cGMP Pharmaceutical Analysis Services
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Method Feasibility, Development & Validation
Developing, transferring and validating analytical methods are essential for the successful completion of accurate pharmaceutical analysis. Our method-engineering process is designed to maximize communication and efficiency, thereby facilitating a thorough, well-designed approach. Application of this process is performed by a highly skilled technical staff dedicated and trained in the use of state-of-the-art equipment.
Stability & Release Testing
Timely and accurate evaluation of identity, strength, quality, purity and potency are key to successfully managing stability and release programs. Starting with evaluation and characterization of active pharmaceutical ingredients and excipients, through stability and release of commercial drug products, Covance provides individual programs or fully integrated global launches.
Covance scientists can design, initiate and conduct all aspects of your stability and batch release studies across virtually all dosage forms and delivery technologies. Our complete preclinical and clinical capabilities provide you with a wider selection of study types and rapid study starts, and allows us flexibility to meet your schedule.
We understand the need for rapid turnaround when the release of a product into the market is in the balance. Our specialized instrumentation and expertise keep your projects moving forward. We:
- Provide assays that determine the presence of degradants and impurities, identity, chemical structure of the API and quantification levels
- Analyze the physical-chemical properties of the substance to verify the identity of the drug product, API and excipients
- Evaluate the organoleptic properties including appearance, hardness and moisture
- Monitor the potency, availability and microbial quality
In addition, our specialized and ICH-qualified environmental chambers constantly monitor activities via a validated computer system. These chambers enable researchers to evaluate product stability based on real-time, accelerated and long-term protocols by controlling temperature and relative humidity. We also employ specialized equipment required for the ICH Option 2 photostability evaluation.
Extractables & Leachables
Toxic and carcinogenic compounds extracted from various matrices are routinely monitored to ensure they are eliminated or maintained at levels below safety limits. These components have been manufactured from materials such as nylon, plastics, and synthetic and natural rubber, and include packaging and closure systems for consumer products, inhalation and non-inhaled drug products and foods.
Covance has been a leader in the testing of extractables and leachables — from developing the first AOAC method for testing the unique N-nitrosamines in the early 1970s, to 15 years of experience with new inorganic and organic compounds today.
Our range of experience includes the following materials and matrices:
Materials
- N-nitrosamines
- Irganox
- Nylon monomer, dimer and trimer
- Oxolanes
- BADGE
- Propanol derivatives
- THF
- Oxanes
- Glycidethers
- Biophenols
- Residual solvents
- Metals
- Polyaromatic hydrocarbons
Matrices
- Adhesives
- Dyes
- Elastomeric compounds
- Polymers
- Consumer products
- IV solutions
- Liquid formulations
- Lacquer
- Valves/seals
- Biotech products
Inhalation Products
The unique characteristics of inhaled products must be considered during development with respect to formulation, stability, manufacturing, container and closure system and quality control. The diversity of testing needed for MDIs, DPIs and nasal inhalation devices requires a broad range of expertise and methodologies. Covance has established a center of excellence for inhalation products at our laboratory in Harrogate, UK, where we have tested more than 1 million samples in hundreds of different studies since 1990. Covance can perform the complete testing suite recommended to meet regulatory and scientific standards.
Delivery systems
- Metered dose inhalers
- Dry powder inhalers
- Aqueous mist inhalers
- Nebulizers
- Aerosols
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