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Container closures, polymer leachate analysis, pharmaceutical drug testing
Testing of Containers USP <661>
Containers composed of plastics which are intended for packaging products for parenteral use must meet the requirements of Physicochemical Testing - Plastics found in the current USP23. These tests are designed to measure the properties of impurities extracted from plastics when leached with extraction medium over a specified period and temperature. Unless otherwise specified in a specific monograph, the extraction medium is purified water. The value of these tests become important to insure the efficacy of product within the container.
In order to obtain representative data it is important that the proper surface area be available for extraction. The current minimum surface area requirement is 540 cm2. Please consult the laboratory regarding available surface area, our mathematicians are always willing to help.
The following tests under USP <661> are offered:
Non Volatile Residue (NVR)- measures organic/inorganic residues soluble in extraction media
Residue On Ignition - this test is performed when the NVR is greater than 15 milligrams
Buffering Capacity - measures the alkalinity or acidity of the extract
Heavy Metals - detects the presence of metals such as lead, tin, zinc, etc.
Elastomeric Closure for Injections USP <381>
Certain container closures used in pharmaceuticals for injection may fall into this test class. Typically two extraction media are used, purified water and isopropanol. Where pharmaceuticals are aerosols the drug vehicle is used as a third medium. The extraction is performed at a specified temperature and time period. The following testing is performed: turbidity, pH change, reducing agents, heavy metals, and total extractables.
These tests may also be applicable where such information is valuable to the stability and properties of a product or reagent in contact with the closure. A good example is lyophilized material.
The minimum surface area for each extraction solvent is 100 cm2. If you have container components which require either USP <661> or <381> or would like to inquire whether this testing regimen fits your needs please contact Eric or Jack for details.
In addition to normal USP procedures, we analyze for a full range of polymer additives and impurities in leachates from your container. These include antioxidants, mold release agents, stabilizers, trace metals, and trace organics. For a quotation...
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