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USP - Reference Standards

USP Reference Standards – Standards of the United States Pharmacopeia

USP reference standards are the global quality benchmark for the analytical validation of pharmaceuticals, biologics, and excipients. Manufacturers of APIs, generics, complex biologics, or pharmaceutical raw materials require comparator substances that regulatory authorities and international pharmacopoeias fully trust.

As an authorized USP specialist retailer, we exclusively deliver standards – with the highest product safety, reliable supply chains and valid results for maximum patient safety.

The range of USP reference standards

Our portfolio includes thousands of USP standards , including:

✔ Drug active ingredient standards (APIs)
✔ Excipient standards
✔ Impurities & Degradation Products
✔ Nitrosamine standards
✔ Pharmaceutical Analytical Impurities (PAI)
✔ Analytical Reference Materials (ARM)
✔ Biologics Standards
✔ Compendial reagents
✔ Dissolution Performance Verification Standards (DPVS)

USP Pharmaceutical Analytical Impurities

USP Pharmaceutical Analytical Impurities (PAI) are high-quality analytical reference materials that help pharmaceutical companies to detect impurities in active pharmaceutical ingredients and drugs early, to characterize them, and to develop analytical methods.

They complement the official USP reference standards by covering critical process and degradation products, as well as impurities, that are mentioned in USP monographs but not available as official standards. In this way, PAIs support robust quality control, accelerated analysis, and regulatory certainty in research, development, and production.

The use of the numerous Pharmaceutical Analytical Impurities (PAI) of the USP greatly facilitates the reliable identification of potential impurities in active pharmaceutical ingredients and drugs.

Application ranges:

✔ Research & Development (R&D): Early identification and characterization of impurities supports robust analytics from the outset.

✔ Method development: Optimization and validation of analytical methods such as stress, degradation and spiking studies.

✔ Manufacturing: Control of critical process and degradation products to ensure consistent product quality.

✔ Quality control: Support for precise impurity analyses and reliable release tests.

✔ Stability testing: Identification of impurities that form under ICH stability conditions.

✔ Post-market surveillance: Continuous monitoring of impurities to ensure long-term drug safety.

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USP Biologics

USP Biologics offers high-quality reference standards for the quality control of modern biotherapeutics – from mAbs to mRNA and oligonucleotides to cell and gene therapies.

✔ For identity, purity and potency testing

✔ Recognized worldwide by authorities and pharmacopoeias

✔ Ideal for development, QC and regulatory submissions

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USP Analytical Reference Materials

USP Analytical Reference Materials (ARMs) are high-quality, characterized substances specifically developed for pharmaceutical analysis and quality control. They are ideal for active pharmaceutical ingredients, formulations, or complex generics for which no USP monograph exists and provide reliable support for analytical testing.

ARM enables:

✔ Method development and validation

✔ Quality control of complex APIs and generics

✔ Identification and quantification of impurities

✔ Support for regulatory submissions

With extensive accompanying data and high analytical reliability, USP ARMs are an important complement to monographed USP reference standards – for precise results and maximum regulatory acceptance.

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USP-Standards from the United States Pharmacopeia

