General Chapter Prospectus: <582> Water-Soluble Vitamin Assay by Liquid Chromatography—Mass Spectrometry
Input Deadline: April 25, 2017
Current or Proposed GC Title: <582> Water-Soluble Vitamin Assay by Liquid Chromatography—Mass Spectrometry
Suggested audience: Suppliers and manufactures of dietary ingredients, dietary supplements and testing organizations and dietary supplement products related regulatory agencies.
Estimated proposal PF: 43 (5) [Sep.-Oct. 2017]
Background and objective(s): USP is requesting early input from stakeholders on a new proposed General Chapter <582> Water-Soluble Vitamin Assay by Liquid Chromatography—Mass Spectrometry (LC-MS), which will be published for comment in Pharmacopeial Forum 43(5) [Sep.–Oct. 2017].
Conventional chromatographic procedures using HPLC coupled with UV-Vis detection may not be appropriate for quantitative determination of water-soluble vitamins when a mixture of the vitamins are present at low microgram levels per dosage form due to the sensitivity of the UV-Vis detection as well as chromatographic interferences by other components. An alternative methodology, microbiological quantitation, is often utilized, but known to possess inherent, high variability as well as matrix interferences resulting from microbial growth variations. To overcome the above challenges, LC-MS/MS procedures have recently been broadly adopted by manufacturers of dietary supplements and infant formula as an alternative methodology, because the selectivity and sensitivity of LC-MS/MS has been demonstrated to be fit for purpose.
The Non-Botanical Dietary Supplements Expert Committee recently reviewed LC-MS/MS procedures, which have been validated according to <1225> Validation of Compendial Procedures, for determining water-soluble vitamins in dietary dosage forms (tablets, softgels, and powders). The Expert Committee intends to propose a new general chapter that describes detailed testing procedures using LC-MS/MS for quantitative determination of water-soluble vitamins.
Preliminary outline: The proposed General Chapter will provide procedures for quantitatively determining a mixture of water-soluble vitamins as a pharmaceutical ingredient, a dietary supplement ingredient, or a component in the dietary supplements or pharmaceutical dosage forms (e.g. tablets, capsules, powders). The water-soluble vitamins include thiamine, riboflavin, niacinamide, pantothenate, pyridoxine, folic acid, biotin and cyanocobalamin. The scope of the chapter will include sample preparation, standard preparation including isotopic standards, instrument conditions, system suitability, instrument analysis and data analysis.
Contact: Seong Jae Yoo, Ph.D., (301-230-6366, email@example.com).