Foothill Ranch, CA
cGMP dissolution and drug release testing to USP <711> and <724>, from an FDA-registered, DEA-licensed lab. Method Development, QC Testing, run by scientists who follow up.
Dissolution testing measures the rate and extent to which an active ingredient releases from a solid oral dose, such as a tablet or capsule, into a defined liquid medium under controlled temperature and agitation. It is one of the most relied-on performance tests in pharmaceutical quality, tying a batch on the bench to how the product is expected to behave.
Regulated drug products call for dissolution data at several points in their life. It supports QC batch release against a specification, tracks performance through a stability program, and justifies formulation, site, or scale changes under SUPAC. It is a required part of ANDA and NDA CMC packages, and it underpins biowaiver requests where an in vitro result can stand in for an in vivo study.
The dosage form sets the test. ACTA runs dissolution and drug release against the compendial chapters your submission and your specification reference.
Conventional tablets and capsules are tested against a single acceptance point, as established in the individual monograph.
Modified-release products are characterized by a multi-point profile taken across several hours, mapping the full release curve rather than one moment. Extended-release is covered by USP <724> Drug Release.
Apparatus and dosage-form scope is detailed below.
USP <711> defines standardized dissolution apparatus. For conventional tablets and capsules, Apparatus 1 and Apparatus 2 are the workhorses. The list below shows the compendial framework.
Specialty dissolution and drug elution work, including non-compendial products and dosage forms, is a growing area of demand. Ask us about your specific product.
When no compendial method fits, ACTA develops and validates one. USP <1092> guides the work, from first principles to a procedure an auditor can trust.
Method development starts with the drug and the dose. It sets the medium and pH, addresses deaeration, and establishes sink conditions so the result reflects the product and not the limits of the test. Apparatus choice, agitation, sampling times, and the analytical finish are fixed and qualified, then the method is validated to USP <1225>.
The output is a defensible procedure with acceptance criteria, ready for release testing, stability, and regulatory filing.
New client. Small batch. Odd dosage form. Start here.
The national labs bid on large programs and pass on everything else. A single-batch dissolution study is exactly the work ACTA takes on.
You reach a scientist, not a queue. Quotes come back fast, and someone owns your project from sample receipt to report.
Many ACTA relationships begin with one test and expand into method development, stability, and the full specification panel over time.
Dissolution data has to survive an audit. ACTA runs to cGMP and holds the registrations that regulated clients require of a testing partner.
