FCC Errata Table - All

CSV View April 18, 2022 through April 19, 2024 All Errata for FCC How to use
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Monograph Title Section Source Publication Page Number Errata Post Date Errata Effective Date Target Errata Print Publication Target Online Fix Publication Description
DIOCTYL SODIUM SULFOSUCCINATE SPECIFIC TESTS/Chromatographic Purity FCC 8th Edition 363 28-Dec-2012 1-Jan-2013 FCC 9th Edition Second Supplement to FCC 8th Edition Line 13 of Analysis: Change
rs is the dioctyl sodium sulfosuccinate response obtained from the Standard solution.
to:
rs is the docusate sodium related compound B response obtained from the Standard solution.
GERANIOL OTHER REQUIREMENTS FCC 8th Edition 482 28-Dec-2012 1-Jan-2013 FCC 9th Edition Second Supplement to FCC 8th Edition Line 1 of Aldehydes: Change
M-2d, Appendix XI
to:
M-2c, Appendix XI
CARMINE IMPURITIES/Inorganic Impurities/Lead FCC 8th Edition 215 28-Dec-2012 1-Jan-2013 FCC 9th Edition Second Supplement to FCC 8th Edition Line 1 of Control: Change
10 µg Pb (10 mL of Diluted Standard Lead Solution)
to:
2 µg Pb (2 mL of Diluted Standard Lead Solution)
ALITAME ASSAY/Procedure FCC 8th Edition 33 28-Dec-2012 1-Jan-2013 FCC 9th Edition Second Supplement to FCC 8th Edition Line 1 of Mobile phase: Change
Acetonitrile and Solution A (1:4)
to:
Dilute 250 mL of acetonitrile to 1 L with Solution A.
SODIUM CHLORIDE SPECIFIC TESTS/Iron FCC 8th Edition 1023 28-Dec-2012 1-Jan-2013 FCC 9th Edition Second Supplement to FCC 8th Edition Line 3 of Sample solution: Delete
Add 40 mg of ammonium persulfate crystals and 10 mL of ammonium thiocyanate TS.
YEAST EXTRACT SPECIFIC TESTS/Sodium Chloride FCC 8th Edition 1203 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Analysis: Change
suitable spectrophotometer,
to:
suitable atomic absorption spectrophotometer,
YEAST EXTRACT SPECIFIC TESTS/Potassium FCC 8th Edition 1203 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Analysis: Change
suitable spectrophotometer,
to:
suitable atomic absorption spectrophotometer,
SODIUM PHOSPHATE, MONOBASIC ASSAY/Procedure FCC 8th Edition 1053 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 10 of Analysis: Change
A = 5 – x
to:
A = |5 – x|
SODIUM PHOSPHATE, DIBASIC SPECIFIC TESTS/Pyrophosphate FCC 8th Edition 1052 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 2 of Standard stock solution: Change
tetra sodium pyrophosphate
to:
tetrasodium pyrophosphate
AND
Line 19 of Analysis: Change
tetra sodium pyrophosphate
to:
tetrasodium pyrophosphate
SODIUM METABISULFITE IMPURITIES/Inorganic Impurities/Iron FCC 8th Edition 1046 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Control: Change
1.0 mL (10 µg Fe)
to:
0.5 mL (5 µg Fe)
SODIUM CHLORIDE IMPURITIES/Inorganic Impurities/Calcium and Magnesium FCC 8th Edition 1023 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Buffer solution A: Change
67.5 mg
to:
67.5 g
POTASSIUM PHOSPHATE, MONOBASIC ASSAY/Procedure FCC 8th Edition 944 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 10 of Analysis: Change
A = 5 – x
to:
A = |5 – x|
MALIC ACID IMPURITIES/Organic Impurities FCC 8th Edition 683 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 2 of Fumaric and Maleic Acids: Delete
[Note—For all reference standards, do not dry before use and keep the containers tightly closed and protected from light. Determine the water content of the USP Fumaric Acid RS titrimetrically before use and make the necessary correction in… Read More
ASTAXANTHIN ESTERS FROM HAEMATOCOCCUS PLUVIALIS ASSAY FCC 8th Edition 89 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Sample solution: Add
[Note—Prepare one Sample solution as follows from each of the three Sample stock solutions.]
AND
Line 2 of Analysis: Change
Sample solution
to:
Sample solutions
AND
Line 12 of Analysis… Read More
KELP IMPURITIES/Inorganic Impurities/Arsenic FCC 8th Edition 612 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 2 of Apparatus: Change
Figure 14
to:
Figure 4
KELP IMPURITIES/Inorganic Impurities/Arsenic FCC 8th Edition 612 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 1 of Control: Change
6.0 µg As (6.0 mL Standard Arsenic Solution).
to:
2.0 µg As (2.0 mL Standard Arsenic Solution).
