HPLC analysis from a lab that actually gets back to you.

cGMP HPLC assay and impurities testing on pharmaceutical APIs and drug products, to USP, BP, JP, and EP methods or a method ACTA develops for you. Send a specific test on a specific material and a chemist scopes it directly.

HPLC · UV / DADcGMP
Response (mAU)Retention time (min)
MODE reverse-phaseDETECTION UV / DAD / RI / FLDOUTPUT assay + impurities
FDA Registered
DEA Licensed I to V
cGMP Compliant
Analyzing Since 1990
ANALYTICAL CHEMISTRY

What ACTA analyzes by HPLC

ACTA Laboratories is a cGMP, FDA-registered testing laboratory that performs HPLC analyses on pharmaceutical APIs (active pharmaceutical ingredients) and finished drug products. Typical work includes assay (potency) and related substances / impurities testing.

We follow USP, BP, JP, CP, and EP compendial methods, or develop a method for your material, with method validation and verification to meet FDA requirements. You receive a cGMP Certificate of Analysis (COA) for submission or release.

Detection Capabilities
UV-Visible Absorbance (UV-VIS)Photodiode ArrayElectrochemical (ECD)ConductivityFluorescenceEvaporative Light Scattering (ELSD)Charged Aerosol (CAD)
THE METHOD

How an HPLC analysis works

HPLC (high-performance liquid chromatography) separates a mixture using a solid stationary phase packed in a column and a liquid mobile phase pumped through it. Different compounds are retained to different degrees, so they exit the column at different times. A detector measures each compound as it elutes, and its response is compared against a known standard to determine concentration.

HOW AN HPLC SYSTEM WORKSflow
SAMPLEThe solvent reservoir supplies the liquid mobile phase.MOBILE PHASEsolvent reservoirA high-pressure pump drives the mobile phase at a constant flow.PUMPhigh pressureYour sample is injected into the mobile-phase stream.INJECTORsample inThe C18 column separates compounds by how strongly they interact.COLUMNC18 stationary phaseThe detector (UV / DAD) measures each compound as it elutes.DETECTORUV / DADChromatography software converts the signal into a quantitative result.DATA SYSTEMchromatogramsignalwaste

Sample is injected into the mobile-phase stream, separated on the column, and measured by the detector. Hover any stage to see what it does.

WHY A SMALLER LAB

Big labs won't take a project your size. We will.

As the big labs consolidate, they have stopped taking projects that are not large enough, and just getting into their queue can take a month. ACTA is FDA-registered, DEA-licensed, and cGMP, and small enough to actually respond and follow up. Many of our largest accounts started as one small test.

1990Analyzing since
13,000 sq ftTwo buildings, Foothill Ranch CA
DEA Schedules I to VFDA-registered, DEA-licensed, cGMP
Pharma + deviceFDA-regulated clients only
HOW WE RUN IT

Four steps, and a person on the other end of each one.

ScopeA chemist reviews your material and method, or the problem.
MethodFollow USP, BP, JP, or EP, or develop and validate a method for your material.
AnalysisHPLC with the right detector for your compound, under cGMP.
ReportA cGMP Certificate of Analysis (COA), reviewed and released, and we follow up.
Inside the labHPLC BENCH / METHOD DEVELOPMENT & VALIDATION
ACTA scientists at a bank of HPLC systems in the Foothill Ranch laboratory

The HPLC bench and the scientists who run your method.

The chemists who develop and validate your method are the same people at the instrument who run it. No handoff to a faceless queue, no method that changes hands three times before a result reaches you. Every result is reviewed and approved by Quality before it is released.

You reach the scientist leading the work, not a queue.

USP <621>Chromatography
Assay& Related Substances
Quality reviewBefore release
HPLC-UVAcquiring
Detector λ254 nm
Main peak tR4.82 min
MethodUSP <621>
Signed byQuality or Management
REGISTRATIONS & COMPLIANCE

Registrations, scope, and quality systems

FDA Establishment RegistrationRegistered · FEI No. 1000125694
DEA LicenseSchedules I to V · License No. RA0256239
Quality SystemcGMP, 21 CFR Parts 210, 211, and 820
Data Integrity21 CFR Part 11 Computer Systems coupled with Good Documentation Practices
CompendiaUSP, BP, JP, and EP methods
FDA Inspection History14 inspections (NDA, ANDA, and general cGMP) · Most recent Sept. 2026, 2 minor observations
HPLC DetectorsSeven detector types · UV-VIS, PDA, ECD, Conductivity, Fluorescence, ELSD, CAD
Certificate of AnalysisConcise 1 to 2 page cGMP Certificate of Analysis (COA)
Established1990 · 13,000 sq ft, two buildings · Foothill Ranch, CA
ScopePharmaceutical and medical device, FDA-regulated only
Typical Quote Turnaround1 working day

Send us your HPLC project.

A specific test on a specific material. We will scope it, get you a quote, and a chemist will follow up. FDA-registered, DEA-licensed, cGMP since 1990.
Request a Quote
949-595-0641
info@actalabs.com