About SST : Quality Assurance

Every batch of HepZone SST vegi-capsules manufactured by HepCare, Inc. in Phoenix Arizona is tested and certified by Honso in Japan to ensure the same specifications and highest quality standard.

 

Honso’s GMP pharmaceutical facilities in Japan offer unrivaled high standards, from selection of the highest grade materials to perfection of proprietary processing techniques that ensure maximum quality, efficacy and safety. 

 

Every lot of the Honso® Kampo product is routinely tested by its Quality Control Department. They are tested for key herbal constituents, heavy metals, purity, and microbial content to eliminate any contaminant. This is the most rigorous way to maintain consistency of quality from batch to batch each time.

 

At Honso the quality control of a finished herbal formula is performed under the scrutiny of the Ministry of Health and Welfare at two levels on every lot: first assay each individual herb qualitatively by TLC, and then measure at least two active constituents quantitatively by HPLC.

 

For example, sho-saiko-to is processed as follows:

 

TLC testing:

To identify Bupleurum, Ginger, Scutellaria, Jujube, Ginseng, and Glycyrrhiza.

 

HPLC testing:

Specification is as such: 24.7-46.0 mg/day of Glycyrrhizin, 110.6-205.6 mg/day of Baicalin, and 6.5-19.7 mg/day of Saikosaponin.

 

Other testing is routinely performed on each lot according to the Japanese Pharmacopoeia, including heavy metals, arsenic, and water content and microbiological tests.

 

According to Japanese GMP for importing pharmaceutical materials (GMPi), tests are performed to assurance consistency of herbal species. First Honso identify where the plant are grown and harvested and chooses the specific method of preparation based on tissue and cell morphology, and differentiates it from similar raw herbs. Then Honso performs the extract content test to determine the content of ingredients soluble in water, absolute ethanol or ether as overall content of the active ingredients.

 

The loss-of-drying test is performed to determine water content in the raw herbs as confirmation of proper production procedures and storage stability. A total ash test is done to determine inorganic content in the raw herbs. The acid-insoluble ash is tested to identify the amount of earth and sand attached to the raw herbs.

 

Copyright © HepCare, Inc.  HepZone™ is a registered trademark of HepCare, Inc.
For more information send an email to info@hepzone.com
designed by studiothink