Stability, Impurity & Method Development Services

Accurate stability testing, impurity profiling, and method development, driving reliable, compliant results.

Scientific Excellence in Stability, Impurity & Method Validation

Robust solutions from raw material to finished product.

At Clinivex, we provide comprehensive stability testing, impurity profiling, and method development services designed to meet the highest scientific and regulatory standards. Our expertise ensures that every compound is analyzed with precision, helping you identify, quantify, and control impurities while validating methods that guarantee accuracy and reproducibility.

With a strong focus on quality, compliance, and innovation, we deliver tailored solutions for pharmaceuticals, biotechnology, and research industries. From stability studies to robust method validation, Clinivex empowers you with reliable data, regulatory confidence, and the scientific excellence needed to accelerate discovery and development.

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Robust Solutions From Raw Material to Finished Product

Clinivex leverages advanced analytical infrastructure and expert scientific talent to meet your quality and regulatory needs at every stage of development.

ICH-compliant stability testing, including accelerated and long-term studies.
Structural elucidation and isolation of known/unknown impurities.
Comprehensive method development and validation (HPLC, GC, LC-MS).
Degradation profiling and batch release testing.
Services aligned with ANDA, DMF, and FDA/EMA submission requirements.

Robust Solutions From Raw Material to Finished Product

Clinivex Impactful numbers

2000+

Trustable Clients
120+

Countries Served
98%

On Time Deliveries

Where Expertise Meets Precision and Quality is Standard

Every product reflects our commitment to expert craftsmanship, accurate results, and global quality standards.

Our Expertise

Expertise is the driving force behind precision and the foundation of quality. With years of experience in pharmaceuticals, life sciences, and industrial markets, our team delivers solutions built on scientific insight, technical excellence, and regulatory compliance. Every product reflects a commitment to accuracy, safety, and reliability.

Customized Solutions

Every research and production challenge is unique, and so are our solutions. By combining scientific expertise with a customer-first approach, we design tailored strategies that address specific requirements, whether it's sourcing rare reference standards, developing impurity libraries, or ensuring compliance-driven logistics.

Quality Assurance

Quality is not just a standard, but it’s a promise. Every product and solution undergoes rigorous validation, compliance checks, and international certifications to ensure reliability at every stage. From raw material sourcing to final delivery, our processes are designed with precision and consistency, giving researchers and industries the confidence to innovate without compromise.

why Choose Clinivex?

At Clinivex, we earn trust by delivering impeccable service, expert guidance, and reliable solutions that drive long-term success. With a skilled team and customer-first approach, we stand as a leading pharmaceutical reference standards supplier in the USA and Canada.