regulations and Guidance Documents in second paragraph: Change
http://www.emea.europa.eu/pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf
to:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003712.pdf
AND
Line 1 of bullet 6 of International Regulations and Guidance Documents in second paragraph: Change
Terrestrial animal health code 2007. Available at http://www.oie.int/eng/normes/mcode/code2007/anc-en_summary.htm.
to:
Terrestrial animal health code. Available at http://www.oie.int/doc/ged/D10905.pdf.