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Residual Solvents

We offer:

 

In an industry where precision and reliability are at utmost importance, we provide customized solutions that guarantee the safety and compliance of your products with the international standards. Our comprehensive analytical services assist you in meeting regulatory requirements, improving the efficiency of your documentation, and ensuring the safety of your end products.

At CURRENTA, we provide reliable services in the areas of pharmaceutical research, approval, production, and quality control. For the analysis of residual solvents we can apply our in-house methods  as well as the methods described in the

 

 

How can we support you?

 

  • Quantitative and qualitative analysis: Comprehensive analysis of more than 45 residual solvents.
  • Method validation and verification: Available upon request to ensure accuracy and reliability.
  • Flexibly expandable screening method: Customizable to ensure your products comply with regulatory requirements and quality standards.
  • Individual method creation: Tailor-made methods and individual text modules for your submission documents.
  • Product safety insights: Gain valuable information about the safety of your products.
  • Audited laboratories: Our laboratories are certified according to Good Manufacturing Practice (GMP) guidelines and registered with the FDA

 

 

This means that our efficient and flexible analyses under GMP- as well as non-GMP conditions allow us to react quickly and flexibly to different requirements and sample types.

 

For you, this means that our measurements on your products comply with the set limits of ICH Q3C specifications. We can also assist you on individual requirements. Our analyses provide you with valuable insights into the safety of your products – raw materials, active ingredients, intermediates or formulations. This helps you to identify potential risks at an early stage and ensure the safety of your end products.

Challenge us and benefit from the efficiency and expertise of our specialized laboratory.

Focus on your advantages:

 

Our techniques: Gas chromatography (Headspace and direct injection) with FID and MS detection

Sample matrices: All pharmaceutical products, e.g. raw materials, active ingredients, intermediates and finished products

Within the framework of the analysis using the in-house method, there are no restrictions with regard to the number of samples. Furthermore, the measurement of the samples can be carried out independently of the product.

 

Feel free to contact us!

 

Contact

Sandra Tulke
Sandra Tulke

Schneller Kontakt zur Analytik

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