Test for Purified water and
water for injection
• 8th semester
• Madina college of Pharmacy
Lecturer HAJRA IQBAL; Rph
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unioffaisalabad
Topic: Test for Purified water and water for injection
When Distilled or Deionized or Demineralized Water is prescribed, Purified
Water shall be used. Purified water is prepared by distillation of potable water
or by ion-exchange treatment. Injections are prepared with Water for
Injections (Wl) only. Water for Injection is prepared by distilling potable water
from a still fitted with a device for preventing the entrainment of droplets,
rejecting the first portion of the distillate and collecting the remainder in a
sterile container and immediately sterilizing in an autoclave or by filtration.
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Definition of Purified Water
Purified Water:
Purified water is water that has been mechanically filtered or processed
to remove impurities and contaminants.
Importance in Pharmaceuticals
In the pharmaceutical industry, purified water ensures the safety and
efficacy of drugs and medical preparations.
Production Methods
Common methods include reverse osmosis, distillation, deionization,
and filtration.
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Quality Control Tests: pH, Acidity, and
Alkalinity
1 pH Testing 2 Acidity and Alkalinity Techniques
The pH level indicates the acidity Essential for determining the Utilizing pH meters or indicator
or alkalinity of water; acceptable chemical balance of water, strips, clear images illustrate the
range is 5 to 7 influencing stability in use like methodology and comply with lab
pharmaceuticals. protocols.
Between 5.0 and 7.0
deetermined potentiometrically To 20 ml add 1 drop of phenol
red solution. If the solution is
yellow it becomes red on
adding 0.1 ml of 0.01 N
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Quality Cotrol Tests: Copper, Iron, and Lead
Testing Methods
Metal Contaminants
Atomic absorption spectroscopy
Testing for metals such as
2 (AAS) and inductively coupled plasma
copper, iron, and lead is critical mass spectrometry (ICP-MS) provide
since these substances can be precise measurement.
toxic in concentrated amounts. 1
To 100 ml add 1 drop of Quantitative Analysis
sodium sulfide solution, the
3
liquid remains clear and Quantification involves comparing test
colourless. results against permissible levels in
pharmacopeia.
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Quality Control Tests: Chloride, Ammonia, and
Calcium
Chloride: Ammonia: Calcium:
Chloride ions can Monitored in Critical for
affect stability and purified water to solubility and
indicate protect biological bioavailability;
contamination; systems; various titrimetric
titration with silver colorimetric methods provide
nitrate is standard. methods or ion- accurate readings.
selective
electrodes are
To 100 ml add 1
used.
ml of barium To 100 ml add 2
chloride ml of
To 50 ml add 2 ammonium
remains clear and
ml of alkaline oxalate
colourless. solution,no
potassium
turbidity is
mercuric iodide
produced.
solution and
view in a
Nessler cylinder
standing on
white surface;
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Quality Control Tests: Oxidizable Metals and Total Solids
Total Solids
Determines the total solids content in
Oxidizable Metal Test purified water using gravimetric
2
methods.
Measures the presence of
oxidizable metals and their Evaporate 100 ml on a water bath
potential health impacts. to dryness, and dry the residue at
1 105°C for 1 hour, not more than 1
Boil 100 ml for three minutes mg of residue remains (10 parts
with 10 ml of dilute sulphuric per million).
acid; add 0.1 ml of 0.1 N
potassium permanganate and
boil again for 10 minutes, the 3
pink colour does not Impacts of High Solids
completely disappear.
Excessive solids can cause unwanted
chemical reactions and affect product
efficacy.
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Definition of Water for Injection
Water for injection (WFI) is essential for formulating injectable medications. It must comply with strict microbiological and
chemical purity standards, ensuring safety for patients and healthcare professionals.
Water for Injection (WFI) Distinguishing Features Importance in Healthcare
Definition WFI must be free of bacterial WFI is crucial for antibiotic
Water for injection is a highly purified endotoxins, necessitating rigorous preparation, vaccines, and
form of water intended for injectable quality control. intravenous solutions.
medications.
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Test for Non-Volatile Matter
Significance of Measurement
2
Understanding Non- Ensures the quality of water used in
Volatile Matter 1 pharmaceuticals.
Refers to substances remaining
after water evaporation.
Methodology
3 Utilizes analytical balances under
controlled conditions.
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Water for Injection, in addition to the tests described under Purified Water, also complies with the following tests:
Non-volatile matter:
Evaporate 100 ml to dryness on a water-bath and dry the residue at 105°C for one hour; not more than 2 mg of residue
remains (20 parts per million).When water for Injection is packed and sterilized in a glass
container with a capacity of 30 ml or less, the total solids may not exceed 40 parts per million and when in containers of more
than 30 ml but not more than 100 ml capacity, the total solids may not exceed 30 parts per million.
Sterility:
Complies with the test for sterility.
Pyrogen:
Complies with the test for pyrogens.
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Sterility Testing
Definition of Sterility Testing Methods Importance of Compliance
Sterility testing confirms that water is Common methods include Regulatory compliance requires
free from viable microorganisms, membrane filtration and direct rigorous testing to prevent
ensuring the integrity of sterile inoculation, with controlled contamination, with non-compliance
products. incubation to observe growth leading to serious consequences.
effectively.
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Pyrogen Testing
Pyrogen testing plays a vital role in the pharmaceutical industry by ensuring that products intended for human use are safe
from fever-inducing substances. The use of the LAL test, among other methodologies, helps manufacturers comply with strict
regulatory standards, mitigating risks to patient health.
Testing Techniques
Pyrogens Overview The Limulus Amebocyte Lysate
(LAL) test identifies endotoxins using Regulatory Significance
Pyrogens are substances that can horseshoe crab blood.
induce fever when introduced to the Manufacturers must adhere to
human body, posing a significant risk guidelines on permissible levels of
in sterile products. pyrogens to ensure product safety.
1 3
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Quality Control of Purified Water and Water for Injection
2
Regulatory Compliance
Testing ensures compliance with
regulatory standards.
Essential for Safety
1
Ensures the safety of
pharmaceutical products.
Rigorous Testing
Includes assessments of physical,
chemical, and microbiological
3 properties.
