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FCC Errata Table - All

CSV View March 22, 2022 through March 28, 2024 All Errata for FCC How to use
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Monograph Title Section Source Publication Page Number Errata Effective Date Target Errata Print Publication Target Online Fix Publication Description
SODIUM CHLORIDE SPECIFIC TESTS/Iron FCC 8th Edition 1023 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.
GERANIOL OTHER REQUIREMENTS FCC 8th Edition 482 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
PECTINS IDENTIFICATION/Procedure FCC 8th Edition 851 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
ALITAME ASSAY/Procedure FCC 8th Edition 33 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.
DIOCTYL SODIUM SULFOSUCCINATE SPECIFIC TESTS/Chromatographic Purity FCC 8th Edition 363 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.
CARMINE IMPURITIES/Inorganic Impurities/Lead FCC 8th Edition 215 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)
ISOPULEGOL OTHER REQUIREMENTS FCC 8th Edition 608 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
KELP IMPURITIES/Inorganic Impurities/Arsenic FCC 8th Edition 612 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 2 of Apparatus: Change
Figure 14
to:
Figure 4
BROMINATED VEGETABLE OIL IDENTIFICATION/Procedure FCC 8th Edition 134 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).
CARRAGEENAN IMPURITIES/Inorganic Impurities/Lead FCC 8th Edition 219 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
DIOCTYL SODIUM SULFOSUCCINATE SPECIFIC TESTS/Chromatographic Purity/Table 1 FCC 8th Edition 363 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)
INVERT SUGAR SPECIFIC TESTS/Total Solids FCC 8th Edition 567 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.
ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX IDENTIFICATION/D. Viscometric Characterization Second Supplement to FCC 8th Edition 1743 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 1 of Standard: Change
USP Alginate-Konjac-Xanthan Polysaccharide Complex RS
to:
USP Alginate-Konjac-Xanthan Polysaccharide Complex for Viscosity Identification RS
ARABINOGALACTAN IDENTIFICATION/B. Procedure FCC 8th Edition 80 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.
CARMINE IMPURITIES/Inorganic Impurities/Arsenic FCC 8th Edition 215 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),
CARRAGEENAN IMPURITIES/Inorganic Impurities/Mercury FCC 8th Edition 219 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
FERROUS CITRATE IMPURITIES/Inorganic Impurities/Sulfate FCC 8th Edition 450 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
KELP IMPURITIES/Inorganic Impurities/Arsenic FCC 8th Edition 612 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).
ASPARTAME IMPURITIES/Organic Impurities/5-Benzyl-3,6-dioxo-2-piperazineacetic Acid FCC 8th Edition 84 1-Jul-2013 FCC 9th Edition Third Supplement to FCC 8th Edition Line 10 of Analysis: Change
100%
to:
100
CARRAGEENAN IMPURITIES/Inorganic Impurities/Cadmium FCC 8th Edition 219 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
CITRONELLOL OTHER REQUIREMENTS FCC 8th Edition 266 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
INVERT SUGAR ASSAY/Invert Sugar FCC 8th Edition 567 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
MALIC ACID IMPURITIES/Organic Impurities FCC 8th Edition 683 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
SODIUM METABISULFITE IMPURITIES/Inorganic Impurities/Iron FCC 8th Edition 1046 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)
YEAST EXTRACT SPECIFIC TESTS/Potassium FCC 8th Edition 1203 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Analysis: Change
suitable spectrophotometer,
to:
suitable atomic absorption spectrophotometer,
Pepsin Activity REAGENTS AND SOLUTIONS Second Supplement to FCC 8th Edition 1789 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 3 of Sample Solution: Change
0.60–0.70
to:
0.9–1.0
POTASSIUM PHOSPHATE, MONOBASIC ASSAY/Procedure FCC 8th Edition 944 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 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
