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Impurities Analysis in Pharmaceuticals

2016-10-27
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Chemical Synthesis Services

As a leading provider of Chemical Synthesis Services, we provide reference compounds, intermediates, drug candidates, impurities, metabolites, and other small molecule chemicals from milligram to kilogram level (including GMP quality).

  • From milligram to kilogram level high quality product preparation

  • Special reagent, intermediate and template preparation

  • API or related material preparation

  • Impurity and metabolite study

  • Analytical Support

  • Related reports

Medicilon is a comprehensive CRO in the field of biology and medicine. We commit to provide customers with fast and efficient service. Our unique “customized” process development model is also fully embodies this idea.  We can collaborate with the clients to get the API as soon as possible in order to begin the clinical study.

The Chemistry Synthesis Service comes with weekly updates, final reports and ordered amounts of the compound under strict confidentiality. Final reports contain sufficient information for you to readily repeat the chemistry in house if needed.

Impurity synthesis and analysis is a very important step during the development of new drugs and pesticide. Pharmaceutical and pesticide impurities are chemicals, other than the main active ingredients, generated during the production, storage and other processes. The presence of the impurities affects the pharmaceutical, pesticide safety and the stability. So the drug production, storage and other processes must be strictly controlled to avoid the formation of impurities. The impurity is an important indicator of the quality control of drugs. Qualitative and quantitative analysis of impurities are always required in medicine, pesticide reporting, new product developments and quality control.

Impurities Analysis in Pharmaceuticals

Depending on the product application, the presence of an unknown component or impurity at even trace levels can cause irreparable damage to a product, rendering it unusable. Unknown components and impurities can appear from several sources and, once present, can be extremely difficult to remove.We have proven methodologies for specific material types that allow us to efficiently isolate and identify the material, followed by determining its source.

Unknown and impure materials can come from numerous sources, including:

Process Contaminants
API and/or Non-Active Component Degradation
Oxidated Polymer Additives
Un-reacted Monomers / Oligomers
Extractables / Leachables

Impurities in products often represent minor components, and the ability to detect these in the presence of significant product is a challenge. Once detected, the need to assign a structure to the impurity or degradantis the next challenge.  Both of these challenges are aided by Orbitrap™ technology. The high sensitivity and wide dynamic range of the Thermo Scientific Orbitrap Elite MS means that even minor components can be detected and valuable data gathered, while MSn fragmentation aids in structure determination.

Contact Us 

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips : Above is part of Impurities Analysis in Pharmaceuticals and impurity test. You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.


Related Articles:

Medicilon Drug Impurity Analysis Service

Impurity Identification Services



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