Safety Assessment of Ubiquinol Acetate: Subchronic Toxicity and Genotoxicity Studies

Table 2

Specifications & certificate of analysis of the ubiquinol acetate.

Sl.	Tests	Results	Limits
No.
1	Appearance	Off-white solid	White to off-white solid
2	Melting range	46.7°C to 48.4°C	46°C to 52°C
3	Solubility	Very soluble in toluene and ethyl acetate	Very soluble in toluene and ethyl acetate
		Freely soluble in hexane	Freely soluble in hexane
		Sparingly soluble in ethanol	Sparingly soluble in ethanol
		Vey slightly soluble in methanol	Very slightly soluble in methanol
		Practically insoluble in water	Practically insoluble in water
4	Identification by IR	Complies	Should comply with that of standard
5	Purity by HPLC (area %)	98.2 %	Not less than 98.0 %
	Single largest unspecified impurity	RRT at 1.27=0.64%	Not more than 1.0 %
	Ubiquinone	0.19 %	Not more than 1.0 %
6	Assay (By HPLC) (% w/w)	99.1 %	Between 98.0% and 102.0%
7	Water Content by KF	0.30 %	Not more than 0.5 %
8	Residue on Ignition	0.02 %	Not more than 0.2 %
9	Heavy Metal	Less than 10 ppm	Not more than 10 ppm
10	Residual solvent by GC-HS
	Ethanol	89 ppm	Not more than 500 ppm
	Pyridine	1 ppm	Not more than 200 ppm
	n-Heptane	8 ppm	Not more than 100 ppm
11	Acetic acid contents by GC	Not detected	Not more than 500 ppm
12	Microbial Analysis
	TAMC	Nil	Not more than 100 CFU/g
	TYMC	Nil	Not more than 10 CFU/g
	E. Coli	Absent	Should be absent for 10 g
	Salmonella	Absent
	Pseudomonas	Absent
	Staphylococcus	Absent