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

Water depyrogenation

A. Distillation (BP)

It is the principal method to avoid water contamination with pyrogens (non-volatile).
It depends on high molecular weight and heat stability of the endotoxins. Low molecular weight
solvents are purified by boiling, condensed vapour collected in pyrogen free container.

B. Reverse osmosis (USP)

Filtration of water under high pressure through semi-permeable membrane (cellulose ester or
polyamides) that separate all substances and most ions (used to prepare water for injection).

C. Ultrafiltration

Can remove endotoxins from solutions by molecular weight.

Depyrogenation of packing materials and
equipment

A. Rinsing with non-pyrogen water

Removing pyrogens from surfaces (Heat labile-materials)

B. Dry Heat:

Inactivation of pyrogens by dry heat at 250°C for 30 min (for thermostable glass ware and
equipment; not for plastic).

3. Clarity

Parenteral solutions must be clear.
Completely free from foreign particles (dust, glass, fiber): WHY?

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