The Uniformity of Content test is critical for single-dose pharmaceutical preparations, especially for

those with low doses of active ingredients. Here’s a breakdown of the guidelines as per the British
Pharmacopoeia (BP), Indian Pharmacopoeia (IP), and International Pharmacopoeia (PhInt):

1. Scope:

o BP: This test applies to single-dose preparations like suspensions, powders, and granules
intended for oral solutions or suspensions, provided the active ingredient is less than 2
mg or less than 2% of the total mass. If there are multiple active substances, the test
only applies to those that meet these conditions.

o IP: Applies to single-dose suspensions, powders, or granules with less than 10 mg or less
than 10% active ingredient.

2. Procedure:

o BP: Perform an assay on 10 individual units using a suitable analytical method. Assay the

delivered dose. The acceptance value is calculated using the formula: ∣M−X∣+KS|M - X| +
dose removed from each container, ensuring it's mixed well, and express results as

KS∣M−X∣+KS Where:

 MMM = Reference value

 XXX = Mean of individual content as a percentage of label claim

 KKK = Acceptability constant

 SSS = Sample standard deviation

3. Acceptance Criteria:

o As per BP, IP, and PhInt:

 The preparation passes if no more than one unit is outside 85–115% of the
average content and none are outside 75–125%.

 It fails if more than three units are outside 85–115%, or if any unit is outside 75–
125%.

 If two or three units fall between 85–115% but within 75–125%, test another 20
units. The preparation passes if, among the 30 units, no more than three units
are outside 85–115%, and none are outside 75–125%.

4. PhInt Specifics:

o PhInt specifies this test for single-dose oral suspensions containing less than 5 mg or less
than 5% of the total weight per dose.

5. Content Uniformity (CU) vs. Mass Variation (MV):

o According to BP and USP-NF, limits for CU and MV are as follows:

 Solutions: MV for both high and low doses.

he Uniformity of Mass test is essential for ensuring consistent mass across single-dose preparations.
Here’s a breakdown of the requirements according to the British Pharmacopoeia (BP), European
Pharmacopoeia (PhEur), and International Pharmacopoeia (PhInt):

1. Applicability:

 BP: This test applies to single-dose preparations in various forms, including:

o Solutions and emulsions

o Single-dose powders and granules intended for syrups, oral solutions, or suspensions

o Single-dose powders for oral drops

2. Procedure:

 Weighing: Select 20 dosage units randomly and weigh each individually, ensuring the contents
are emptied as completely as possible. Calculate the average mass.

3. Acceptance Criteria:

 Solutions and Emulsions: As per BP, PhEur, and PhInt, not more than 2 of the 20 individual
masses should deviate by more than 10% from the average mass, and none should deviate by
more than 20%.

 Powders and Granules: For single-dose powders and granules, BP specifies that no more than 2
individual masses should deviate from the average mass by the percentage limits in Table 2
below, and none should deviate by more than twice that percentage.

4. BP Limits for Uniformity of Mass:

 Table 2 provides BP limits for allowable deviations based on the average mass:

Average Mass (mg) Percentage Deviation (%)

Less than 300 10%

300 or more 7.5%

This test ensures the mass of single-dose preparations remains within acceptable limits, enhancing
dosage accuracy and patient safety.

.6 Mass Variation

The Mass Variation test in the British Pharmacopoeia (BP) ensures uniformity in the active ingredient's
content for liquid doses:

1. Procedure:

o Weighing: Measure the mass of the liquid removed from each of 10 individual
containers under normal use conditions.
 o Volume Calculation: If necessary, compute the equivalent volume by determining the
density.

o Content Calculation: Calculate the active substance content for each container from the
mass removed and the assay results.

2. Acceptance Value Calculation:

o Use the formula: Xi=Wi×AWX_i = W_i \times \frac{A}{W}Xi=Wi×WA Where:

 XiX_iXi: Individual estimated content of the dosage unit

 WiW_iWi: Individual mass of the dosage unit

 AAA: Content of active substance as a percentage of the label claim (from assay)

 WWW: Mean of individual weights

3. Acceptance Criteria:

o Initial Test: The requirement is met if the acceptance value of the 10 units is ≤ 15%.

o Re-test if Necessary: If the acceptance value > 15%, test an additional 20 units.

o Final Requirement: The preparation passes if the final acceptance value of 30 units is ≤
15%, and no individual content is less than (1−25×0.01)M(1 - 25 \times
0.01)M(1−25×0.01)M or more than (1+25×0.01)M(1 + 25 \times 0.01)M(1+25×0.01)M,
ensuring the content remains within ±25% of the label claim.

