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