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
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Developmental to clinical
to commercial analytical capabilities
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Advanced product development, in-process, & quality assurance analytical capabilities
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Full pipeline support for discrete analytical services
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Analytical method development, validation,
& transfer
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Regulatory filing support
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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
