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Chemical analysis under Good Manufacturing Practices (GMP) Standards

At IQS we offer to pharmaceutical industry a physicochemical quality control testing service under GMP regulatory framework.

MANY YEARS OF EXPERIENCE IN THE FIELD OF PHYSICO-CHEMICAL ANALYSIS IS OUR GUARANTEE

In response to bio-health sector needs, IQS offers the possibility to perform different physicochemical tests under GMP regulatory framework. Since September 2017, IQS has been certified as GMP pharmaceutical laboratory to carry out Quality Control activities (physicochemical analysis) of active ingredients, medicines and raw materials in general; related to both marketed medicines and medicines under investigation.

IQS has a total of 6 laboratories: chromatography, spectroscopy, photochemistry, electrochemistry, metal analysis and thermal analysis, which carry out quality control activities to support the industrial sector (pharmaceutical, veterinary, active ingredients, biotechnology, etc.).

SERVICES:

  • Development, validation and transfer of analytical analysis
  • Batch analysis for quality control
  • Identification and quantification of impurities
  • Quantification of active ingredients
  • Determination of residual solvents
  • Determination of ethylene oxide and dioxane residues
  • Determination of elemental impurities or trace metals
  • Identification and quantification of nitrosamines
  • Analysis by DSC, TGA, IR, NMR, KF

GMP ACCREDITATION

IQS has the certificate of compliance with Good Manufacturing Practices, established in Directive 2003/94/EC, Directive 91/412/EC, which is issued by the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).

FACILITIES

Metal Analysis Laboratory

Thermal Analysis Laboratory

Chromatography Laboratory

Spectroscopy Laboratory

Photochemistry Laboratory

Electrochemical Laboratory

RESEARCH GROUP:

GQF

Grup de Química Farmacèutica

School of Engineering

Pharmaceutical Chemistry Group

The research focuses on two main areas: New Drugs in Biomedicine and Health Sciences and Flow Chemistry Processes.

EQBA

Electroquímica i Bioanàlisi

School of Engineering

Electrochemistry and Bioanalysis Group

EQBA's activity is structured around the different analytical, spectrometric, chromatographic, electrochemical and optical techniques, both in their application and in their development.

LINKED NEWS

News

Analysis of nitrosamines, nitrites, and nitrates in drugs

08/01/2021
In July 2018, public health authorities became aware of the presence of the N-nitrosodimethylamine (NDMA) impurity in Valsartan batches for the first time. In the following months, other nitrosamines in drugs were detected from the same family (sartans), such as Ibersartan or Losartan, and in other drugs such as pioglitazone, ranitidine, and metformin.
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