Synacinn™: Bacterial reverse mutation test data in five histidine-requiring strains of .

The present data described the analysis of mutagenicity in Synacinn by assessing the point mutations occurring due to Synacinn™ exposure to five tester strains of (TA1537, TA1535, TA98, TA100 and TA102), in the presence or absence of an exogenous mammalian metabolic activation system (S9). It was conducted in two Phases - Phase I (Dose Range Finding experiment-DRF) and Phase II (Mutagenicity Assay 1 and 2). DRF and Mutagenicity Assay 1 was conducted employing plate incorporation method, while Mutagenicity Assay 2 was performed using pre-incubation method.

Analytical method cross validation by HPLC for identification of five markers and quantification of one marker in Synacinn formulations and its bone marrow micronucleus test data.

A HPLC method has been validated for identifying five markers (gallic acid, rosmarinic acid, catechin, andrographolide and curcumin) and quantifying curcumin in Synacinn formulation. The validation (bracketed strengths of 10 mg/mL and 100 mg/mL) involved assessment of selectivity, precision, Limit of Detection (LOD), Limit of Quantification (LOQ), linearity, accuracy, stability in diluent and formulation stability. Meanwhile, bone marrow micronucleus test data was presented to evaluate the toxicity potential of Synacinn™ to cause clastogenicity and/or disruption of the mitotic apparatus, as measured by its ability to induce micronucleated polychromatic erythrocytes (MN PCE) in Sprague Dawley rat bone marrow.