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Subcategory of Pharmaceuticals and APIs

Impurities and reference standards

Pharmacopoeial impurities, related compounds and reference standards used for quality control and method validation.
Chemicals
9,002
Suppliers
6,275
Tablets, capsules and glass vials in a pharmaceutical lab
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About impurities and reference standards

Reference standards are highly characterised materials used to identify substances and measure their purity and impurities. This group covers pharmacopoeial reference standards from bodies such as the USP and the EDQM, secondary or working standards traceable to them, impurity standards and related compounds, metabolites, degradation products, nitrosamine standards, and isotope-labelled internal standards for mass spectrometry.

Read more about impurities and reference standards

Quality control labs, contract research organisations and API manufacturers buy them in milligram quantities for method development, validation and routine release testing. Because a single impurity standard can be hard to make, prices are high and availability changes often. Many suppliers synthesise impurities on request.

Look for a certificate of analysis that explains how the material was characterised, typically by NMR, mass spectrometry, HPLC purity, water and residual solvent content, with an assigned purity or potency value and its uncertainty. Producers accredited to ISO 17034 for reference material production and ISO/IEC 17025 for testing give extra confidence. Check the storage conditions and retest date, and confirm whether a secondary standard is traceable to a primary pharmacopoeial lot.

Top impurities and reference standards

Showing 1 to 48 of 9,002 chemicals, most searched and traded first.

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Guides for buyers

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Frequently asked questions

Quick answers about buying impurities and reference standards on CompoundList.

What are impurities and reference standards?

Pharmacopoeial impurities, related compounds and reference standards used for quality control and method validation.

How many impurities and reference standards are listed on CompoundList?

CompoundList lists 9,002 chemicals in impurities and reference standards. 6,275 suppliers offer products in this category.

Which impurities and reference standards are the most popular?

The most searched and traded impurities and reference standards on CompoundList include Phosphate, Estradiol hemihydrate, Cysteine hydrochloride, Vancomycin and Uridine. They are part of the wider pharmaceuticals and APIs family.

How do I buy impurities and reference standards in bulk?

Open a chemical to compare its suppliers, or post one buy request with the product, grade, quantity and destination. Matching suppliers send you quotes, and your contact details stay private until you accept one.

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Cannot find the impurities and reference standards you need?

Post one buy request with the grade, quantity and destination. Matching suppliers send you quotes, and your contact details stay private until you accept one.