Pharmaceutical/API Drug Impurities/Metabolites

An impurity is “any component of the product which is not the chemical entity defined as the active substance or an excipient in the product”.

API Drug Impurities are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. .

A metabolite is the intermediate end product of metabolism. The term metabolite is usually restricted to small molecules. A drug metabolite is a by-product of break down, or “metabolizing,” a drug into a different substance. .

The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product. The control of impurities is an important task pharmaceutical impurities as per the regulatory norms. High Pure and Well characterized impurity Standards are used for Related Substances, Organic impurities and Validation of Analytical Methods. 

Clinivex is the most reliable impurity standards supplier in Canada & USA. We specialized in the custom synthesis of isotopically labelled active pharmaceutical ingredients (API) and their metabolites.

Our quality enables your accuracy, helping you to create ever better safer medicines: products in our Clinivex range of more than 50.000 pharmaceutical API reference standards each come with a comprehensive Certificate of Analysis detailing the material’s characterisation process, supporting your testing needs.

At Clinivex we believe in building long-term relationships – together, we can build solutions to address your specific challenges and requirements. In addition, Clinivex offers quality, consistency, and reliability of supply.

Clinivex catalog showcases a wide range of products, with more than 1,50,000 products in inventory. We provide an extended portfolio of reference standards, research tools, and building blocks expanding product lines includes unique, highly specialized chemicals for drug development, medical and biochemical research.

  • Clinivex is specialized in providing high-quality biochemicals in custom pack sizes to satisfy any quantity required.
  • We distribute products to companies worldwide, usually providing overnight delivery in North America via FedEx Express. We also offer alternative carrier options to meet worldwide delivery and special import requirements and dangerous goods.
  • We have a dedicated professional customer service team positioned to ensure customer satisfaction and technical support.
  • Our expertise in research chemical synthesis, combined with a dedicated & knowledgeable customer service team, makes Clinivex a one-stop solution for all your research needs.


Intended Use: For laboratory research use only and is not suitable for human or animal consumption

Any images used are not necessarily representative of any product offering from the Clinivex and do not constitute the basis for purchase decisions.

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  1. Cimetidine EP Impurity I

  2. Atracurium EP Impurity D Iodide (Mixture of Diastereomers)

  3. Mirabegron EP Impurity C

  4. 2-Amino-5-bromopyridine-3,4,6-d3

  5. N-Acetyl-d -5-methoxytryptamine

  6. (±)-Anatabine-d3 (1,2,3,6-tetrahydropyridinyl-3,3,4-d3)

  7. 2'-Deoxycytidine-5,6-d2

  8. [13C2,15N]-2-(Trifluoromethyl)isonicotinic acid

  9. [15N2]-Hydrazine sulfate salt

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