1. What is Uniformity of Weight?

Uniformity of weight is a pharmaceutical quality control test that ensures consistency in the weight of individual dosage units. It involves weighing 20 units and calculating the average weight, with specific acceptance criteria for deviation percentages.

2. How Does the Calculator Work?

The calculator uses the following formula:

Acceptance Criteria:

• No more than 2 individual weights deviate by more than 7.5% from the average weight
• No individual weight deviates by more than 15% from the average weight
• For units weighing 300mg or less, different criteria may apply

3. Importance of Weight Uniformity

Details: Weight uniformity testing ensures consistent drug content in each dosage unit, which is critical for patient safety and therapeutic efficacy. It is a mandatory quality control test for solid oral dosage forms.

4. Using the Calculator

Tips: Enter the individual weights of 20 units in milligrams, separated by commas or spaces. The calculator will compute the average weight and check compliance with pharmacopeial requirements.

5. Frequently Asked Questions (FAQ)

Q1: Why test 20 units specifically?
A: Testing 20 units provides a statistically significant sample size to ensure consistency across the entire batch while maintaining practical testing efficiency.

Q2: What if my units weigh less than 300mg?
A: For units weighing 300mg or less, the acceptance criteria are typically more stringent. Consult the relevant pharmacopeia for specific requirements.

Q3: When should weight uniformity testing be performed?
A: This test should be performed during product development, process validation, and as part of routine quality control testing for solid dosage forms.

Q4: What factors can affect weight uniformity?
A: Machine calibration, powder flow properties, granule size distribution, and compression force can all impact weight uniformity.

Q5: Are there alternatives to weight uniformity testing?
A: For some products, content uniformity testing may be required instead of or in addition to weight uniformity testing, especially for low-dose drugs.