Analytical Testing Services

Extractable and Leachable testing is to identify packaging related impurities in components, raw material drug products and equipment. These tests are important for both regulatory compliance and patient safety.

The presence of particles and their analysis can affect the safety and quality of parenteral drugs as particles can be potentially harmful to patients.  Managing contaminant issues during the manufacturing process can reduce the risk of future contamination and potentially avoid costly product recalls.

Visual inspection during the manufacturing process of drug products is important to ensure both patient safety and cost effective supply. This is especially true for parenteral & ophthalmic medications.

This nondestructive procedure evaluates the ability of the container closure system to maintain a suitable barrier against potential contaminants (e.g. microorganisms, oxygen, etc…). This evaluation is important for patients’ safety and/or drug product stability.

Glass delamination testing is necessary to analyze the durability of glass containers and their interactions with specific drug products.

In the development of pMDIs and nasal sprays, particle/droplet size and spray pattern or plume are two of the most significant factors that affect the deposition of the sprays in the mouth and nose cavities.

Aerosol characterization tests for inhaled products are important to determine the dose emitted, particle size, purity of the API as well as various stresses on the device such as mechanical shock, vibration, and light exposure.

Drug dissolution testing is used to provide in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.

Several tests are used during the design and development of drug delivery devices to test their ‘fitness for intended use’. One such test is the actuation force.

These tests help quantify the deposition of a nasally administered drug in the various regions of the nasal cavity.

Bioequivalence testing is used to compare the performance of two different versions of a particular drug product (e.g. generic vs. originator). This testing can be performed in vitro or in vivo. The use of clinically relevant in vitro testing brings opportunities to de-risk complex and expensive clinical studies.

We provide official certificates for each batch to attest that the product supplied meets all relevant specifications. This certificate typically details product specifications, the analytical methods used and the analytical results obtained.