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Simple Qualification Support

The Msynth®plus line makes qualification as simple as possible. Specially developed for organic synthesis in quality-conscious or regulated industries, such as pharma, electronics or cosmetics, Msynth®plus products are accompanied by the necessary quality documentation to help you easily fulfill regulatory requirements. The portfolio is qualified for use in both GMP and non-GMP synthesis, and is optimized for research, process development and production. Comprising basic organic and inorganic chemicals, the portfolio includes building blocks, reagents, solvents, process chemicals and additives.

Msynth®plus products are manufactured in compliance with ISO 9001 guidelines, but not according to GMP requirements. Each batch is subjected to extensive in-house testing, which is described in the Qualification Dossier included with every product. Furthermore, traceability is secured through change control agreements with our suppliers. This enables us to offer our customers comprehensive change control agreements. With Msynth®plus products, you have more transparency and more safety for your manufacturing process.

Qualification Dossiers Ensures Safety Through Transparency

A detailed Qualification Dossier comes standard with every Msynth®plus product. Inside you will find comprehensive information about product quality as well as essential regulatory support documents. This not only enables you to easily monitor quality yourself, but also saves time and costs in qualifying Msynth®plus products in-house and in producing your own documentation for regulatory agencies. All the documents are also available 24 hours a day through our secure, validated IT systems. The Qualification Dossier provides you with complete transparency to ensure product safety.

Each Qualification Dossier Includes
  • Specification
  • Safety Data Sheet
  • Testing procedure
  • Continent of origin
  • Content of residual catalysts and metal reagents
  • Content of residual solvents
  • Principle of synthesis
  • BSE/TSE Certificate
  • RoHS Certificate

Our Change Control Agreement Prevents Surprises

Change control agreements between our suppliers and us ensure the traceability of our Msynth®plus products. We are notified of all essential product and process changes. This is the basis for change control agreements that we are offering to sign with you. This extensive qualification process provides you with added transparency and security for your synthesis processes.

Our offering of signing change control agreements with you comprises information on any change in the following:

  • Specification
  • Plant or manufacturing site
  • Batch definition
  • Synthetic route and starting materials used
  • Product specific certificates (e.g. residual solvents, TSE/BSE)

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Tailor-Made Chemicals for Organic Synthesis

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