FCC Errata Table - All

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 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 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 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 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 potassium permanganate. Cover the beaker with a watch glass, boil for a few seconds and cool.
to:
Weigh an amount equivalent to 5.0 g of sodium hydroxide sample (as determined in the Assay) into a 100-mL beaker, add 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 potassium permanganate. Cover the beaker with a watch glass, boil for a few seconds and cool.

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(C₆H₅O₇)₂.

Line 2 of Fumaric and Maleic Acids: Delete
[Note—For all reference standards, do not dry before use and keep the containers tightly closed and protected from light. Determine the water content of the USP Fumaric Acid RS titrimetrically before use and make the necessary correction in preparing the Standard solution.]

In Invertase Sumner Unit Activity/Analysis/paragraph 4: Change
To prepare the glucose standards, add 1 mL of the Standard sucrose solution to each of the 3 appropriate Sucrose substrate solution test tubes.
to:
To prepare the glucose standards, add 1 mL of the Standard glucose solution to each of the 3 appropriate Sucrose substrate solution test tubes.