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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 Effective Date Target Errata Print Publication Sort descending Target Online Fix Publication Description
IDENTIFICATION TESTS PHOSPHATE FCC 9th Edition 1343 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.
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,
TEST SOLUTIONS (TS) AND OTHER REAGENTS NITRIC ACID FCC 9th Edition 1486 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 2: Delete
(69.0%–71.0% of HNO3)
DECYL ACETATE IDENTIFICATION Second Supplement to FCC 9th Edition 1915 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
SODIUM FERROUS CITRATE IMPURITIES/Inorganic Impurities/Sulfate Second Supplement to FCC 9th Edition 1948 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 3 of Acceptance criteria: Change
(NMT 4.8 mg/kg as SO4.)
to:
(NMT 4.8 g/kg as SO4.)
SUCROSE IMPURITIES/Organic Impurities/Invert Sugar Second Supplement to FCC 9th Edition 1950 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 1 of the second Equation of Analysis: Change
Result = (HS/HL) × (RRFS/WS) × [(WL × WISS2)/200] × 104
to:
Result = (HS/HL) × (RRFS/WS) × [(WL × W… Read More
BIFIDOBACTERIUM ANIMALIS SSP. LACTIS BI-07 IDENTIFICATION/Nucleic Acid-Based Identification/Acceptance criteria Third Supplement to FCC 9th Edition Online 14-Sep-2015 FCC 10th Edition FCC 10th Edition Line 1 of Primer set 2: Change
The PCR sample preparation prepared with Primer set 2 gives an amplification product of 492 base pairs with an SNP identified as (underlined in the following 15 base pair sequence): GCGGGCAAGTGCTGG.
to:
The PCR sample… Read More
BIFIDOBACTERIUM ANIMALIS SSP. LACTIS HN019 IDENTIFICATION/Nucleic Acid-Based Identification/Acceptance criteria Third Supplement to FCC 9th Edition Online 14-Sep-2015 FCC 10th Edition FCC 10th Edition Line 1 of Primer set 1: Change
The PCR sample preparation prepared with Primer set 1 gives an amplification product of 351 base pairs with an SNP identified as (underlined in the following 15 base pair sequence): CTTCAGATTTTAGGC. The SNP location is 44 base pairs from… Read More
LACTOBACILLUS ACIDOPHILUS NCFM IDENTIFICATION/Nucleic Acid-Based Identification/Acceptance criteria Third Supplement to FCC 9th Edition Online 14-Sep-2015 FCC 10th Edition FCC 10th Edition Line 1 of Primer set 1: Change
The PCR sample preparation prepared with Primer set 1 gives an amplification product of 365 base pairs with two SNPs. The first SNP is identified as (underlined in the following 15 base pair sequence): GAGTAAATTCCATCA and the location is… Read More
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.
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
APPENDIX XIII PESTICIDE RESIDUES: ADULTERANTS AND CONTAMINANTS IN FOOD INGREDIENTS Third Supplement to FCC 9th Edition Online 1-Jan-2016 FCC 10th Edition FCC 10th Edition Please see the compendial notice here: http://www.usp.org/food-ingredients/notices/correction-fcc-9-third-supp…
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
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
MALIC ACID SPECIFIC TESTS/Optical (Specific) Rotation, Appendix IIB FCC 9th Edition 728 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
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°
L-SERINE IMPURITIES/Inorganic Impurities/Lead, Lead Limit Test, Appendix IIIB FCC 9th Edition 1061 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 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 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
SUCROSE IMPURITIES/Organic Impurities/Invert Sugar FCC 9th Edition 1165 1-Jan-2015 FCC 10th Edition Second Supplement to FCC 9th Edition Line 5 of Internal standard solution: Add
[NOTE—The change in the density of the solution due to addition of the lactose is insignificant, therefore 200 mL is equivalent to 200 g.]
AND
Line 26 of Analysis: Change
RRF = (HL/HS) × [(WSDF × W… Read More
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
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.
BRILLIANT BLACK PN IMPURITIES/Uncombined Intermediates and Products of Side Reactions FCC 9th Edition 150 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Row 2 of Column 4 of Table 2: Change
134-34-9
to:
6409-21-8
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
GLUCOSE SYRUP, DRIED SPECIFIC TESTS/Total Solids FCC 9th Edition 528 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
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 CHLORIDE IMPURITIES/Inorganic Impurities/Heavy Metals (as Pb)/Method 1 FCC 9th Edition 1078 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
SULFUR IMPURITIES/Inorganic Impurities/Arsenic FCC 9th Edition 1173 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 1 of Acceptance criteria: Change
1 mg/kg
to:
NMT 1 mg/kg
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
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)
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
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
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).
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
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
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 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.
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]
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.
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
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]
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 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 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 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.
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).
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
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)
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