Home > Custom Synthesis / Bulk Chemicals > Quality Control

Quality Control

Quality Analysis

Our analytical staff with the experiences and skill for various types of quality analysis performs assured and appropriate analysis based on the analysis experiences for more than 27,000 reagents.

Many abundant experience staff performs analysis with high degree of accuracy on manual analyses including the analysis of various chelating agents which needs complicated combustion process, gravimetric method, ion exchange and redox titration etc. high degree of accuracy on manual analyses including titrations of chelation method with complicated combustion process, gravimetric method, ion exchange method, and redox titration etc.

TCI also has established an alternative method of analysis to avoid the use of hazardous substances such as mercuric acetate (II), or international controlled substances.

TCI performs in-process tests in a timely manner. We routinely test products to ensure the manufacturing processes.


Using official government analysis criteria, we follow the following standards: The Japanese Industrial Standard (JIS), Japanese pharmacopeia (JP), US pharmacopeia, European pharmacopeia, Japan's Specifications and Standards for Food Additives, and Japanese Standards of Quasi-drug Ingredients.

Analytical Equipment

TCI has a wide range of analytical equipment including various apparatus for Chromatography and metals analysis.

Gas Chromatography Analysis:
TCI retains numerous results of residual solvent measurements. TCI makes the measurements with vaporization method possible as we have not only general solution injection method (packed columns or capillary columns), but also the head space equipment.

Liquid Chromatography Analysis:
With coronavirus detector(CAD), TCI analyzes sugar group which has no UV absorption and insensitive by RI detection or quaternary ammonium salt etc. Additionally, we perform reliable qualitative analysis and identify chemical structures of trace impurities by LC-QTOF.

Metal Measurement:
TCI reponds to the requests for metal analysis with various specialized equipments. Furthermore, we measure ppb levels which recently receive requestion from many customers.



Quality Control in Manufacturing

ISO

Fukaya Factory has been granted ISO9001 and ISO14001 for excellence and reliability in manufacturing.

Certification Standard Name ISO 9001: 2008 ISO 14001: 2004
Certification Registration Date June 14th, 2002 June 9th, 2006
Certification Range Planning, developing, and manufacturing for organic reagents, fine chemicals, and bulk pharmaceuticals
Certification Organization JAPAN QUALITY ASSURANCE ORGANIZATION

Kumagaya Manufacturing Site is also registered as the office related to the “manufacturing for organic reagents, fine chemicals, and bulk pharmaceuticals”.

ISO 9001 Certificate of Registration

 ISO 9001 Certificate of Registration

ISO 9001 Appendix

 ISO 9001 Appendix

ISO 14001 Certificate

 ISO 14001 Certificate of Registration

ISO 14001 Appendix

 ISO 14001 Appendix

LIMS

TCI manage quality and analytical information using LIMS (Laboratory Information Management System).



  Contact Us!
E-mail: Sales-IN@TCIchemicals.com

Page Top