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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 Sort descending Page Number Errata Effective Date Target Errata Print Publication Target Online Fix Publication Description
BENTONITE IMPURITIES/Inorganic Impurities/Lead FCC 10th Edition 132 1-May-2018 FCC 12th Edition First Supplement to FCC 11th Edition Line 3 of Acceptance criteria: Change
(NMT 4 mg/kg).
to:
(NMT 40 mg/kg).
APPENDIX X: CARBOHYDRATES (STARCHES, SUGARS, AND RELATED SUBSTANCES) SULFUR DIOXIDE DETERMINATION FCC 10th Edition 1537 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 2: Change
(Based on AOAC Method 962.16)
to:
(Based on AOAC Method 990.28)
THIAMINE MONONITRATE IDENTIFICATION/D. Procedure FCC 10th Edition 1287 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 2 of Analysis: Change
potassium ferrocyanide TS
to:
potassium ferricyanide TS
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.
SODIUM HYDROXIDE SOLUTIONS IMPURITIES/Inorganic Impurities/Mercury FCC 10th Edition 1171 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 1 of Sample solution: Change
Transfer 10.0 g of sample into a 100-mL beaker, dissolve in 15 mL of water, add 2 drops of phenolphthalein TS and, while constantly stirring, slowly neutralize with 1:2 hydrochloric acid. Add 1 mL of 1:5 sulfuric acid and 1 mL of a 40 mg/mL solution of… Read More
SODIUM HYALURONATE (FROM MICROBIAL FERMENTATION) SPECIFIC TESTS/Intrinsic Viscosity FCC 10th Edition 1169 1-Jan-2018 FCC 11th Edition FCC 11th Edition First equation in Analysis: Change
ηr = [ti (B/ti2)]/[t0 – (B/ti2)]
to:
ηr = [ti – (B/ti2)]/[t0 − (B/t02)]
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
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]
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
INOSITOL IMPURITIES/Inorganic Impurities/Sulfate, Choride and Sulfate Limit Tests, Chloride Limit Test, Appendix IIIB FCC 10th Edition 655 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,
FRUCTOSE IMPURITIES/Inorganic Impurities/Sulfate, Chloride and Sulfate Limit Tests, Chloride Limit Test, Appendix IIIB FCC 10th Edition 538 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,
FERRIC PHOSPHATE IMPURITIES/Inorganic Impurities FCC 10th Edition 515 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
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
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).
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
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.
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]
APPENDIX II: PHYSICAL TESTS AND DETERMINATIONS/C. OTHERS INSOLUBLE FOREIGN MATTER IN AMINO ACIDS/Apparatus FCC 10th Edition Online 1-Jul-2016 FCC 11th Edition FCC 10th Edition Footnote 4: Add
Millipore catalog number NY1H04700, or equivalent.
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
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
PALM OIL (UNHYDROGENATED) SPECIFIC TESTS/Free Fatty Acids FCC 10th Edition 952 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
LACTOBACILLUS ACIDOPHILUS NCFM IDENTIFICATION/Nucleic Acid-Based Identification FCC 10th Edition 723 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).
KONJAC FLOUR IDENTIFICATION/Heat-Stable Gel Test FCC 10th Edition 705 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
CALCIUM HYDROXIDE IMPURITIES/Inorganic Impurities/Lead, Lead Limit Test, Appendix IIIB FCC 11th Edition 202 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In the Control: Change
5 µg Pb (5 mL of Diluted Standard Lead Solution)
to:
2 µg Pb (2 mL of Diluted Standard Lead Solution)
BETAINE IDENTIFICATION/Infrared Absorption, Spectrophotometric Identification Tests, Appendix IIIC FCC 11th Edition 142 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In the Acceptance criteria: Change
The spectrum of the sample exhibits absorption bands at approximately the following wavelengths, which correspond in intensity and wavelength to those in the spectrum of the Reference standard (s = strong, m =… Read More
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)
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
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
VITAMIN A SPECIFIC TESTS/Absorbance Ratio FCC 11th Edition 1239 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
[Note—The Absorbance ratio is the ratio of absorbances corrected/observed at 325 nm.]
