Asahi Kasei Pharma Corporation. Asahi KASEI
Asahi Kasei Pharma Corporation has been producing natural-type coenzyme Q10 by fermentation in accordance with the standards for manufacture of medicines (GMP) for more than 25 years and supplying it around the world.We have adopted various safety measures, such as avoiding the use of recombinant microorganisms for fermentation and using no raw materials of animal origin in any of the manufacturing processes.
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Organization for Quality Assurance Compatible with ICHQ7a (GMP for Active Pharmaceutical Ingredients)
GMP Document System
Strategy for Ensuring Safety As a Food
Specification of CoQ10
Standard Item Specification (Excerpt)
JP Assay (HPLC) Not less than 98.0%
Heavy metals Not more than 20ppm
Related substances (HPLC) Not more than standard solution peak area (1.0%)
Water Not more than 0.20%
Residue on ignition Not more than 0.10%
EP Assay (UV) 97.0 to 103.0%
Each related substances Not more than 0.5% (individual)
Total related substances Not more than 1.0%
Impurity F (Isomer) Not more than 0.5%
Sulphated ash Not more than 0.1%
USP Assay (HPLC) 98.0 to 101%
Related substances (Reverse-phase HPLC) Not more than 1.0%
Related substances (Normal-phase HPLC) Not more than 1.0%
Related substances (Total) Not more than 1.5%
Food Arsenic Not more than 2ppm
Total Aerobic Microbial Count Not more than 100cfu/g
Total Yeast & Mold Count Not more than 100cfu/g
Coliforms Negative
The quality of the product is guaranteed by not only conformity with three pharmacopoeia specifications but also conformity with the specification for the microbial count and coliforms, etc.
GMP certificate for medicines by Ministry or Health, Labour, and Welfare, JAPAN
 
Kosher certificate
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