Quality control parameters and safety profile of siddha herbal formulation: pirandai vadagam.

Abstract

Introduction: Pirandai Vadagam is a traditional Siddha herbal formulation recommended for managing digestive disturbances and inflammatory disorders. It is prepared using thirteen medicinal ingredients. Establishing reliable quality control standards is crucial to ensure its safety, efficacy, and therapeutic consistency.Objective: The present study was undertaken to develop and validate quality control parameters for Pirandai Vadagam. Methods: The formulation was subjected to evaluation of organoleptic characters, physicochemical properties, heavy metal content, aflatoxin levels, and microbial load. Results: The physicochemical analysis revealed that the loss on drying at 105 °C, total ash, acid-insoluble ash, and water-soluble extractive values were 15.38%, 6.18%, 0.93%, and 119.25%, respectively. Microbial counts and aflatoxin levels were found to be within the permissible pharmacopoeial limits. Likewise, the concentrations of heavy metals were within the safe threshold values. Discussion and Conclusion: The established physicochemical parameters of Pirandai Vadagam fall within acceptable standards, indicating stability, purity, and favorable solubility that may enhance bioavailability. The absence of harmful levels of contaminants, heavy metals, and toxins supports the safety of this formulation, thereby justifying its continued use in Siddha clinical practice.