Pharmaceutical Analytical Testing

Our many years of experience in pharmaceutical analytical testing have enabled us to develop effective and phase-appropriate analytical development and control strategies with well-established robust platform methods and late phase readiness built into early-stage development programs.

Our fully integrated analytical solutions across the product lifecycle reduce risk, accelerate timelines and ensure that your data will be compliant with current regulatory guidance.

CAPABILITIES

Analytical CMC Solutions for Drug Substance & Drug Product

Having a comprehensive understanding of drug substance development and drug product characterization and control is critical. Our method expertise and product understanding drive a faster pharmaceutical development and control strategy.

drug substance ready for pharmaceutical analytical testing

Drug Substance

CMC testing of a drug substance primarily centers on the small molecule API, which is the key chemical compound responsible for the therapeutic effect. Identifying the physiochemical properties and particle characterization is critical.

Understanding the impurity profile including elemental impurities, organic impurities (intermediates, PRIs and residual solvents), enantiomeric impurities and microbial limits is an essential element of the CMC package.

drug product ready for pharmaceutical analytical testing

Drug Product

CMC analysis of a drug product extends beyond the API to encompass the entire formulation, including excipients, additives, and other components. Among the different dosage forms (oral solids & liquids, OINDPs, topicals & parenterals) it is important to have control over the uniformity of the dosage units.

Impurity profiling must take into consideration not just the API but degradation products, process related impurities and genotoxic impurities, such as nitrosamines in the final drug product.

Comprehensive Pharmaceutical Analysis

Characterization, comparability studies, method development and validation, release testing, and stability testing are closely related and interdependent activities that collectively ensure the quality, safety, and efficacy of the final product.

Characterization is the cornerstone of an effective CMC program. Ensuring robust characterization of your molecule will reduce the risk of finding unexpected issues and enable seamless comparability testing. Our expert scientists can help distinguish between normal variability and changes that can affect efficacy and safety.

We offer a broad toolkit of analytical platform methods, making the process faster and reducing the time and expense of extensive optimization. You will also receive complete method protocols. Our method selection and development is based on PQTTP and QBD principles with phase appropriate validations, strategy and execution.

Release testing is required for all clinical and commercial batches. Well established CQAs and validated methods are important for both drug substance and drug product release testing.

Jumpstart your stability studies and take advantage of our capacity. We offer a comprehensive storage and testing portfolio with experience in real-time and accelerated studies. Just bring your molecules.

Equipment & Capabilities

Solvias uses leading edge equipment and assays to ensure complete characterization and analysis of your drug substance or product. Our scientific team is on the forefront of learning and incorporating new technology and methods.

Separation Science

  • LC (HPLC, UPLC, FPLC)
    Modes: RP, NP, IC, IEX, SEC/GPC, HIC
    Detectors: UV, DAD, FLD, MALS, RI, QELS, ELSD, ECD, MS, MS/MS
  • AF4, AUC
  • GC & Headspace GC (FID, TCD, MSD)
  • CE (UV, FLD) Modes: CZE, CE-SDS, cIEF
  • Gel Electrophoresis, Western Blot
  • TLC

Physical & Material Science

  • X-ray Powder Diffraction (XRPD)
  • Microscopy Imaging: SEM, TEM, Light, IR, Raman
  • Particle Sizing: Laser Diffraction, Microscopy
  • Rheology, Viscosity
  • Thermal Methods: TG, DSC, TAM, Dynamic Vapor Sorption
  • Dissolution
  • Spectroscopy (IR/UV-VIS/RAMAN)

Elemental Analysis

  • XRF
  • ICP-OES
  • ICP-MS
  • AAS (FAAS, ETAAS, CVAAS, HGAAS)
  • SEM with EDX
  • Karl-Fischer Titration
  • Classical elemental analysis (e.g., Combustion, TOC, TNb, Kjeldahl)

Biological Analysis

  • Microbiology
  • Cellular Biology
  • Virology
  • Molecular Biology
  • Toxicology

Contact Us

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