Qualification of Impurities 1200×500

QUALIFICATION-OF-IMPURITIES-AS-A-SERVICE

We perform the assessments required for your product with respect to impurities – regardless of their origin.


There are different categories of impurities that can occur in a pharmaceutical product, all with the potential to affect its safety and efficacy. We perform the assessments required for your product, determine necessary limit values, and support you with implementing the subsequent measures.

PDE

In shared facilities it’s essential to know how many residues of a certain substance could technically remain in the used equipment without causing any harm. We determine the Permitted Daily Exposure Limit for any substance and provide you with the according PDE report.

Learn more

E&L

Materials used in pharmaceutical packaging or in the manufacturing process can pose health risks if they migrate to the finished pharmaceutical product. We assess the risks of materials and determine which ones are compatible with your product.

Learn more

Elemental Impurities

Traces of metal in a pharmaceutical product can endanger the safety of patients. To limit the risk of these potentially toxic elemental impurities, we provide you with the required risk assessment and help you to establish risk control strategies.

Learn more

Toxicological Evaluation of Organic Imprurities

Unwanted substances without any therapeutic effect can endanger the safety and efficacy of your pharmaceutical product. We perform toxicological evaluations to ensure the safety of your product – and to avoid expensive recalls.

Learn more

Cleaning Validation

Properly cleaning the equipment used in manufacture is essential, especially when multiple pharmaceutical products are manufactured in shared facilities. We help you to establish reliable cleaning procedures – and prevent your product from being contaminated.

Learn more

For more information

please contact our Senior Toxicologist Dr. Heidi Becker.

QUALIFICATION-OF-IMPURITIES-AS-A-SERVICE

We perform the assessments required for your product with respect to impurities – regardless of their origin.


There are different categories of impurities that can occur in a pharmaceutical product, all with the potential to affect its safety and efficacy. We perform the assessments required for your product, determine necessary limit values, and support you with implementing the subsequent measures.

PDE

In shared facilities it’s essential to know how many residues of a certain substance could technically remain in the used equipment without causing any harm. We determine the Permitted Daily Exposure Limit for any substance and provide you with the according PDE report.

Learn more

E&L

Materials used in pharmaceutical packaging or in the manufacturing process can pose health risks if they migrate to the finished pharmaceutical product. We assess the risks of materials and determine which ones are compatible with your product.

Learn more

Elemental Impurities

Traces of metal in a pharmaceutical product can endanger the safety of patients. To limit the risk of these potentially toxic elemental impurities, we provide you with the required risk assessment and help you to establish risk control strategies.

Learn more

Toxicological Evaluation of Organic Imprurities

Unwanted substances without any therapeutic effect can endanger the safety and efficacy of your pharmaceutical product. We perform toxicological evaluations to ensure the safety of your product – and to avoid expensive recalls.

Learn more

Cleaning Validation

Properly cleaning the equipment used in manufacture is essential, especially when multiple pharmaceutical products are manufactured in shared facilities. We help you to establish reliable cleaning procedures – and prevent your product from being contaminated.

Learn more

For more information

please contact our Senior Toxicologist Dr. Heidi Becker.


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THE FORCE is an active member of the EUROTOX Corporate Program.
 
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