Dietary Supplements
A definitive resource and compendium providing access to in-depth, comprehensive information for all aspects of quality in dietary supplements manufacturing, including monographs, general chapters, and admission evaluation summaries.
Dietary Supplements Compendium (DSC)
An annually updated definitive resource providing access to in-depth, comprehensive information for all aspects of quality in dietary supplements manufacturing, research, and regulatory affairs.
Dietary Supplements Verification Program
An independent third-party verification program offered by USP that evaluates dietary supplement manufacturing facilities, reviews documentation, and tests products to ensure quality and compliance with standards.
USP-NF
United States Pharmacopeia-National Formulary providing standards for medicines, dosage forms, drug substances, excipients, and dietary supplements.
USP–NF and USP Education subscription bundle
A combined subscription offering the USP–NF alongside a discounted USP Education Subscription.
USP-NF Online
Online access providing updates on new official text, notices, commentary, errata, and more for standards.
[N-Acetyl-His1]-Exenatide
USP reference standard for [N-Acetyl-His1]-Exenatide provided at 1 mg in a vial.
N-Acetyl-L-Tyrosine
USP Dietary Supplement Reference Standard, 100 mg quantity.
N-Acetyl-D,L Methionine
USP Dietary Supplement Reference Standard, 100 mg quantity.
N-Acetyl-L-Leucine
USP Dietary Supplement Reference Standard, 100 mg quantity.
Oligosaccharide System Suitability Mixture A
Glycan profiling reference standard for Oligosaccharide System Suitability Mixture A (Cat # 1478210).
Oligosaccharide System Suitability Mixture A RS
USP reference standard mixture for oligosaccharide system suitability analysis.
Pharmaceutical Analytical Impurities
USP offers over 1000 impurity analytical reference materials covering over 300 Active Pharmaceutical Ingredients (APIs) across 30+ therapeutic categories, supporting early analytical R&D, process development, and impurity-related testing.
Pharmaceutical Analytical Impurities (PAI)
A growing catalog of impurities offered alongside USP Reference Standards for impurities.
E. coli Genomic DNA
Impurities reference standard for E. coli Genomic DNA (Cat # 1231557).
E. coli Genomic DNA RS
USP reference standard for residual DNA testing from E. coli host cells.
CHO Genomic DNA
Impurities reference standard for CHO Genomic DNA (Cat # 1130710).
CHO Genomic DNA RS
USP reference standard for residual DNA testing in Chinese Hamster Ovary cells.
Polyethylene Glycol
Polyethylene Glycol 1000 reference standard provided in a 1 g vial, supplied by the U.S. Pharmacopeial Convention.
USP Polyethylene Glycol 4000 RS
USP Reference Standard for polyethylene glycol 4000 used in excipient quality testing.
USP Polyethylene Glycol 200 RS
USP Reference Standard for polyethylene glycol 200 used in excipient quality testing.
USP Polyethylene Glycol 400 RS
USP Reference Standard for polyethylene glycol 400 used in excipient quality testing.
Monoclonal antibody
A monoclonal antibody reference standard developed by USP to build consistency and reproducibility into analytical methods for monoclonal antibodies.
Monoclonal antibody Reference Standards
Reference materials designed for the characterization and quality control of monoclonal antibodies and biologic therapeutics.
Sorbitol
USP reference standard for Sorbitol used as an excipient in mAb manufacturing.
USP Sorbitol RS
USP Reference Standard for sorbitol used in excipient quality testing.
N-Nitroso-1,2,3,6-tetrahydropyridine
N-Nitroso Rasagiline Solution provided at 1 mL (1 mg/mL) concentration for pharmaceutical analytical applications, identified by CAS RN 2470278-90-9.
N-Nitroso Desmethyl Diltiazem Solution (1 mL (1 mg/mL)) ((2S,3S)-2-(4-Methoxyphenyl)-5-{2-[methyl(nitroso)amino]ethyl}-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl acetate)
N-Nitroso Desmethyl Diltiazem Solution supplied as a pharmaceutical analytical impurity standard in an ampule container.
