Purified water

DB Lab offers analyses of purified water according to Ph. Eur. monograph 0008 “Water, Purified”. It can be solely/exclusively microbiological analyses or the entire monograph.

DB Lab would be pleased to forward sterile containers for sampling for the microbiological analyses and we start the analyses within 24 hours after sampling as agreed with the customer.

In case the entire monograph is to be completed, we would be pleased to forward acid washed flasks for the chemical analyses.

In the microbiological laboratory, we analyse for:

  • Microbial count, Purified water in bulk: Membrane filtration
  • Microbial count, Purified water in containers
  • Bacterial endotoxins

In the chemical laboratory, we analyse for purified water in bulk:

  • Oxidisable substances
  • Conductivity
    • If the test for conductivity does not comply with the criteria described in the monography for water for injection (Ph. Eur. 0169), a risk assesment according to the general Ph. Eur. chapter 5.20 Elemental impurities must be carried out. In Ph. Eur. is written: ”The risk assessment should consider the role of water in the manufacturing process, in particular when water is used in a process but is no longer present in the final product”. DB Lab cannot perform this risk assesment, but we are available with setup and validation of metal analyses conducted by analysis method ICP-MS. 
  • Nitrates

Purified water in containers:

  • Acidity or alkalinity
  • Oxidisable substances
  • Chlorides
  • Sulphates
  • Ammonium
  • Calcium and magnesium
  • Residue on evaporation

 

 

 

Contact

Contact Azra for questions regarding analysis of purified water.