Pharmaceutical Waters Flashcards
Drinking water
No monograph
Same as potable water
Distilled water
No monograph
Vapourize liquid and condense it to a purer state
Deionized water
No monograph
Ion-exchange process in which contaminating ions replaced with H+ and OH-
Filtered water
No monograph
Filtered to remove any particles that could interfere with analyses
High purity water
No monograph
Deionize distilled water, then filter through 0.45um membrane
Ammonia-free water
No monograph
Negligible ammonia concentration
Carbon dioxide-free water
No monograph
Purified water, boiled, protected from atmospheric carbon dioxide
Deaerated water
No monograph
Decreased content of dissolved air
LAL reagent water, Organic-free water, lead-free water
No monograph
Reagent grade water used in making reagents, contains four different grades
LAL reagent water = endotoxin free water
Organic-free water = no interfering gas chromatography peaks
Lead-free water = transfers analyte in lead test
Filtration technique
Removes particulate matter (large and small)
Activated carbon beds
Granular activated carbon beds adsorb low MW material and oxidizing additives and remove them from water
Can also use chemical additives
Advantage: Used for safe chlorine removal
Disadvantage: Bacterial proliferation (must be hot/steam sterilized)
Deionization
Systems have charged resins that require periodic regeneration with an acid/base
Cationic resins regenerated with hydrochloric or sulphuric acid (replace H+)
Anionic resins regenerated with sodium or potassium hydroxide (replace OH-)
Microbial control and separate cations and anions
Reverse osmosis
Semi-permeable membrane, water is flushed along it
Pressure used to drive water through (only water molecules pass)
Can be used in combination with deionization
Technique used to make drinking water out of salt water
Ultrafiltration
Used to remove endotoxins from water stream
Polysulfone membrane exaggerated to prevent polymer molecules from reaching smaller equilibrium proximities
Distillation
Heat water to vapour, cool it to create water for injection
Bacteria will not become airborne in vapour so water is bacteria-free
Single effect, multi-effect, and vapour compression
Less rigorous control of feed water quality than membrane systems
Need high amount of energy to convert water to steam, reason why steam is so dangerous and used in sterilization
Two general types of pharmaceutical waters
Bulk waters (produced on-site) Packaged waters (produced to preserve microbial quality)
Purified water
Excipient used in official preparations in pharmaceutical applications
Prepared using drinking water, purified using deionization, distillation, ion-exchange, reverse osmosis, and filtration
Sterile purified water
NOT for parenteral use
Non-parenteral compounding where sterile purified water is needed
Water for injection
Injections and some pharmaceutical applications
Drinking water is the source, which is then purified and subjected to distillation and reverse osmosis
Must meet requirements for bacterial endotoxins test
Sterile water for injection
Intended for extemporaneous prescription compounding and is distributed in sterile units
Packaged in single-dose containers (only difference from water for injection is that it is packaged)
Bottled and sterilized - used for IV injections
Bacteriostatic water for injection
Sterile water for injection to which >1 antimicrobial preservative has been added
Used as a diluent, so cannot use more than 30mL
Sterile water for irrigation
Water for injection, packaged in single-dose containers
Intended for rapid delivery and does not need to meet requirements for small-volume injections under particulate matter
Sterile water for inhalation
Water for injection intended for use in inhalators/inhaled solutions
Water for hemodialysis
Reduced chemicals and microbiological components
Not intended for injection
No added anti-microbials
Steam USP
Pure steam = clean steam
Directly contacts surfaces where no subsequent processes used to remove impurities
Prepared from suitably pre-treated water used for injection/purified water
Must meet bacterial endotoxin specifications