N-Nitroso Sitagliptin Amine (NTTP) Solution (1 mL (1 mg/mL)) (7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine)
Pharmaceutical analytical impurity reference solution of N-Nitroso Sitagliptin Amine (NTTP) provided in a 1 mL ampule at 1 mg/mL concentration.
N-Nitroso-1,2,3,6-tetrahydropyridine (NTHP) Solution (1 mL (1 mg/mL)) (1-nitroso-1,2,3,6-tetrahydropyridine)
N-Nitroso-1,2,3,6-tetrahydropyridine (NTHP) Solution provided as 1 mL at 1 mg/mL for pharmaceutical analytical impurity applications.
N-Nitroso Rasagiline Solution (1 mL (1 mg/mL)) ((R)-N-(2,3-Dihydro-1H-inden-1-yl)-N-(prop-2-yn-1-yl)nitrous amide)
N-Nitroso Rasagiline Solution provided at 1 mL (1 mg/mL) concentration for pharmaceutical analytical applications, identified by CAS RN 2470278-90-9.
N-Nitroso Duloxetine Solution (1 mL (1 mg/mL)) ((S)-N-Methyl-N-(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)nitrous amide)
N-Nitroso Duloxetine Solution supplied in a 1 mL ampule at a concentration of 1 mg/mL, classified as a Pharmaceutical Analytical Impurity.
USP mAb 001
Non-compendial monoclonal antibody reference standard, a recombinant humanized IgG1 expressed in CHO cell culture.
USP mAb-001 Reference Standard
USP monoclonal antibody reference standard (IgG1) used to assess method performance and verify the suitability of analytical methods for charge variant analysis.
USP mAb 001, Monoclonal IgG1 RS
USP reference standard for monoclonal IgG1 used in analytical procedures.
USP mAb 001, Monoclonal IgG1 (2 mg) (INTERNATIONAL COLD CHAIN SHIPMENT REQUIRED)
Monoclonal IgG1 reference standard provided in a 2 mg quantity, requiring international cold chain shipment.
USP mAb 003
Non-compendial monoclonal antibody reference standard, a recombinant humanized IgG1 expressed in CHO cell culture.
USP mAb-003 Reference Standard
USP monoclonal antibody reference standard (IgG1) used to assess method performance and verify the suitability of analytical methods for charge variant analysis.
USP mAb 003, Monoclonal IgG1 RS
USP reference standard for monoclonal IgG1 used in analytical procedures.
USP mAb 003, Monoclonal IgG1 (2 mg)
USP mAb 003, Monoclonal IgG1 (2 mg) reference standard for biologic applications, requiring international cold chain shipment.
USP mAb 002
Non-compendial monoclonal antibody reference standard, a recombinant humanized IgG1 expressed in CHO cell culture.
USP mAb-002 Reference Standard
USP monoclonal antibody reference standard (IgG1) used to assess method performance and verify the suitability of analytical methods for charge variant analysis.
USP mAb 002, Monoclonal IgG1 RS
USP reference standard for monoclonal IgG1 used in analytical procedures.
mAb 004,
USP monoclonal antibody reference standard (IgG4) used to assess method performance and verify the suitability of analytical methods for charge variant analysis.
USP mAb-004 Reference Standard
USP monoclonal antibody reference standard (IgG4) used to assess method performance and verify the suitability of analytical methods for charge variant analysis.
USP mAb 004, Monoclonal IgG4 RS
USP reference standard for monoclonal IgG4 used in analytical procedures.
N-Acetylneuraminic Acid
Glycan profiling reference standard for N-Acetylneuraminic Acid (Cat # 1612619).
N-Acetylneuraminic Acid RS
USP reference standard for monosaccharide and glycan analysis.
