Compounds that are released from a package or delivery system in the presence of a solvent under exaggerated storage conditions. The results of the extractables study can be used to inform the design of subsequent leachables and stability studies.
Compounds that are present in a packaged drug product released from the package or delivery system under normal storage conditions. Compounds found in leachables studies need to be assessed for their impact on quality, efficacy, and stability of the product.
E&L Studies are not One-Size-Fits-All
Standard, off-the-shelf, E&L packages are not product specific and may not meet regulatory requirements. A well-designed E&L program will reduce the risk of delays in the approval process, additional data requests, deferrals and rejections.
We combine our skills in structural elucidation, regulatory knowledge and our extensive, proprietary database to identify all unknowns with over 99% success. Our high-resolution capabilities allow us to obtain more information from each sample and identify compounds at very low LOQ (limit of quantitation).
Work closely with our experts to design a custom E&L program tailored to your drug product's unique characteristics, administration routes, and closure systems, all within the framework of current regulatory requirements.
With over 100 combined years of hands-on scientific and regulatory experience, our experts can confidently adapt to different modalities while anticipating challenges and ensuring timely results.
Promote Safer Drug Products With Solvias’ Extensive GMP-Compliant E&L Services
Solvias offers a broad panel of services operating under strict guidelines to cover your regulatory requirements so you can bring safer products to patients.
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OINDP are the highest risk drug products in relation to the potential introduction and impact of impurities via container closure contact.
We provide expert support across the entire OINDP development cycle on a wide range of products, such as:
- pressurized Metered Dose Inhalers (pMDI)
- Nasal sprays
- Dry Powder Inhalers (DPI)
- Soft Mist Inhalers (SMI)
Parenteral preparations are administered directly into the body through injection, infusion or implantation and rely on the quality of their container closure systems. Regulatory authorities pay increased attention to parenteral products because the formulation is injected or infused directly into the blood stream. Large volume parenterals have a greater surface area and a greater opportunity to leach compounds into the product. The large volume being injected or infused into the patient will result in a high daily administered dose and will require low analytical evaluation thresholds (AET) that can be challenging to detect.
Solvias has invested in the latest LC/GC-MS and High-Resolution Accurate Mass technology to allow highly sensitive identification and quantification of E&L to ensure successful regulatory outcomes.
Drugs delivered orally can be formulated as pills, liquid, aerosols, or powders. Although drugs delivered by the oral route are in the lower risk categories, all packaging has the potential to introduce leachables and requires comprehensive risk assessment. Orally delivered drugs may have a longer shelf life and patients may store them for an extended period. E&L studies must assess the potential for leachables to accumulate over time under various storage conditions. Detecting and quantifying leachables in orally delivered drugs can be challenging due to the complexity of the drug matrix.
Solvias’ scientists are skilled in structural evaluation of unknown compounds, enabling in-depth understanding of the extractables & leachables profile.
Topical and transdermal products are mostly complex, non-aqueous formulations designed to penetrate the skin, leading to unique analytical challenges. Topical and transdermal drugs are often formulated in the liquid phase and thus have a high potential for leaching compounds from the packaging into the dosage form. The variety of materials and dosage forms used in topical and transdermal products can introduce leachables that can interact with drug formulation and affect stability, potentially leading to adulteration, degradation, or reduced efficacy of the product.
Our scientists have a proven history of expertly designed transdermal drug delivery E&L studies.
Single-use systems (SUS) reduce cross contamination risks from classical stainless steel and glass equipment but can introduce leachables into the drug product. Single use systems such as films and bags, tubing, connectors, and filters may contain compounds that could leach into the drug product during processing. Both USP and BPOG guidance emphasizes the importance of conducting risk assessments and taking a systematic and science-based approach to evaluating single-use systems.
Solvias has a long track record of successful material qualification studies for disposable component manufacturers and pharmaceutical companies.
Equipment & Infrastructure
- GC/MS & GC/MS/MS
- Headspace GC/NPD & GC/FID & GC/MS
- UPLC/DAD/MS & UPLC/MS/MS
- UPLC-HRAM (Orbitrap/Q-TOF)
- GC-HRAM & Headspace GC-HRAM (Orbitrap)
- Full stability storage
- Total Organic Carbon (TOC)
- Microwave extraction oven
- Reflux Apparatus
- Soxhlet Apparatus
- Orbital Rotation Incubators
- High Speed Mill
- Hydraulic Press
Ready to Take Your Extractables and Leachables Testing to the Next Level?
Develop your unique risk-based study design with one of our experts and fast-track your drug product to commercialization.