How to Use the FCC Errata Table

  • Searching: Type keyword in search field at top of page. Search by all or part of a monograph title. For searches using multiple criteria, you will find items that match each of the specified criteria unless quotation marks are used.
    • For example, a search on Aminosalicylic Acid Tablets will result in anything that contains “Aminosalicyclic” OR “Acid” OR “Tablets”
    • A search for “Aminosalicylic Acid Tablets” will result in anything that specifically contains “Aminosalicylic Acid Tablets”
  • Sorting: Click on any blue column header title to sort alphabetically or chronologically in ascending or descending order. Note: the page load column is sorted alphabetically so that a number is ordered by first digit vs. by the actual number; thus, numbers will not always be in order.
    • For example, page 2178 will come before page 74 on a page sort.
  • Downloading: You can download the Errata table in Comma-separated Value (.csv) or Excel format (.xls). The download will include all Errata from the database.
  • Printing: The table will print the view of the data as it has been filtered or sorted. To print a table of all Errata in the database, clear any keyword searches you have applied and select “Show: All”.
Monograph Title Section Source Publication Page Number Errata Effective Date Target Errata Print Publication Target Online Fix Publication Description

CARNAUBA WAX

DESCRIPTION

FCC 10th Edition

271 01-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.







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 01-Jan-2017

FCC 11th Edition

Second Supplement to FCC 10th Edition

Line 3: Change
CAS: [1119-34-12]
to:
CAS: [1119-34-2]


Line 3: Change
CAS: [1119-34-12]
to:
CAS: [1119-34-2]

LACTITOL

ASSAY/Procedure

FCC 10th Edition

719 01-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


Line 2 of Acceptance criteria: Change
calculated on the dried basis
to:
calculated on the anhydrous basis

SOLUTIONS AND INDICATORS

Test Solutions (TS) and Other Reagents

FCC 10th Edition

1624 01-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).

Add
Acetic Acid (approximately 17.5 N) Use ACS reagent-grade Acetic Acid, Glacial (99.7% of CH3COOH).

APPENDIX II: PHYSICAL TESTS AND DETERMINATIONS/C. OTHERS

INSOLUBLE FOREIGN MATTER IN AMINO ACIDS/Apparatus

FCC 10th Edition

ONLINE 01-Jul-2016

FCC 11th Edition

FCC 10th Edition

Footnote 4: Add
Millipore catalog number NY1H04700, or equivalent.

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 01-Jul-2016

FCC 11th Edition

FCC 10th Edition

Line 1 of Chromatographic system: Change
Chromatographic system,
to:
Chromatographic system, Appendix IIA


Line 1 of Chromatographic system: Change
Chromatographic system,
to:
Chromatographic system, Appendix IIA

KONJAC FLOUR

IDENTIFICATION/Heat-Stable Gel Test

FCC 10th Edition

705 01-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







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 01-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).


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 01-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


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 01-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 90.0%, calculated on the anhydrous and ash-free basis







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 90.0%, calculated on the anhydrous and ash-free basis

ADVANTAME

ASSAY/Procedure/Chromatographic system/System suitability

Second Supplement to FCC 9th Edition

1902 01-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 injected six consecutive times, the relative standard deviation of the advantame content (when calculated according to the instructions in the Analysis section) is NMT 3.0% for the Standard solution having the concentration of USP Advantame RS closest to 160 µg/mL.

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 injected six consecutive times, the relative standard deviation of the advantame content (when calculated according to the instructions in the Analysis section) is NMT 3.0% for the Standard solution having the concentration of USP Advantame RS closest to 160 µg/mL.

APPENDIX XIII

PESTICIDE RESIDUES: ADULTERANTS AND CONTAMINANTS IN FOOD INGREDIENTS

Third Supplement to FCC 9th Edition

ONLINE 01-Jan-2016

FCC 10th Edition

FCC 10th Edition

LABDANUM OIL

DESCRIPTION

FCC 9th Edition

660 01-Jan-2016

FCC 10th Edition

FCC 10th Edition

Line 6: Change
Cistus ladaniferus L.
to:
Cistus ladanifer L.

Line 6: Change
Cistus ladaniferus L.
to:
Cistus ladanifer L.

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 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.

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 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.

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 the 5′ end of the forward primer described in Primer set 1. The sequence of the amplicon should be determined by validated, standard sequencing technologies.
to:
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 the 5′ end of the forward primer described in Primer set 1. The sequence of the amplicon should be determined by validated, standard sequencing technologies.
AND

Line 1 of Primer set 2: Change
The PCR sample preparation prepared with Primer set 2 gives an amplification product of 531 base pairs with an SNP identified as (underlined in the following 15 base pair sequence): GCCCGCTCAAACGAA. The SNP location is 279 base pairs from the 5′ end of the forward primer described in Primer set 2. The sequence of the amplicon should be determined by validated, standard sequencing technologies.
to:
The PCR sample preparation prepared with Primer set 2 gives an amplification product of 531 base pairs with an SNP identified as (underlined in the following 15 base pair sequence): GCCCGCTCAAACGAA. The SNP location is 279 base pairs from the 5′ end of the forward primer described in Primer set 2. The sequence of the amplicon should be determined by validated, standard sequencing technologies.

