Program Capabilities

The SJNL is specialized in pharmaceutical drug analysis and is accredited under ISO/IEC 17025. The laboratory has experience in the analysis of a wide variety of drug products such as tablets, capsules, creams, suspensions, ophthalmic solutions, metered-dose inhalers (MDIs), dry-power inhalers (DPIs), nasal sprays, transdermal patches, and active pharmaceutical ingredients (API). The laboratory analyzes a variety of compliance and consumer complaint samples. SJNL participates in the Shelf-Life Extension Program (SLEP) and a Collaborative Research and Development Agreement with the US Pharmacopeia (CRADA). The target of the CRADA is the modernization of testing monographs through method development using improved technologies, the validation of new methods presented by the USP, and the recertification of USP reference materials.

Specialized Capabilities

SNJL staff routinely use technologies such as FTIR (including ATR-FTIR); UV/VIS spectroscopy; gas chromatography; liquid chromatography/mass spectrometry; gas chromatography/mass spectrometry; and various titrations including Karl Fisher Water Determination and Potentiometric Titrations. Other analytical equipment includes pH meters, conductivity meters, density meters, melting point apparatus, and analytical balances. The drug analysis performed in San Juan is heavily focused on high-performance liquid chromatography (HPLC). This is the largest concentration of major instrumentation in the laboratory. Nineteen HPLCs are in use with a variety of detectors, including, UV, photo diode array, refractive index, conductivity, mass, and fluorescence detectors. The laboratory also has capabilities for ion chromatography and polarimetry. Additional specialized equipment available in San Juan includes dissolution for the analysis of a variety of dosage forms including transdermal patches and Anderson Cascade Impactors, to determine dose uniformity (content of active ingredient in the discharged spray) for metered-dose inhalers (MDIs), and dry-powder inhalers (DPIs).