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FCC Errata Table - All

CSV View March 21, 2022 through March 28, 2024 All Errata for FCC How to use
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Monograph Title Section Sort descending Source Publication Page Number Errata Effective Date Target Errata Print Publication Target Online Fix Publication Description
TEST SOLUTIONS (TS) AND OTHER REAGENTS Acetic Acid FCC 12th Edition 1560 1-Jul-2021 NA Third Supplement to FCC 12th Edition Change
Use ACS reagent-grade Acetic Acid, Glacial (99.7% of CH3COOH; approximately 17.5 N).
to:
(approximately 17.5 N) Use ACS reagent-grade Acetic Acid, Glacial (NLT 99.7% of CH3COOH).
TEST SOLUTIONS (TS) AND OTHER REAGENTS Methylene Orange TS Third Supplement to FCC 10th Edition Online 1-Jan-2018 FCC 11th Edition FCC 11th Edition All references to methylene orange TS in FCC should be changed to methyl orange TS
SOLUTIONS AND INDICATORS Test Solutions (TS) and Other Reagents FCC 10th Edition 1624 1-Jan-2017 Second Supplement to FCC 10th Edition FCC 11th Edition Add
Acetic Acid (approximately 17.5 N) Use ACS reagent-grade Acetic Acid, Glacial (99.7% of CH3COOH).
PANCREATIN ACTIVITY AMYLASE ACTIVITY FCC 9th Edition 1408 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,
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
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
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
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
OX BILE EXTRACT ASSAY/Procedure FCC 9th Edition 879 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.
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|
BHA ASSAY/Procedure FCC 11th Edition 143 1-Jul-2018 FCC 12th Edition First Supplement to FCC 11th Edition Line 3 of System suitability: Change
3-tert-butyl-4-hydroxyanisole and 2-tert-butyl-4-hydroxyanisole
to:
2-tert-butyl-4-hydroxyanisole and 3-tert-butyl-4-hydroxyanisole
CALCIUM BENZOATE ASSAY/Procedure FCC 11th Edition 193 1-Jul-2018 FCC 12th Edition First Supplement to FCC 11th Edition Line 7 of Analysis: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × N × 100
to:
Result = (rU/rS) × (CS/CU) × (Mr1/MRead 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.
POLYDEXTROSE ASSAY/Procedure FCC 10th Edition 1015 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
HYDROXYPROPYL METHYLCELLULOSE ASSAY/Procedure FCC Online Online 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.
FOLIC ACID ASSAY/Procedure FCC Online Online 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
β-APO-8'-CAROTENAL ASSAY/Procedure FCC 11th Edition 84 1-Jul-2019 FCC 12th Edition Third Supplement to FCC 11th Edition In the variable definition list in Analysis: Change
A = absorbance of Sample solution B
to:
A = absorbance of the Sample solution
LACTITOL ASSAY/Procedure FCC 10th Edition 719 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
CHOLINE CHLORIDE ASSAY/Procedure FCC 10th Edition 313 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
CALCIUM CITRATE ASSAY/Procedure FCC 11th Edition 197 1-Jan-2020 FCC 12th Edition FCC 12th Edition In Analysis: Change
Each mL of 0.05 M disodium EDTA is equivalent to 8.300 mg of Ca3(C6H5O7)2.
to:
Each mL of 0.05 M disodium EDTA is equivalent to 8.307 mg of Ca3(C6H… Read More
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 SELENATE ANHYDROUS ASSAY/Procedure FCC 10th Edition 1199 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 3 of Analysis: Change
add 10 mL of a hydroxylamine hydrochloride solution (0.5/mL).
to:
add 10 mL of a 50% (w/v) hydroxylamine hydrochloride solution.
ADVANTAME ASSAY/Procedure/Chromatographic system/System suitability Second Supplement to FCC 9th Edition 1902 1-Jan-2016 FCC 10th Edition FCC 10th Edition Line 1 of Suitability requirement 2: Change
When injected six consecutive times, the relative standard deviation for the retention time of the advantame peak is NMT 1.0% for the Standard solution having the concentration of USP Advantame RS closest to 160 µg/mL.
