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Monograph Title Section Source Publication Page Number Errata Effective Date Target Errata Print Publication Target Online Fix Publication Description

CHOLINE CHLORIDE

ASSAY/Procedure

FCC 10th Edition

313 01-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


Line 4 of Analysis: Change
mercuric acetate
to:
mercuric acetate TS

FERRIC PHOSPHATE

IMPURITIES/Inorganic Impurities

FCC 10th Edition

515 01-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: Change
Figure 16
to:
Figure 6







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: Change
Figure 16
to:
Figure 6

FRUCTOSE

IMPURITIES/Inorganic Impurities/Sulfate, Chloride and Sulfate Limit Tests, Chloride Limit Test, Appendix IIIB

FCC 10th Edition

538 01-Jul-2017

Third Supplement to FCC 10th Edition

Third Supplement to FCC 10th Edition

Line 1: Change
Chloride Limit Test,
to:
Sulfate Limit Test,


Line 1: Change
Chloride Limit Test,
to:
Sulfate Limit Test,

INOSITOL

IMPURITIES/Inorganic Impurities/Sulfate, Choride and Sulfate Limit Tests, Chloride Limit Test, Appendix IIIB

FCC 10th Edition

655 01-Jul-2017

Third Supplement to FCC 10th Edition

Third Supplement to FCC 10th Edition

Line 1: Change
Chloride Limit Test,
to:
Sulfate Limit Test,


Line 1: Change
Chloride Limit Test,
to:
Sulfate Limit Test,

RUTIN

CHEMICAL INFORMATION

FCC 10th Edition

1116 01-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


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

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
XLS CSV