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Analysis of Contamination in Pharmaceutical Products
Extractables and Leachables
Foreign Particulate Matter Analysis in Pharmaceutical Products
Materials Characterisation
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LGC

LGC
An international leader in the laboratory services, measurement standards, reference materials and proficiency testing marketplaces, LGC is an established leading supplier of outsourced contract analytical testing services in the global pharmaceutical, healthcare and medical device sectors.

Timely delivery, high-quality reporting and customer service excellence

LGC combines technical expertise with an array of modern technologies, knowledge of regulatory issues and a strong commitment to quality. This makes the company the ideal outsource partner to meet your analytical testing and development requirements.

LGC’s laboratories have been inspected by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) compliance.

The company arranges staff in multi-functional project teams and they are highly experienced in working to the tight timelines and stringent regulatory requirements of the pharmaceutical sector.

It provides leading-edge and cost-effective services in:

  • Extractables and leachables
  • Materials characterisation
  • Foreign particulates
  • Characterisation of impurities
  • Quantitative analysis
  • Trace metals analysis
  • Contamination
  • Method development and validation

Contact

LGC
Queens Road
Teddington
Middlesex
TW11 0LY
United Kingdom
www.lgc.co.uk

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Top Products from LGC


Analysis of Contamination in Pharmaceutical Products

Extractables and Leachables

Foreign Particulate Matter Analysis in Pharmaceutical Products
View all Products & Services

Analysis of Contamination in Pharmaceutical Products

Contamination can occur at any stage of product manufacture and can arise from the raw materials, cleaning materials, chemicals or equipment used in production, packaging or from degradation during storage. It can be inorganic or organic in nature andin solid or liquid form.

In many cases, the contamination can be due to visible or sub-visible particulate matter, and we are able to identify and count such particles.For further information on particulate contamination, please see our data sheet:Foreign Particulate Matter Analysis in Pharmaceutical ProductsWe have many years experience in solving contamination problems in the pharmaceutical and healthcare sector. Typical…
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Extractables and Leachables

As regulatory pressure increases on pharmaceutical companies to investigate the potential interaction between a dosage form and the components of the primary closure and transfer system employed, leachables and extractables studies are becoming essential. LGC helps clients to identify and quantify the nature of the compounds present in contacting components and the likelihood of clinical exposure to these.

Our servicesDevise strategies for testing polymeric materialsFull analysis of leachables and extractables on various delivery systems, including inhalers, injectables, catheters and blister packsExtractables screening, leachables monitoringMethod development, validation and technology transfer of analytical methods for product testing and quality controlWhat typical technologies does LGC use?Solvent extraction including ultrasonication, microwave, ASE (Automated Solvent Extraction), Soxhlet and…
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Foreign Particulate Matter Analysis in Pharmaceutical Products

In the pharmaceutical sector there is an increasing regulatory requirement for the characterisation and counting of visible and sub-visible foreign particles in pharmaceutical products. LGC has significant expertise in this area.

Our facilities and capabilities include:ISO14644 Class 5 standard (FS 209 Class 100) laminar flow cabinets to minimise contamination of samplesExtensive methods for the isolation of particulate matter for example manipulation of small particles, filtration and centrifugationOptical microscopy with image analysisScanning electron microscopy with EDX for qualitative elemental analysis of particlesHigh Resolution SEM with Field Emission…
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Materials Characterisation

LGC is highly experienced in the application of leading edge technologies and well established materials characterisation techniques. We help our clients in the pharmaceutical sector to understand the key physical and chemical characteristics of a variety of materials such as process impurities, degradation products, metabolites and formulated products.

The technologies used at LGC include, but are not limited to:SpectroscopyCompound/polymer identification by vibrational spectroscopyFourier Transform Infra Red (FT-IR) and Raman (microscopy);Ultraviolet (UV), fluorescenceDetermining variations in complex products and processesNear Infra Red (NIR)Structural elucidation of chemicals and biologicalsFourier Transform Ion Cyclotron Resonance Mass Spectrometry (FT-ICR-MS)Tandem Mass Spectrometry (MS/MS)Nuclear Magnetic ResonanceMatrix Assisted Laser Desorption Ionisation Time-of-Flight…
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Quantitative Analysis

Scientists at LGC are highly skilled in the accurate quantification of trace elements in challenging matrices. In addition to carrying out the analyis for clients in our own laboratories we also develop and validate methods for transfer to client's laboratories. Our expertise in this area, combined with an array of modern technologies and detailed knowledge of regulatory issues in the pharmaceutical sector, makes LGC your ideal partner.

Typical technologies include, but are not limited to:Advanced sample preparationSolvent extraction including ASE (Automated Solvent Extraction), Soxhlet and Soxtect;Solid phase extractionAdvanced separation scienceSeparation with full range of detectionHigh Performance Liquid Chromatography (HPLC) coupled to UV, light scattering;Gas chromatography (GC) with either Flame Ionisation (FID) Nitrogen Phosphorus (NPD) or Electron Capture (ECD) detectionCapillary Electrophoresis (CE) coupled…
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