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Extractable Leachable analysis

Extractable and Leachable Analysis of Products and Materials

What are Extractables and Leachables:
Extractables and leachables are chemical compounds that leach out of a product or material during service or storage conditions. These leachables could be hazardous if present in excessive limits. An example could be leaching of chemical species from storage container or packaging material in to food products or medicines or medically implanted devices. Hence, in order to determine the safety of a product or material in direct contact with food or drugs/pharmaceutical products, it becomes imperative to perform extractable and leachable analysis.
Extractables and leachables studies give qualitative and quantitative analysis of the material/product under examination. These studies can help build a comprehensive database of all the extractables and leachables that can potentially affect the performance/safety of a product/drug/pharmaceutical product.

Extractables and Leachables Analysis Process:
A range of chemical extraction solvents such as methylene chloride, chloroform, methanol, water or combinations are used in order to perform the extractable and leachable analysis. This process uses an extraction apparatus that does a rigorous chemical extraction on the product and is operated continuously from 4 hours to 24 hours per sample based on the nature of sample and the applicable ASTM or MIL standards. The final leachable products get collected in the apparatus. These extracts can be further analyzed (chemical analysis of these extracted species) with a wide range of analytical instruments including GC/MS, HPLC, ICP, LC/MS, UV/VIS, FT/IR.

Extractable and Leachable Testing Identifiables:

  • Polymer additives

  • Polymers and Monomers

  • Hydrocarbons

  • Additives

  • Degradants

  • Oils and Lubricants

  • Adhesives

  • Colorants



Analytical Techniques for Extractable and Leachable Testing:
  • Soxhlet Extraction Apparatus

  • Gravimetric Analysis

  • Colormetric Analysis

  • HPLC, LC/MS, GC/MS Analysis

  • FTIR Analysis, UV/VIS Spectroscopy

  • ICP Analysis

  • Total Organic Carbon (TOC)



Extractable and Leachable Testing Applications:
  • Polymers, Rubbers and Composites

  • Container Closure Systems

  • Vials and Syringes

  • Disposable Medical Devices

  • Drugs

  • Pharmaceutical Products and Packaging

  • Food Packaging Materials


Criterion Scientific will work with you to for all your testing needs. We perform all the testing and analysis per international standards, including ASTM, ICH, ISO, DIN, JIS and MIL STD. Criterion Scientific can also provide cGMP compliant extractable and leachable analysis of products and materials. We can also work with you to develop a customized testing protocol that best suits your product development needs.

Related Services:-

Surface analysis services


Polymer analysis services


Failure analysis services


Corrosion analysis services


Contact us to find out how chemical analysis labs at Criterion Scientific can add value to your business!!

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Software application development factsheet © 2013-2014 Criterion Scientific LLC.
SITEMAP
Founded:2010
Offices:USA and India
Industries:Automotive Industries, Aerospace and Defense Industries, Medical Device Industries, Polymer Industries, Consumer Product Industries, Construction Industries, Electronics and Semiconductor Industries and Manufacturing Industries.
Services:Analytical testing labs, Materials Analysis Services, Chemical analysis services, Mechanical testing services, Plastic testing, Failure analysis services, Corrosion analysis, Microstructure analysis
Technologies: SEM-EDX, TEM, XPS-ESCA, FT-IR,OM, UTM, ICP, GCMS, LCMS. DSC, TGA, TMA
Enterprise Skills:Materials Testing & Analysis Services Competitor Product Analysis Services
Industry Partnerships:Privately Owned Company
Clients:Clients from all industrial sectors including Automotive Industries, Aerospace and Defense Industries, Medical Device Industries, Polymer Industries, Consumer Product Industries, Construction Industries, Electronics and Semiconductor Industries and Manufacturing Industries