water of pharmacopoeial qUALITY

Pharmacopoeia defines conditions for quality control of several types of water:

Water, Purified/Aqua purificata (Ph. Eur. 01/2009:0008) - used for the preparation of liquid medicines (preparation of individually prepared medicinal products in a pharmacy) and in the process of cleaning the manufacturing/laboratory equipment.

Water for injections/Aqua pro injectione (Ph. Eur. 01/2009: 0169) - used in the preparation of liquid medicines, especially in the production of injection and infusion solutions, furthermore in the production of eye and nose drops prepared individually in pharmacies.

Dialysis Water/Aqua dialysis (Ph. Eur. 01/2009:1167) - used in the preparation of dialysis solutions in specialised dialysis departments of hospitals and medical centres.

Since the use of water in drug manufacturing is essential, the scope of control required by the authorities is quite extensive. Our laboratory provides full service in this area, not only in carrying out chemical analyses in accordance with legislative requirements, but also in providing sterile samplers that are very important when inspecting water quality.

  • Acid and alkaline reactants
  • Chlorides, sulphates, ammonia
  • Heavy metals
  • Nitrates
  • Oxidising substances
  • Calcium and magnesium
  • Residue after evaporation
  • Conductivity
  • Fluorides
  • Appearance
  • Total organic carbon
  • Total free chlorine
  • pH
  • Total amount of viable microorganisms
  • Metals: Al, Ca, Mg, Hg, K, Na, Zn

Regarding quality control of water according to pharmacopoeial quality, the ALS laboratory operates under GMP regulations using a modern and accurate turbidimetric method for quantitative determination of bacterial endotoxins.

It is based on the photometric determination of turbidity caused by the precipitation of lysate from amebocytes of a horseshoe crab (Limulus polyphemus) in the presence of endotoxins. The method reaches a quantification limit of 0.005 EU / ml and, unlike the gel method, it provides a specific result, which gives valuable information to the water manufacturer.