FCC Errata Table - All

CSV View April 18, 2022 through April 20, 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
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
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.
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
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-ARGININE MONOHYDROCHLORIDE CHEMICAL INFORMATION FCC 10th Edition 99 30-Dec-2016 1-Jan-2017 FCC 11th Edition Second Supplement to FCC 10th Edition Line 3: Change
CAS: [1119-34-12]
to:
CAS: [1119-34-2]
KRILL OIL DESCRIPTION Third Supplement to FCC 8th Edition 1841 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 6: Change
acetone
to:
solvent
KRILL OIL IDENTIFICATION, Fatty Acid Composition First Supplement to FCC 11th Edition 1743 28-Dec-2018 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In the Myristic acid Row and Lower Limit Column of Table 1: Change
4.5
to:
3.0
AND
In the Palmitic acid:Myristic acid ratio Row and Upper Limit Column of Table 1: Change
2.8
to:
3.6
AND… Read More
KRILL OIL CONTENT OF ASTAXANTHIN First Supplement to FCC 11th Edition 1743 28-Dec-2018 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In the Acceptance criteria: Change
NLT ▲85▲1S(FCC 11) µg/g
to:
NLT 50 µg/g
KRILL OIL IDENTIFICATION/Fatty Acid Composition Second Supplement to FCC 11th Edition Online 28-Jun-2019 1-Jul-2019 FCC 12th Edition Third Supplement to FCC 11th Edition In the Monounsaturated fatty acids/cis-Palmitoleic acid Row of the Upper Limit Column of Table 1: Change
6.2
to:
8.5
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
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
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
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
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.
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,
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.
HYDROXYPROPYL METHYLCELLULOSE ASSAY/Procedure FCC Online Online 16-Dec-2022 1-Jan-2023 NA Second Supplement to FCC 13th Edition In Internal standard solution: Change
Dilute 2.5 g of toluene to 1000 mL with o-xylene.
to:
Dilute 2.5 g of toluene to 100 mL with o-xylene.
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
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
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
Glucoamylase Activity (Amyloglucosidase Activity) CALCULATIONS FCC 9th Edition 1397 27-Jun-2014 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 12: Change
µ/g
to:
U/g
Glucoamylase Activity (Amyloglucosidase Activity) CALCULATIONS FCC 9th Edition 1397 27-Jun-2014 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 12: Change
ε
to:
M
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
GENERAL PROVISIONS AND REQUIREMENTS FCC SPECIFICATIONS First Supplement to FCC 9th Edition 1807 19-Dec-2014 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.
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,
FOLIC ACID ASSAY/Procedure FCC Online Online 30-Jun-2023 1-Jul-2023 NA Third Supplement to FCC 13th Edition In System suitability/Suitability requirements/Resolution: Change
NLT 3.6 between calcium formyltetrahydrofolate (related compound A) and folic acid, System suitability solution
to:
NLT 3.6 between leucovorin calcium and folic… Read More
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
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
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
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.
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)
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
DEXTROSE IMPURITIES/Inorganic Impurities FCC Online Online 24-Jun-2022 1-Jul-2022 NA First Supplement to FCC 13th Edition Change
• Chloride
Sample: 2.0 g
Acceptance criteria: Sample shows no more chloride than corresponds to 0.50 mL of 0.020 N hydrochloric acid. (NMT 0.018%)
to:
• Chloride, Chloride and Sulfate Limit Test, Chloride… Read More
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
DECYL ACETATE IDENTIFICATION Second Supplement to FCC 9th Edition 1915 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Change the test name
Infrared Absorption
to:
Infrared Spectra
AND
Line 1 of Acceptance criteria: Change
The spectrum of the sample exhibits maxima at the same wavelengths as those in the spectrum displayed below.
to:
The spectrum of the sample exhibits relative… Read More
Color Determination SODIUM SULFATE FCC 9th Edition 1366 27-Jun-2014 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].
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
CITRIC ACID SPECIFIC TESTS/Oxalate FCC Online Online 16-Dec-2022 1-Jan-2023 NA Second Supplement to FCC 13th Edition In Analysis: Change
Transfer the solution into a glass cylinder with a ground glass stopper and add an equal volume of concentrated hydrochloric acid and 0.25 mL of 5% potassium ferricyanate solution.
to:
Transfer the solution into a glass cylinder… Read More
CINNAMON BARK OIL, CEYLON TYPE CHEMICAL INFORMATION FCC 11th Edition 293 28-Dec-2018 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In FEMA: Change
2290
to:
2291
CHOLINE CHLORIDE ASSAY/Procedure FCC 10th Edition 313 30-Jun-2017 1-Jul-2017 Third Supplement to FCC 10th Edition Third Supplement to FCC 10th Edition Line 4 of Analysis: Change
mercuric acetate
to:
mercuric acetate TS
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
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
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/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