Thiamine Hydrochloride Oral Solution DEFINITION Thiamine Hydrochloride Oral Solution contains NLT 95.0% and NMT 135.0% of the labeled quantity of thiamine hydrochloride (C12H17ClN4OS·HCl). IDENTIFICATION • A. Sample solution: Dilute a portion of Oral Solution with water to a concentration of 10 mg/mL of thiamine hydrochloride. Analysis: To 0.5 mL of the Sample solution add 5 mL of 0.5 N sodium hydroxide, then add 0.5 mL of potassium ferricyanide TS and 5 mL of isobutyl alcohol. Shake the mixture vigorously for 2 min, and allow the liquid layers to separate. Illuminate from above by a vertical beam of UV light, and observe the airliquid meniscus at a right angle to this beam. Acceptance criteria: The airliquid meniscus shows a vivid blue fluorescence, which disappears when the mixture is slightly acidified, but reappears when it is again made alkaline. ASSAY • Procedure Mobile phase: Methanol and 0.04 M aqueous monobasic potassium phosphate (45:55) Internal standard solution: 100 µg/mL of methylparaben in Mobile phase Standard stock solution: 500 µg/mL of USP Thiamine Hydrochloride RS in Mobile phase Standard solution: Dilute a mixture of equal volumes of the Standard stock solution and Internal standard solution with Mobile phase to obtain a concentration of USP Thiamine Hydrochloride RS of about 50 µg/mL. Sample stock solution: Equivalent to 500 µg/mL of thiamine hydrochloride in Mobile phase from an accurately measured volume of Oral Solution Sample solution: Dilute a mixture of equal volumes of the Sample stock solution and Internal standard solution with Mobile phase to obtain a concentration of thiamine hydrochloride of about 50 µg/mL. Chromatographic system Mode: LC Detector: UV 254 nm Column: 3.9-mm × 30-cm; packing L1 Flow rate: 1 mL/min Injection size: 25 µL System suitability Sample: Standard solution [NoteThe relative retention times for thiamine and methylparaben are about 0.35 and 1.0, respectively. ] Suitability requirements Resolution: NLT 6.0 between thiamine and methylparaben Relative standard deviation: NMT 2.0% Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of thiamine hydrochloride (C12H17ClN4OS·HCl) in the portion of Oral Solution taken: Result = (RU/RS) × (CS/CU) × 100
Acceptance criteria: 95.0%135.0% OTHER COMPONENTS • Alcohol Determination, Method II 611: 90.0%110.0% of the labeled quantity of C2H5OH, using acetone as the internal standard ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight, light-resistant containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4836 Pharmacopeial Forum: Volume No. 28(2) Page 379Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |