USP <643> Compliant Total Organic Carbon Testing
Independent laboratory testing for organic impurities in purified water and WFI systems.
TOC Testing Built for Pharmaceutical Quality Standards
When pharmaceutical water quality must meet strict standards, dependable data is essential. Bird Dog Laboratories provides USP <643>-compliant Total Organic Carbon (TOC) testing through an ISO 17025-accredited laboratory, helping teams evaluate organic contamination, support quality programs, and make informed decisions based on reliable laboratory results.
What Does Total Organic Carbon Testing Measure?
TOC testing provides a precise measure of carbon associated with organic compounds in pharmaceutical water. Rather than identifying individual contaminants, it helps indicate whether organic contamination may be affecting overall water quality. USP <643> establishes the framework for separating organic from inorganic carbon and accurately evaluating water purity.
Water Purity
Assess water purity by measuring the overall level of organic carbon, which clearly indicates potential organic contamination.
Purification System Performance
Reveal changes in purification system performance, helping identify potential contamination, process inconsistencies, or other issues that may require further investigation.
Potential Contamination
Indicate potential contamination, prompting further investigation into the water system, process conditions, materials, or other possible sources of organic impurities.
Process Consistency
Monitor process consistency over time, confirming that organic contamination remains controlled and supporting reliable pharmaceutical water quality standards.
Who Needs USP <643> Total Organic Carbon Testing?
Pharmaceutical Manufacturers
For teams verifying pharmaceutical water quality, supporting quality-control programs, evaluating unexpected results, or documenting regulatory compliance.
Quality & Regulatory Teams
For organizations that need independent laboratory data for internal quality procedures, investigations, validation activities, or supporting documentation.
Pharmaceutical & Biopharmaceutical Operations
For organizations using purified water or WFI that need to assess organic contamination in their water systems.
Other Regulated Industries
- Pharmaceutical & Biopharmaceutical
- Medical Device
- Packaging Manufacturers
- Chemical Manufacturers
- Consumer Products
Understanding USP <643> Requirements
USP <643> establishes acceptance criteria for evaluating TOC results in pharmaceutical water. Compliance may include system suitability testing with reference standards and response-efficiency requirements, with final interpretation based on the applicable USP methodology and laboratory procedures.
- Appropriate instrumentation
- Ability to distinguish organic from inorganic carbon
- Instrument/system suitability
- Reference standards
- Representative sampling
- Sample/container preparation
- Documented procedures
- Evaluation against the applicable acceptance criteria
Why TOC Testing Matters for Pharmaceutical Water
Pharmaceutical water is used throughout formulation, processing, and equipment cleaning, making its purity essential to protecting product quality, process consistency, and patient safety.
Even trace organic contaminants can compromise batch quality, risk microbial growth, and trigger costly regulatory citations. Our USP <643> testing provides the precision and documentation needed to keep your operations compliant and moving forward.
How to Send TOC Samples to Bird Dog Laboratories
Sending your Total Organic Carbon (TOC) samples to Bird Dog Laboratories is a straightforward process designed to ensure accurate and reliable testing. Follow these steps to ensure your samples are handled correctly and meet all necessary requirements.
1. Discuss Your Testing Requirements
2. Receive Sampling & Shipping Instructions
3. Collect Your Samples
4. Ship Samples to the Laboratory
5. Receive Your Results
Bird Dog completes the testing and supplies the applicable laboratory documentation/report.
6. Follow Up With Questions
Bird Dog remains available to answer questions, clarify results, and guide additional testing needs.
From Sample to Report: What Working With Bird Dog Looks Like
Technical Testing. Tailored to Your Requirements.
ISO 17025-Accredited Testing
Bird Dog provides independent, ISO 17025-accredited laboratory testing, including USP <643> TOC testing.
Decades of Industry Experience
Decades of pharmaceutical and package-testing experience give us a thorough understanding of regulated environments, technical requirements, and quality expectations.
Testing Built Around Your Requirements
Our team tailors testing and reporting to your specific objectives, helping ensure each project aligns with your technical and quality requirements.
Pharmaceutical Expertise & Beyond
Bird Dog supports pharmaceutical organizations and other regulated industries with technical laboratory testing tailored to diverse products, materials, and quality requirements.
FAQs About Total Organic Carbon Testing
What is a total organic carbon test?
A total organic carbon (TOC) test measures the amount of carbon associated with organic compounds in water. It provides an overall indicator of organic contamination and is commonly used to help assess pharmaceutical water purity and system performance.
Why is TOC measured in pharmaceutical water?
TOC is measured in pharmaceutical water to help monitor organic impurities that could affect water quality, manufacturing processes, or finished products. Routine testing supports quality control, regulatory compliance, and the ongoing evaluation of purified water and Water for Injection (WFI) systems.
What is USP <643>?
USP <643> is a US Pharmacopeia general chapter that establishes requirements for measuring TOC in pharmaceutical water. It provides a standardized framework for evaluating organic contamination and supporting the quality control of purified water and Water for Injection (WFI).
How should I ship samples for USP <643> TOC testing?
Collect, label, store, and ship samples according to Bird Dog Laboratories’ specific instructions to help prevent contamination or sample degradation. Contact the laboratory before shipping to confirm container requirements, sample volume, handling procedures, documentation, and any time-sensitive shipping requirements.
How long does TOC testing take?
Turnaround times for TOC testing vary by project scope, sample requirements, and laboratory workload. Bird Dog Laboratories can provide an estimated timeline after reviewing your testing needs and confirming the appropriate USP <643> testing parameters.
Get Clear, Reliable TOC Data for Your Next Step
Support pharmaceutical water quality with reliable USP <643> Total Organic Carbon testing from an independent, ISO 17025-accredited laboratory. Bird Dog provides dependable data for purified water and Water for Injection (WFI) systems, plus customized support to meet quality requirements, inform regulatory decisions, and keep your testing program moving forward.
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Let’s Get Started.
Ensuring product quality through functional testing of packaging systems.
