Page 61 - Dosage 1-part2 -ebook_Neat

30/10/2025, 00:02 Pharmaceutical Solutions & Sterile Dosage Forms

Disadvantages

Many factors may affect the test results (pH, ions in solution)

Detect pyrogens of Gram-negative bacteria (more dangerous and common) but not that of
Gram positive or pyrogenic material.

Clarity test for sub-visible particles

1. Direct measurement:

Measure the number and size of the particles present in the solution directly Using coulter
counter or laser diffraction:

Product Type Max particles ≥ 10 μm Max particles ≥ 25 μm
LVP 25 particles /mL 3 particles /mL
SVP 6000 particles / container 600 particles / container

2. Microscopical measurement:

Filter a certain volume of injection through membrane filter.
Calculate the number and size of particles microscopically:

Product Type Max particles ≥ 10 μm Max particles ≥ 25 μm
LVP 12 particles /mL 2 particles /mL
SVP 3000 particles / container 300 particles / container

Sterile Liquid Dosage Forms (Parenteral Preparations) - Lecture 3 58/77
Faculty of Pharmacy, Alexandria University

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