FCC Errata Table - All

CSV View April 18, 2022 through April 18, 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
OLIVE POMACE OIL, REFINED IDENTIFICATION/H. Specific Extinction, Ultraviolet Absorption FCC Online Online 16-Dec-2022 1-Jan-2023 NA Second Supplement to FCC 13th Edition In Analysis: Change
Measure the absorbance of the Sample preparation against Solvent A
to:
Measure the absorbance of the Sample preparation against Solution A
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.
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
PANCREATIN ACTIVITY AMYLASE ACTIVITY FCC 9th Edition 1408 26-Jun-2015 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,
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
Pepsin Activity REAGENTS AND SOLUTIONS Second Supplement to FCC 8th Edition 1789 27-Dec-2013 27-Dec-2013 FCC 9th Edition FCC 9th Edition Line 3 of Standard Solutions: Change
0.45–0.90
to:
0.70– 1.25
Pepsin Activity REAGENTS AND SOLUTIONS Second Supplement to FCC 8th Edition 1789 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 3 of Sample Solution: Change
0.60–0.70
to:
0.9–1.0
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
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
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|
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 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
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 FERROCYANIDE CHEMICAL INFORMATION FCC 10th Edition 1164 29-Dec-2017 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 3: Change
CAS: [13601-19-9]
to:
CAS: [14434-22-1]
SODIUM FERROUS CITRATE IMPURITIES/Inorganic Impurities/Sulfate Second Supplement to FCC 9th Edition 1948 26-Jun-2015 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.)
SODIUM HYALURONATE (FROM MICROBIAL FERMENTATION) ASSAY/Sodium Hyaluronate Content FCC 10th Edition 1169 29-Dec-2017 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 29-Dec-2017 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 29-Dec-2017 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 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|
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
SODIUM SELENATE ANHYDROUS ASSAY/Procedure FCC 10th Edition 1199 29-Dec-2017 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.
SOLUTIONS AND INDICATORS Test Solutions (TS) and Other Reagents FCC 10th Edition 1624 30-Dec-2016 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).
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
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
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.
SUCROSE IMPURITIES/Organic Impurities/Invert Sugar Second Supplement to FCC 9th Edition 1950 26-Jun-2015 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
SUCROSE IMPURITIES/Organic Impurities/Invert Sugar FCC 9th Edition 1165 19-Dec-2014 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
SULFUR IMPURITIES/Inorganic Impurities/Arsenic FCC 9th Edition 1173 26-Jun-2015 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
TBHQ SPECIFIC TESTS/Ultraviolet Absorbance (Polynuclear Hydrocarbons) FCC 9th Edition 1192 27-Jun-2014 1-Jul-2014 First Supplement to FCC 9th Edition First Supplement to FCC 9th Edition Line 18 of Sample preparation: Change
0.5% solution of 75 : 25 ethanol and water–ascorbic acid.
to:
25:75 (v/v) ethanol water solution containing 0.5% ascorbic acid.
TEST SOLUTIONS (TS) AND OTHER REAGENTS NITRIC ACID FCC 9th Edition 1486 26-Jun-2015 1-Jul-2015 FCC 10th Edition Third Supplement to FCC 9th Edition Line 2: Delete
(69.0%–71.0% of HNO3)
TEST SOLUTIONS (TS) AND OTHER REAGENTS Methylene Orange TS Third Supplement to FCC 10th Edition Online 29-Dec-2017 1-Jan-2018 FCC 11th Edition FCC 11th Edition All references to methylene orange TS in FCC should be changed to methyl orange TS
TEST SOLUTIONS (TS) AND OTHER REAGENTS Acetic Acid FCC 12th Edition 1560 25-Jun-2021 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).
THIAMINE MONONITRATE IDENTIFICATION/D. Procedure FCC 10th Edition 1287 29-Dec-2017 1-Jan-2018 FCC 11th Edition FCC 11th Edition Line 2 of Analysis: Change
potassium ferrocyanide TS
to:
potassium ferricyanide TS
TRIETHYL CITRATE CHEMICAL INFORMATION FCC 11th Edition 1217 27-Dec-2019 1-Jan-2020 FCC 12th Edition FCC 12th Edition Change
INS: 1519
to:
INS: 1505
VITAMIN A SPECIFIC TESTS/Absorbance Ratio FCC 11th Edition 1239 27-Dec-2019 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
YEAST EXTRACT SPECIFIC TESTS/Potassium FCC 8th Edition 1203 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Analysis: Change
suitable spectrophotometer,
to:
suitable atomic absorption spectrophotometer,
YEAST EXTRACT SPECIFIC TESTS/Sodium Chloride FCC 8th Edition 1203 27-Dec-2013 1-Jan-2014 FCC 9th Edition FCC 9th Edition Line 1 of Analysis: Change
suitable spectrophotometer,
to:
suitable atomic absorption spectrophotometer,
β-APO-8'-CAROTENAL ASSAY/Procedure FCC 11th Edition 84 28-Jun-2019 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