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Potency Testing Benefits and Requirements

ARL BioPharma POTENCY TESTING BENEFITS AND REQUIREMENTS

Potency testing measures the concentration of the active pharmaceutical ingredient (API). This essential test ensures the API concentration matches its intended amount and provides value-added benefits to pharmacies including:

Extending Beyond Use Dating and Release Testing

The practice of assigning beyond-use dates for compounded sterile preparations (CSPs) is complicated and often misunderstood. A CSP's beyond-use date identifies the time by which the preparation – once mixed – must be used before it is at risk for chemical degradation, contamination, and packaging permeability.

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Endotoxin Essentials

Pyrogens are a group of fever causing substances.  The most widely known pyrogen is bacterial endotoxins.

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Basics of Sterility Testing

According to research data from Pew Charitable Trusts, over 50 compounding errors with 1,227 adverse events and 99 deaths have been reported from 2001-2017.  Contamination of sterile products was the most common compounding error. 

Testing the finished drug product is important to ensure drugs delivered to patients are free of contamination.  

USP <797> Pharmaceutical Compounding – Sterile Preparations states that certain compounded sterile preparations (CSPs) must undergo sterility testing prior to being dispensed. This requirement is based on multiple factors, including batch size, risk level, and storage conditions.

A validated sterility test can detect microbial contamination in a drug product.

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