Tech Bulletin | June 2018

Method
DYNALABS has New Method Transfers
  • Succinylcholine
  • Vecuronium
  • Cyclosporine
  • Buprenorphine
  • Nicardipine

Clients can send validation extensions for these method from now until July 31st for no charge. Please request quotes for extensions. After that time, normal charges will occur for validation extensions.

Validation
Validation Extensions Procedure

As DYNALABS strives to improve quality for its customers, the Validation Extensions procedure is being altered. In addition to current practice, DYNALABS will now be performing stress studies on the formulation as well as the placebos. The benefit of this change is a more robust degradation profile for the formulation. The new procedure is effective July 1st.

Additional testing may be performed at the customer’s request to meet the needs set for their testing and studies. This could include product sample stress under more extreme conditions, by additional pathways, or the injection of customer provided impurities that may be common to their materials and processes.

Validation Extensions Necessity

During method development, sample precision and sample specificity are typical analyzed by aqueous samples. To demonstrate that a client’s formulation shows specificity on DYNALABS’ methods, a validation extension needs to be performed. The validation extension is especially crucial for samples that are non-sterile or suspensions due to the nature of these products.

Method
USP 71 Claims for Stock Solutions

Per USP <71>, stock solutions are not able to receive the USP <71> claim. The USP <71> claim is only valid for end use product.

Storage
Hazardous Drugs per NIOSH

As USP <800> becomes effective December 2019, DYNALABS wants to be at the forefront of helping our clients be compliant with USP <800>.

The link below is the NIOSH list of current Hazardous Drugs

https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

Storage
Storage Fees

Sample storage fees will be changed from a flat fee of $350 per study to $1 per lot/day with a minimum charge of $100/study. If a study is currently in-process, it will not be affected. This is effective as of June 1st.

API
Actives Removed from API list
  • Acetylcysteine
  • Calcifediol
  • Flurbiprofen
  • Mepivacaine
  • Remifentanil

To download the most recent version (05/23/2108)For additional information please refer #, A-E | F-K | L-O | P-S | T-Z. or Download the whole list HERE.

If you don’t see your API, please contact our Marketing Technical Services group to discuss a method development project.

MarketingTechServices@dynalabs.us.

F D A
U.S. Food and Drug Administration
Division of Dockets Management
Dockets Management Staff (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852Re: Docket No. FDA-2018-D-1067
Draft Guidance for Industry – Evaluation of Bulk Drug Substances Nominated for Use in Compounding
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.DOWNLOAD FULL LETTER >>>


Any questions regarding these updates can be directed to customer support by calling 888.396.2522 or info@dynalabs.us

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