Are you ICH Q3D and USP<232><233> ready?

 

Let our experts at ChemTrace guide you through our comprehensive portfolio of elemental analyses.

 

From Silicon Valley to the Pharma Alley – ChemTrace brings 20 plus years of experience in elemental analysis of a wide variety of chemicals and materials to the pharmaceutical industry.

 

Our expertise in micro-contamination has made us the premier laboratory for one of the most demanding industries in the world. Over the last two decades ChemTrace has developed some of the most advanced and innovative analytical techniques to measure elemental impurities for the semiconductor industry. ChemTrace is now applying those same techniques and know-how to help the pharmaceutical industry successfully implement the new requirements under ICH Q3D, USP<232><233>.

 

How may ChemTrace help you today?

 

Device failures from metallic impurities in high tech electronic equipment are costly in terms of lost productivity, profit and low yields. Metallic impurities in pharmaceutical products are even more costly when you take into account the detrimental effect it can have on public health. ChemTrace can help you identify and quantify those impurities before they ever make it into the final drug product by measuring impurities in excipients to ultra-low levels.

 

WHY CHOOSE CHEMTRACE?

  • 20 plus years of experience to share with you
  • A proven track record in developing methods in low level elemental analysis that are accurate, reproducible, and reliable
  • Cleanrooms equipped to allow strict control of background contamination, for the lowest possible method detection limits.
  • Daily analysis of the most complex liquid, gel, and solid matrices, and expanding our knowledge base with every new challenge.

 

PORTFOLIO OF PRODUCTS AND SERVICES

Elemental Impurities Analysis from many Sources

  • Excipients
  • Catalysts
  • Reagents
  • Manufacturing process/equipment
  • Container closure systems

Method Setup for Elemental Analysis: The Whole Package – Start to Finish

  • Method development: Our lab and personnel for your R&D
  • Method validation: Proven to work, before you begin
  • Method transfer: Training your analysts to carry it forward

On-site Laboratory Training and Consulting Services

  • Certification for clean sample collection: Avoiding contamination at the source
  • Certification for clean sample preparation: Transform your technique for eliminating cross contamination
  • ICP–MS Operation and upkeep: Run your instrument like a ChemTrace analyst ChemTrace Patented Ultra High Purity Sampling System
  • Pre-cleaned and certified PFA bellows and sampling tubes: Collect and preserve liquid for trace metals analysis

 

 


Inquiries

For more information, please contact us:

Technology Center and Principal Laboratory

44050 Fremont Blvd

Fremont, California 94538

USA

Phone: +1-510-687-8000

ChemTrace Northwest

12130 NE Ainsworth Circle Suite 210

Portland, Oregon 97220

USA

Phone: +1-503-254-2828

ChemTrace Korea

517-19 Samcheonbyeongma-ro

Paltan myeon, Hwaseong-si,

Gyeonggi-do, 445-911

South Korea

Office: 031 703 3669

Mobile: 010 8993 0081

ChemTrace Hsinchu, Taiwan

No.9, Datong Road

Hukou Township Hsinchu County

30352, Taiwan

Phone:+886-35975129

ChemTrace Tainan, Taiwan

No.7, Gongye 3rd Road

Annan District, Tainan

709, Taiwan

Phone:+886-982-319-680

Email: Info@ChemTrace.com