Residual Solvent Analysis

Residual Solvent Analysis

Organic volatile impurities (OVIs), generally represent the chemical compounds in products, and are mainly produced by incomplete removal of the residual solvent during the manufacturing of active pharmaceutical ingredients (APIs), excipients and drug products. Recognizing the fact that these OVIs have an obvious adverse effect on the quality, safety, stability, potency and other performance of the finish products or intermediates, complete or partial removal of a solvent or solvents is therefore a pivotal stage in many pharmaceutical processes. However, toxic solvents and correspondingly acceptable limits can vary in different pharmacopoeias. According to the ICH Q3C Guideline for Residual Solvents, the residual solvents can be defined into three classes based on their potential toxicity level:

 Residual Solvent Analysis

Class Ⅰ: Residual solvents that are able to cause unacceptable toxicities such as human carcinogens, and environmental hazards

Class Ⅱ: Residual solvents with medium severe toxicities such as on-genotoxic animal carcinogens and certain causative agents that can lead to neurotoxicity or teratogenicity

Class Ⅲ: Residual solvents with the least toxic, are required with no health-based exposure limit

Below is a list of OVIs testing services (include but not limit following):

  • Pharmacopoeial Analysis
  • Drug Product Release Testing
  • Raw Materials Analysis
  • Method Development & Validation
  • Residual Solvent Analysis
  • Cleaning Validations
  • Comparative Studies
  • Dissolution Testing
  • Metals Analysis
  • Stability Testing and Storage
  • Investigative Analysis
  • Physical Characterization Techniques
  • Medical Device Support
  • Water Testing
  • Analytical Technologies

Our Advantages

  • Well trained professionals experienced in pesticide residue chemistry.
  • Extensive experience with numerous compound classes and matrix types.
  • Federally inspected and licensed as cGMP compliant testing facility.
  • Meet OECD and FDA guidelines.
  • Multiple assay testing options.
  • Precise qualitative and quantitative analysis for both liquid and solid matrices.

We provide full solvent residue testing services for a wide range of companies covering dietary supplements, cosmetics, pet foods, and the bio/pharmaceutical products. Our experts have extensive experience in dealing with various complex challenges and our Residual Solvent laboratories have established the highest industry standards.

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