FCC Errata Table - All

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.

In System suitability/Suitability requirements/Resolution: Change
NLT 3.6 between calcium formyltetrahydrofolate (related compound A) and folic acid, System suitability solution
to:
NLT 3.6 between leucovorin calcium and folic acid, System suitability solution

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

In the Myristic acid Row and Lower Limit Column of Table 1: Change
4.5
to:
3.0
AND
In the Palmitic acid:Myristic acid ratio Row and Upper Limit Column of Table 1: Change
2.8
to:
3.6
AND
In the Eicosapentaenoic acid Row and Upper Limit Column of Table 1: Change
17.0
to:
19.6

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 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.]