Monoclonal IgG1,
Monoclonal antibody reference standard used for positive control or analytical quality testing procedures.
Monoclonal IgG1, mAb002
Monoclonal antibody reference standard used for positive control or analytical quality testing procedures.
Monoclonal IgG1, mAb003
Monoclonal antibody reference standard used for positive control or analytical quality testing procedures.
Monoclonal IgG1, mAb001
Monoclonal antibody reference standard used for positive control or analytical quality testing procedures.
N-Glycolylneuraminic Acid
Glycan profiling reference standard for N-Glycolylneuraminic Acid (Cat # 1294284).
N-Glycolylneuraminic Acid RS
USP reference standard for monosaccharide and glycan analysis.
CHO HCP
Analytical Reference Material heavy peptide for CHO Glutathione-S-Transferase P1 measurement.
CHO HCP PLBL2 Peptide ARM
Analytical Reference Material peptide for CHO host cell protein measurement.
CHO HCP Lipoprotein Lipase Peptide ARM
Analytical Reference Material peptide set for CHO Lipoprotein Lipase measurement.
CHO HCP Peroxiredoxin 1 Heavy Peptide 3 ARM
Analytical Reference Material heavy peptide for CHO Peroxiredoxin 1 measurement.
CHO HCP Cathepsin D Heavy Peptide 1 ARM
Analytical Reference Material heavy peptide for CHO Cathepsin D measurement.
CHO HCP Protein Disulfide Isomerase (PDI) Peptide ARM
Analytical Reference Material peptide for CHO Protein Disulfide Isomerase measurement.
methods for analysis
USP emerging standard method for the analysis of the monoclonal antibody Bevacizumab.
Methods for the Analysis of Rituximab
USP emerging standard method for the analysis of the monoclonal antibody Rituximab.
USP Reference Standards
Over 7,000 highly characterized physical specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents, and performance calibrators.
USP Compounding Compendium
A comprehensive compendium containing official standards, guidelines, monographs, and general chapters for pharmaceutical compounding.
Agnuside
USP Dietary Supplement Reference Standard, 25 mg quantity.
N Acetylglucosamine
USP Dietary Supplement Reference Standard, 200 mg quantity.
Reference Standard Catalog
A catalog offering more than 3,500 Reference Standards to ensure quality in pharmaceutical development and manufacturing.
Adenine
USP Dietary Supplement Reference Standard, 200 mg quantity.
Ademetionine Disulfate Tosylate
USP Dietary Supplement Reference Standard, 500 mg quantity.
S-Adenosyl-L Homocysteine
USP Dietary Supplement Reference Standard, 50 mg quantity.
Actein
USP Dietary Supplement Reference Standard, 20 mg quantity.
Agigenin
USP Dietary Supplement Reference Standard, 25 mg quantity.
Food Chemicals Codex (FCC)
Compendium of internationally recognized standards for the purity and identity of food ingredients.
Excipient Impurity Reference Standards
Highly-characterized official Reference Standards for excipient impurities such as diethylene and ethylene glycol (DEG and EG) in high-risk excipients.
USP Nitrosamines Reference Standards
A comprehensive portfolio of USP Reference Standards for nitrosamine impurities to help companies identify and prevent the occurrence of unacceptable impurities and support testing and risk assessment.
Losartan Potassium
Losartan Potassium reference standard material supplied in a 150 mg vial.
Small molecule Reference Standards
Reference standards tailored for small molecule active pharmaceutical ingredients and drugs.
Andrographolide Reference Standard
Andrographolide Reference Standard provided in a 50 mg vial for analytical and laboratory use.
Quality Solution Sheets
A single resource that integrates monographs associated with an API or Excipient with all relevant general chapters, Reference Standards, Pharmaceutical Analytical Impurities (PAIs) and excipients and materials commonly used in formulations.
USP Triethylene Glycol RS
USP Reference Standard for triethylene glycol impurity testing in pharmaceutical excipients.