5445 products

Showing 5137 - 5160 of 5445 products

Showing 5137 - 5160 of 5445 products
Order no. Article name Batch number CAS Number Unit Price € Quantity
USP-1A08720
1.022,39 €
 Torsemide Ethyl Carbamate (25 mg)
(Ethyl {[4-(3-tolylamino)pyridin-3-yl]sulfonyl}carbamate)
 F232X0 72810-57-2 1.022,39 €
USP-1A08730
1.045,76 €
 Telmisartan tert-butyl ester (25 mg)
(tert-Butyl 4'-[(1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzo[d]imidazol-3'-yl)methyl]biphenyl-2-carboxylate)
 R27210 144702-26-1 1.045,76 €
USP-1A08740
815,57 €
 5-Methylisoxazole-4-carboxylic acid (25 mg)
(5-Methyl-1,2-oxazole-4-carboxylic acid)
 F23300 42831-50-5 815,57 €
USP-1A08750
863,48 €
 Estradiol Divalerate (25 mg)
(Estra-1,3,5(10)-triene-3,17beta-diyl divalerate)
 F23310 63042-28-4 863,48 €
USP-1A08780
408,96 €
 N-Nitroso N-Desmethyl Pyrilamine Solution (1 mL (1 mg/mL))
(N-(2-((4-methoxybenzyl)(pyridin-2-yl)amino)ethyl)-N-methylnitrous amide)
 F235C0 N/A 408,96 €
USP-1A08800
642,64 €
 N-Nitroso Desmethyl Rizatriptan Solution (1 mL (1 mg/mL))
(N-(2-(5-((1H-1,2,4-triazol-1-yl)methyl)-1H-indol-3-yl)ethyl)-N-methylnitrous amide)
 F235D0 N/A 642,64 €
USP-1A08810
379,74 €
 N-Nitroso Safinamide Solution (1 mL (1 mg/mL))
((2S)-2-[[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]nitrosoamino]propanamide)
 F23750 2657645-00-4 379,74 €
USP-1A08820
321,32 €
 N-Nitroso-(E)-N,6,6-trimethylhept-2-en-4-yn-1-amine Solution (1 mL (1 mg/mL))
((E)-N-(6,6-dimethylhept-2-en-4-yn-1-yl)-N-methylnitrous amide)
 F235E0 N/A 321,32 €
USP-1A08830
455,69 €
 N-Nitroso Vilanterol Solution (1 mL (1 mg/mL))
((R)-N-(6-{2-[(2,6-Dichlorobenzyl)oxy]ethoxy}hexyl)-N-{2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethyl}nitrous amide)
 F235F0 3085658-79-0 455,69 €
USP-1A08850
408,96 €
 N-Nitroso Piperazine Solution (1 mL (1 mg/mL))
(1-nitrosopiperazine)
 F235G0 5632-47-3 408,96 €
USP-1A08860
376,24 €
 N-Nitroso Folic Acid Solution (1 mL (1 mg/mL))
((4-(((2-amino-4-oxo-3,4-dihydropteridin-6-yl)methyl)(nitroso)amino)benzoyl)-L-glutamic acid)
 F235H0 26360-21-4 376,24 €
USP-1A08870
572,54 €
 N-Nitroso Acebutolol Solution (1 mL (1 mg/mL))
(N-(3-acetyl-4-(2-hydroxy-3-(isopropyl(nitroso)amino)propoxy)phenyl)butyramide)
 F235J0 3038740-99-4 572,54 €
USP-1A08880
321,32 €
 N-Nitroso Brinzolamide Solution (1 mL (1 mg/mL))
((R)-4-(ethyl(nitroso)amino)-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide)
 F235K0 N/A 321,32 €
USP-1A08890
321,32 €
 N-Nitroso Cinacalcet Solution (1 mL (1 mg/mL))
((R)-N-(1-(naphthalen-1-yl)ethyl)-N-(3-(3-(trifluoromethyl)phenyl)propyl)nitrous amide)
 F235L0 3036581-83-3 321,32 €
USP-1A08910
321,32 €
 N-Nitroso Desloratadine Solution (1 mL (1 mg/mL))
(8-chloro-6,11-dihydro-11-(1-nitroso-4-piperidinylidene)-5H-Benzo[5,6]cyclohepta[1,2-b]pyridine)
 F235N0 1246819-22-6 321,32 €
USP-1A08920
262,90 €
 N-Nitroso Dorzolamide Solution (1 mL (1 mg/mL))
((4S,6S)-4-(ethyl(nitroso)amino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide)
 F235P0 N/A 262,90 €
USP-1A08940
321,32 €
 N-Nitroso N-Desmethyl Pheniramine Solution (1 mL (1 mg/mL))
(N-methyl-N-(3-phenyl-3-(pyridin-2-yl)propyl)nitrous amide)
 F235Q0 N/A 321,32 €
USP-1A08950
379,74 €
 N-Nitroso N-Desmethyl Sumatriptan Solution (1 mL (1 mg/mL))
(N-methyl-1-(3-(2-(methyl(nitroso)amino)ethyl)-1H-indol-5-yl)methanesulfonamide)
 F235R0 3036581-86-6 379,74 €
USP-1A08960
321,32 €
 N-Nitroso N-Desmethyl Tamoxifen Solution (1 mL (1 mg/mL))
((Z)-N-(2-(4-(1,2-diphenylbut-1-en-1-yl)phenoxy)ethyl)-N-methylnitrous amide)
 F235U0 N/A 321,32 €
USP-1A08970
321,32 €
 N-Nitroso N-Methyl-1-naphthylmethylamine Solution (1 mL (1 mg/mL))
(N-Methyl-N-nitroso-1-naphthalenemethanamine)
 F235V0 296760-88-8 321,32 €
USP-1A08990
292,11 €
 N-Nitroso N-Desmethyl Tetracaine Solution (1 mL (1 mg/mL))
(2-(methyl(nitroso)amino)ethyl 4-(butylamino)benzoate)
 F23690 3050754-69-0 292,11 €
USP-1A09010
578,38 €
 N-Nitroso N-Desmethyl Trimethobenzamide Solution (1 mL (1 mg/mL))
(3,4,5-trimethoxy-N-(4-(2-(methyl(nitroso)amino)ethoxy)benzyl)benzamide)
 F236B0 3080808-21-2 578,38 €
USP-1A09020
408,96 €
 N-Nitroso N-Desmethyl Venlafaxine Solution (1 mL (1 mg/mL))
(N-[2-(1-Hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl]-N-methylnitrous amide)
 F236C0 2680662-11-5 408,96 €
USP-1A09030
262,90 €
 N-Nitroso N-Desmethyl Zolmitriptan Solution (1 mL (1 mg/mL))
((S)-N-methyl-N-(2-(5-((2-oxooxazolidin-4-yl)methyl)-1H-indol-3-yl)ethyl)nitrous amide)
 F236D0 3085658-77-8 262,90 €
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