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News Headlines

GCP Inspection

A new certificate of GCP compliance was issued on 29th March 2017.

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GLP Inspection

CEMAS has been inspected by the United Kingdom GLP Monitoring Authority

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Pharmaceutical Analysis

Pharmaceutical Analysis

CEMAS carries out a range of cGMP-compliant studies in support of the development or registration of drug substances and formulations for both the human and animal health industry to current ICH and VICH guidelines.

CEMAS has a fully equipped analytical facility to provide support to studies including method development, method validation and sample analysis.

Pharmaceutical services:

  • Active ingredient/Related substances content
  • Method development and validation
  • Method transfer/cross-validation
  • QC release/Certificates of Analysis
  • Photostability testing
  • Storage stability trials to ICH guidelines

Services Offered:

  • Active Ingredient Content
  • Related Substances/Impurity Content
  • Residual Volatile Organic Compounds Determination
  • Uniformity of Content
  • QC release, Certificates of Analysis
  • Raw Material Analysis
  • Range of Physical Testing
  • Method Development including stability indicating methods
  • Method Transfer/Cross-Validation
  • Photostability Testing
  • Storage Stability Trials to current ICH Guidelines (storage cabinets at 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, and additionally a range of temperature controlled storage at ambient humidity)
  • Continuous computer monitoring of all temperature and humidity storage locations

Equipment Available:

  • HPLC (UV/Vis, DAD, EC, RI, fluorescence)
  • GC (FID, FPD, NPD, ECD)
  • GC Headspace Sampler
  • GC-MS (EI and CI modes)
  • LC-MS/MS - four SCIEX API 4000, one with a QTRAP, three with Spark-Holland SymbosisTM Pharma, one Sciex API 5000 plus four SCIEX API 5500
  • Chromatographic data acquisition, processing and retention through Agilent ChemstationTM, Agilent ChemstoreTM, and PE Sciex AnalystTM (LC-MS/MS) software
  • UV/Vis spectroscopy
  • TLC
  • Osmometer
  • Melting Point Apparatus
  • Viscometers (cone and plate, spindle)
  • Density Meter
  • Karl Fischer Titrators

News Headlines

GCP Inspection

A new certificate of GCP compliance was issued on 29th March 2017.

read on

GLP Inspection

CEMAS has been inspected by the United Kingdom GLP Monitoring Authority

read on

Contact Us for more Information

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Contact

Tel:+ 44 (0)1344 887 100