INVERT SUGAR SPECIFIC TESTS/Total Solids FCC 8th Edition 567 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 1: Change
Total Solids, Invert Sugar, Appendix X
to:
Total Solids, Appendix X
AND
Line 1 of Analysis: Change
Determine as directed using the table provided.
to:
Determine as directed under Invert Sugar.
INVERT SUGAR ASSAY/Invert Sugar FCC 8th Edition 567 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 1: Change
Invert Sugar, Total Solids, Appendix X
to:
Invert Sugar Determination, Appendix X
FERROUS CITRATE IMPURITIES/Inorganic Impurities/Sulfate FCC 8th Edition 450 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 1: Change
Sulfate, Chloride and Sulfate Limit Tests, Chloride Limit Test, Appendix IIIB
to:
Sulfate, Chloride and Sulfate Limit Tests, Sulfate Limit Test, Appendix IIIB
DIOCTYL SODIUM SULFOSUCCINATE SPECIFIC TESTS/Chromatographic Purity/Table 1 FCC 8th Edition 363 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Row 1 of Column 2: Change
Relative Retention Time (min)
to:
Approximate Retention Time (min)
CITRONELLOL OTHER REQUIREMENTS FCC 8th Edition 266 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 1 of Aldehydes: Change
M2-d, Appendix XI
to:
M2-c, Appendix XI
CARRAGEENAN IMPURITIES/Inorganic Impurities/Mercury FCC 8th Edition 219 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 15 of Analysis: Change
Determine the corrected absorbance values by subtracting the Reagent blank absorbance from each of the Standard solutions and from the Sample solution absorbances.
to:
Determine the corrected absorbance value for the Sample… Read More
CARRAGEENAN IMPURITIES/Inorganic Impurities/Lead FCC 8th Edition 219 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 8 of Analysis: Change
Determine the corrected absorbance values by subtracting the Reagent blank absorbance from each of the Standard solutions and from the Sample solution absorbances.
to:
Determine the corrected absorbance value for the Sample… Read More
CARRAGEENAN IMPURITIES/Inorganic Impurities/Cadmium FCC 8th Edition 219 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 8 of Analysis: Change
Determine the corrected absorbance values by subtracting the Reagent blank absorbance from each of the Standard solutions and from the Sample solution absorbances.
to:
Determine the corrected absorbance value for the Sample… Read More
CARMINE IMPURITIES/Inorganic Impurities/Arsenic FCC 8th Edition 215 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 10 of Sample solution: Change
Pour the distillate mixture into a 600-mL beaker add 20 mL of bromine water,
to:
Pour the distillate mixture into a 600-mL beaker, and add 20 mL of bromine TS (bromine water),
BROMINATED VEGETABLE OIL IDENTIFICATION/Procedure FCC 8th Edition 134 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 2 of Acceptance criteria: Change
an excess of stronger ammonia water.
to:
an excess of ammonia TS, stronger (stronger ammonia water).
ASPARTAME IMPURITIES/Organic Impurities/5-Benzyl-3,6-dioxo-2-piperazineacetic Acid FCC 8th Edition 84 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 10 of Analysis: Change
100%
to:
100
ARABINOGALACTAN IDENTIFICATION/B. Procedure FCC 8th Edition 80 28-Jun-2013 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 1 of Acceptance criteria: Change
No precipitate forms.
to:
A precipitate forms.
PECTINS IDENTIFICATION/Procedure FCC 8th Edition 851 28-Dec-2012 1-Jan-2013 FCC 9th Edition Second Supplement to FCC 8th Edition Line 16 of Analysis: Delete
Report the value of U as U × 105
AND
Line 1 of Acceptance criteria: Change
U is greater than 0.5, whereas other gums show essentially no change
to:
The amount of unsaturated product produced, U, is NLT 0.5 x 10−5.… Read More
ISOPULEGOL OTHER REQUIREMENTS FCC 8th Edition 608 28-Dec-2012 1-Jan-2013 FCC 9th Edition Second Supplement to FCC 8th Edition Line 1: Change
Angular Rotation, Aldehydes, M-2d, Appendix XI
to:
Aldehydes, M-2c, Appendix XI
DEXTROSE IMPURITIES/Inorganic Impurities/Arsenic FCC 9th Edition 360 27-Jun-2014 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Add
Acceptance criteria: NMT 1 mg/kg
DEXTRIN IMPURITIES FCC 9th Edition 358 27-Jun-2014 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Row 4 of Column 1 of table: Change
0.1
to:
1.0
CASEIN AND CASEINATE SALTS SPECIFIC TESTS/Lactose FCC 9th Edition 263 27-Jun-2014 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 2 of Standard stock solutions: Change
500-mL
to:
100-mL
TEST SOLUTIONS (TS) AND OTHER REAGENTS NITRIC ACID FCC 9th Edition 1486 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 2: Delete
(69.0%–71.0% of HNO3)
PANCREATIN ACTIVITY AMYLASE ACTIVITY FCC 9th Edition 1408 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 14 of Procedure: Change
10.0 mL of 1 N iodine VS,
to:
10.0 mL of 0.1 N iodine VS,
IDENTIFICATION TESTS PHOSPHATE FCC 9th Edition 1343 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 3: Change
With ammonium molybdate TS, a yellow precipitate, which is soluble in 6 N ammonium hydroxide, is formed.
to:
Acidified solutions of orthophosphates yield a yellow precipitate with ammonium molybdate TS, which is soluble in 6 N ammonium hydroxide.
