Confidence and certainty about impurities
Confidence and certainty about impurities

Confidence and certainty about impurities

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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 that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

 

Acetaminophen

Acetaminophen

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

RS General Chapters 

Included Excipients 

Adapalene

Adapalene

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

RS General Chapters 

Included Excipients 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

General Chapters 

Included Excipients 

Alprazolam

Alprazolam

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

General Chapters 

Included Excipients 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Amlodipine

Amlodipine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters 

  • 〈11〉 USP Reference Standards
  • 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
  • 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
  • 〈71〉 Sterility Tests 〈85〉 Bacterial Endotoxins Test USP Endotoxin RS
  • 〈197〉 Spectroscopic Identification Tests
  • 〈201〉 Thin-Layer Chromatographic Identification Test USP Bacitracin Zinc RS USP Neomycin Sulfate RS USP Polymyxin B Sulfate RS
  • 〈223〉 Dimethylaniline
  • 〈425〉 Iodometric Assay—Antibiotics
  • 〈621〉 Chromatography
  • 〈659〉 Packaging and Storage Requirements
  • 〈695〉 Crystallinity
  • 〈698〉 Deliverable Volume
  • 〈701〉 Disintegration
  • 〈711〉 Dissolution USP Dissolution Performance Verification Standard-Prednisone RS
  • 〈791〉 pH
  • 〈905〉 Uniformity of Dosage Units
  • 〈921〉 Water Determination USP Sodium Tartrate Dihydrate RS 

Included Excipients 

  • USP Monograph: Magnesium Stearate
  • USP Monograph: USP Palmitic Acid RS
  • USP Monograph: USP Stearic Acid RS
  • USP Monograph: Silicon Dioxide
  • USP Monograph: Microcrystalline Cellulose
    • USP Microcrystalline Cellulose RS
  • USP Monograph: Titanium Dioxide
  • USP Monograph: Talc
  • USP Monograph: Hypromellose
Amoxicillin

Amoxicillin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters 

  • 〈11〉 USP Reference Standards
  • 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
  • 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
  • 〈71〉 Sterility Tests 〈85〉 Bacterial Endotoxins Test USP Endotoxin RS
  • 〈197〉 Spectroscopic Identification Tests
  • 〈201〉 Thin-Layer Chromatographic Identification Test USP Bacitracin Zinc RS USP Neomycin Sulfate RS USP Polymyxin B Sulfate RS
  • 〈223〉 Dimethylaniline
  • 〈425〉 Iodometric Assay—Antibiotics
  • 〈621〉 Chromatography
  • 〈659〉 Packaging and Storage Requirements
  • 〈695〉 Crystallinity
  • 〈698〉 Deliverable Volume
  • 〈701〉 Disintegration
  • 〈711〉 Dissolution USP Dissolution Performance Verification Standard-Prednisone RS
  • 〈791〉 pH
  • 〈905〉 Uniformity of Dosage Units
  • 〈921〉 Water Determination USP Sodium Tartrate Dihydrate RS 

Included Excipients 

  • USP Monograph: Magnesium Stearate
  • USP Monograph: USP Palmitic Acid RS
  • USP Monograph: USP Stearic Acid RS
  • USP Monograph: Silicon Dioxide
  • USP Monograph: Microcrystalline Cellulose
    • USP Microcrystalline Cellulose RS
  • USP Monograph: Titanium Dioxide
  • USP Monograph: Talc
  • USP Monograph: Hypromellose

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Azithromycin

Azithromycin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Benztropine

Benztropine

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Included General Chapters

Included Excipients

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Included General Chapters

Included Excipients

Cefaclor

Cefaclor

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Chlordiazepoxide

Chlordiazepoxide

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Chlorhexidine

Chlorhexidine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Chlorothiazide

Chlorothiazide

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

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

Ciprofloxacin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

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

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Citalopram

Citalopram

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Clobetasol

Clobetasol

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Included General Chapters

Included Excipients

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Included General Chapters

Included Excipients

Clotrimazole

Clotrimazole

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Cytarabine

Cytarabine

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Diclofenac

Diclofenac

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Diphenhydramine

Diphenhydramine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Docetaxel

Docetaxel

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Compound B, Compound D

Included General Chapters

Included Excipients

Dorzolamide

Dorzolamide

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Compound B, Compound D

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Fexofenadine

Fexofenadine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Fluticasone

Fluticasone

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Furosemide

Furosemide

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Glimepiride

Glimepiride

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters 

Included Excipients 

Glyburide

Glyburide

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters 

Included Excipients 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Irinotecan

