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PharmaGMP Testing – GBA Pharma LabsExtractables & Leachables

Extractables & Leachables

GBA Pharma Labs - Extractables and leachables Studies

Our goal is to support manufacturers

Our goal is to support manufacturers of pharmaceutics to select the best primary packaging material for their products.

Primary packaging materials for products such as injectables, inhalers, and generally liquid and topical preparations are made of different materials. Extractables and Leachables (E&L) studies allow to analyse the impact of primary packaging material on the product and determine criteria for a selection and processing, which ultimately serve one purpose: to provide maximum patient protection.

Unfortunately, binding regulatory requirements on how to perform E&L studies are still missing and affected producers are often uncertain about the necessary efforts, costs and testing procedures.

In the field of E&L we have the experience, the know-how and the necessary equipment to offer you a comprehensive guidance when selecting the primary package material or planning E&L offer studies.

GBA Pharma Labs - Extractables and leachables packaging materials

Our Services in Detail

  • Review and Optimization of the Packaging System
  • Analysis of the Production Process
  • Risk Assessment of Product Quality
  • Optimizing of the Manufacturing and Packaging Process
  • Characterizing and Selecting Suitable Packaging Materials for Maximum Product Protection
  • Examining Possible Interactions between Packaging Components and Product
  • Conducting Extraction Studies and Analysis with Coupled Techniques such as GC/MS and Headspace-GC/MS, LC-MS, ICP-MS

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs - GMP Testing

GBA Pharma Labs – GMP Testing

GBA Pharma Labs - GMP Quality Control

GMP Quality Control

GBA Pharma Labs - Method Development & Validation

Method Development & Validation

GBA Pharma Labs - Stability Studies

Stability Studies

GBA Pharma Labs - Dissolution


GBA Pharma Labs - Extractables & Leachables

Extractables & Leachables

GBA Pharma Labs - Packaging Material Testing

Packaging Material Testing

GBA Pharma Labs - Particle Determination

Particle Determination

GBA Pharma Labs - Elemental Impurities Testing

Elemental Impurities Testing

GBA Pharma Labs - Microbiology


GBA Pharma Labs - Regulatory Services

Regulatory Services

GBA Pharma Labs - Amino Acid Analysis

Amino Acid Analysis

GBA Pharma Labs - Instrumentation


GBA Pharma Labs - N-nitrosamines


GBA Pharma Labs - qPCR


GBA Pharma Labs - iCEF


GBA Pharma Labs - Protein characterization

Protein Characterization

GBA Pharma Labs - Limit test for DEG and EG by GC

Limit test for DEG and EG by GC

GMP Testing

Contact us!

To learn more about us and what we can do for you please contact us.

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