Extracted Elements in Solution

Proactive USP <1660> Services

The ‘extracted elements in solution’ test evaluates the level of conductivity/pH or the concentration of extracted elements in solution that can be attributed to the glass container. Conductivity/pH meters are used to measure conductivity and pH. In contrast, inductively-coupled plasma-mass spectrometry (ICP-MS) or inductively-coupled plasma-optical emission spectrometry (ICP-OES) are used to measure SiO2 concentration. 


The results of this test provide insights into the level or concentration of extracted elements contributed by the glass container’s inner surface. An increase in conductivity/pH or SiO2 concentration indicates that the inner glass surface may be releasing glass-related elements into the solution, which is a sign of breakdown or degradation of the inner surface. 

Gateway Analytical - Analysis Solutions

A Clearer View of Glass Safety

With our cutting-edge ‘Extracted Elements in Solution’ test, part of the comprehensive USP 1660 services suite, we meticulously analyze your drug containers for any signs of glass delamination

Secure Gateway Solutions: Expert
Glass Delamination

Our sophisticated methods, including ICP-MS and ICP-OES, offer an unparalleled look into the integrity of your glass containers, ensuring every product is safe and reliable before it reaches the patient.<br><br>Companies that fail to collect baseline elemental data from unaged samples of solution filled into the container may lose the ability to detect a future glass delamination event before it occurs. If you have any questions or concerns about glass delamination screening, please feel free to get in touch with Gateway Analytical today.

Gateway Analytical - Analysis Solutions

Early-Phase Development

Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.

Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

Particulate
Analysis

Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

Medical Device
Analysis

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.

Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.