Stability Study Services

Confirming a stability claim for a drug product is an essential, yet expensive and time-consuming exercise.  At DYNALABS, we strive to use our extensive experience and knowledge of industry guidance, to minimize the significant costs associated with this exercise.  We begin by working with our client to organize their products into families by active and formulation.  We then use Bracketing and Matrixing and our comprehensive knowledge of the inherent stability characteristics of medications, to design cost effective, yet comprehensive stability programs.  Contact us now to learn how you can start saving today.

Deployed Enhancements

DYNALABS recently deployed many enhancements to our website, which is designed to make the sample submission process more straightforward and stream lined for sending in New Products, and overall, lead to a better experience when testing with DYNALABS.

Below are the features/updates from our latest deployment. 

1. Changes in Rush Options—For New Compounds, only second day Rush will be available.  This is due to the extra time required to review  and accurately build your compound prior to testing.
2. New Compound/New Product Information – In order to  further improve the process of getting your new compound/product “built” in our system, we now offer an option to upload your formula worksheet upon submission.  There is also a box in which to indicate other product specific information, such as NDC number and salt form.  This will cut down on any delays in getting your new compound set in our system.
3. Unknown Compound/Product Information– In order to expedite the receiving process for “unknown” samples, there are several boxes available to describe what the client believes the compound to be (these types or samples are generally samples that are suspected to be diverted and therefore the final concentration is “unknown”).  The additional information given will allow  us to better determine what  to test.
4. Volume Requirements for Labels – We are now requiring that all container labels for products sent to DYNALABS include the volume of the sample.
5. Time Study Storage Fee – All non-quoted time studies will receive a storage fee equal to $1/day of storage per lot.
6. Investigation Reports – Investigation Reports will be available while in process, via sample tracking.  The final investigation Reports will now be electronically signed.
7. Password Security – The DYNALABS website will lock user accounts after 5 incorrect log-in attempts.  The client will need to contact their customer service representative to “unlock” the account.  Reset password link will be available for 24 hours.  This feature allows for increased security and compliance with 21 CFR Part 11.  Restrictions must be in place to prevent unauthorized access.