to:
[Note—The Absorbance ratio is the ratio of absorbances corrected/observed at 325 nm. Only apply to other forms of Vitamin A in the Assay… Read More
TRIETHYL CITRATE CHEMICAL INFORMATION FCC 11th Edition 1217 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
INS: 1519
to:
INS: 1505
STANNOUS CHLORIDE CHEMICAL INFORMATION FCC 11th Edition 1138 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
INS: 521
to:
INS: 512
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]
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]
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
APPENDIX V: ENZYME ASSAYS PLANT PROTEOLYTIC ACTIVITY FCC 11th Edition 1389 1-Jul-2019 FCC 12th Edition Third Supplement to FCC 11th Edition In Reagents and Solutions/Stock Standard Solution: Change
USP Papain Reference Standard
to:
USP Papain RS
AND
In the third paragraph of Calculation: Change
USP Papain Reference Standard,
to:
USP Papain RS,
POTASSIUM PHOSPHATE, DIBASIC SPECIFIC TESTS/Pyrophosphate FCC 11th Edition 981 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
LACTYLIC ESTERS OF FATTY ACIDS IMPURITIES/Inorganic Impurities FCC 11th Edition 677 1-Jul-2019 FCC 12th Edition Third Supplement to FCC 11th Edition In Lead: Change
Appendix IIB
to:
Appendix IIIB
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
APPENDIX XV: MICROBIAL FOOD CULTURES INCLUDING PROBIOTICS IDENTITY/Yeast Starter Culture FCC 11th Edition 1453 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In footnote 18: Change
[cited 5 March 2011]. Available from http://www.efsa.europa.eu/en/efsajournalpub/1944.htm.
to:
[cited 30 August 2018]. Available from… Read More
APPENDIX XV: MICROBIAL FOOD CULTURES INCLUDING PROBIOTICS USES OF MICROBIAL FOOD CULTURES IN FOOD PRODUCTION FCC 11th Edition 1453 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In MFC Used to Transform Foods/footnote 4: Change
10.1002/mnfr.201100010, http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2-1… Read More
APPENDIX XV: MICROBIAL FOOD CULTURES INCLUDING PROBIOTICS INTRODUCTION TO MICROBIAL FOOD CULTURES FCC 11th Edition 1453 1-Jan-2019 FCC 12th Edition Second Supplement to FCC 11th Edition In footnote 2: Change
[cited 5 March 2011]. Available from ftp://ftp.fao.org/docrep/fao/009/a0512e/a0512e00.pdf.
to:
[cited 30 August 2018]. Available from… Read More
LITHOL RUBINE BK IMPURITIES/Organic Impurities/Uncombined Intermediates and Products of Side Reactions and Subsidiary Coloring Matters FCC 11th Edition 707 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,
GLYCERIN IDENTIFICATION/B. Procedure FCC 11th Edition 535 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
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
DIMETHYLPOLYSILOXANE IDENTIFICATION/Infrared Absorption FCC 12th Edition 390 1-Jul-2021 NA Third Supplement to FCC 12th Edition In Reference standard: Change
USP Dimethylpolysiloxane RS
to:
USP Polydimethylsiloxane RS
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).
CALCIUM ASCORBATE IDENTIFICATION/C. Infrared Absorption FCC 12th Edition 185 1-Jul-2021 NA Third Supplement to FCC 12th Edition In Reference standard: Change
USP Calcium Absorbate RS
to:
USP Calcium Ascorbate RS
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
CALCIUM PHOSPHATE, MONOBASIC IMPURITIES/Inorganic Impurities/Flouride FCC 12th Edition 211 1-Jul-2020 First Supplement to FCC 12th Edition First Supplement to FCC 12th Edition In Analysis: Change
Result = 100 × (CS/CB)/W
to:
Result = 100 × (CS - CB)/W
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