2. SOLVENTS
• “Solvents are integral part of chemical
reactions and it is difficult to imagine
reactions without solvents.”
• Reactions are solvent selective.
• Solvents is a liquid substance capable to
dissolve other substances (solutes) without
chemical changes.
4. AQUEOUS SOLVENTS
WATER AS A SOLVENT:
• Universal solvent.
• Polar in nature.
PROPERTIES OF WATER FOR
PHARMACEUTICAL USE:
• Like any pharmaceutical
material, water must
confirm to GMPnorms.
• Must be portable and
comply with WHO guide
lines for drinking water
quality.
5. TYPES OF
PHARMACEUTICAL WATER
• Purified water.
• Water for injection.
BULK
FORM
• Bacteriostatic Water for injection.
• Sterile water for inhalation.
• Sterile water for injection.
• Sterile water for irrigation.
• Sterile purified water.
PACKAGED
FORM
7. Purified water is water that has been
mechanically filtered or processed to
remove impurities and make it suitable for
use.
DEFINITION
8. DESCRIPTION:
• May originate from either a spring or surface or
groundwater source or directly from the tap.
• It simply doesn’t matter. Since, the purification
process is designed to remove virtually all types of
impurities, the quality of the source water has little
bearing on the quality of the final product.
• Best choice of water.
9. USES:
• as excipients in manufacturing of
pharmaceuticals.
• for Equipment Cleaning.
• Preparation of bulk chemicals.
• Prepared using potable water as feed.
• Must meet ionic, organic chemical and
microbial requirements.
10. PARAMETERS OF PURITY:
• Purified water is usually produced by the purification of
potable water.
The impurities that may need to be removed are:
• inorganic ions.
• organic compounds.
• Bacteria.
• endotoxins and nucleases.
• particulates (typically controlled by filtration)
• gases (typically managed by degassing when required)
21. DEFINITION
• This is pyrogen-free water,
purified by distillation for
the preparation of products
for parenteral use.
• It is intended for use as
solvent only in solution
• That are to be sterilized
after preparation and
endotoxin content must be
controlled.
22. REQUIREMENTS
• Water for injection can be prepared under
aseptic conditions.
• It contain no added substance.
• It must meet the requirements of pyrogen test
and sterility test for purified water
23. TYPES OF WATER FOR INJECTION
• Potable Water:
Used in early stages of chemical synthesis.
• Purified Water:
Used as excipients in manufacturing of
pharmaceuticals.
• Bacteriostatic Water for
injections(USP):
Contains added antimicrobial preservatives
which prevent the growth of
microrganisms.
24. • Sterile water for injection
USP is a sterile, non
pyrogenic preparation
which contains no
bacteriostatic, antimicrobial
agent or added buffer and is
supplied only in single dose
containers to dilute or
dissolve drugs for injection.
26. REVERSE OSMOSIS
Reverse osmosis (RO) is a water purification technology that uses
a semi permeable membrane to remove larger particles from
water.
27. BY DISTILLATION METHOD
Water for Injections is a specially prepared form of distilled
water. It is a clear, colorless sterile liquid and it does not
contain any other ingredients.
29. ADVANTAGES OF WATER INJECTION:
There are a variety of reasons why drugs would be
injected rather than taken through other methods.
Some of the advantages are:
Increased effect
More efficient usage
30. DISADVANTAGES:
In addition to general problems associated with any IV drug
administration, there are some specific problems associated
with the informal injection of drugs by non-professionals, which
are:
• Increased chance of infection
• Increased chance of overdose
• Arterial damage
31. PRECAUTIONS :
• Do not use for intravenous injection unless the osmolar
concentration of additives results in an approximate isotonic
admixture.
• Consult the manufacturer’s instructions for choice of vehicle,
appropriate dilution or volume for dissolving the drugs to be
injected, including the route and rate of injection.
• Inspect reconstituted (diluted or dissolved) drugs for clarity (if
soluble) and freedom from unexpected precipitation or
discoloration prior to administration.
33. Sterile Water for Injection, USP
is a sterile, nonpyrogenic
preparation of water for
injection which contains no
bacteriostat, antimicrobial
agent or added buffer and is
supplied only in single-dose
containers to dilute or dissolve
drugs for injection. For I.V.
injection, add sufficient solute
to make an approximately
isotonic solution.
DESCRIPTION
34. Indications and Usage for Sterile Water
for Injection
This parenteral preparation is indicated only for diluting or
dissolving drugs for intravenous, intramuscular or subcutaneous
injection, according to instructions of the manufacturer of the
drug to be administered.
