ThomasNet News Logo
Sign Up | Log In | ThomasNet Home | Promote Your Business

Pharmaceutical Manufacturers Turn to U.S. Based, High Purity Suppliers of Raw Materials to Ease Transition to New USP Standards

Print | 
Email |  Comment   Share  

GFS Chemicals, Inc.
3041 Home Rd., P.O. Box 245
Powell, OH, 43065
USA



Press release date: January 27, 2014

In anticipation of the official implementation of the United States Pharmacopoeia Chapter <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures in August of 2015, pharmaceutical manufacturers are turning to their supply chain for higher purity raw materials that are already tested to more rigid standards.

USP<232> outlines a number of proposed changes, including increasing the Permitted Daily Exposure (PDE) limits from 10 to 16 analytes with the addition of the PGE catalyst elements Pt, Pd, Ru, Rh, Os and Ir.  Furthermore, the maximum permitted levels will be defined according to toxicity, rather than method capability.

One of the primary goals of the proposed new USP General Chapters is to replace the current subjective, 100 year-old colorimetric test defined in USP General Chapter <231> with new analytical methods based on modern instrumentation such as ICP-MS and ICP-OES. 

Although there are differences in the type of spectroscopy utilized to analyze for trace metals, both ICP techniques are capable of detecting very low levels of these impurities.  Of the two, ICP-MS is capable of detecting lower concentrations, often down to the part per trillion level.  ICP-OES, though not as sensitive, is still capable of measuring most trace metals in the parts per billion (ppb) range.

Instead, pharmaceutical companies are looking to source higher purity raw materials from their supply chain.  By purchasing from U.S-based batch manufacturers that already routinely utilize ICP testing, such as GFS Chemicals, they hope to reap the rewards of greater transparency and consistency of product.

The Ohio-based GFS manufactures a variety of high purity and low trace metal grade organic and inorganic chemicals for the pharmaceutical industry.  The company specializes in producing a customized product to the customer's exact specifications.

All of GFS' incoming raw materials and finished products are tested using ICP-OES equipment.  GFS is transparent with its testing methods and shares the results with customers, when requested.

This is in sharp contrast to some foreign raw material suppliers that run continuous processing and do not perform such testing, leading to variability even within what is considered to be a single lot.

In addition to benefiting from the ICP testing, there are many advantages to working with a true domestic manufacturer such as GFS.  This includes an ability to address any quality issues that arise more easily, transparency of supply chain, and superior consistency of product batch to batch, and year to year.

For more information please contact:

Liza Tallon
Director of Marketing
liza@gfschemicals.com

GFS Chemicals
PO Box 245
Powell, OH 43065
740-917-5925

Print | 
Email |  Comment   Share  
Contacts: View detailed contact information.


 

Post a comment about this story

Name:
E-mail:
(your e-mail address will not be posted)
Comment title:
Comment:
To submit comment, enter the security code shown below and press 'Post Comment'.
 



 See related product stories
More .....
 See more product news in:
Test and Measuring Instruments
 More New Product News from this company:
Alkynyl Ester Synthesis can be accomplished without butyllithium.
More ....
| Featured Manufacturing Jobs
 Other News from this company:
Bulk Grignard Reagents and Deriviatives for Pharmaceutical Development
GFS Chemicals Expands Product Line for Electronics Manufacturers
GFS Chemicals Expands Rare Earth Manufacturing Facility
In-SpecŪ 'Nano' Kit for DNA/RNA Quantification Tests
More ....
 Tools for you
Watch Company 
View Company Profile
Company web site
More news from this company
E-mail this story to a friend
Save Story
Search for suppliers of
Spectroscopes
Chemical & Analytical Instruments
Measuring Instruments
Join the forum discussion at:
Tools of the Trade


Home  |  My ThomasNet News®  |  Industry Market Trends®  |  Submit Release  |  Advertise  |  Contact News  |  About Us
Brought to you by Thomasnet.com        Browse ThomasNet Directory

Copyright © 2014 Thomas Publishing Company. All Rights Reserved.
Terms of Use - Privacy Policy



Error close

Please enter a valid email address