FCC Errata Table - All

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

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)

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.

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 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. Other gums show essentially no change.

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.]

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.