YEAST EXTRACT SPECIFIC TESTS/Sodium Chloride FCC 8th Edition 1203 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Analysis: Change
suitable spectrophotometer,
to:
suitable atomic absorption spectrophotometer,
KRILL OIL DESCRIPTION Third Supplement to FCC 8th Edition 1841 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 6: Change
acetone
to:
solvent
ASTAXANTHIN ESTERS FROM HAEMATOCOCCUS PLUVIALIS ASSAY FCC 8th Edition 89 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
SODIUM CHLORIDE IMPURITIES/Inorganic Impurities/Calcium and Magnesium FCC 8th Edition 1023 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Buffer solution A: Change
67.5 mg
to:
67.5 g
SODIUM PHOSPHATE, MONOBASIC ASSAY/Procedure FCC 8th Edition 1053 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 10 of Analysis: Change
A = 5 – x
to:
A = |5 – x|
Pepsin Activity REAGENTS AND SOLUTIONS Second Supplement to FCC 8th Edition 1789 27-Dec-2013 FCC 9th Edition FCC 9th Edition Line 3 of Standard Solutions: Change
0.45–0.90
to:
0.70– 1.25
DEXTRIN IMPURITIES FCC 9th Edition 358 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
KRILL OIL SPECIFIC TESTS/Content of Astaxanthin FCC 9th Edition 654 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 4 of Analysis: Change
percent
to:
amount
Color Determination SODIUM SULFATE FCC 9th Edition 1366 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 8: Change
tetrahydroquinone sulfate indicator
to
tetrahydroxyquinone indicator(CAS: 319-89-1)5
AND
Add a footnote
[fn: 5 >95% purity (Catalog Number 099165, Matrix Scientific, Columbia, SC, USA), or equivalent].
DEXTROSE IMPURITIES/Inorganic Impurities/Arsenic FCC 9th Edition 360 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Add
Acceptance criteria: NMT 1 mg/kg
SUCROMALT DESCRIPTION FCC 9th Edition 1162 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 11: Change
and 40%–60% higher glucooligosaccharides of 12+ DP.
to:
and NLT 40% higher saccharides of DP 3+ and an average of DP 10.
Glucoamylase Activity (Amyloglucosidase Activity) CALCULATIONS FCC 9th Edition 1397 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 12: Change
µ/g
to:
U/g
CASEIN AND CASEINATE SALTS SPECIFIC TESTS/Lactose FCC 9th Edition 263 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
GLUTARALDEHYDE ASSAY/Procedure FCC 9th Edition 532 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 1 of Sample: Change
300 g
to:
300 mg
TBHQ SPECIFIC TESTS/Ultraviolet Absorbance (Polynuclear Hydrocarbons) FCC 9th Edition 1192 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 18 of Sample preparation: Change
0.5% solution of 75 : 25 ethanol and water–ascorbic acid.
to:
25:75 (v/v) ethanol water solution containing 0.5% ascorbic acid.
Glucoamylase Activity (Amyloglucosidase Activity) CALCULATIONS FCC 9th Edition 1397 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 12: Change
ε
to:
M
FLUORIDE LIMIT TEST METHOD II (ION-SELECTIVE ELECTRODE METHOD A) FCC 9th Edition 1350 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
BUTYL STEARATE OTHER REQUIREMENTS/Saponification Value, Appendix VII FCC 9th Edition 177 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 1 of Acceptance criteria: Change
65–180
to:
165–180
L-SERINE SPECIFIC TESTS/Optical (Specific) Rotation, Appendix IIB FCC 9th Edition 1061 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 3 of Acceptance criteria: Change
+13°
to:
+13.2°
SODIUM SELENATE ANHYDROUS ASSAY/Procedure FCC 9th Edition 1120 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 1 of Acceptance criteria: Change
NMT
to:
NLT
GENERAL PROVISIONS AND REQUIREMENTS FCC SPECIFICATIONS First Supplement to FCC 9th Edition 1807 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 6 of third paragraph: Change
FCC 8, including any Supplement that is current at the time.
to:
the effective edition of FCC, including any Supplement that is effective at the time.
IRON, CARBONYL IMPURITIES/Inorganic Impurities/Lead FCC 9th Edition 611 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