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PHARM 331 > Pharmaceutical Waters > Flashcards

Pharmaceutical Waters Flashcards

1
Q

Drinking water

A

No monograph

Same as potable water

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2
Q

Distilled water

A

No monograph

Vapourize liquid and condense it to a purer state

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3
Q

Deionized water

A

No monograph

Ion-exchange process in which contaminating ions replaced with H+ and OH-

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4
Q

Filtered water

A

No monograph

Filtered to remove any particles that could interfere with analyses

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5
Q

High purity water

A

No monograph

Deionize distilled water, then filter through 0.45um membrane

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6
Q

Ammonia-free water

A

No monograph

Negligible ammonia concentration

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7
Q

Carbon dioxide-free water

A

No monograph

Purified water, boiled, protected from atmospheric carbon dioxide

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8
Q

Deaerated water

A

No monograph

Decreased content of dissolved air

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9
Q

LAL reagent water, Organic-free water, lead-free water

A

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

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10
Q

Filtration technique

A

Removes particulate matter (large and small)

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11
Q

Activated carbon beds

A

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)

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12
Q

Deionization

A

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

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13
Q

Reverse osmosis

A

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

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14
Q

Ultrafiltration

A

Used to remove endotoxins from water stream

Polysulfone membrane exaggerated to prevent polymer molecules from reaching smaller equilibrium proximities

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15
Q

Distillation

A

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

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16
Q

Two general types of pharmaceutical waters

A 
Bulk waters (produced on-site)
Packaged waters (produced to preserve microbial quality)
17
Q

Purified water

A

Excipient used in official preparations in pharmaceutical applications
Prepared using drinking water, purified using deionization, distillation, ion-exchange, reverse osmosis, and filtration

18
Q

Sterile purified water

A

NOT for parenteral use

Non-parenteral compounding where sterile purified water is needed

19
Q

Water for injection

A

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

20
Q

Sterile water for injection

A

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

21
Q

Bacteriostatic water for injection

A

Sterile water for injection to which >1 antimicrobial preservative has been added
Used as a diluent, so cannot use more than 30mL

22
Q

Sterile water for irrigation

A

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

23
Q

Sterile water for inhalation

A

Water for injection intended for use in inhalators/inhaled solutions

24
Q

Water for hemodialysis

A

Reduced chemicals and microbiological components
Not intended for injection
No added anti-microbials

25
Q

Steam USP

A

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

PHARM 331 (7 decks)

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