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 the 5′ end of the forward primer described in Primer set 1. The sequence of the amplicon should be determined by validated, standard sequencing technologies.
to:

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 49 base pairs from the 5′ end of the forward primer described in Primer set 1. The second SNP is identified as (underlined in the following 15 base pair sequence): TTCAATTGAAGTTTG and the location is 241 base pairs from the 5′ end of the forward primer described in Primer set 1. The sequence of the amplicon should be determined by validated, standard sequencing technologies.
to:
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 49 base pairs from the 5′ end of the forward primer described in Primer set 1. The second SNP is identified as (underlined in the following 15 base pair sequence): TTCAATTGAAGTTTG and the location is 241 base pairs from the 5′ end of the forward primer described in Primer set 1. The sequence of the amplicon should be determined by validated, standard sequencing technologies.
AND
Line 1 of Primer set 2: The PCR sample preparation prepared with Primer set 1 gives an amplification product of 433 base pairs with two SNPs. The first SNP is identified as (underlined in the following 15 base pair sequence): AAGCATTCAATACAC and the location is 72 base pairs from the 5′ end of the forward primer described in Primer set 2. The second SNP is identified as (underlined in the following 15 base pair sequence): ATATGGTTCTTACCT and the location is 215 base pairs from the 5′ end of the forward primer described in Primer set 2. The sequence of the amplicon should be determined by validated, standard sequencing technologies.
to:
The PCR sample preparation prepared with Primer set 1 gives an amplification product of 433 base pairs with two SNPs. The first SNP is identified as (underlined in the following 15 base pair sequence): AAGCATTCAATACAC and the location is 72 base pairs from the 5′ end of the forward primer described in Primer set 2. The second SNP is identified as (underlined in the following 15 base pair sequence): ATATGGTTCTTACCT and the location is 215 base pairs from the 5′ end of the forward primer described in Primer set 2. The sequence of the amplicon should be determined by validated, standard sequencing technologies.

Line 1 of Primer set 1: Change

Read more

BRILLIANT BLACK PN

IMPURITIES/Uncombined Intermediates and Products of Side Reactions

FCC 9th Edition

150 01-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

Row 2 of Column 4 of Table 2: Change
134-34-9
to:
6409-21-8

DECYL ACETATE

IDENTIFICATION

Second Supplement to FCC 9th Edition

1915 01-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 maxima at the same wavelengths as those in the spectrum displayed below.

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 maxima at the same wavelengths as those in the spectrum displayed below.

GLUCOSE SYRUP, DRIED

ASSAY/Reducing Sugars Assay

FCC 9th Edition

528 01-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

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 01-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 reducing sugar content is between 20.0% and 88.0%, calculated on the anhydrous basis

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 reducing sugar content is between 20.0% and 88.0%, calculated on the anhydrous basis

Identification Tests

PHOSPHATE

FCC 9th Edition

1343 01-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.

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.

OX BILE EXTRACT

ASSAY/Procedure

FCC 9th Edition

879 01-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.

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.

Pancreatin Activity

AMYLASE ACTIVITY

FCC 9th Edition

1408 01-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,

Line 14 of Procedure: Change
10.0 mL of 1 N iodine VS,
to:
10.0 mL of 0.1 N iodine VS,

SODIUM CHLORIDE

IMPURITIES/Inorganic Impurities/Heavy Metals (as Pb)/Method 1

FCC 9th Edition

1078 01-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

to:
Entirely transfer one of the two equal portions prepared in the Sample solution

AND
Line 1 of Solution C: Change
Transfer 25 mL of Sample solution

to:
Entirely transfer the second equal portion prepared in the Sample solution

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

to:
Entirely transfer one of the two equal portions prepared in the Sample solution

AND
Line 1 of Solution C: Change
Transfer 25 mL of Sample solution

to:

Read more

SODIUM FERROUS CITRATE

IMPURITIES/Inorganic Impurities/Sulfate

Second Supplement to FCC 9th Edition

1948 01-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.)

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 01-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 × WISS2)/200] × 100

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 × WISS2)/200] × 100

SULFUR

IMPURITIES/Inorganic Impurities/Arsenic

FCC 9th Edition

1173 01-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

Line 1 of Acceptance criteria: Change
1 mg/kg
to:
NMT 1 mg/kg

TEST SOLUTIONS (TS) AND OTHER REAGENTS

NITRIC ACID

FCC 9th Edition

1486 01-Jul-2015

FCC 10th Edition

Third Supplement to FCC 9th Edition

Line 2: Delete
(69.0%–71.0% of HNO3)

Line 2: Delete
(69.0%–71.0% of HNO3)

XLS CSV