Plastic and other drug container materials can contribute soluble chemicals into drug products. There is a growing acknowledgement of the need to test for these extractable and leachable chemicals in these products. Chemical Solutions, partnering with Chemic Laboratories Inc., will utilize well established and developed chromatographic and spectroscopic analytics to provide Extractable & Leachable data assessing material compatibility and suitability for pharmaceutical use.
Common Sample Types
Single-Use Systems (SUS)
Pharmaceutical delivery devices
Container closure systems
Drug Product Intermediates
Elements Commonly Analyzed
Any elements of concern that are a part of the manufacturing process or inherent in the packaging materials of drug products. Chemical Solutions Ltd. has developed its own method for the following elements:
Gold, Aluminum, Arsenic, Silver, Barium, Calcium, Cadmium, Cobalt, Chromium, Copper, Iron, Mercury, Iridium, Lithium, Magnesium, Manganese, Molybdenum, Nickel, Osmium, Lead, Palladium, Platinum, Rhodium, Ruthenium, Antimony, Selenium, Silicon, Tin, Titanium, Thallium, Vanadium, Tungsten, Zinc
We Can Assist You In Testing For These Regulations
21 CFR Part 211.65
States that “Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.” This regulation applies to all materials including metals, glass, and plastics.
Extraction/leachable tests are designed to characterize the extracted components and identify possible migrants. This chapter references heavy metals as performed for method USP <231>. The USP is moving from <231> to <232>/<233> and Chemical Solutions is capable of helping you to carry out that transition.