Analytical Services

Characterization Expertise for
Dependable Results

Rigorous analytical capabilities are essential for drug product development, reproducibility, and quality assurance from pre-formulation to commercialization. Whether for formulation development, process development, or quality systems, Tedor’s robust analytical services support product development, process optimization, regulatory filing support, and quality assurance from developmental to clinical to commercial production.

Tedor Analytical Services At-a-Glance

  • Beaker Developmental to clinical 
to commercial analytical capabilities
  • Clipboard Advanced product development, in-process, & quality assurance analytical capabilities
  • Pipeline Full pipeline support for discrete analytical services
  • Analysis Analytical method development, validation, 
& transfer
  • Shield Regulatory filing support
  • Data Integrity Robust data integrity

Analytical Services

At Tedor, you can rely on our comprehensive portfolio of analytical method development, optimization solutions, and testing services to rapidly deliver your product to market. In addition to our extensive service capabilities, we are passionate about our dedication to data integrity, allowing us to comprehensively support your regulatory filings and be confident in your commercial product’s quality.

  • Material characterization
  • Stability-indicating assays
  • Thermal analysis
  • Particle size determination
  • Dissolution studies
  • Solution stability
  • Filter/flush evaluation
  • Limit of detection
  • Limit of quantitation
  • Linearity and range
  • Specificity, including forced degradation analysis
  • Product release testing

Analytical Technologies

Our highly skilled analytical team, state-of-the-art instrumentation, and robust profile of analytical methods support every aspect of the solid dose product lifecycle. High-potency, delayed or modified release, poor solubility, and other complex products that have become increasingly common often require advanced instrumentation and methods. Tedor’s analytical team has decades of experience and can rise to the most demanding challenges.

  • Refractive index
  • IR spectroscopy
  • Chromatography by HPLC
  • Wet chemistry
  • Gas-headspace chromatography
  • Dissolution
  • UV-VIS

Analytical Method Development, Validation & Transfer

Analytical method development and validation of compendial methods can pose significant challenges during the development, process optimization, and manufacturing of traditional and novel solid dose products. Tedor’s analytical experts are well-suited to tackle your method development, optimization, and validation challenges. Additionally, our team employs well-development procedures to manage analytical method transfer smoothly.

  • Stability-indicating methods
  • Impurity identification/quantification methods
  • Residual solvent detection
  • Identification and material potency
  • Discriminating dissolution methods
  • Cleaning methods
  • Particle characterization methods
  • Release testing
  • In-process testing
  • Raw material testing

Your Go-To Solid Dose Manufacturing Partner

Get in touch to learn how we can support your products’ development and manufacture.