Foothill Ranch, CA
ACTA writes your stability protocols, stores your samples under ICH storage conditions, and tests every pull point on time. cGMP compliant, built to satisfy the FDA.
ACTA has, at all times, a standby generator that maintains power to the stability chambers in the event of a power failure, along with an alarm system that will alert quality and laboratory management in the event that any stability chamber fails to maintain its temperature or humidity set points. These controls ensure that projects placed in the stability chambers are stored as required and tested promptly.
Backup power holds every stability chamber at its set point through an outage. Reducing the risk of lost storage time or compromised samples.
If any chamber drifts from its temperature or humidity set points, quality and laboratory management are alerted right away.
We store your samples under the standard ICH stability conditions, from long-term through accelerated, plus refrigerated and frozen storage. Custom temperature and humidity conditions are available on request.
Hot and humid climatic zone conditions (for example 30°C / 75% RH) and controlled-substance stability storage under DEA license are available on request. Ask us about the conditions your registration requires.
Conditions follow the ICH stability guidelines (Q1 / Q1A(R2)). ICH is consolidating the Q1 stability guidelines into a single Q1 document, with adoption planned for November 2026; ACTA will cite the current guideline on publication.
ACTA can write your stability protocol or assist with one you already have, so the study is fully cGMP compliant and meets the requirements of the FDA. We track each project carefully and test at every scheduled pull point, then report results with trend monitoring at each time point.
Protocol to specifications to scheduled storage to on-time pulls to final report.
Stability data is only as good as the methods behind it. ACTA runs your study on validated, stability-indicating HPLC and GC methods that separate the active from its degradation products, so potency loss and impurity growth are measured accurately over time.
Assay and impurities by stability-indicating HPLC, the workhorse of most stability programs.
View HPLC →Methods validated to USP and ICH and shown to be stability-indicating before your study begins.
View Method Validation →TOC, conductivity, and microbial testing to support your product and facility.
View Water Testing →Many large labs will not take on a stability study unless the project is big enough, and getting into their system can take weeks. ACTA takes the project, gets back to you quickly, and works it directly. Stability programs run for months or years, so you want a lab that stays responsive the whole way. Many of our smaller projects grow into much larger relationships.
ACTA is an FDA-registered, DEA-licensed, cGMP-compliant contract analytical laboratory. Stability studies are run to the same standard, with documentation built to satisfy FDA review.
