• • What is a batch size?
    • A batch size is the total amount of material you specifically created, in which samples are pulled from and shipped to be tested
  • Why didn’t my packing slip print?
    • The most common reason for a packing slip not to print is that your computer is blocking pop ups. Make sure to enable pop-ups for dynalabs.us.
    • Your printer may not be on or connected to your computer
  • What can cause my sterility tests to have an Indeterminate – Turbid result?
    • • Sample contaminated – Sample is plated day turbidity is observed. Plate is incubated. If no growth is observed, sample is transferred on day 14, then incubated for 4 additional days. Final result will be on day 18. If growth is observed on the plate, sample will be updated as positive.
    • • Sample reaction with media causes turbidity – Sample is transferred on day 14, then incubated for 4 additional days. Final result will be on day 18.
    • • Sample falling out of solution – Sample is plated day turbidity is observed. Plate is incubated.  If no growth is observed, sample is transferred on day 14, then incubated for 4 additional days. Final result will be on day 18. If growth is observed on the plate, sample will be updated as positive.
    • Sample form is turbid in nature – Sample is transferred on day 14, then incubated for 4 additional days. Final result will be on day 18.
  • How much does testing cost?
    
    • 
    • We have three service levels, which detail different turnaround times based on your pharmacy’s needs. Once a service level is chosen, our Pricing Guide can be reviewed for pricing.  Please contact your Regional Sales Manager and/or Customer Support Specialist for more information.

• Where is your API list?
  • https://www.dynalabs.us/products-services/api-list
    
• How much sample should I send in?
  • While entering information on our Test Request Form, click the “review amounts required” button and all necessary amounts will appear
  • You can also find Sample Submission requirements at the following website for potency, sterility, endotoxin, particulate, pH, and specific gravity testing.
    1. https://www.dynalabs.us/products-services/sample-submission
       
• Can I just send in 1 sample for multiple tests?
  • No, each test requires a unique container, sometimes multiple containers

• Is DYNALABS’ website HIPAA and/or GDPR compliant?
  • DYNALABS does not collect, process, or store personal information of any kind. Therefore, DYNALABS does not fall under the regulatory requirements for either HIPAA (Health Information Portability and Accountability Act of 1996), or for GDPR (General Data Protection Regulation) in the European Union.
    DYNALABS maintains an ongoing Data Integrity Program to ensure industry best practices for enterprise security.

• What are the regulatory requirements for DYNALABS information security?
  • DYNALABS is regulated by the FDA (Food and Drug Administration). We are governed by both 21 CFR Part 11 for data integrity and by the FDA GAMP (Good Automated Manufacturing Practices) requirement for software validation.
    DYNALABS maintains an ongoing Data Integrity Program to ensure that we maintain regulatory compliance with 21CFR Part 11, and that we maintain a level of enterprise security that is consistent with industry best practices.
• What is an NDC number and why does DYNALABS need it?
  • The NDC, or National Drug Code, is a unique 10-digit, 3-segment number. It is a universal product identifier for human drugs in the United States. The code is present on all nonprescription (OTC) and prescription medication packages and inserts in the US. DYNALABS requests it because when you submit new samples that have never been tested with DYNALABS before, DYNALABS accurately builds your specific formulation onto our website to ensure accuracy and quality results. The NDC number including or along side your formulation allows DYNALABS to know what to test for. For example, the difference between Fentanyl and Fentanyl Citrate could throw the results off by more than 10% or Testosterone Cypionate and Testosterone Propionate is not the same. This one time process will ensure moving forward all results are accurate and precisely the way they should be tested.