Medicilon's Residual Solvent Analysis

Medicilon is a comprehensive CRO in the field of biology and medicine. We commit to provide integrated and efficient service. Our unique “tailored” process development mode also fully embodies this idea.  We can collaborate with the clients to get target compound as soon as possible.

Process Analytical Science

Our process analytical sciences group provides support for research, development, and commercial production. For Details

At Medicilon, the importance of analytical support in pharmaceutical development and manufacturing is well understood. We provide our clients with analytical method development and all other services required to support their regulatory needs.

Services Offered

• Analytical Method Development, Qualification and Validation for

  • Assay

  • Related Compounds

  • Water Content

  • Chiral Analysis

  • Residual Solvents Analysis

  • Trace Metals Analysis

• IPC and Release Testing

• Impurity Isolation and Structure Elucidation

• Reference Standard Qualification

• Stability Studies

• PGI Method Development, Validation and Testing

• Specification and other Regulatory Filing Documentation Preparation

We have the following key instrumentation to support our analytical activities

• Chromatography: UPLC, HPLC, LC-MS, GC, GC-HS

• Solid State Characterization: DSC, TGA, XRPD, PSD, Polarized light microscopy

• Elemental Analysis: ICP-OES

• Identification: NMR, FT-IR

• General Testing: KF, UV-Vis, Polarimeter

Residual solvents are organic volatile impurities arising from the manufacture of drug products. While it is impossible to eliminate all solvents from production processes, manufacturers minimize the use of solvents where possible.

USP Residual Solvents is separated into three classes based on their potential toxicity level. Class 1 residual solvents are known to cause unacceptable toxicities; Class 2 residual solvents are associated with less severe toxicities and Class 3 residual solvents are considered the least toxic.  Authorities class them into three categories:

– Class 1 solvents: Solvents to be avoided—known human carcinogens, strongly suspected human carcinogens, and environmental hazards.
– Class 2 solvents: Solvents to be limited—on-genotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity. Solvents suspected of other significant but reversible toxicities.
– Class 3 solvents: Solvents with low toxic potential—solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDEs of 50 mg or more per day.

USP Residual Solvents methods are radically changing and the procedure now requires a different approach (similar to the current EP methods):

• Preliminary GC Screening

• Confirmatory analysis using dissimilar column chemistry

• Identification of any solvent identified under both analyses above

• Quantitative analysis

Medicilon provides expert and rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

Why Choose Medicilon’s Service?

– Identify and quantify residual solvents in a product.
– Detect residual solvents in packaging.
– We have extensive experience in all classes of solvents, using direct injection GC, Headspace GC and HPLC approaches.
– We offer protocol writing capabilities to support projects.
– The flexibility we offer for systems, customize approaches and deliverables allows us to meet each client’s unique needs.

Contact Us 

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

Tips : Above is part of residual solvent testing and residual solvent analysis. 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.