Laboratorio de análisis Echevarne

Pharmaceutical Industry

Pharmaceutical Industry

Our Pharmaceutical Industry service is certified by the GMP certificate. Monitoring of Spanish, European and American Pharmacopoeia.

The Industrial Area of ​​Laboratorio Echevarne offers quality controls on raw materials and finished products, physical-chemical, toxicological, medicinal plants, classified rooms, as well as validation of analysis methods and stability studies according to ICH.

Quality Controls on raw materials and finished products

  • Microbiological control
  • Count
  • Identification of pathogens
  • Bacterial endotoxins (LAL)
  • Evaluation of antibiotics
  • Control of sterility
  • Preservative challenge test

Physical and chemical control

  • Quantification of active ingredients
  • Determination of residual solvents
  • Determination of ethylene oxide, dioxane residues
  • Determination of traces of metals
  • Determination of fatty acids in raw material
  • Determination of sterols in raw material
  • Disintegration test for capsules and tablets
  • Crystallinity
  • Injectable particles: subvisible and visible
  • Grain sizes

Toxicological control

  • Pyrogen testing
  • Acute toxicity (DL50)
  • Abnormal toxicity (safety test)
  • Local tolerance tests
  • Mucous membrane irritation tests (oral, rectal, vaginal...)

Control of medicinal plants

  • Thin-layer identification
  • Determination of metals
  • Determination of ash
  • Raw fibre
  • Determination of moisture content / dry extract
  • Determination of pesticides
  • Determination of mycotoxins
  • Determination of residual solvents

Control of purified and production water

  • Microbiological control
  • Bacterial endotoxins (LAL)
  • Physical and chemical control

Control of classified rooms

  • Surface areas
  • Environments
  • Particles

Validation of analysis methods / Stability studies according to ICH

  • Microbiological assays
  • Physical and chemical assays
  • Photostability
  • Rental of climatic chambers

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