Pharmaceutical Waters - PCeutics 2

Purified Water

What type of water is intended for human consumption with no added ingredients and is prepared by distillation, ion exchange, or other appropriate means?

Purified Water

Which type of water is used as a recipient in non-parenteral preparations and for cleaning equipment, with a microbial limit of 100 CFU/ml?

Purified Water

In which type of water must pathogens be absent, and its purification process must comply with pharmacopeial standards?

Water for injection (WFI)

What type of water is used as an excipient in parenteral preparations and must have its endotoxin content controlled?

Water for injection (WFI)

Which type of water is prepared by distillation, reverse osmosis, or a membrane process and is stored at 80-90°C?

Water for injection (WFI)

What is the pH range for Water for Injection (WFI)?

5.0 to 7.0

What is the pH range for Water for Injection (WFI)?

Distillation, reverse osmosis, and membrane process

How is Water for Injection (WFI) prepared?

For the production of parenteral products and for cleaning contact parts of equipment

What are the primary uses of Water for Injection (WFI)?

Sterile water for injection (SWFI)

Which type of water is sterilized within 12 hours of collection and distributed only in single-dose containers not larger than 1 liter?

Sterile water for injection (SWFI)

What type of water is used mainly as a solvent for parenteral preparations like powders for injection?

Not more than 10 CFU per 100 ml

What is the recommended microbial limit for Sterile Water for Injection (SWFI)?

Distillation

How is Sterile Water for Injection (SWFI) prepared?

It is distributed as a dry solid because of the limited solubility of its solution

Why is Sterile Water for Injection (SWFI) often distributed in a dry form?

Bacteriostatic Water for injection

What type of water is Sterile Water for Injection with suitable antimicrobial preservatives added?

Bacteriostatic Water for injection

Which type of water is used as a diluent for multi-dosage parenteral products and is packaged in containers not larger than 30 ml?

Multi-dosage parenteral products requiring continuous contents withdrawal

For what type of products is Bacteriostatic Water for Injection primarily used?

Sterile Water for inhalation

What type of water is Water for Injection that is packaged and sterilized for use in inhalators and inhalation solutions?

Sterile Water for inhalation

Which type of water is not suitable for parenteral applications due to less stringent bacterial endotoxin specifications?

Inhalators and the preparation of inhalation solutions

What are the uses of Sterile Water for Inhalation?

Sterile water for irrigation

What type of water is Water for Injection that is packaged and sterilized in single-dose containers larger than 1 liter?

Sterile water for irrigation

Which type of water is used for irrigation and does not need to meet the requirements for small-volume injections?

Container sizes larger than 1 liter

In what size containers is Sterile Water for Irrigation stored?

For irrigation and applications where pure water is indicated but a good water system is absent

When is Sterile Water for Irrigation typically used?

Purified Water

Which water type has the highest microbial limit (100 CFU/ml) among the various official water types?

Water for injection (WFI) and Sterile water for injection (SWFI)

For which two types of water is the Total Organic Carbon (TOC) limit specified as not more than 0.5 mg/liter (IP) or 500 PPB (USP/BP)?

Parenteral preparations

For which type of pharmaceutical preparation is Water for Injection (WFI) specifically required?

Non-parenteral preparations

For which type of pharmaceutical preparation is Purified Water typically used?

The first portion of the distillate is discarded

What specific step is taken during the distillation process for preparing Water for Injection (WFI)?

Ultraviolet lamps or sealed containers

How is Water for Injection (WFI) stored to maintain its quality?

Up to one month

What is the maximum storage period for Water for Injection (WFI) in a special tank?

A single dose for IV administration after adding solute

How is Water for Injection (WFI) stored when intended for IV use?

It carries less stringent specifications for bacterial endotoxins

Why is Sterile Water for Inhalation not suitable for parenteral applications?

It allows quick delivery of contents and is not mandatory to meet small-volume injection requirements

Why is Sterile Water for Irrigation packaged in large, single-dose containers?

Bacteriostatic Water for injection

Which pharmaceutical water has benzyl alcohol as a preservative?

Benzyl alcohol

What preservative is present in Bacteriostatic Water for injection that is contraindicated to neonates (Gasping syndrome risk)?