Folic Acid Tablets
DEFINITION
Folic Acid Tablets contain NLT 90.0% and NMT 115.0% of the labeled amount of folic acid (C19H19N7O6).
IDENTIFICATION
• A. Ultraviolet Absorption
Sample solution: Digest the quantity of powdered Tablets, equivalent to 100 mg of folic acid, with 100 mL of 0.1 N sodium hydroxide, and filter. Adjust with hydrochloric acid to a pH of 3.0. Cool to 5
, filter, and wash the precipitate of folic acid with cold water until the last washing shows an absence of chloride. Then wash with acetone, and dry at 80 for 1 h. Dissolve the residue in 0.1 N sodium hydroxide to obtain a 10-µg/mL solution.
, filter, and wash the precipitate of folic acid with cold water until the last washing shows an absence of chloride. Then wash with acetone, and dry at 80 for 1 h. Dissolve the residue in 0.1 N sodium hydroxide to obtain a 10-µg/mL solution.Acceptance criteria: The UV absorption spectrum of the Sample solution exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Folic Acid RS, concomitantly measured. The absorbance ratio A256/A365 is 2.80–3.00.
ASSAY
• Procedure
Mobile phase: Transfer 35.1 g of sodium perchlorate and 1.40 g of monobasic potassium phosphate to a 1-L volumetric flask. Add 7.0 mL of 1 N potassium hydroxide and 40 mL of methanol, dilute with water to volume, and mix. Adjust with 1 N potassium hydroxide or phosphoric acid to a pH of 7.2.
Diluent: Aqueous solution containing 2 mL of ammonium hydroxide and 1 g of sodium perchlorate per 100 mL
System suitability solution: 0.2 mg/mL each of USP Folic Acid RS and USP Folic Acid Related Compound A RS in Diluent. [Note—Before use, pass through a filter of 1-µm or finer pore size. ]
Standard solution: 0.20 mg/mL of USP Folic Acid RS, corrected for water content in Diluent
Sample solution: Equivalent to 0.2 mg/mL of folic acid, from NLT 20 powdered Tablets in Diluent; shake gently to aid dissolution, and filter, discarding the first portion.
Chromatographic system
Mode: LC
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; packing L1
Flow rate: 1 mL/min
Injection size: 25 µL
System suitability
Samples: System suitability solution and Standard solution
Suitability requirements
Resolution: NLT 3.6 between folic acid related compound A (calcium formyltetrahydrofolate) and folic acid, System suitability solution
Relative standard deviation: NMT 2.0%, Standard solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of folic acid (C19H19N7O6) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak area of folic acid from the Sample solution |
| rS | = | = peak area of folic acid from the Standard solution |
| CS | = | = concentration of USP Folic Acid RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of folic acid in the Sample solution (mg/mL) |
Acceptance criteria: 90.0%–115.0%
PERFORMANCE TESTS
• Dissolution 
711
711 Medium: Water; 500 mL
Apparatus 2: 50 rpm
Time: 45 min
Standard solution: Solution having a known concentration of USP Folic Acid RS, corrected for water content, in Medium
Sample solution: Filtered portion of the solution under test, suitably diluted with the Medium if necessary
Analysis
Samples: Standard solution and Sample solution
Proceed as directed in the Assay, making any necessary modifications.
Calculate the percentage of the labeled amount of folic acid (C19H19N7O6) dissolved:
Result = (rU/rS) × (CS × D × V/L) × 100
| rU | = | = peak area of folic acid from the Sample solution |
| rS | = | = peak area of folic acid from the Standard solution |
| CS | = | = concentration of USP Folic Acid RS in the Standard solution (mg/mL) |
| D | = | = dilution factor for the Sample solution |
| V | = | = volume of Medium, 500 mL |
| L | = | = label claim (mg/Tablet) |
Tolerances: NLT 75% (Q) of the labeled amount of folic acid (C19H19N7O6) is dissolved.
• Uniformity of Dosage Units 905: Meet the requirements
905: Meet the requirementsADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in well-closed containers.
• USP Reference Standards 11
11 USP Folic Acid RS 
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USP Folic Acid Related Compound A RS
Calcium formyltetrahydrofolate.
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Calcium formyltetrahydrofolate.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova Scientific Liaison 1-301-816-8328 | (DS2010) Monographs - Dietary Supplements |
| 711 | Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106 | (GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3276
Pharmacopeial Forum: Volume No. 29(2) Page 409Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.