Services
Analytical and Quality Control Services
Our fully equipped onsite analytical lab supports every stage of your program. We offer everything from incoming raw material qualification through stability storage and final release testing to keep your program moving.
See our analytical and quality capabilities
We handle all your critical analytical testing needs, in-house.
Raw Material Release Testing
We perform comprehensive incoming testing (identity, purity, physical and chemical properties) on raw materials to catch supplier issues before they enter the production floor.
Method Validation & Transfer
We validate, verify, and transfer analytical procedures tailored to your formulation and regulatory requirements.
In-process Testing
We monitor critical quality attributes in real-time during manufacturing to optimize or course-correct the formulation.
Release Testing
Every batch leaves with full confidence. We confirm quality, potency, and regulatory compliance.
Stability Testing
Establish shelf life, retest dates, and storage conditions with ICH-compliant long-term, intermediate, and accelerated stability studies.
Impurity Profiling
We identify and quantify impurities, including degradation products and residual solvents, to support safety, purity, and regulatory submissions.
Let's discuss your QC needs
Our lab is fully equipped to support your program
Every vial filling run is executed under our fully validated quality system. Our lines are compliant with FDA (21 CFR 210, 211, 820), Annex 1, USP, EP, and JP. PUPSIT is available.
View analytical methods
Appearance USP <790>
Color and Clarity Ph. Eur 2.2.2 and 2.2.1
pH USP <791>
Conductivity USP <1644>
Osmolality USP <785> FPD
Refractive Index USP <831>
Container Content USP <697>
Viscosity USP <912>
Fats & Fixed Oils USP <401>
Density
Bioburden USP <61>
Endotoxin USP <85>
HPLC (RP, IEX, SEC)
CCIT — CO₂ Headspace (Lighthouse)
UV/Vis & Fluorescence concentration
Nucleic acid concentration
FTIR
ELISA
RT-qPCR
DNase & RNase detection
Nitrates (purified water)
View laboratory equipment
HPLC/ UHPLC
UHPLC 1290 Infinity II — Agilent
CE-SDS/ cIEF
[Add Instrument]
FTIR
Nicolet Summit FTIR — ThermoFisher
DLS
[Add Instrument]
ELISA
Biotek ELx808 Plate Reader — Charles River
UV/Vis& Fluorescence / SoloVPE
SpectraMax384 Plus Spectrophotometer — Molecular Devices
Gemini XPS Microplate Spectrofluorometer — Molecular Devices
NanoDropOneC — ThermoFisher
CTech SoloVPESystem
RefractiveIndex
RX-5000i Digital Refractometer — Atago
Appearance
Light Box (USP & Ph. Eur compliant) — Phoenix Imaging
pH
Seven Compact pH Meter — Mettler Toledo
Conductivity
TOC/Conductivity Analyzer M9 — Sievers
Seven Compact Conductivity Meter — Mettler Toledo
Osmolality
Fiske Micro-Osmometer Model 210 — Advanced Instruments
Density/ Viscosity
D4 Density Meter — Mettler Toledo
Bioburden
MilliflexOasis
CCIT
FMS-Carbon Dioxide Headspace Analyzer — Lighthouse Instruments
MoistureContent (KF)
[Add Instrument]
Break-loose/ Glide force
Instron 8400 — Instron
View Stability storage conditions
-80°C
-20°C
5°C
25°C / 60% RH (long-term)
40°C / 75% RH (accelerated)
We meet the regulatory standards your program requires.
Our certifications are maintained and audit-ready, and we follow all current and best practices.
- FDA Registered
- cGMP
- 21CFR 210/211 compliant
- ISO 13485:2016 (QMS)
- CA FDB inspected (California Food and Drug Branch)
- QSR 21 CFR 820 (device testing)
- ICH Q1 (drug product stability)
Our facility is validated, monitored, and always on.
Our fully equipped onsite lab delivers faster turnaround, tighter chain of custody, and a single point of contact for your entire program
Why Choose Argonaut for QC?
Our fully equipped onsite lab delivers faster turnaround, tighter chain of custody, and a single point of contact for your entire program
Ready to start your program?
Argonaut Non-Aseptic Fill Finish FAQs
SWIPE FOR MORE