31/3/2020 USP-NF

Printed on: Tue Mar 31 2020, 07:53:14 am

Impreso por: Mariluz Garzon
Estado o cial: actualmente o cial el 31-mar-2020
Fecha o cial: o cial anterior a 2013
Tipo de documento: USP y DS
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© 2020 USPC

Folic Ácido

C H N O 441.40
19 19 7 6
L -Ácido glutámico, N - [4 - [[(2-amino-1,4-dihidro-4-oxo-6-pteridinil) metil] amino] benzoil] -;
N - [ p - [[(2-Amino-4-hidroxi-6-pteridinil) metil] amino] benzoil] - 1 -ácido glutámico [ 59-30-3 ] ; UNII: 935E97BOY8.

DEFINICIÓN
Folic El ácido contiene NLT 97.0% y NMT 102.0% de fólico ácido (C H N O ), calculado sobre la base anhidra.
19 19 7 6

IDENTIFICACIÓN
• A. ABSORCIÓN ULTRAVIOLETA 〈 197U 〉 AL
Solución de muestra: 10 µg / mL en solución de hidróxido de sodio 0.1 N
Criterios de aceptación: Cumple los requerimientos. La relación A /A es 2.80–3.00.
256 365

ENSAYO
CI
• PROCEDURE
[ NOTA - Utilice cristalería de baja acción a lo largo del siguiente procedimiento. ]
Ácido fosfórico 3 N: 98 g / L de ácido fosfórico en agua
Hidróxido de amonio 6 N: Diluir 40 ml de hidróxido de amonio con agua a 100 ml.
FI

Fase móvil: Trans era 2.0 g de fosfato de potasio monobásico a un matraz aforado de 1000 ml y disuélvalo en 650 ml de agua.
Añadir 15,0 ml de una solución de hidróxido de tetrabutilamonio 0,5 M en metanol, 7,0 ml de ácido fosfórico 3 N y 270 ml de
metanol. Enfriar a temperatura ambiente, ajustar con ácido fosfórico 3 N o hidróxido de amonio 6 N a un pH de 5.0, y diluir con agua
al volumen. Vuelva a veri car el pH antes de usar.
Solución estándar interna: 2 mg / ml de metilparabeno en fase móvil . Disuelva el metilparabeno primero con metanol
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(aproximadamente el 4% del volumen nal) y diluya con la fase móvil en volumen.

Solución estándar de stock: 1 mg / ml de USP Folic Acid RS in Mobile phase. Dissolve the folic acid with the aid of 10% ammonium
hydroxide (about 1% of the nal volume), and dilute with Mobile phase to volume.
Standard solution: Transfer 4.0 mL of Standard stock solution and 4.0 mL of Internal standard solution to a 50-mL volumetric ask, and
dilute with Mobile phase to volume.
Sample stock solution: Transfer 100 mg of Folic Acid to a 100-mL volumetric ask, and dissolve in 40 mL of Mobile phase and 1 mL
of 10% ammonium hydroxide. Dilute with Mobile phase to volume.
Sample solution: Transfer 4.0 mL of Sample stock solution and 4.0 mL of Internal standard solution to a 50-mL volumetric ask, and
dilute with Mobile phase to volume.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 280 nm
Column: 4.0-mm × 25-cm; packing L1
Flow rate: 1.2 mL/min
Injection size: 10 µL
System suitability

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31/3/2020 USP-NF

Sample: Standard solution

Suitability requirements
Resolution: NLT 3.6 between methylparaben and folic acid
Relative standard deviation: NMT 2.0% for the ratios of the folic acid peak area to the internal standard peak area
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of folic acid (C19H19N7O6) in the sample taken:

Result = (RU/RS) × (CS/CU) × 100

RU = internal standard ratio (peak response of folic acid/peak response of the internal standard) from the Sample solution

RS = internal standard ratio (peak response of folic acid/peak response of the internal standard) from the Standard
solution

CS = concentration of USP Folic Acid RS in the Standard stock solution (mg/mL)

CU = concentration of Folic Acid in the Sample stock solution (mg/mL)

Acceptance criteria: 97.0%–102.0% on the anhydrous basis

IMPURITIES
• RESIDUE ON IGNITION 〈281〉: NMT 0.3%
• RELATED COMPOUNDS
3 N phosphoric acid, 6 N ammonium hydroxide, Internal standard solution, Standard stock solution, Standard solution, and
Chromatographic system: Proceed as directed in the Assay.
Sample solution: Use the Sample stock solution, prepared as directed in the Assay.
Analysis
Sample: Sample solution
AL
Allow the Sample solution to elute for NLT 2 times the retention time of folic acid. Record the chromatogram, and measure the
areas of all the peaks.
Calculate the percentage of total secondary peaks in the portion of Folic Acid taken:
CI
Result = (rU/rT) × 100

rU = sum of the areas of all the peaks except that of the folic acid peak

rT = sum of the areas of all the peaks

FI

Acceptance criteria: NMT 2.0%

SPECIFIC TESTS
O

• WATER DETERMINATION, Method I〈921〉

Analysis: Proceed as directed in the chapter, except stir the methanol solvent before and during the addition of the test specimen and
during the titration.
Acceptance criteria: NMT 8.5%

ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed, light-resistant containers.
• USP REFERENCE STANDARDS 〈11〉
USP Folic Acid RS

Auxiliary Information- Please check for your question in the FAQs before contacting USP.

Topic/Question Contact Expert Committee

FOLIC ACID Natalia Davydova NBDS2015 Suplementos dietéticos no

Scienti c Liaison botánicos 2015

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31/3/2020 USP-NF
Información de la base de datos cromatográ ca : base de datos cromatográ ca

Apareció más recientemente en:

Foro farmacopeico: Volumen No. 29 (2)

Información de la página:

USP42-NF37 - 1979
USP41-NF36 - 1865
USP40-NF35 - 4322

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CI
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