Tech Bulletin | January 2018

Validation Extensions

For our clients to keep up with regulations for stability indicating methods, DYNALABS offers validation extensions for client specific products.

The Validation Extension process is performed on each active contained in a specific product.

A Validation Extension consist of performing specificity and method precision for a specific product.

Method precision:  the sample is prepared 6 times to the target range of the method and injected on a qualified HPLC. The %RSD of the 6 injection needs to be less than %RSD capability of the method.

Specificity: A set of placebos are held for a 24-hour incubation. One placebo is held at room temperature and the other placebo is held at 70 C. (UV exposure can be included, if applicable) After the 24-hour incubation each placebo is prepared as the release sample for testing.  The room temperature placebo is used to ensure that the matrix components do not interfere with the active peak. The heated placebo ensures degradants or extractables are not created and interfering with the active peak.

Release Testing For Injectables

Per USP <797> the minimum amount of testing to release injectables is Potency by stability indicating method, USP <85> Endotoxin Testing, Sterility Testing and Visual Inspection/Description of Product. DYNALABS understanding of cGMP the following test should also be performed for release testing for injectables at minimum.

USP <788> Testing – Subvisible particle testing
USP <791> pH
USP <71>
Preservative Assay (if applicable to client’s product)

DYNALABS has updated our API list for Potency Testing to include the following:

  • Riluzole – Tier 2

An updated, comprehensive list can be found by clicking the link here. Any active that is dictated with “Special” in the tier column requires a quote/pre-approval before proceeding with testing.  If you wish to test something not on this list, please contact DYNALABS for Method Feasibility and Method Development.

New method transfers:

  • Cefepime – Tier 3
  • Morphine – Tier 1
  • Hydromorphone – Tier 1

Clients with existing Validation Extensions can send validation extension materials for these methods from now until February 25th for no charge. Please request quotes for extensions. After that time normal charges will occur for validation extensions.

Stability Studies/Drug Shortage

Stability studies are a testing protocol that are used to extend the use date of a compounded product. Justification of extending the use date of the product from the data collected in the study shows that the product retains the sample properties and characteristics that it possessed at the time of compounding. During drug shortages, having stability data is beneficial because  compounders have justification of using drugs compounded for longer of periods of time than from use dates stated in USP <797>.

DYNALABS strives to help its customers during times of drug shortages. We provide the validation work and stability testing necessary for clients to have successful stability studies. This extends the use date of their products and minimizes the effects of the shortages, helping to provide better patient health and safety.

FDA Current Drug Shortages>