FCC Errata Table - All

CSV View April 18, 2022 through April 20, 2024 All Errata for FCC How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Post Date Errata Effective Date Target Errata Print Publication Target Online Fix Publication Description
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
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)
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.
DIMETHYLPOLYSILOXANE IDENTIFICATION/Infrared Absorption FCC 12th Edition 390 25-Jun-2021 1-Jul-2021 NA Third Supplement to FCC 12th Edition In Reference standard: Change
USP Dimethylpolysiloxane RS
to:
USP Polydimethylsiloxane RS
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
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
FERRIC PHOSPHATE IMPURITIES/Inorganic Impurities FCC 10th Edition 515 30-Jun-2017 1-Jul-2017 Third Supplement to FCC 10th Edition Third Supplement to FCC 10th Edition Line 2 of Arsenic, Arsenic Limit Test, Appendix IIIB: Change
[NOTE—Assemble the special distillation apparatus as shown in Figure 13.]
to:
[NOTE—Assemble the special distillation apparatus as shown in Figure 3.]
AND
Lines 3 and 10 of Mercury/Analysis… 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
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
GLUTARALDEHYDE ASSAY/Procedure FCC 9th Edition 532 27-Jun-2014 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
GLYCERIN IDENTIFICATION/B. Procedure FCC 11th Edition 535 28-Dec-2018 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In Row 4 of Column 1 in the temperature program table: Change
100
to:
120
FRUCTOSE IMPURITIES/Inorganic Impurities/Sulfate, Chloride and Sulfate Limit Tests, Chloride Limit Test, Appendix IIIB FCC 10th Edition 538 30-Jun-2017 1-Jul-2017 Third Supplement to FCC 10th Edition Third Supplement to FCC 10th Edition Line 1: Change
Chloride Limit Test,
to:
Sulfate Limit Test,
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
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.
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
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
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).
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
KRILL OIL SPECIFIC TESTS/Content of Astaxanthin FCC 9th Edition 654 27-Jun-2014 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 4 of Analysis: Change
percent
to:
amount
INOSITOL IMPURITIES/Inorganic Impurities/Sulfate, Choride and Sulfate Limit Tests, Chloride Limit Test, Appendix IIIB FCC 10th Edition 655 30-Jun-2017 1-Jul-2017 Third Supplement to FCC 10th Edition Third Supplement to FCC 10th Edition Line 1: Change
Chloride Limit Test,
to:
Sulfate Limit Test,
LABDANUM OIL DESCRIPTION FCC 9th Edition 660 18-Dec-2015 1-Jan-2016 FCC 10th Edition FCC 10th Edition Line 6: Change
Cistus ladaniferus L.
to:
Cistus ladanifer L.
LACTYLIC ESTERS OF FATTY ACIDS IMPURITIES/Inorganic Impurities FCC 11th Edition 677 28-Jun-2019 1-Jul-2019 FCC 12th Edition Third Supplement to FCC 11th Edition In Lead: Change
Appendix IIB
to:
Appendix IIIB
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
KONJAC FLOUR IDENTIFICATION/Heat-Stable Gel Test FCC 10th Edition 705 24-Jun-2016 1-Jul-2016 FCC 11th Edition FCC 10th Edition Line 1 of Sample mixture: Change
prepared by heating the mixture in a water bath
to:
prepared by heating the mixture in a boiling water bath
AND
Line 4 of Analysis: Change
hold quiescently for 2 h
to:
hold for 2 h
LITHOL RUBINE BK IMPURITIES/Organic Impurities/Uncombined Intermediates and Products of Side Reactions and Subsidiary Coloring Matters FCC 11th Edition 707 28-Dec-2018 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In the Standard solution: Change
80 μL of Standard stock solution B,
to:
400 μL of Standard stock solution B,
LACTITOL ASSAY/Procedure FCC 10th Edition 719 30-Dec-2016 1-Jan-2017 FCC 11th Edition Second Supplement to FCC 10th Edition Line 2 of Acceptance criteria: Change
calculated on the dried basis
to:
calculated on the anhydrous basis
LACTOBACILLUS ACIDOPHILUS NCFM IDENTIFICATION/Nucleic Acid-Based Identification FCC 10th Edition 723 24-Jun-2016 1-Jul-2016 FCC 11th Edition FCC 10th Edition Line 6 of PCR amplification: Change
or for 1 min (for Primer set 2; step 4).
to:
or for 1 min (for Primer set 3; step 4).
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
MALIC ACID CHEMICAL INFORMATION FCC 11th Edition 734 27-Dec-2019 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
CAS: [617-48-1]
to:
CAS: [6915-15-7]
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
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.
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|
PALM OIL (UNHYDROGENATED) SPECIFIC TESTS/Free Fatty Acids FCC 10th Edition 952 24-Jun-2016 1-Jul-2016 FCC 11th Edition FCC 10th Edition Line 4 of Analysis: Change
Free fatty acids as lauric acid, e = 25.6
to:
Free fatty acids as palmitic acid, e = 25.6
POTASSIUM PHOSPHATE, DIBASIC SPECIFIC TESTS/Pyrophosphate FCC 11th Edition 981 28-Jun-2019 1-Jul-2019 FCC 12th Edition Third Supplement to FCC 11th Edition In Standard stock solution: Change
The resulting solution contains 1000 mg/mL of pyrophosphate anion
to:
The resulting solution contains 1000 µg/mL of pyrophosphate anion
POLYDEXTROSE ASSAY/Procedure FCC 10th Edition 1015 24-Jun-2016 1-Jul-2016 FCC 11th Edition FCC 10th Edition Line 1 of Standard solution: Change
4.0 mg/mL of USP Polydextrose RS, calculated on the anhydrous and ash-free basis, in Mobile phase
to:
4.0 mg/mL of USP Polydextrose RS in Mobile phase
AND
Line 1 of Acceptance criteria: Change
NLT 90.0%
to:
NLT… Read More
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.
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
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 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 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|
L-SELENOMETHIONINE CHEMICAL INFORMATION FCC 11th Edition 1054 27-Dec-2019 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
CAS: [1464-42-2]
to:
CAS: [3211-76-5]
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°
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
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
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
RUTIN CHEMICAL INFORMATION FCC 10th Edition 1116 30-Jun-2017 1-Jul-2017 Third Supplement to FCC 10th Edition Third Supplement to FCC 10th Edition Line 3: Change
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4H-chromen-4-one-3-yl 6-O-α-L-rhamnopyranosyl-β-D-glucoside
to:
2-(3,4-Dihydroxyphenyl)-5,7-dihydroxy-4-oxo-4H-chromen-3-yl 6-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranoside trihydrate
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
SUCRALOSE CHEMICAL INFORMATION FCC 12th Edition 1123 26-Jun-2020 1-Jul-2020 First Supplement to FCC 12th Edition First Supplement to FCC 12th Edition Change:
Formula wt: 397.64
to:
Formula wt: 397.63
STANNOUS CHLORIDE CHEMICAL INFORMATION FCC 11th Edition 1138 27-Dec-2019 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
INS: 521
to:
INS: 512
SUCROMALT DESCRIPTION FCC 9th Edition 1162 27-Jun-2014 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.