FCC Errata Table - All

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 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 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 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 the second Equation of Analysis: Change
Result = (H_S/H_L) × (RRF_S/W_S) × [(W_L × W_ISS2)/200] × 10⁴
to:
Result = (H_S/H_L) × (RRF_S/W_S) × [(W_L × W_ISS2)/200] × 100

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.

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 = (H_L/H_S) × [(W_SDF × W_DFS)/W_DF] × [200/(W_IDF × W_ISS1)]
to:
RRF = (H_L/H_S) × [(W_SDF × W_DFS)/W_DF] × [200/(W_L × W_ISS1)]
AND
Line 38 of Analysis: Change
200 = final volume of the Internal standard solution(mL)
to:
200 = final weight of the Internal standard solution (g)
AND
Line 40 of Analysis: Change
W_IDF = weight of the Internal standard solution usedto prepare the Dextrose/Fructose solution (g)
to:
W_L = weight of lactose usedto prepare the Internal standard solution (g)
AND
Line 53 of Analysis: Change
Result = (H_S/H_L) × (RRF_S/W_S) × [(W_IDF × W_ISS2)/200] × 10⁴
to:
Result = (H_S/H_L) × (RRF_S/W_S) × [(W_L × W_ISS2)/200] × 10⁴
AND
Line 61 of Analysis: Change
W_IDF = weight of the Internal standard solution usedto prepare the Dextrose/Fructose solution (g)
to:
W_L = weight of lactose usedto prepare the Internal standard solution (g)
AND
Line 65 of Analysis: Change
200 = final volume of the Internal standard solution (mL)
to:
200 = final weight of the Internal standard solution (g)