USP Monoclonal IgG System Suitability RS
USP reference standard referenced in USP General Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies.
Calcipotriene
Calcipotriene reference standard supplied as 200 mg with CAS number 112965-21-6, current lot number R091L0, and molecular formula C27H40O3.
DESFLUORO RISPERIDONE
USP reference standard for Desfluoro Risperidone with catalog number 1A11840 and lot number F262A0.
Teriparatide Reference Standard, USP-1643962
Teriparatide Reference Standard provided by USP for analytical and laboratory use, supplied in a vial.
Ampicillin Trihydrate
Ampicillin Trihydrate (200 mg), CAS 7177-48-2 reference standard in a vial.
Neostigmine Bromide
Neostigmine Bromide reference standard in a 200 mg vial.
Vinpocetine Reference Standard, 100 mg
Vinpocetine Reference Standard, USP-1714608 supplied in a 100 mg quantity.
4-(N-Methyl-N-nitrosamino)-1-(pyridin-3-yl)-1-butanone (NNK) Solution
4-(N-Methyl-N-nitrosamino)-1-(pyridin-3-yl)-1-butanone (NNK) Solution (1 mL (1 mg/mL)) provided as a pharmaceutical analytical impurity standard.
Emodin Reference Standard
USP Reference Standard for Emodin, supplied as 30 mg in a vial for quality control and analytical testing.
Sodium Ascorbate Reference Standard, USP-1613509
Sodium Ascorbate Reference Standard provided by USP for analytical and laboratory use.
Oxaliplatin 125 mg
Oxaliplatin reference standard supplied in a vial containing 125 mg, current lot number R156C0.
Parachlorophenol
Parachlorophenol reference standard, 500 mg.
Herbal Medicines Compendium
A resource providing quality standards for botanical and herbal ingredients used in medicines and supplements.
Trientine Hydrochloride
Trientine Hydrochloride reference standard supplied in a 200 mg vial.
Calcium Saccharate
USP Reference Standard for Calcium Saccharate (200 mg).
Butyl Palmitate
USP Reference Standard for Butyl Palmitate (500 mg).
Butylparaben
USP Reference Standard for Butylparaben (200 mg).
Tribasic Calcium Phosphate
USP Reference Standard for Tribasic Calcium Phosphate (1 g) (AS).
Calcium Propionate
USP Reference Standard for Calcium Propionate (100 mg).
Benzalkonium Chloride
5 mL of approx. 4% aqueous solution reference standard for pharmaceutical testing.
Butyl Stearate
USP Reference Standard for Butyl Stearate (500 mg).
USP Maltitol RS
USP Reference Standard for maltitol used in excipient quality testing.
Butylated Hydroxytoluene
USP Reference Standard for Butylated Hydroxytoluene (500 mg).
Butyraldehyde
USP Reference Standard for Butyraldehyde (3 x 1.2 mL).
USP Propylene Glycol RS
USP Reference Standard for propylene glycol used in excipient quality testing.
Butane-1,3-diol
USP Reference Standard for Butane-1,3-diol (1 mL).
USP Glycerin RS
USP Reference Standard for glycerin used in excipient quality testing and pharmaceutical analysis.
Endotoxins
Adventitious agents reference standard for Endotoxins (Cat # 1235503).
Acetaminophen (400 mg)
Acetaminophen (400 mg) reference standard with CAS number 103-90-2 and molecular formula C8H9NO2.
Candelilla Wax
USP Reference Standard for Candelilla Wax (250 mg).
USP Endotoxin RS
Reference standards to support endotoxin testing and microbiological quality control.
USP Particle Count Set RS
Reference standards designed to help ensure suitability of particle count testing setup and test for particulate matter.
Compendial Tools
Informational resources that may aid users in the application of USP standards.
Etanercept (Recombinant TNF Receptor II Fc Fusion Protein) for Bioassays RS
USP reference standard for biological assays involving Etanercept.
