Chemistry Services

COMMITTED TO QUALITY

Our laboratory is equipped with high-technology instruments and equipment that allow us to deliver high accuracy and precision in our test results, including HPLC and UPLC equipped with UV-VIS, PDA, QDA, CAD, fluorescence detectors as well as GC-MS, ICP-OES, and TOC capabilities.

Our wide range of equipment and testing options allows us to provide our customers with testing that is most suitable to their needs.

In addition to release testing, Eagle offers stability studies in accordance with ICH guidelines to ensure that drug products retain their physicochemical quality at their intended storage conditions throughout their intended shelf life. Stability studies are required to not only to comply with the expiration dating of a drug product per CGMP requirements but also to extend the default beyond-use date (BUD) in accordance with USP <795> and USP <797>.

Analytical Testing

Routine Release Testing
- Assay/Potency (API/Preservative)
- Appearance
- USP <791> pH
Raw Material Testing
- Assay
- Impurities
- Monograph Testing (USP/NF/EP/JP/BP)
Identification Tests
USP <3> Topical and Transdermal
USP <233> Elemental Impurities
USP <281> Residue on Ignition
USP <643> Total Organic Carbon
USP <645> Water Conductivity
USP <731> Loss on Drying (LOD)
USP <741> Melting Range or Temperature
USP <781> Optical Rotation
USP <785> Osmolality & Osmolarity
UPS <841>Specific Gravity
USP <905> Uniformity of Dosage Units
USP <911> Viscosity-Capillary Methods
USP <912> Viscosity-Rotational Methods
USP <921> Water Determination
USP <1730> Plasma Spectrochemistry (ICP-OES)
Density
Environmental Wipe Sampling (SurfaceShield)

An image of Eagle's chemistry laboratory with various lab equipment.

Research and Development Services

Stability Indicating Method Development and Validation Services

OUR LABORATORIES

Eagle’s cutting-edge 35,000-square-foot facility and laboratory are equipped with advanced technologies and specialized segregated laboratory spaces to meet the diverse needs of our clients. This behind-the-scenes video provides you with an opportunity to witness testing while touring our laboratory.

RELATED SERVICES

Microbiological Department

Laboratory Testing and Services Pricing

Chemistry Team

Our Chemistry Team is composed of knowledgeable and capable professionals in Chemistry, who always aim to high-quality results, accuracy, and customer satisfaction as our main goals.