USP/EP Water Tests

USP Water Test: Custom protocol or test set

Non monograph waters may be tested upon request. Refer to study matrix for offered tests.

Water for hemodialysis, USP

Water for hemodialysis is water which has been treated to reduce chemical and microbiological components that may have the potential to produce significant negative effects in patients undergoing hemodialysis.  It contains no added antimicrobials and is not intended for injection.

The USP monograph requires:

• Bacterial Endotoxins (LAL)
• Microbial limits
• Conductivity
• Oxidizable substances

Sterile water for irrigation, USP

Sterile water for irrigation is water for injection that is sterilized and suitably packaged.  It contains no antimicrobial agent or other added substance.  It is normally packaged in single-dose containers of larger than 1 L in size that allows rapid delivery of its contents.

The USP monograph requires:

• Bacterial Endotoxins (LAL)
• Sterility
• Conductivity
• Oxidizable substances

Sterile water for inhalation, USP

Sterile water for inhalation is water for injection that is sterilized and suitably packaged.  It contains no antimicrobial agents, except where used in humidifiers or other similar devices and where liable to contamination over a period of time, or other added substance.  It is intended for use in inhalators and in the preparation of inhalation solutions.

The USP monograph requires:

• Bacterial Endotoxins (LAL)
• Sterility
• Conductivity
• Oxidizable substances

Sterile water for injection, USP

Sterile water for injection is water for injection that is sterilized and suitably packaged.  It contains no antimicrobial agent or other added substance.  It is normally packaged in single-dose containers not larger than 1 L in size.

The USP monograph requires:

• Particulate matter
• Bacterial Endotoxins (LAL)
• Sterility
• Oxidizable substances
• pH
• Sulfate
• Calcium
• Carbon dioxide
• Ammonia
• Chloride

Bacteriostatic water for injection, USP (except preservative test)

Bacteriostatic water for injection is water for injection that is sterilized and suitably packaged, containing one or more suitable antimicrobial agents.  It is normally packaged in single-dose or multiple-dose containers not larger than 30 mL.

The USP monograph requires:

• Particulate matter
• Bacterial Endotoxins (LAL)
• Sterility
• Antimicrobial agents
• pH
• Sulfate
• Calcium
• Carbon dioxide

Water for injection, USP

Water for injection is water which has been purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms.

The USP monograph requires:

• Bacterial Endotoxins (LAL)
• Conductivity
• TOC

Pure steam, USP

Pure steam is water which has been heated above 100°C and vaporized.  Because the quality of pure steam is difficult to assess in a vapor state, the attributes of its condensate are used to test its quality.

The USP monograph requires:

• Bacterial Endotoxins (LAL)
• Conductivity
• TOC

Sterile purified water, USP

Sterile purifed water is purified water which has been sterilized and suitably packaged.

The USP monograph requires:

• Sterility
• Conductivity
• Oxidizable substances

Purified water, USP

Purified water is water which has been purified using unit operations that include deionization, distillation, ion exchange, reverse osmosis, filtration, or other suitable purification procedures.  It must meet requirements for ionic and organic chemical purity and be protected from microbial contamination.

The USP monograph requires:

• Conductivity
• TOC (Total Organic Carbon)