Comprehensive method development and validation can be designed for a full range of analytical techniques. In addition to custom methods, we are experienced at identifying and applying ASTM and USP test methods. We specialize in testing materials for compliance with <661> Containers - Plastics and <1663> Extractables Associated with Pharmaceutical Packaging / Delivery and <1664> Drug Product Leachables Associated with Pharmaceutical Packaging / Delivery Systems.
Aspen Research Corporation performs testing that is compliant with the standards found in the U.S. Pharmacopoeia and National Formulary (USP-NF). USP-NF contains monographs applicable to drug substances, dosage forms, compounded preparations, excipients, medical devices and dietary supplements. Each monograph consists of a series of tests, procedures for performing the test and acceptance criteria. USP-NF is recognized by the U.S. Food and Drug Administration as its official set of quality standards for drug products within the United States. USP standards are also used in over 140 countries worldwide.
Aspen’s capabilities with regards to USP testing are dependent upon the material being tested and its applicable monograph. Aspen is experienced with testing materials for compliance with <661> Containers – Plastics. Aspen has also performed extensive work related to Assessment of Extractables and Leachables and is versed in the guidelines found in USP <1663> Extractables Associated with Pharmaceutical Packaging / Delivery Systems and <1664> Drug Product Leachables Associated with Pharmaceutical Packaging / Delivery Systems.
Navigating the many existing testing agencies in order to identify an appropriate testing procedure can be a challenging task. The expansion of global trade has driven regulatory agencies and quality management systems to define standardized test methods. This ensures accuracy and uniformity of testing, data collection and reporting.
If needed, Aspen will assist clients in identifying a standard appropriate for their requirements and needs. For example, the standards published by ASTM International cover a wide spectrum of materials, products, systems and services, several of which Aspen periodically conducts for its clients. Click below for a list of ASTM Test Methods which Aspen periodically has used for its clients.
Method validation is designed in collaboration with the customer and is based on their specific needs. Validation protocols can be written by our staff using our validation template or they can be provided by the customer. All protocols written by Aspen are submitted to the customer for approval.
Upon completion of all method development and/or method validations, a comprehensive report is provided to the customer. The report can be customized to meet the specific needs of the customer and can be supplied both electronically and via traditional paper format. The report includes:
The objective of any analytical method is to secure test methods which are reproducible and accurate. This is done to provide objective evidence that the test method is specific for its intended use. Depending on the client’s requirement, method validation maybe required. The validation of a test method demonstrates that the method is fit for its intended purpose. Aspen has the capability to develop new test methods, as well as perform method validation.