Total Organic Carbon (TOC) Testing

Why is TOC Testing Important?

TOC is a unit of measurement of organic carbon in a sample. In the pharmaceutical industry, it is used as a comprehensive indicator of water quality to evaluate the concentration of organic pollutants in water bodies and the degree of pollution of water quality. Since high-purity water plays a key role in the entire pharmaceutical production process,  pharmaceutical companies can evaluate whether the water quality meets the standard requirements for pharmaceutical production and whether it may have an impact on product quality by measuring the organic carbon content in water samples. High organic carbon content may lead to the proliferation of microorganisms in the water, affecting product purity and stability, and even affecting clinical trial results. Additionally, organic compounds can combine with other elements to form molecules that can cause harm to the environment once the water is discharged.

Explore Our Total Organic Carbon (TOC) Testing Services

As an expert in the development of innovative drug delivery systems and a global leader in CMC analysis, CD Formulation provides unparalleled TOC analysis services to global customers for drug development to monitor the overall level of organic compounds in pharmaceutical water.

Our TOC analysis experts can provide a variety of oxidation and detection methods based on the nature, concentration, and analysis requirements of TOC to be measured, including:

• High-temperature combustion: Involves high-temperature combustion at 1,200°C in an oxygen-rich atmosphere and is measured by non-dispersive infrared absorption (NDIR).
• Catalytic oxidation: Involves high-temperature catalytic oxidation using a platinum catalyst at 680°C in an oxygen-rich atmosphere, followed by NDIR measurements.
• Thermochemical oxidation: This involves combining thermochemical oxidation with heat and a chemical oxidizing agent (usually persulfate) for measurement.
• Photochemical oxidation: This involves combining photochemical oxidation with UV light and persulfate for measurement.
• Photooxidation: Involves the use of UV light or catalysts for measurement.

Note:

• For water with high TOC concentration (ppm or higher) or high particulate matter content, we usually use high-temperature combustion methods and catalytic oxidation methods.
• For pharmaceutical water from drinking water to pharmaceutical and electronic grade, we usually use the thermochemical oxidation method and photochemical oxidation method.
• For ultrapure water, we usually use photooxidation.

CD Formulation also has the ability to perform TOC analysis on cleaning validation samples to ensure that no cross-contamination or other quality issues arise during subsequent production processes.

How do We Measure TOC?

Our TOC analysis experts usually use a TOC analyzer for measurement. Once completed a TOC analysis, the following parameters are measured:

• Total organic carbon (TOC)
• Total Carbon (TC)
• Inorganic carbon (IC)
• Can purify organic carbon (POC)
• Non-removable organic carbon (NPOC)
• Dissolved organic carbon (DOC)
• Insoluble organic carbon (NDOC)

Your target TOC result is:

• TOC = TC - TIC
• TOC = POC + NPOC
• TOC = DOC + NDOC

Applicable Standards

CD Formulation's team of TOC analysis experts has the ability to perform TOC testing according to the following standards to ensure that our testing meets regulatory and pharmacopeia requirements.

• United States Pharmacopoeia (USP)
• Japanese Pharmacopoeia (JP)
• European Pharmacopoeia (EP)

Why Choose CD Formulation for Total Organic Carbon (TOC) Testing?

• A wide range of testing options and analysis conditions to meet a variety of sample analysis and data reporting needs.
• Flexible, tailor-made solutions.
• Comprehensive quality assurance expertise in total organic carbon analysis.
• Fast and efficient service ensures that customer projects can be completed on time.

CD Formulation has extensive experience and expertise in performing TOC analysis services. Our team of experienced scientists will work with you to develop a customized testing plan that meets your specific needs. Please contact us to learn more about how we can help you conduct TOC testing and verify the safety of your products to regulatory requirements.