Free press releases distribution network?

Agency / Source: Sinclair & Co.

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!



Metrics, Inc. Introduces Melamine Contamination Test for Start Materials - FDA recommends that pharma companies test at-risk components, including gelatin capsule shells
Metrics, Inc. Introduces Melamine Contamination Test for Start Materials

 

PRZOOM - /newswire/ - Greenville , NC, United States, 2010/03/30 - FDA recommends that pharma companies test at-risk components, including gelatin capsule shells.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Metrics, Inc. has developed and validated a test that detects melamine in pharmaceutical start materials.

Metrics developed its test because of a recent U.S. Food and Drug Administration recommendation that urges pharmaceutical companies to test at-risk components for the presence of melamine.

Headquartered in Greenville, N.C., Metrics provides quality pharmaceutical formulation development; clinical material manufacturing for Phase I, II and III trials; commercial manufacturing; and analytical method development and validation services to the pharmaceutical industry.

The FDA recommendation follows two separate but widespread incidents of melamine contamination in consumable products. In both cases, the start materials were manufactured in China and exported to the United States, where they were used to make pet food and baby formula.

According to the FDA, melamine was added to start materials to bolster apparent protein content – thus making them appear more nutritious than they actually were.

Melamine alone is not necessarily dangerous. But in the presence of a similar compound called cyanuric acid, the two loosely associate and accumulate in the body, leading to kidney failure.

“There is no legitimate reason why melamine should be present in any pharmaceutical product,” said Dr. Jack E. Pender, senior scientist at Metrics Inc. “Because of the severity of melamine’s potential toxicity, it’s critical that companies accurately test at-risk start materials before they manufacture drug or food products.”

The motivation for melamine contamination can be found in how companies have tested start materials in the past.

To gauge the protein content of start materials, companies typically have tested for nitrogen, a fast and simple “barometer” for protein. But melamine is a nitrogen-based compound, so companies testing for nitrogen alone can’t distinguish melamine from the desired protein content.

Metrics has developed and validated a simple HPLC separation method with UV detection that is capable of detecting melamine down to the FDA recommended limit of 2.5 parts per million. For added reliability, Metrics evaluates matrix interferences on each sample tested and confirmed.

“Our method was designed to be simple in principle and easily adaptable to additional sample matrices as needed,” Pender said.

Pender reports that to date, pharmaceutical companies have most frequently requested melamine testing for gelatin capsule shells, which are derived from animal collagen.

“Because of the wide range of color combinations possible for gelatin capsule shells, the presence of various coloring agents means each gelatin capsule represents a different challenge for identifying and quantifying melamine at trace levels,” Pender said. “The test Metrics has developed easily adapts to those differences.”

The FDA recommends that companies test for melamine in start materials derived from milk or animal products, as well as start materials that contain more than 2.5 percent nitrogen in the compound by weight.

For a list of specific materials the FDA deems at risk for melamine contamination, please refer to the agency’s “Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination,” which can be found on the FDA Website.

Since our start in 1994, Metrics Inc. has evolved from a start-up analytical laboratory into one of the fastest-growing contract pharmaceutical development and manufacturing organizations in the United States.

Metrics (metricsinc.com) offers the latest development and analytical equipment housed within a state-of-the-art, 92,000-square-foot cGMP facility. Facilities include a dedicated potent products suite; seven analytical laboratories; seven pharmaceutical development suites; seven large-scale manufacturing and packaging rooms for Phase III clinical trial and commercial manufacturing; stability storage; and a microbiology laboratory.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Agency / Source: Sinclair & Co.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick PRZOOM - Press & Newswire Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


Metrics, Inc. Introduces Melamine Contamination Test for Start Materials

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name PRZOOM - Press & Newswire and LINK as the source.
 
  For more information, please visit:
Is this your article? Activate ALL web links by Upgrading to Press Release PREMIUM Plan Now!
|
Contact: Erin Smith - Sinclair-Co.com 
919-833-9102 esmith[.]sinclair-co.com
 
PRZOOM / PRTODAY - Newswire Today disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Sinclair & Co. securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!




Read Latest Press Releases From Sinclair & Co. / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Press Releases:

First Pulmonary Embolism Patients in Hong Kong Treated with the EKOS® System
Ipsen to Acquire Oncology Assets from Merrimack Pharmaceuticals
FDA Grants Genentech’s Cancer Immunotherapy Tecentriq® (Atezolizumab) Priority Review in Additional Type of Advanced Bladder Cancer
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Myopic Choroidal Neovascularization
Sugar Element of Keratan Sulfate Halts the Progress of Emphysema Finds RIKEN
Exelixis and Ipsen Amend Exclusive Licensing Agreement for the Commercialization and Development of Cabozantinib to Include Canada
FDA Extends Review of Application for OCREVUS™ (Ocrelizumab)
MDxHealth Announces AceCGT Life Science Limited as the Exclusive Distributor for SelectMDx in Hong Kong and Macao China
Pulse Certified As A Level Four Multichannel Content Agency by Veeva Systems
BD Launches Advanced Prefillable Syringe for Higher Volume Injection of Biologics

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
 
NewswireToday Celebrates 10 Years in Business
Find business coaching, life coaching, executive coaching and corporate coaching, best selling coaching books, ...



PREMIUM Members


Visit  JobsWare.com

Visit  La Bella Bakery Artisan Bakery Arizona

Visit  Intrinsic Executive Search Ltd







 
  ©2017 PRZOOM — Limelon Advertising, Co.
Home | About PRZOOM | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneur newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today