High-Purity Reference Standards and Impurities for Reliable Pharmaceutical Research

In modern pharmaceutical research, even the smallest variation can change the outcome of a study. That is why high-purity reference standards and certified impurities are not just laboratory tools, they are the foundation of reliable drug development. Regulatory agencies, such as the US FDA and EMA, emphasise the use of validated standards to ensure accuracy, reproducibility, and safety. By working with these benchmarks, scientists can confirm analytical methods, profile drug substances with confidence, and expedite submissions for global approvals.
For over two decades, Pharmaffiliates has partnered with leading pharmaceutical companies and CROs worldwide, offering an extensive catalog of reference standards designed to simplify complex R&D challenges.

The Importance of Certified Impurities and Metabolites
Certified impurities and metabolites are crucial for method validation, stability studies, and safety assessments. Using standardised compounds, such as Niflumic Acid impurities or Olmesartan Desmethyl, ensures reproducible results across laboratories. This level of precision is vital for drug development, regulatory submissions, and quality control processes. Explore Pharmaffiliates’ impurity profiling solutions for detailed insights.

Niflumic Acid Impurities for Accurate Drug Profiling
Pharmaffiliates offers high-purity Niflumic Acid impurities, including:
- Impurity A (CAS 2942-59-8)
- Impurity C (CAS 98-16-8)
These impurities are essential for precise drug profiling and analytical method development, ensuring accurate results in pharmaceutical research.

Key Standards Supporting Cardiovascular and CNS Research
Research in cardiovascular and CNS therapeutics requires precise standards. Pharmaffiliates provides:
- Nortriptyline HCl – Impurity E (CAS 6202-23-9) – supports CNS drug studies.
- Olmesartan Desmethyl (CAS 144689-29-2) – essential for cardiovascular research.
These reference standards help researchers validate methods, quantify metabolites, and maintain regulatory compliance.

Advanced Metabolites and Specialized Compounds in Development
Pharmaffiliates also offers specialized compounds and advanced metabolites:
- Carboxy Pioglitazone (CAS 146062-48-8)
- Pitavastatin 3-Oxo Ethyl Ester (CAS 148901-69-3)
These compounds are pivotal for studying drug metabolism, pharmacokinetics, and the development of novel therapeutic agents.

Pharmaffiliates: Trusted Global Partner for Quality Standards
As an ISO 9001:2015, ISO 17025, and ISO 17034 certified company, Pharmaffiliates combines scientific expertise with rigorous compliance practices. Our catalog of more than 10,000 impurity standards and 300,000 compounds is backed by a global network of researchers who rely on our solutions for stability studies, impurity profiling, and method validation.
Clients across the US, Europe, and Asia trust Pharmaffiliates not only for product quality but also for scientific consultation and custom synthesis services. By supporting projects ranging from early-stage discovery to regulatory submissions, we help ensure that pharmaceutical innovations reach patients faster and with uncompromised safety.