Water For Pharmaceutical Purposes

Pharmacopoeia defines the following types of water and their cleanliness:

  • Aqua purificata (Ph. Eur. 01/2009:0008) is used for preparation of liquid medicines and in the cleaning process of production/laboratory facilities.
  • Aqua pro injectione (Ph. Eur. 01/2009:0169) is used for preparation of liquid medicines, especially in the production of injections and infusion solutions, as well as in the production of eye and nasal drops, prepared individually in pharmacies.
  • Aqua dialysis (Ph. Eur. 01/2009:1167) is used for dialysis solutions' preparation in specialized dialysis clinics and health centers.

Due to the inevitability of such waters in pharmaceutical production, the compulsory range of tested parameters is wide and thorough. ALS provides a complete service for pharmacopoeial water testing and offers cost-effective method packages, including crucial sterile sampling bottles, in accordance with Pharmacopoeias.

  • Acidity or Alkalinity
  • Chlorides, Sulfates and Ammonium
  • Heavy metals
  • Nitrates
  • Oxidisable substances
  • Calcium and Magnesium
  • Residue on evaporation
  • Conductivity
  • Fluorides
  • Appearance
  • Total Organic Carbon
  • Total available chlorine
  • pH
  • Total Viable Count
  • Metals: Al, Ca, Mg, Hg, K, Na, Zn etc.

On top of that, ALS offers exact turbidimetric method for the determination of bacterial endotoxins (LAL test). This method, in comparison with the gel method, provides result of exact value which is useful for trend evaluation etc. The limit of quantification is 0.005 EU/ml.

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