Product Data Sheets and Certificates of Analysis
Shenandoah is on a mission to be completely transparent with our customers! Have reformatted our Product Data Sheets (PDS) and Certificate of Analysis (COA) documents to include even more information.
In addition to the information currently included with our products, we have added:
- 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 many cases our limit is much higher than the results for each lot). 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, but will not be listed as acceptance criteria.
- The purity is now 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 are 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 is not 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.
If you have any questions, just let us know.