Irinotecan

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters 

Isoflurane

Isoflurane

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Ketoprofen

Ketoprofen

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Ketorolac

Ketorolac

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Latanoprost

Latanoprost

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Levodopa

Levodopa

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Levofloxacin

Levofloxacin

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Lidocaine

Lidocaine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Linezolid

Linezolid

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Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Memantine

Memantine

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Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Metformin

Metformin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Methotrexate

Methotrexate

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Methylphenidate

Methylphenidate

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

General Chapters

Included Excipients 

Naloxone

Naloxone

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General Chapters

Included Excipients 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Naproxen 

Naproxen 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

  • 〈11〉 USP Reference Standards
  • 〈197〉 Spectrophotometric Identification Tests
  • 〈281〉 Residue on Ignition
  • 〈621〉 Chromatography
  • 〈711〉 Dissolution
    • USP Dissolution Performance Verification Standard-Prednisone RS
  • 〈724〉 Drug Release
  • 〈731〉 Loss on Drying
  • 〈857〉 Ultraviolet-Visible Spectroscopy
  • 〈905〉 Uniformity of Dosage Units

Included Excipients

  • USP Monograph: Magnesium Stearate
    • USP Palmitic Acid RS
    • USP Stearic Acid RS
  • USP Monograph: Lactose Monohydrate
    • USP Dextrose RS
    • USP Fructose RS
    • USP Lactose Monohydrate RS
    • USP Sucrose RS
  • USP Monograph: Magnesium Stearate
    • USP Palmitic Acid RS
    • USP Stearic Acid RS
  • USP Monograph: Talc
  • USP Monograph: Hypromellose
Nifedipine

Nifedipine

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

  • 〈11〉 USP Reference Standards
  • 〈197〉 Spectrophotometric Identification Tests
  • 〈281〉 Residue on Ignition
  • 〈621〉 Chromatography
  • 〈711〉 Dissolution
    • USP Dissolution Performance Verification Standard-Prednisone RS
  • 〈724〉 Drug Release
  • 〈731〉 Loss on Drying
  • 〈857〉 Ultraviolet-Visible Spectroscopy
  • 〈905〉 Uniformity of Dosage Units

Included Excipients

  • USP Monograph: Magnesium Stearate
    • USP Palmitic Acid RS
    • USP Stearic Acid RS
  • USP Monograph: Lactose Monohydrate
    • USP Dextrose RS
    • USP Fructose RS
    • USP Lactose Monohydrate RS
    • USP Sucrose RS
  • USP Monograph: Magnesium Stearate
    • USP Palmitic Acid RS
    • USP Stearic Acid RS
  • USP Monograph: Talc
  • USP Monograph: Hypromellose

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Olanzapine

Olanzapine

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Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

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Included General Chapters

Included Excipients

Ondansetron

Ondansetron

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Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Orlistat

Orlistat

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Omeprazole

Omeprazole

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Oxaliplatin

Oxaliplatin

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Paclitaxel

Paclitaxel

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Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

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Included General Chapters

Included Excipients

Palonosetron

Palonosetron

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Included General Chapters

Included Excipients

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Included General Chapters

Included Excipients

Praziquantel

Praziquantel

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Included General Chapters

Included Excipients

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Included General Chapters

Included Excipients

Pregabalin

Pregabalin

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Included General Chapters

Included Excipients

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Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Ritonavir

Ritonavir

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Pharmaceutical Analytical Impurities

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Included Excipients

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Sertraline

Sertraline

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

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RENAL

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Sevelamer

Sevelamer

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RENAL

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Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Sulfamethoxazole

Sulfamethoxazole

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Pharmaceutical Analytical Impurities

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Tacrolimus

Tacrolimus

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Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

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Included General Chapters

Included Excipients

Telmisartan

Telmisartan

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Included General Chapters

Included Excipients

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Pharmaceutical Analytical Impurities

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Included Excipients

Timolol

Timolol

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Pharmaceutical Analytical Impurities

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Included Excipients

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Included General Chapters

Included Excipients

Tinidazole

Tinidazole

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Included General Chapters

Included Excipients

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Pharmaceutical Analytical Impurities (PAI)

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Included Excipients

Travoprost

Travoprost

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI)

Included General Chapters

Included Excipients

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients

Valproate

Valproate

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters

Included Excipients