Application: TOC in Pharmaceutical Waters

The US Pharmacopeia specifies Total Organic Carbon (TOC) for the detection of organic contaminants in Purified Water (PW) and Water For Injection (WFI).

Pharmaceutical Industry Oversight:

Broadly, the pharmaceutical industry manufactures medicines, food ingredients, and supplements. While the Food and Drug Administration (FDA) provides oversight and regulation, many of the standards enforced by the FDA are developed, documented and maintained by the US Pharmacopaeia (USP).

Pharmaceutical Waters:

Since pharmaceutical products are largely intended for human consumption, strict purity standards exist for Pure Water (PW) and Water for Injection (WFI). Monitoring contaminants at near-zero levels requires instruments that can pass a rigorous System Suitability Test (SST) and can be calibrated using USP-compliant methods.

USP specifies Total Organic Carbon (TOC) for the detection of organic contaminants in pharmaceutical waters. Purified Water (PW) and Water For Injection (WFI) must be maintained at TOC levels ≤ 500 ppb (≤ 0.5 mg/L). Many pharmaceutical plants choose to monitor TOC online, which enables continuous, rapid detection of upsets in the water filtration systems.

What is TOC?

Since there are millions of organic compounds, organic contaminants are detected as an aggregate rather than analyzing for specific analytes, and since all organic compounds contain carbon, measuring carbon content provides a means of detecting organic compounds. A few carbon compounds are not organic. To achieve a true TOC measurement, these inorganic compounds can be removed through acidification before measuring the sample.

Selecting an Appropriate TOC Analyzer:

For TOC, USP does not specify the equipment or method to be used. Instead, the selected equipment must stand up to the challenges of a defined System Suitability Test (SST). The SST challenges the analyzer to measure two chemicals of different chemical composition (but equal carbon content) to respond equally. The USP’s SST specifies solutions of sucrose (easy to oxidize) and 1,4- benzoquinone (difficult to oxidize) as testing reagents. These two organic compounds challenge the bond-breaking and oxidation abilities of the analyzer. During the SST, reagent water is also analyzed to establish suitable rates of recovery.

A TOC Analyzer Designed for the Pharmaceutical Industry:

The QuickTOCtrace has been developed to measure TOC accurately and repeatably in the very low ppb ranges found in high purity water. The analyzer utilizes a straight-forward differential conductivity method.

The QuickTOCtrace Advantages
• No pre-filtration required
• A single UV light source with a long life span
• Built-in SST procedure complies with US Pharmacopeia
• <30 second response, fast recovery time (less than 3 minutes)
• Easy to use / maintain – complete access to analyzer
• Calibration only required annuallyl

Click HERE to find out more about the QuickTOCtrace