Houston, TX (April 25, 2019) – Pharmaceutical contract manufacturer WDPrx – Woodfield Pharmaceutical, LLC installed new ICP-OES equipment to expand testing services to include impurities in raw materials that may affect product quality and patient safety.
Pharmaceutical manufacturing is complex. Challenges arise during each phase of Development, Validation, Analytical Testing, Quality Assurance, Quality Control, Manufacturing, Packaging, Labeling and Regulatory Compliance. Unique obstacles arise during scale-up and manufacture of oral solutions and suspensions.
An important step in the process involves testing for ingredient impurities. Some elemental impurities including heavy metals that may be found in raw ingredients may be toxic. Non-toxic inorganic substances including copper, nickel and other metals can affect product quality. For example, impurities may render a medication ineffective prior to the expiration date printed on the label.
Technologically advanced equipment is required to effectively detect elemental impurities in pharmaceutical ingredients. Inductively Coupled Plasma – Optical Emission Spectrometry, known as ICP-OES involves nebulizing mainly water-dissolved ingredients into an argon plasma. Precise treatment of the aerosol with extreme heating, cooling and electrical current results in electrons emitting energy as light. Each element in the sample has a unique wavelength that is measured with a spectrometer and individually identified to confirm ingredient purity.
The ICP-OES system is superior to older wet-chemistry methods to measure impurities because it provides results faster using smaller initial sample quantities.
According to Jay Patel, WDPrx Manager of Research & Development and Quality Control, “The ICP-OES equipment adds to the wide range of laboratory services offered at our on-site laboratory. Complete microbiological testing from raw ingredients through manufacturing and finished goods stability supports our clients at every stage of product development, technology transfer, scale-up, production, packaging and order fulfillment.”
Adds WDPrx Business Development Director Angela Holley, “The addition of ICP-OES capabilities responds to the pharmaceutical market that requires CMO partners to collaborate with manufacturers at every point within the supply chain to reduce cost, increase productivity and maintain product quality for patients.”
For further information contact Lawrence Hotz at firstname.lastname@example.org or 561-998-3885 x304