Product Data Sheets and Certificates of Analysis
Shenandoah is on a mission to be completely transparent with our customers! We are reformatting our Product Data Sheets (PDS) and future Certificate of Analysis (COA) documents to include even more information.
- Acceptance criteria for endotoxin, percent purity, and biological activity (where applicable). It is important to note that the acceptance criteria listed on our documents is the limiting range that a product is required to test at in order to pass our quality assurance. The acceptance criteria values are set via a combination of historical results for each product and/or self-reported standards from competitors in the market. The acceptance criteria values do not reflect the results of the quality control tests for each product. In situations where the typical range of test results is different from the acceptance criteria, it will be listed on the PDS documents. For some products, we have limited access to the reproducible bioassays required to set the criteria at this time and therefore no biological activity acceptance criteria will be listed. Additional assays used during product testing will also be included on the website product pages.
- The purity will now be denoted as ≥90% or ≥95%, where applicable, instead of listing the specific purity values, such as 96%, 97%, 98%, etc. This is done in an effort to enhance method standardization across all Shenandoah products.
- The results of the biological activity assays will no longer be reported as a range of values. Instead, the exact calculated ED50 and specific activity will be reported on the COA.
- In the cases where the biological assays (western blots, ELISAs, chemotaxis, etc) are more qualitative than the proliferation assays, the specific activity will not be reported. This is because the specific activity is calculated from the ED50 value. When the data does not produce a curve from which the ED50 can be calculated, the specific activity can not be accurately determined or reported.
All production lots manufactured starting July 1, 2016 will be documented in the new format. Large production lots that remain in inventory for the duration of 2016 will reflect this change retroactively. The change will be gradual, so expect a mix of old and new COA and PDS documents along with a progressive conversion of our web content.
If you have any questions, just let us know.