Pharmaceutical development is a broad term used to describe the process of how a new or generic pharmaceutical product is approved for human or animal use. This is typically a long process with many regulatory stages. Pharmaceutical development requires a variety of chemical and biochemical tests to be performed, with all showing the new product is both safe and efficacious for its intended use.
Pharmaceutical Testing (Analytical) at EKG Labs
The team at EKG Labs has years of experience providing analytical services to support pharmaceutical product development for a variety of therapeutic indications involving diverse chemistries. Our services help companies fully understand the chemical profile of their API, drug substance, or drug product as well any associated excipients, impurities, and degradants. EKG Labs provides services that help companies answer questions like:
- What are these impurities and/or degradants in my product and are they a concern?
- What is the extractable and leachable profile of my product and its container closure system?
- How can I develop a stability-indicating method for my drug product?
- What type of methods do I need to support QC activities?
- How do I validate an analytical method and when do I need to do it?
Our pharmaceutical testing services include:
- Extractables and Leachables
- USP 661, USP 661.1, USP 661.2, and USP 665 testing
- Chemical Characterization
- Impurity Identification, including USP 476
- Elemental Impurities
- Method Development
- Method Validation
EKG Labs Pharmaceutical Testing Therapeutic Expertise:
EKG Labs Pharmaceutical Testing Dosage Form Expertise:
- Solid Oral
- Oral Suspensions