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

Antimicrobial agents in parenterals

Antimicrobial agents are added to multi-dose vials.
Protect the injection from contamination during production, use and storage.

Preservatives are not added to LVP (single dose containers discarded after opening); WHY??

Not used if the drug itself has antimicrobial effect.

NOTE: Preservative uptake is more significant with natural and neoprene rubber.

Much less uptake with butyl rubber closures.

An ideal preservative must be:

Effective against a wide range of bacteria
Non-toxic in the concentration used
Stable
Compatible with injection component (No interaction)

Commonly used preservatives in multi-dose injections

Preservative Concentration

Phenol 0.5%

m-Cresol 0.1-0.3%

Chlorobutanol 0.5%

Thimerosal 0.001-0.01%

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