Analytical testing is essential to ensuring injectable drug products are safe, effective, and consistently manufactured. Our fully equipped onsite analytical laboratories provide comprehensive support throughout your program, including product-specific method transfer, qualification, and validation, compendial method verification, raw material testing, in-process, and final product testing, and stability storage and testing.

We manage all your critical analytical testing needs, with most testing performed in-house.

Raw Material Release Testing

We perform testing on incoming raw materials to ensure they conform with manufacturer specifications before they enter the production floor.

Method Validation & Transfer

We transfer, verify, qualify and validate phase-appropriate analytical methods tailored to your formulation and regulatory requirements.

In-process Testing

We monitor critical quality attributes in real-time during manufacturing to confirm the formulation meets the critical quality attributes and adjust as needed.

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 quantify impurities, including degradation products, to support safety, purity, and regulatory submissions.

Let's discuss your QC needs

Our lab is fully equipped to support your program

Our comprehensive analytical capabilities support product quality, regulatory compliance, and patient safety throughout development and commercial manufacturing. Explore the methods, equipment, and stability storage conditions available in our laboratories.

Compendial Testing

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 Oil Analysis USP <401>
Bioburden USP <61>
Endotoxin USP <85>
Subvisible particulate matter <787>, <788>, <789>
Sterility Testing <71> [outsourced]

Product-Specific Testing

HPLC (RP, IEX, SEC)
CCIT — CO₂ Headspace (Lighthouse)
UV/Vis & Fluorescence concentration
Nucleic acid concentration
FTIR
ELISA
RT-qPCR
DNase & RNase detection
Density
Nitrates (purified water)
cIEF
CE-SDS
Electrophoretic mobility and hydrodynamic size

View laboratory equipment

HPLC/ UHPLC: UHPLC 1290 Infinity II — Agilent

‍CE-SDS/ cIEF

FTIR: Nicolet Summit FTIR — ThermoFisher

‍DLS: Waters Zetastar

‍ELISA: SpectraMax384 Plus Spectrophotometer

‍UV/Vis& Fluorescence / SoloVPE: SpectraMax384 Plus Spectrophotometer — Molecular Devices, Gemini XPS Microplate Spectrofluorometer — Molecular Devices, NanoDropOneC — ThermoFisher –Repligen,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

Endotoxin

‍CCIT: FMS-Carbon Dioxide Headspace Analyzer — Lighthouse Instruments‍

Moisture Content (KF): Metrohm 905 Titrando titrator

Break-loose/ Glide force Instron

Viscosity: Brookfield, DV1 Viscometer

View Stability storage conditions

-80°C

-20°C

5°

25°C / 60% RH (long-term)

40°C / 75% RH (accelerated)

Get comprehensive analytical support for your fill-finish program

Our fully equipped onsite lab delivers faster turnaround, tighter chain of custody, and a single point of contact for your entire program.

Analytical & Quality Control FAQs

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What types of QC testing services does Argonaut offer?

We provide raw material, in-process, release, stability, impurity testing, and container closure integrity testing. Learn more on our QC Services page

Can you handle testing for high-potency or hazardous materials?

We support testing and material handling for compounds up to and including SafeBridge Category 3 (OEL < 1 µg/m³).

Can you support testing for both clinical and commercial products?

Yes. We support in-process, release, and stability testing for clinical and commercial programs.

Can you transfer or validate analytical methods?

Yes. We provide method validation, verification, qualification, and transfer services.

Do you offer analytical testing in-house?

Yes. Our onsite laboratory supports release testing, stability studies, and method transfer activities. Learn more on our QC Services page

Do you perform container closure integrity testing?

Yes. We perform non-destructive CCIT using a Lighthouse CO₂ headspace analyzer.

Do you perform release testing?

Yes. We perform release testing to verify product quality and compliance before distribution.

Do you perform stability studies?

Yes. We design and execute ICH-compliant stability studies. Learn more on our QC Services page

Do you provide detailed QC testing reports?

Yes. Our reports include required data, test results, analysis, and supporting documentation for quality and regulatory needs.

How do you determine pricing for QC services?

Pricing is based on the scope of testing required, the analytical methods involved, sample volume, and the overall complexity of your program.

How do you handle sample storage and retention?

Retention samples (for stability testing, investigations, or future reference) are stored under approved environmental conditions and maintained according to client and regulatory requirements.

What analytical testing services do you offer?

Our laboratory supports raw material testing, in-process testing, release testing, stability studies, impurity profiling, and CCIT.

What kind of support do you offer during audits or regulatory inspections?

We provide full audit support, including document preparation, participation in inspections, and responding to regulatory inquiries.

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Analytical and Quality Control Services

We manage all your critical analytical testing needs, with most testing performed in-house.