Services
Analytical and Quality Control Services
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>
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.