Quality control

Physical-Chemical Analysis

Liquid chromatography
  • HPLC - DAD
  • UHPLC-UV-VIS
  • HPLC-UV-VIS
  • HPLC-RID
Gas Chromatography
  • GC-FID-flame ionization
  • Active ingredients
  • Heavy Metals
  • Nutritional Analysis
  • Dissolution test
  • Analysis of medicinal plants
  • Monograph essays Ph. Eur.
  • Validation of analytical methods according to ICH
  • Analytical transfers
  • Physical-Chemical Analysis of raw materials, semi-finished and finished products
  • Humidity
  • pH
  • Viscosity
  • Disintegration
  • Calcination residue
  • Loss due to desiccation
  • Dissolution test
  • Conductivity
control de calidad

Microbiology

NCF Laboratory
Classified room (Class C)
Laminar flow cabinet (Class A)
WHO Good Practices for Pharmaceutical Microbiology Laboratories WHO GMPs
Specifications adapted to the corresponding standards:

a) Plate count:

  1. Aerobic bacteria
  2. Mushrooms
  3. Yeast
  4. Enterobacteriaceae

b) Research:

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

c) Quality Control:

  1. H2O quality control
  2. Surface control of classified rooms
  3. Environmental control of classified rooms
  4. Challenge test

Stability

Climatic chambers and procedures for the development of Stability Studies according to ICH for the registration and commercialization of drugs and dietary supplements:
  • Preparation of Stability Study reports.
  • Long term studies: 25ºC, 60% RH or 30ºC, 75% RH
  • Studies in intermediate conditions: 30ºC, 65% HR
  • Accelerated studies: 40ºC, 75% HR
  • Fluorescence / UV radiation for photo-stability studies

Study period
Conditions
Long term (IV)25º C ± 2ºC / 60% HR ± 5% HR
Long term (IVB)30ºC / 75% HR
Intermediate30ºC ± 2ºC / 65% HR ± 5% HR
Accelerated40º C ± 2ºC / 75% HR ± 5% HR