SULFUR IMPURITIES/Inorganic Impurities/Arsenic FCC 9th Edition 1173 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 1 of Acceptance criteria: Change
1 mg/kg
to:
NMT 1 mg/kg
SODIUM CHLORIDE IMPURITIES/Inorganic Impurities/Heavy Metals (as Pb)/Method 1 FCC 9th Edition 1078 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 1 of Sample solution: Change
10 g in 35 mL of water
to:
10 g in 35 mL of water. [NOTE—Prepare enough solution to be used for further analysis. Split the final volume into two equal portions.]
AND
Line 1 of Solution B: Change
Transfer 25 mL of Sample solution… Read More
OX BILE EXTRACT ASSAY/Procedure FCC 9th Edition 879 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 10 of Analysis: Change
Determine the absorbance of each solution in a 1-cm cell at the wavelength of maximum absorbance at about 650 nm.
to:
Determine the absorbance of each solution in a 1-cm cell at 650 nm.
GLUCOSE SYRUP, DRIED SPECIFIC TESTS/Total Solids FCC 9th Edition 528 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 1 of Acceptance criteria: Change
NLT 90% when the reducing sugar content is 88% or greater; NLT 93% when the reducing sugar content is between 20.0% and 88.0%
to:
NLT 90% when the reducing sugar content is 88% or greater, calculated on the anhydrous basis; NLT 93% when the… Read More
GLUCOSE SYRUP, DRIED ASSAY/Reducing Sugars Assay FCC 9th Edition 528 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 2 of Acceptance criteria: Change
calculated on the dried basis
to:
calculated on the anhydrous basis
BRILLIANT BLACK PN IMPURITIES/Uncombined Intermediates and Products of Side Reactions FCC 9th Edition 150 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Row 2 of Column 4 of Table 2: Change
134-34-9
to:
6409-21-8
FLUORIDE LIMIT TEST METHOD II (ION-SELECTIVE ELECTRODE METHOD A) FCC 9th Edition 1350 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 4 of Fluoride Standard: Change
1000 mg
to:
1000 µg
AND
Line 2 of Fluoride Standard Solution: Delete
to a 1000-mL volumetric flask, and dilute with water to volume. Take 1 mL of this solution and transfer
SUCROSE IMPURITIES/Organic Impurities/Invert Sugar FCC 9th Edition 1165 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 5 of Internal standard solution: Add
[NOTE—The change in the density of the solution due to addition of the lactose is insignificant, therefore 200 mL is equivalent to 200 g.]
AND
Line 26 of Analysis: Change
RRF = (HL/HS) × [(WSDF × W… Read More
SODIUM SELENATE ANHYDROUS ASSAY/Procedure FCC 9th Edition 1120 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 1 of Acceptance criteria: Change
NMT
to:
NLT
SODIUM CHLORIDE SPECIFIC TESTS/Iron FCC 9th Edition 1078 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 1 of Control solution: Change
Dissolve 10 mL of Iron Standard Solution
to:
Dissolve 1 mL of Iron Standard Solution
L-SERINE IMPURITIES/Inorganic Impurities/Lead, Lead Limit Test, Appendix IIIB FCC 9th Edition 1061 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Add Acceptance criteria: NMT 5 mg/kg
L-SERINE SPECIFIC TESTS/Optical (Specific) Rotation, Appendix IIB FCC 9th Edition 1061 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 3 of Acceptance criteria: Change
+13°
to:
+13.2°
MALIC ACID SPECIFIC TESTS/Optical (Specific) Rotation, Appendix IIB FCC 9th Edition 728 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 1 of Acceptance criteria: Change
[α]D25 between −0.10° and +0.10°
to:
[α]D25 between −0.10° and +0.10°, on the as-is basis
IRON, CARBONYL IMPURITIES/Inorganic Impurities/Lead FCC 9th Edition 611 19-Dec-2014 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 1 of Standard solution: Change
Transfer 5.0 mL of Lead nitrate stock solution
to:
Transfer 2.0 mL of Lead nitrate stock solution
AND
Line 15 of Standard solution: Change
The organic solvent layer contains 2.0 µg of lead/mL,and is the Standard… Read More