Polysorbate 20
USP reference standard for Polysorbate 20 used as an excipient in mAb manufacturing.
Polysorbate 80
USP reference standard for Polysorbate 80 used as an excipient in mAb manufacturing.
L-Phenylalanine
USP reference standard for L-Phenylalanine used as an excipient in mAb manufacturing.
Sodium chloride
USP reference standard for Sodium chloride used as an excipient in mAb manufacturing.
L-Lysine hydrochloride
USP reference standard for L-Lysine hydrochloride used as an excipient in mAb manufacturing.
Mannitol
USP reference standard for Mannitol used as an excipient in mAb manufacturing.
Glacial acetic acid
USP reference standard for Glacial acetic acid used as an excipient in mAb manufacturing.
Sucrose
USP reference standard for Sucrose used as an excipient in mAb manufacturing.
Sodium acetate trihydrate
USP reference standard for Sodium acetate trihydrate used as an excipient in mAb manufacturing.
Monosodium glutamate
USP reference standard for Monosodium glutamate used as an excipient in mAb manufacturing.
Glycine
USP reference standard for Glycine used as an excipient in mAb manufacturing.
L-Methionine
USP reference standard for L-Methionine used as an excipient in mAb manufacturing.
Sodium citrate
USP reference standard for Sodium citrate used as an excipient in mAb manufacturing.
L-Threonine
USP reference standard for L-Threonine used as an excipient in mAb manufacturing.
Trehalose
USP reference standard for Trehalose used as an excipient in mAb manufacturing.
Citric acid
USP reference standard for Citric acid used as an excipient in mAb manufacturing.
Dextrose
USP reference standard for Dextrose used as an excipient in mAb manufacturing.
N-Nitrosodipropylamine (NDPA) Solution (1 mL (1 mg/mL)) (N,N-dipropylnitrous amide)
N-Nitrosodipropylamine (NDPA) Solution supplied in a 1 mL volume at 1 mg/mL concentration, categorized as a pharmaceutical analytical impurity.
Glutamic Acid
USP reference standard for Glutamic Acid used as an excipient in mAb manufacturing.
L-Histidine monohydrochloride monohydrate
USP reference standard for L-Histidine monohydrochloride monohydrate used as an excipient in mAb manufacturing.
Pentetic acid
USP reference standard for Pentetic acid used as an excipient in mAb manufacturing.
Purified Recombinant CHO Phospholipase B like 2 protein (PLBL2) [HIS] ARM
Analytical Reference Material for recombinant CHO PLBL2 protein analysis.
Good Manufacturing Practices (GMP) Audit Only Program
USP’s Good Manufacturing Practices (GMP) Audit Only Program for dietary supplement and dietary ingredient manufacturers helps ensure manufacturing sites conform with current Good Manufacturing Practices based on regulatory and industry standards.
Rubber Oligomer Analytical Reference Materials
A set of Rubber Oligomer ARMs developed by USP along with a technical guide on GC-MS methods to test rubber oligomer leachables.
USP Reference Materials Mobile App
Mobile application designed to make inventory management easier for reference materials.
USP-ID
USP-ID is a qNMR automated software solution developed by USP and delivered by Mestrelab Research to streamline NMR analysis, identify impurities, and calculate sample purity and concentration.
CHO Null Cell Harvest Cell Culture Fluid (HCCF) ARM
Analytical Reference Material for host cell protein testing.
IgG4 Isotype Specific Reference Standard
New product-specific emerging biologic standard for IgG4 isotype characterization.
Characterization of pooled CHO null cell harvest cell culture fluid analytical reference material
Technical reference material for cell culture media and host cell protein contaminant analysis.
DPVS–Prednisone Tablets
Performance Verification Testing tablets that address issues that enhanced mechanical calibration alone cannot resolve.
Medicine Supply Map
A graph-based predictive data model that generates insights into the upstream medicine supply chain using machine learning and advanced analytics.