Impurities Reference Standards

Impurities that go undetected and are not controlled below acceptable limits pose risks to drug development and manufacturing. It’s crucial for manufacturers to limit impurity levels early and throughout the product lifecycle. This involves developing robust analytical methods for impurity detection and control, while also optimizing production to meet patient needs.

Trust official USP Reference Standards, Pharmaceutical Analytical Impurities (PAIs), monographs and general chapters to help ensure accurate complex impurity profiling; develop robust, fit-for-purpose analytical methods; design appropriate stability studies and have confidence about your impurity controls.

 

 

Click on each featured drug to explore USP impurities solutions:

Please note: some links below require a USP-NF account to access.

Included General Chapters

Included Excipients

 

Acetaminophen

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Included General Chapters

Included Excipients

 

Included General Chapters

Included Excipients

Amlodipine

Included General Chapters

Included Excipients

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Azithromycin

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

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Included General Chapters

Included Excipients

Chlorothiazide

Included General Chapters

Included Excipients

Included General Chapters

Included Excipients

  • Magnesium Stearate
    • USP Palmitic Acid RS
    • USP Stearic Acid RS
  • Titanium Dioxide Microcrystalline Cellulose
    • USP Microcrystalline Cellulose RS
  • Corn Starch
  • Silicon Dioxide

Ciprofloxacin

Included General Chapters

Included Excipients

  • Magnesium Stearate
    • USP Palmitic Acid RS
    • USP Stearic Acid RS
  • Titanium Dioxide Microcrystalline Cellulose
    • USP Microcrystalline Cellulose RS
  • Corn Starch
  • Silicon Dioxide

Diclofenac

Included General Chapters

Included Excipients

Diclofenac

Diclofenac

Included General Chapters

Included Excipients

Included General Chapters

Included Excipients

Fluticasone

Included General Chapters

Included Excipients

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Included General Chapters

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Lidocaine

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Included General Chapters

Included Excipients

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Metformin

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Included General Chapters

Included Excipients

Naproxen 

Included General Chapters

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Included Excipients

Ondansetron

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Included Excipients

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Included General Chapters

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Valsartan

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Included General Chapters

Included Excipients