Preparation of water for injection for Injection dosage form , Parantral

Dosage form

Dear friends from i am giving today some important and valuable information on this
blog about Injections , injectable dosage form pharmaceuticals.
This is the first article on Injection dosage form and in coming days i will be writing
very good articles on injection dosage form which will provide you a basic knowledge
on Injections .

Preparation of water for injection:

An injection is a product which is required to be administered by a hypodermic needle
through one or more layers of skin.
Injection dosage form should meet and comply with following specifications
1.Must be sterile , free from microbial contamination
2.It should be completely free from Pyrogens , i have given over this blog about what
are pyrogens .
3.Injections should be free from particulate matters.
Basic composition of a Injections
1.Active medicament , active ingredient
2.Vehicle
3.Additives
4.Containers
Vehicle most frequently used for injections or parantral dosage form is water for
injections .
Pyrogens :
Pyrogens are organic metabolic waste of microorganisms or dead micro organisms ,it
is produced mainly by bacteria and moulds .
Most potent pyrogens are produced by by gram negative organisms (Bacterial endo-
toxins).
Pyrogens are generally lipopoly saccharides and some times are in conjugation with
peptides,the lipid portion is responsible for pharmacological action and
polysaccharides moiety is responsible for its solubility in water.
Molecular weight ranges from 15000 to 4000000 .Pyrogens are highly water soluble ,
they are responsible for producing raise in body temperature and chills , Cutaneous
vasoconstriction , rigours ,aches, rise in arterial blood pressure , these responses to
pyrogen varies from route of administration and amount of indictable preparation
administered.Most sever effect is seen on large volume parantral administration by IV
route which is critical to patients.
Major sources of contaminations are :
Environmental
Material
Personal
How to eliminate pyrogens in injectable dosage form
1.Dry heat sterilisation
By using Heat , heat the material which we want to make pyrogen free for following
conditions
A. 180 ºC FOR 3 to 4 Hours
B. 269 ºC FOR 45 mins
C. 600 ºC for 1 mins
2.Distillation
Vehicle being(Here we most refer to water) used for injection preparation is rendered
sterile and pyrogen free by method of distillation,
Water may be pretreated by passing through Charcoal bead and ion exchange resin ,
during distillation Kmno4 can be added in water which is required to be distilled for
destruction of oxidisable impurities , and it also serves as a checke for efficiency of
distillation.
We should through away first 10 to 20% of distillate as it may contain dissolved gases
, also
the last 5 to 10 % of water of remaining water should not be distilled to carry over of
decomposed product if any .
Distillate (Pure distilled water ) should be collected in pyrogen free sterile container
and stored at 80 ºC for or 50 ºC for period not exceeding 24 hrs .
Tanks used for storing pyrogen free distilled water should have UV lamps to ensure
sterility, and water should not be allowed to remain stagnant , it should b in
continuous circulation loop.
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Read my earlier article on reverse osmosis for production of water for
pharmaceuticals
This website is a complete guide for pharmaceuticals manufacturing company or unit
and for pharmacists working in pharmaceuticals manufacturing around the globe.

You can search for topics on blog archive there is almost all information about
Pharmaceuticals, Quality assurance for pharmaceuticals , Guidance for
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Detailed information about Injections , injectable dosage form , its requirements of c
gmp for injections.Good manufacturing practice guide for pharmaceuticals
manufacturing
Quality assurance for pharmaceuticals

Vehicles Water for injection:- Contains not more 1 mg per 100 ml water for injection.
Not require to sterile but must be pyrogen free. Free from ions Must be useeeeeed
within preparation of 2 hours. Sterile water for injection:- Sterilized & sitabely
packaged in a closed container not exceeding 1000 ml capacity.& not containing
bacteriostatic agent. Free from pyrogen & used inn the vials to prepare the desired
injection. Bacteriostatic water for Injection:- A sterile water of injection containing
one or more bacteriostatic agent. Boiling of water makes it free from atmospheric
gases & such water should be stored suitably so that reabsorption of oxygen should
not be possible. It is packaged in prefilled syringes or in vials containing not more
than 30 ml of vials. The water is employedb as a sterile vehicle in the preparation of
small volume of injectable preparation. Theoritically presence of bacteriostatic agent
.gives theflexibility of multiple dose vials