Contraindications
Sterile Water for Injection, USP must be made approximately
isotonic prior to use.
35. PRECAUTIONS
• Do not use for intravenous injection unless the osmolar
concentration of additives results in an approximate
isotonic admixture.
• During pregnancy
• Pediatric Use
• Drug Interactions
38. • “Bacteriostatic Water for Injection, USP is a sterile,
non pyrogenic preparation of water for injection
containing 0.9% (9 mg/mL) of benzyl alcohol added
as a bacteriostatic preservative.”
DEFINITION
39. PREPARATION
• Bacteriostatic water for injection is prepared
from water for injection (WFI) that is sterilized
and suitably packaged, containing one or
more suitable anti microbial agents.
40. PACKAGING AND STORAGE:
• Preserve in a single dose or multiple dose glass or
plastic containers.
• Reconstituted solutions may be stored for up to 20
days at 2-8°C prior to use.
41. ADVICE FOR PATIENTS:
Discard reconstituted solution after 20 days.
Previously reconstituted solutions mixed with freshly
reconstituted solutions must be administered within
6 hours following mixing.
Should not used for neonatal medications.
42. SIDE EFFECTS:
Some side effects that may occur after drugs are added
to bacteriostatic water include fever, abscess
formation, venous thrombosis, necrosis and infections.
45. DEFINITION
Sterile Water for Irrigation USP is a sterile,
hypotonic, nonpyrogenic irrigating fluid or
pharmaceutical aid (solvent) entirely composed
of Sterile Water for Injection USP. It is prepared
by distillation and contains no antimicrobial or
bacteriostatic agents or added buffers.”
The pH is 5.7 (5.0-7.0).
46. METHODS OF PREPERATION
Sterile Saline solution has 0.9% Sodium Chloride and is used for
wound irrigation and cleaning:
• Use a pressure cooker.
• Fill the cooker with water.
• Place cooker with water on a heat stove.
• Boil water for a minimum of 20 minutes.
• The temperature within the cooker should be maintained at
121 degrees Celsius or 250 degrees Fahrenheit throughout
the boiling period.
• Your sterile water is ready
47. ADVICE FOR PATIENTS:
• Sterile Water for Irrigation USP is hypotonic and will cause
hemolysis.
• After opening container, its contents should be used promptly.
• Discard unused portion of irrigating solution since it contains
no preservative.
USES:
• Sterile Water for Irrigation USP is indicated for use as an
irrigating fluid or pharmaceutic aid. Sterile Water may also be
used as an adjunct in the preparation of non-intravenously
administered nutrient mixtures.
49. DEFINITION:
Injection that is packaged and rendered sterile and is intended for
use in inhalators and in the preparation of inhalation solutions. It
carries a less stringent specification for bacterial endotoxins than
sterile water for injection, and therefore , is not suitable for
parenteral applications.
EXPLAINATION:
Water for injection that is sterilized and contains no antimicrobial ag
ents.
It is intended for use in inhalators and in the preparation of
inhalation solutions.
50. PHARMACEUTICAL USES
•Used in manufacturing of inhalants; thus deals with the
breathing issues.
•It is also used in humidifiers reservoirs of low-flow oxygen
therapy.
OTHER EXAMPLES:
•Virazole
•Acetytcysteine
51. CAUTIONS
• Should keep them safely.
• Should avoid its mistaken use for the intravenous IV
solutions.
• The practitioners of health care should recognize the
danger of infusing plain sterile water intravenously.
SIDE EFFECTS
• Chest soreness may occur.
• Redness/irritation of eye.
• Worsening of breathing trouble; slow fast
or irregular heart beat.
• Allergic reactions.
53. STERILITY:
Sterility is the absence of life or the absolute freedom from
biological contamination , therefore a product or device is either
sterile or it is contaminated.
STERILIZATION:
It is the process of effectively killing the transmissible agents; such
as micro organisms.
METHODS OF STERILIZATION:
54. What is the need of using STERILE
WATER/its IMPORTANCE ? Why do we
use sterile water for irrigation , injection,
inhalation?
56. IMPORTANCE OF AQUEOUS SOLVENTS:
In addition to solubility, solvent selection is also based on
clarity, toxicity, viscosity, compatibility, with excipients,
chemical inertness, palatability, odour, color and economy .
In most cases, specially solution for oral opthalmic or
parenteral administration, water is preferred solvent because
it meets the majority of the above criteria better than other
available solvents.
A number of fixed oils , such as corn oil, cotton seeds,
peanut oil and sesame oil , serve useful solvent functions.
Water is used as solvent for desired flavoring or medicinal
agent .
