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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 5161 - 5184 of 5445 products

Showing 5161 - 5184 of 5445 products
Order no. Article name Batch number CAS Number Unit Price € Quantity
USP-1A09040
321,32 €
 N-(2,6-Dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide Solution (1 mL (1 mg/mL))
(N-(2,6-Dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide)
 F236E0 N/A 321,32 €
USP-1A09070
379,74 €
 2-[2-(4-Nitroso-1-piperazinyl)ethoxy]ethanol Solution (1 mL (1 mg/mL))
(2-(2-(4-Nitrosopiperazin-1-yl)ethoxy)ethan-1-ol)
 F235Y0 73486-81-4 379,74 €
USP-1A09080
613,43 €
 N-Nitroso Landiolol Solution (1 mL (1 mg/mL))
(((S)-2,2-dimethyl-1,3-dioxolan-4-yl)methyl 3-(4-((S)-2-hydroxy-3-((2-(morpholine-4-carboxamido)ethyl)(nitroso)amino)propoxy)phenyl)propanoate)
 F236G0 3038740-98-3 613,43 €
USP-1A09090
262,90 €
 N-Nitroso Moxifloxacin Solution (1 mL (1 mg/mL))
(1-Cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-1-nitrosooctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid)
 F23600 N/A 262,90 €
USP-1A09110
438,17 €
 N-Nitroso Perindopril Solution (1 mL (1 mg/mL))
((2S,3aS,7aS)-1-(N-((S)-1-ethoxy-1-oxopentan-2-yl)-N-nitroso-L-alanyl)octahydro-1H-indole-2-carboxylic acid)
 F236J0 N/A 438,17 €
USP-1A09120
362,22 €
 N-Nitroso Propafenone Solution (1 mL (1 mg/mL))
(N-{2-Hydroxy-3-[2-(3-phenylpropanoyl)phenoxy]propyl}-N-propylnitrous amide)
 F236K0 3036581-87-7 362,22 €
USP-1A09130
321,32 €
 N-Nitroso Desalkyl Quetiapine Solution (1 mL (1 mg/mL))
(11-(4-nitrosopiperazin-1-yl)dibenzo[b,f][1,4]thiazepine)
 F23610 N/A 321,32 €
USP-1A09150
292,11 €
 N-Nitroso Sertraline Solution (1 mL (1 mg/mL))
(N-((1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-yl)-N-methylnitrous amide)
 F23620 3006789-98-3 292,11 €
USP-1A09160
379,74 €
 N-Nitroso Sotalol Solution (1 mL (1 mg/mL))
(N-[4-[1-Hydroxy-2-[(1-methylethyl)nitrosoamino]ethyl]phenyl]methanesulfonamide)
 F23630 134720-07-3 379,74 €
USP-1A09170
292,11 €
 N-Nitroso Tetracaine Solution (1 mL (1 mg/mL))
(2-(dimethylamino)ethyl 4-(butyl(nitroso)amino)benzoate)
 F236M0 N/A 292,11 €
USP-1A09180
321,32 €
 N-Nitroso Trimetazidine Solution (1 mL (1 mg/mL))
(1-Nitroso-4-[(2,3,4-trimethoxyphenyl)methyl]piperazine)
 F23640 92432-50-3 321,32 €
USP-1A09200
368,06 €
 N-Nitroso Enalapril Solution (1 mL (1 mg/mL))
(N-((S)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl)-N-nitroso-L-alanylproline)
 F23650 2994317-06-3 368,06 €
USP-1A09220
292,11 €
 N-Nitroso Hydrochlorothiazide Solution (1 mL (1 mg/mL))
(6-chloro-3,4-dihydro-4-nitroso-2H-1,2,4-Benzothiadiazine-7-sulfonamide 1,1-dioxide
 F23660 63779-86-2 292,11 €
USP-1A09240
321,32 €
 N-Nitroso Levofloxacin Solution (1 mL (1 mg/mL))
((3S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-nitroso-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid)
 F23670 1152314-62-9 321,32 €
USP-1A09250
379,74 €
 N-Nitroso N-Desmethyl Mifepristone Solution (1 mL (1 mg/mL))
 F236R0 3093646-28-4 379,74 €
USP-1A09280
525,80 €
 N-Nitroso Mitoxantrone Formate Solution (1 mL (1 mg/mL))
(N-(2-{[5,8-Dihydroxy-4-({2-[(2-hydroxyethyl)amino]ethyl}amino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}ethyl)-N-(2-hydroxyethyl)nitrous amide formate)
 F236U0 3085658-78-9 525,80 €
USP-1A09320
379,74 €
 N-Nitroso N-Desmethyl Promethazine Solution (1 mL (1 mg/mL))
(N,a-Dimethyl-N-nitroso-10H-phenothiazine-10-ethanamine)
 F23680 94511-44-1 379,74 €
USP-1A09330
455,69 €
 N-Nitroso Racepinephrine Solution (1 mL (1 mg/mL))
(N-(2-(3,4-dihydroxyphenyl)-2-hydroxyethyl)-N-methylnitrous amide)
 F236Y0 3038740-97-2 455,69 €
USP-1A09340
408,96 €
 N-Nitroso N-Desmethyl Rivastigmine Solution (1 mL (1 mg/mL))
((S)-3-(1-(methyl(nitroso)amino)ethyl)phenyl ethyl(methyl)carbamate)
 F23700 3079775-26-8 408,96 €
USP-1A09360
404,28 €
 N-Nitroso N-Desmethyl Thonzylamine Solution (1 mL (1 mg/mL))
(N-(2-((4-Methoxybenzyl)(pyrimidin-2-yl)amino)ethyl)-N-methylnitrous amide)
 F23720 3080808-22-3 404,28 €
USP-1A09400
321,32 €
 N,N'-Dinitroso Benzathine Solution (1 mL (1 mg/mL))
(N1,N2-Dinitroso-N1,N2-bis(phenylmethyl)-1,2-ethanediamine)
 F237B0 69239-61-8 321,32 €
USP-1A09450
502,43 €
 N-Nitroso Dipivefrin Solution (1 mL (1 mg/mL))
(4-(1-hydroxy-2-(methyl(nitroso)amino)ethyl)-1,2-phenylene bis(2,2-dimethylpropanoate))
 F237F0 N/A 502,43 €
USP-1A09520
321,32 €
 N-Nitroso Ambroxol Solution (1 mL (1 mg/mL))
(N-(2-amino-3,5-dibromobenzyl)-N-((1r,4r)-4-hydroxycyclohexyl)nitrous amide)
 F237K0 N/A 321,32 €
USP-1A09530
321,32 €
 N-Nitroso N-Desmethyl Methylene Blue Solution (1 mL (1 mg/mL))
(3-(dimethylamino)-7-(methyl(nitroso)amino)phenothiazin-5-ium chloride)
 F237L0 N/A 321,32 €
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