to:
When… Read More
GLUCOSE SYRUP, DRIED ASSAY/Reducing Sugars Assay FCC 9th Edition 528 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
SODIUM HYALURONATE (FROM MICROBIAL FERMENTATION) ASSAY/Sodium Hyaluronate Content FCC 10th Edition 1169 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 6 of Calculation: Change
CS = CG × {Z × [100/(100 − hS) × (M1/M2)]}
to:
CS = CG × Z × (M1/M2)
AND
Line 10: Delete
hS= percentage of loss on drying
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
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
APPENDIX XVI: PROTEIN-BASED INGREDIENTS CAPILLARY GEL ELECTROPHORESIS FOR IDENTIFICATION OF FOREIGN PROTEINS IN WHEY PROTEIN INGREDIENTS FCC Online Online 1-Jan-2022 NA FCC 13th Edition In Principle: Change
The threshold of detection is set as a trade-off between these two constrains
to:
The threshold of detection is set as a trade-off between these two constraints
SUCRALOSE CHEMICAL INFORMATION FCC 12th Edition 1123 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
CINNAMON BARK OIL, CEYLON TYPE CHEMICAL INFORMATION FCC 11th Edition 293 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In FEMA: Change
2290
to:
2291
L-ARGININE MONOHYDROCHLORIDE CHEMICAL INFORMATION FCC 10th Edition 99 1-Jan-2017 FCC 11th Edition Second Supplement to FCC 10th Edition Line 3: Change
CAS: [1119-34-12]
to:
CAS: [1119-34-2]
RUTIN CHEMICAL INFORMATION FCC 10th Edition 1116 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
MALIC ACID CHEMICAL INFORMATION FCC 11th Edition 734 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
CAS: [617-48-1]
to:
CAS: [6915-15-7]
SODIUM FERROCYANIDE CHEMICAL INFORMATION FCC 10th Edition 1164 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 3: Change
CAS: [13601-19-9]
to:
CAS: [14434-22-1]
L-SELENOMETHIONINE CHEMICAL INFORMATION FCC 11th Edition 1054 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
CAS: [1464-42-2]
to:
CAS: [3211-76-5]
STANNOUS CHLORIDE CHEMICAL INFORMATION FCC 11th Edition 1138 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
INS: 521
to:
INS: 512
TRIETHYL CITRATE CHEMICAL INFORMATION FCC 11th Edition 1217 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
INS: 1519
to:
INS: 1505
ALPHA-DAMASCONE CHEMICAL INFORMATION FCC 12th Edition 344 1-Jul-2020 First Supplement to FCC 12th Edition First Supplement to FCC 12th Edition Change
4-(2,6,6-Trimethyl-2-cyclohexenyl)-2-butene-4-one
to:
4-(2,6,6-Trimethyl-2-cyclohexenyl)-2-buten-4-one
KRILL OIL CONTENT OF ASTAXANTHIN First Supplement to FCC 11th Edition 1743 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
APPENDIX VIII: OLEORESINS CURCUMIN CONTENT FCC 11th Edition 1415 1-Jul-2018 FCC 12th Edition First Supplement to FCC 11th Edition Line 6 of Procedure: Change
Result = (A × 100)(165 × b × c)
to:
Result = (A × 100)/(165 × b × c)
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.
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
LABDANUM OIL DESCRIPTION FCC 9th Edition 660 1-Jan-2016 FCC 10th Edition FCC 10th Edition Line 6: Change
Cistus ladaniferus L.
to:
Cistus ladanifer L.
CARNAUBA WAX DESCRIPTION FCC 10th Edition 271 1-Jan-2017 FCC 11th Edition Second Supplement to FCC 10th Edition Line 4: Change
Copernicia cereferia (Arruda) Mart.
to:
Copernicia prunifera (Mill.) H.E.Moore
AND
Line 5: Change
C. prunifera (Muell.)
to:
Copernicia cerifera (Arruda) Mart.
APPENDIX XVI: PROTEIN-BASED INGREDIENTS DETERMINATION OF STARCH AND STARCH DEGRADATION PRODUCTS IN SKIM MILK POWDER AND NONFAT DRY MILK First Supplement to FCC 12th Edition 1795 1-Jan-2021 FCC 13th Edition Second Supplement to FCC 12th Edition In Sample solution: Change
Filter the supernatant through a 0.2-mm hydrophilic membrane.
to:
Filter the supernatant through a 0.2-μm hydrophilic membrane.
APPENDIX XIII: ADULTERANTS AND CONTAMINANTS IN FOOD INGREDIENTS DIETHYLENE GLYCOL AND ETHYLENE GLYCOL IN GLYCERIN FCC 10th Edition 1553 1-Jul-2016 FCC 11th Edition FCC 10th Edition Line 1 of Chromatographic system: Change
Chromatographic system,
to:
Chromatographic system, Appendix IIA
APPENDIX V: ENZYME ASSAYS ENZYME PREPARATIONS USED IN FOOD PROCESSING FCC Online Online 1-Jan-2022 NA FCC 13th Edition In Plant Proteolytic Activity: Change
Citric scid solution (0.05 M):
to:
Citric acid solution (0.05 M):
APPENDIX V: ENZYME ASSAYS ENZYME PREPARATIONS USED IN FOOD PROCESSING FCC Online Online 1-Jul-2022 NA First Supplement to FCC 13th Edition In Invertase Sumner Unit Activity/Analysis/paragraph 4: Change
To prepare the glucose standards, add 1 mL of the Standard sucrose solution to each of the 3 appropriate Sucrose substrate solution test tubes.
to:
To prepare the… Read More
APPENDIX V—ENZYME ASSAYS ENZYME PREPARATIONS USED IN FOOD PROCESSING FCC Online Online 1-Jul-2023 NA Third Supplement to FCC 13th Edition In Phytase Activity: Change
Sample preparation, Procedure 1: Suspend or dissolve and dilute accurately weighed amounts of sample in Acetate buffer so that 2.0 mL of the final dilution (g/mL) will contain between 0.02 and 0.08 phytase… Read More
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.