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. 2019 Apr 1;2019:3680757. doi: 10.1155/2019/3680757

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