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1. IPQC and FPQC TESTING
FOR
PARENTERAL DOSAGE
FORMS
BY SHRIYA TELI
KAJAL DESHMUKH

2. PARENTERALS
Parenteral preparations are sterile products which are directly administered into your body by injection.
They are in form of sterile solutions/suspensions of drug in aqueous or oily vehicle which provide faster absorption and
rapid site of action.
They are classified as follows
Based on types of packaging
a) Single dose units: ampoules, infusions and prefilled disposable syringes.
b) Multiple dose units: multiple dose vials.
Based on the production and control
a) Small volume parenteral: volume < 100 ml,
b) Large volume parenteral: volume ≥ 100 ml,
IPQC TESTS
•IPQC means controlling the procedures involved in manufacturing of the dosage forms starting from raw materials
purchase to dispatch of the quality product in ideal packaging.
•It monitors all the features of the product that may affect its quality and prevents errors during processing.
•These are the tests performed between QA and QC and provides for the authorization of approved raw materials
for manufacturing based on actual laboratory testing generally called as IPQC such as physical, chemical,
microbiologic and biologic tests.
• IPQC is concerned with providing accurate, specific & definite descriptions of the procedures to be employed,
from, the receipt of raw materials to the release of the finished dosage forms.

3. Conductivity measurement
• Conductivity test measures the vehicle’s ability to conduct electricity due to presence or absence of certain ions.
• While pure water conducts electricity poorly, water with certain chemicals / elements has certain conductivity of
electricity.
• Also if water is more saline or warmer – it tends to have more conductivity.
• Determined using conductivity meter.
• Conductivity meter is calibrated in std solution and consequently the probe is immersed in samples
• Result / reading should not be more than 1.3 μS/cm at 25⁰C considered within the specification
PH determination
Ph is the critical aspect of parenteral formulation as the target ph should be close to physiological ph.
Acceptable ranges :
• Intravenous injection – ph 2-11
• Subcutaneous injection – ph 4-9
• ph is measured by using a pH meter .
• ph meter is initially calibrated with respective buffer capsule then the pH of the preparation is
measured.
Osmolarity
• Parenteral formulation should be ideally isotonic
• If Hypertonic solution – can cause blood cell deformation
Hypotonic solution – lead to rupture of blood cells – result in heamolysis
• Formulation with osmotic values range of 250-350 OsM are acceptable

4. Content uniformity & weight
it is done to determine the concentration of API in parenteral preparation
The test is mainly intended for sterile parenteral solid preparations
• Determine the content weight of the active ingredient of each of 10 containers taken at random.
• Content is removed from them and empty individual sterile unit is weighed and noted
• The net is calculated as Gross weight – empty sterile unit weight
• The preparation under examination complies with the test if the individual values thus obtained are all
between 85 and 115 percent of the average value.
• The preparation under the examination fails to comply with the test if more than one individual value is
outside the limits 85 to 115 percent of the average value or if any one individual value is outside the limits 75
to 125 percent of the average value. If one individual value is outside the limits 85 to 115 percent but within
the limits 75 to 125 percent of the average value, repeat the determination using another 20 containers taken at
random.
• The preparation under examination complies with the test if in the total sample of 30 containers not more than
one individual value is outside the limits 85 to 115 percent and none is outside the limits 75 to 125 percent of
the average value.

5. Extractable volume
Method I: Where the nominal volume does not exceed 5ml
• Use 6 containers, 5 for the tests and 1 for rinsing the syringe used.
• Using a syringe with appropriate capacity, rinse the syringe and withdraw as much as possible the contents
of one of the containers reserved for the test and transfer, without emptying the needle, to a dry graduated
cylinder of such capacity that the total combined volume to be measured occupies not less than 40% of the
nominal volume of the cylinder.
• Repeat the procedure until the contents of the 5 containers have been transferred and measure the volume.
The average content of the 5 containers is not less than the nominal volume and not more than 115% of the
nominal volume.
• Alternatively the volume of contents in milliliter can be calculated as mass in grams divided by the density.
Method II: Where the nominal volume is more than 5ml
• Transfer the contents of not less than 3 containers separately to dry graduated cylinders such that the
volume to be measured occupies not less than 40% of the nominal volume of the cylinder and measure the
volume transferred.
• The contents of each container are not less than the nominal volume and not more than 110% of the
nominal volume

6. CLARITY TESTING (DETECTION OF PARTICULATE MATTER)
Parenteral preparations should be free from particulate matter and should be clear
Visual method
In visual inspection, each injectable is inspected visually against white and black backgrounds.
• The white background aids in detection of dark colored particles.
• The light or reflective particles will appear against the black back ground. Some visual-enhancing aids can increase the
efficiency.
• A magnifying lens at 2.5x magnification set at the eye level facilitates the inspection. Microscopic examination enhances
detection of particulate matter in injectable.
• Visual inspection gives the qualitative estimation of the particulate matter.
• Acceptance Standards is that each container checked must not contain any visible particulate matter.
Light obstruction method
• Tungsten lamp produces a constant collimated beam of light that pass through a small rectangular passageway and collides
onto a photodiode.
• Liquid can flow through the passageway between the light source and photodiode.
• If a single particle transverses the light beam there results a reduction in normal amount of light received by the photodiode.
This reduction of light and the measurable decrease in the output from the photodiode is proportional to the area of the
particle interrupting the light flow
• Thus light obscuration principle measures particle size based on diameter of circle having equivalent area.
• Acceptance criteria> As per USP
• LVP: NMT 50 particles/ml (size 10 or more than 10 micrometer) & 5 particles/ ml (size more than 25 micrometer)
• SVP: 10,000 particles/ container of size 10 micrometer or greater &NMT 1000 particles/ container greater than 25
micrometer.