Testing for Sterile/Non-sterile Drug Dosage Forms and Raw Materials 
Whether your test is a time study, an investigational study (adverse event or diversion monitoring), quality-assurance testing, or training/process validation, you can be confident that your test results are accurate.
All your test results are stored and tracked on our secure website, and results can be viewed immediately. A limited amount of test history is also available on the website, allowing you to see trends and alert you to potential issues.
Release testing, also known as lot or batch release testing, is a critical step to ensure quality of substances and drug products.
DYNALABS Core Laboratory Services
RELEASE TESTING
Potency/Purity
Test protocols based on USP <621>, USP <851>, and USP <1225>
FORMS TESTED
• troche • tablet • foam
• capsule • suppository • inhalant
• oil • pellet • injectable
• gel • aqueous solution • paste
• cream • powder • ointment
• suspension • lollipop
Sterility
Test protocols based on USP <71>
FORMS TESTED
• all sterile forms
Endotoxin USP 85
Test protocols based on USP <85>
FORMS TESTED
• oil injections • sterile solutions
• pellets • aqueous injections
• suspensions • powders
Particulate Matter
Test protocols based on USP <788> (light obscuration particle count test) and USP <797> (physical inspection) guidelines
FORMS TESTED
• aqueous injections and solutions
• oil injections (physical inspection only)
• medical devices
Microbial Identification
Test protocols include gram staining, microscopic inspection, and amplification of the DNA of contaminating organisms.
FORMS TYPICALLY TESTED
• positive media fill tests
• bench and/or hood swabs
• settling plates
• contaminated samples
Specific Gravity
Testing protocols based on USP <841>
FORMS TYPICALLY TESTED
• liquids • ointments
• oils • gels
• creams
pH
Test protocol based USP <791>
FORMS TESTED
• aqueous injections and solutions