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A Three-Tier Standardization Model for Rasaushadhi: Integrating Classical Siddhi Lakshana, Pharmaceutical Quality Attributes and Advanced Analytical Characterization
Abstract
Abstract
Rasaushadhi are pharmaceutically processed herbo-mineral and mineral formulations in Ayurveda, in which metals and minerals undergo systematic procedures such as Shodhana, Bhavana, Marana, and other formulation-specific operations. Their quality assessment traditionally relies on classical Siddhi Lakshana and Bhasma Pariksha, while contemporary pharmaceutical science provides additional approaches for evaluating identity, composition, physicochemical characteristics, process consistency, and safety. However, these domains are often reported independently, and direct equivalence between classical tests and modern analytical parameters cannot be assumed without formulation-specific validation. This review proposes a three-tier standardization model integrating Tier I—classical pharmaceutical standardization, Tier II—pharmaceutical quality attributes, and Tier III—advanced analytical characterization. The framework incorporates classical process endpoints and quality tests with appropriate physicochemical, elemental, structural, morphological, spectroscopic, and stability assessments. Based on this integrated approach, a Rasaushadhi Quality Matrix and a Minimum Analytical Reporting Dataset are proposed to improve traceability, batch-to-batch comparability, reproducibility, and scientific reporting. The model emphasizes that modern analytical techniques should complement rather than replace classical pharmaceutical knowledge, and that analytical methods should be selected according to the specific formulation and its intended quality attributes. Safety assessment is similarly considered a formulation-, dose-, process-, and exposure-specific question rather than an inference from a single analytical parameter. Prospective validation across representative Rasaushadhi classes is recommended before broader adoption of the framework.
Keywords
Rasaushadhi; Bhasma; standardization; Siddhi Lakshana; quality control; pharmaceutical characterization; analytical characterization; batch consistency.
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