Catalent Expands Capabilities In Testing For Melamine In Food
And Medicinal Products
on: November 5, 2009, 7:51 am
Author: Jennings and Co.
Triangle Park, NC, November 5, 2009 – At a time when melamine-contamination
has received global attention, Catalent Pharma Solutions continues
its legacy of innovation by rapidly developing new FDA guidance-compliant
tests for trace amounts of key contaminants in food and medicine.
Incidents of melamine contamination in milk products, baby formula,
dairy and non-dairy products manufactured in China have been widely
reported, leading to product recalls and increased inspections
by the FDA.
current good manufacturing practice (CGMP) regulations require
that all components (i.e. ingredients or raw materials) be tested
before they are released for use in the manufacture or preparation
of drug products (21 CFR 211.84). It is critical that all manufacturers
determine whether they are using an at risk component for melamine
contamination to manufacture or prepare a drug product.
response to the FDA’s new guidance titled “Pharmaceutical
Components at Risk for Melamine Contamination,” Catalent
has successfully qualified a method for determining if suspect
excipients are contamination-free to within 2.5 parts per million.
The method is based on that provided by the FDA (Laboratory Information
Bulletin No. 4423 “GC-MS Screen for the Presence of Melamine,
Ammeline, Ammelide, and Cyanuric Acid”).
is now able to provide its customers successfully qualified and
validated limits tests for trace levels of melamine, ammeline,
ammelide, and cyanuric acid in lactose.
is a compound made of carbon, nitrogen and hydrogen and is typically
combined with formaldehyde to produce a durable and moldable plastic
that is fire and heat resistant. Trace amounts of melamine have
recently been discovered to be toxic to dogs, cats, pigs, and
chickens by veterinary scientists after kidney or renal failure
occurred due to their food being contaminated with the chemical.
is proud to have satisfied the demanding regulatory standards
the US FDA has provided for detecting melamine,” said Kent
Payne, Vice President and General Manager of Catalent’s
Respiratory, Analytical and Biotechnology Services business. “Detecting
trace levels of melamine in food and medicinal products at these
levels is a challenging process, but is key to help avoid future
public health crises. In order to support this critical public
health need, Catalent can expedite this testing and provide results
within 48 hours from receipt of samples
Fore more information on the US
FDA guidelines, please visit:
Headquartered in Somerset, New Jersey, Catalent is one of the
leading providers of advanced dose form and packaging technologies,
and development, manufacturing, packaging and printing services
for pharmaceutical, biotechnology
and consumer healthcare companies in nearly 100 countries. Catalent
applies its local market expertise and technical creativity to
advance treatments, change markets and enhance patient outcomes.
Catalent employs approximately 9,500 at 30 facilities worldwide
and in fiscal 2009 generated more than $1.6 billion of annual
revenue. For more information, visit www.catalent.com.
Contact Details: Patricia A. McGee
(732) 537 6407