4.7 Uniformity of Volume

The Uniformity of Volume test in the Indian Pharmacopoeia (IP) ensures that oral liquids and
suspensions have consistent fill volumes:

1. Applicability:

o This test applies to oral liquids and viscous oral suspensions.

2. Procedure:

o Sampling: Select a sample of 10 filled containers.

o Weighing: Weigh each container's contents and determine weight per mL to calculate
the net volume.

o Volume Determination for Non-viscous Liquids: For free-flowing liquids, pour contents
into calibrated volume measures to determine the net volume.

3. Acceptance Criteria:
 o Initial Test: The average net volume of the 10 containers should meet or exceed the
labeled amount. No single container should deviate beyond the percentages in Table 3
below.

o Re-test if Necessary: If the initial test fails, measure the net volume of 10 additional
containers.

o Final Requirement: The average net volume of 20 containers should meet or exceed the
labeled amount, and no more than 1 container should fall outside the specified limits
based on labeled volume.

4. IP Limits for Uniformity of Volume:

Net Volume (mL) Percentage Deviation (%)

50 or less 9%

More than 50 but not more than 200 4.5%

More than 200 but not more than 300 3%

This test confirms consistent volume for accurate dosing, especially in liquid formulations.

4.8 Uniformity of Weight

The Uniformity of Weight test, as per the Indian Pharmacopoeia (IP), ensures consistent weight for
powders intended for oral liquids:

1. Procedure:

o Sample Selection: Choose 10 filled containers and remove any labels that may alter the
weight.

o Weighing Process:

 Clean, dry, and weigh each container with its contents.

 Carefully remove the contents from each container. If necessary, open and wash
the container with a suitable solvent, ensuring all parts (e.g., closure) are
retained.

 Dry the container and reweigh it along with its components. The difference
between the two weights gives the net weight of the contents.

2. Acceptance Criteria:

o The average net weight of the 10 containers must be at least the labeled amount.

o No single container should deviate from the labeled amount by more than the limits in
Table 4:
 Net Weight (g) Percentage Deviation (%)

50 or less 9%

More than 50 but not more than 100 4.5%

3. Re-test if Necessary:

o If the initial test fails, measure the net weight of 10 additional containers.

o The average of the 20 containers must meet the labeled amount, and only one container
may be outside the limits of:

 91–109% for labeled amounts ≤ 50 g

 95–104.5% for labeled amounts > 50 g and ≤ 100 g

4.9 Dose and Uniformity of Dose (Oral Drops)

The Dose and Uniformity of Dose test in BP and PhInt ensures precise dosing for oral drops:

1. Procedure:

o Dropping Test: Use the dropping device to add the prescribed number of drops into a
graduated cylinder at a rate not exceeding 2 drops per second. Weigh each addition,
repeating until 10 individual masses are obtained.

2. Acceptance Criteria:

o No single mass should deviate by more than 10% from the average mass.

o The total mass of the 10 doses should not differ by more than 15% from the nominal
mass.

o If needed, measure the total volume of 10 doses, ensuring it does not deviate by more
than 15% from the nominal volume.

4.10 Uniformity of Mass of Delivered Doses (Multi-dose Containers)

For liquid preparations in multi-dose containers, BP and PhInt specify a Uniformity of Mass of Delivered
Doses test to verify consistency in dosing:

1. Procedure:

o Sample Selection: Weigh 20 doses randomly taken from one or more containers, using
the device provided to measure each dose.

o Determine the individual and average mass of the doses.

2. Acceptance Criteria:
 o No more than 2 of the individual masses should deviate from the average by more than
10%.

o No dose should deviate by more than 20%.

These tests ensure accurate dosing and content consistency in pharmaceuticals, particularly in multi-
dose and unit-dose forms.

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