Analytical Testing

Singota Solutions provides specialized cGMP analytical development and testing services for parenteral products. We deliver precise, reliable data that helps teams get therapies to patients faster while supporting batch release, stability, and regulatory readiness.

GMP Analytical & Compendial Services

Our GMP analytical laboratory is responsible for performing
incoming, in‑process, and release testing, including but not limited
to: USP Compendial testing, custom product‑specific methods, and comprehensive in-house microbial and sterility testing. We also support specification design, CoA generation, ICH stability studies, container closure integrity, forced degradation, transportation testing, and full method development, transfer, and validation.

Regulatory Compliance

At Singota, our modern approach to Data Integrity ensures that the data we generate for your program is complete and integral. All data is securely managed in our 21 CFR Part 11–compliant ELN with integrated LIMS functionality, ensuring reliable documentation and regulatory compliance across development and quality control. Singota serves as a trusted partner, committed to efficiency, quality, and
excellence throughout the drug development process.

Technologies & Capabilities

CO2 Analysis for Container Closure Integrity Testing (CCIT)
Full USP/EP Compendial Testing
Premier Testing Laboratory for Captisol® (Cyclodextrins)
HPLC & Detectors: RI, ELSD, CAD, FLD
Mass Spectrometry & Gas Chromatography

ICH Stability Conditions Offered

Quality Control Testing

Singota’s QC Release Testing provides integrated chemistry and microbiology services for clinical and commercial programs. Our chemistry team performs product analysis in accordance with defined material specifications and critical quality attributes, while our microbiology team conducts bioburden, endotoxin, sterility, and microbial challenge testing to support phase-appropriate release and quality assessment.

Chemistry Capabilities Include:

pH-Based Solubility & Stability Profiling
Hydrophobicity Assessment
Forced-Degradation & Compatibility Studies
Excipient Screening for Optimal Formulation Performance

Microbiology Capabilities Include:

Bioburden Testing for Microbial Contamination Control
Bacterial Endotoxin Testing (BET / LAL)
In-House USP Sterility Testing
Microbial Challenge Studies for Lyophilized, Reconstituted, & Multi-Dose Systems

Learn More About Our Analytical Testing Expertise

Discover how Singota’s expertise drives successful, compliant, and efficient drug development programs.

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