Quality Control | TCI Deutschland GmbH

Quality Analysis

Our analytical staff has experience and skill in various types of quality analysis, performing appropriate analysis on more than 30,000 reagents based on years of experience and training.

Many highly-experienced staff perform analysis with a high degree of accuracy on manual analyses including the analysis of various chelating agents – which need complicated combustion process – gravimetric method, ion exchange 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 our manufacturing processes are consistently providing expected results.

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

apparatuses

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.

Trace Metal Analysis：
TCI responds to the requests for metal analysis with various specialized equipment.

TCI is able to measure trace metals at the parts per billion (ppb) level, ensuring customers have the highest quality materials available.

Quality Control in Manufacturing

ISO

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

Certification Standard Name

ISO 9001: 2015

ISO 14001: 2015

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　Appendix

　ISO 14001　Certificate of Registration

　ISO 14001　Appendix

LIMS

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