area de clienteArea de cliente

Quality control.

Physicochemical analysis


Liquid chromatography 

  • HPLC – DAD
  • UHPLC-UV-VIS
  • HPLC-UV-VIS
  • HPLC-RID

Gas Chromatography 

  • GC-FID-flame ionization

 

  • Drug substances
  • Heavy metals
  • Nutritional Analysis
  • Dissolution Test
  • Analysis of medicinal plants
  • Ph. Eur. monograph assays
  • Validation of methods of analysis according to ICH
  • Analytical transfers
  • Physicochemical analysis of starting materials, semi-finished and finished products
  • Humidity
  • pH
  • Viscosity
  • Disintegration
  • Residue of calcination
  • Loss on drying
  • Dissolution test
  • Conductivity

matraces

 

Microbiology


GMP Laboratory

Classified room (Class C)

Laminar flow cabin (Class A)

Good manufacturing practices of the WHO for pharmaceutical microbiology laboratories (GMP)

a)      Plate count:

  1. Aerobic bacteria
  2. Moulds
  3. Yeasts
  4. Enterobacterias

b)      Investigation:

  1. Escherichia coli
  2. Coliformes
  3. Salmonella
  4. Pseudomonas aeruginosa
  5. Staphylococcus aureus
  6. Enterobacterias
  7. Lactobacillus

c)       Quality Control:

  1. Quality Control of H2O
  2. Control of surfaces of classified clean rooms
  3. Environmental control of classified clean rooms
  4. Challenge test

mic

 

Stability


Climatic chambers and procedures for the development of Stability Studies according to ICH for the registration and marketing of medicines and dietary supplements:

  • Drafting of Stability Study reports.
  • Long-term studies: 25ºC, 60% RH or 30ºC, 75% RH
  • Studies under intermediate conditions: 30ºC, 65% RH
  • Accelerated studies: 40ºC, 75% RH
  • Fluorescent Radiation / UV for photostability studies

Study 

Conditions

Long-term (IV) 25º C ± 2ºC / 60% HR ± 5% HR
Long-term (IVB) 30ºC / 75% HR
Intermediate 30º C ± 2ºC / 65% HR ± 5% HR
Accelerated 40º C ± 2ºC / 75% HR ± 5% HR
Camaras-Estabilidad3

 

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