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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

5513 products

Showing 4729 - 4752 of 5513 products

Showing 4729 - 4752 of 5513 products
Order no. Article name Batch number CAS Number Unit Price € Quantity
USP-1A03890
2.278,46 €
 Tofacitinib Amide (25 mg)
(3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanamide)
 F209G0 1675248-19-7 2.278,46 €
USP-1A03910
1.927,93 €
 Vilanterol Diamine Triphenylacetate (25 mg)
(4,4'-((1R,1'R)-((oxybis(hexane-6,1-diyl))bis(azanediyl))bis(1-hydroxyethane-2,1-diyl))bis(2-(hydroxymethyl)phenol), 2,2,2-triphenylacetate))
 F20610 N/A 1.927,93 €
USP-1A03920
496,59 €
 N-Nitroso Varenicline (NNV) Solution (1mL (1 mg/mL))
(8-nitroso-7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4.5-g]quinoxaline)
 F20790 2755871-02-2 496,59 €
USP-1A03930
479,06 €
 N-Nitrosodipropylamine (NDPA) Solution (1 mL (1 mg/mL))
(N,N-dipropylnitrous amide)
 F204R0 621-64-7 479,06 €
USP-1A03940
449,85 €
 N-Nitrosomethylphenidate (NMPH) Solution (1 mL (1 mg/mL))
(Methyl 2-(1-nitrosopiperidin-2-yl)-2-phenylacetate)
 F20720 55557-03-4 449,85 €
USP-1A03950
461,53 €
 N-Nitrosopiperidine Solution (1 mL (1 mg/mL))
(1-Nitrosopiperidine)
 F200C0 100-75-4 461,53 €
USP-1A03960
449,85 €
 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)
 R27100 2892260-32-9 449,85 €
USP-1A03970
455,69 €
 N-Nitroso-1,2,3,6-tetrahydropyridine (NTHP) Solution (1 mL (1 mg/mL))
(1-nitroso-1,2,3,6-tetrahydropyridine)
 F210H0 55556-92-8 455,69 €
USP-1A03980
461,53 €
 N-Nitroso Nortriptyline Solution (1 mL (1 mg/mL))
(N-(3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)propyl)-N-methylnitrous amide)
 F201W0 55855-42-0 461,53 €
USP-1A03990
408,96 €
 N-Nitroso-N-methyl-2-phenylethylamine (NMPEA) Solution (1 mL (1 mg/mL))
(N-methyl-N-phenethylnitrous amide)
 F208T0 13256-11-6 408,96 €
USP-1A04000
455,69 €
 N-Nitroso Duloxetine Solution (1 mL (1 mg/mL))
(N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)-N-nitrosopropane-1-amine)
 R263C0 3078587-36-4 455,69 €
USP-1A04010
455,69 €
 4-(N-Methyl-N-nitrosamino)-1-(pyridin-3-yl)-1-butanone (NNK) Solution (1 mL (1 mg/mL))
(N-methyl-N-(4-oxo-4-(pyridin-3-yl)butyl)nitrous amide)
 F207R0 64091-91-4 455,69 €
USP-1A04020
479,06 €
 1-Methyl-4-nitrosopiperazine (MNP) Solution (1 mL (1 mg/mL))
(1-Methyl-4-nitrosopiperazine)
 F20370 16339-07-4 479,06 €
USP-1A04030
455,69 €
 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)
 F201X0 2470278-90-9 455,69 €
USP-1A04040
490,75 €
 N-Nitroso Dabigatran Etexilate Solution (1 mL (1 mg/mL))
(ethyl 3-(2-((((4-(N-((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate)
 F20780 2892260-29-4 490,75 €
USP-1A04050
496,59 €
 N-Nitroso Tamsulosin Solution (1 mL (1 mg/mL))
((R)-5-(2-((2-(2-ethoxyphenoxy)ethyl)(nitroso)amino)propyl)-2-methoxybenzenesulfonamide)
 F207A0 2892260-31-8 496,59 €
USP-1A04060
493,08 €
 N-Nitrosopyrrolidine (NPYR) Solution (1 mL (1 mg/mL)
(1-Nitrosopyrrolidine)
 F20380 930-55-2 493,08 €
USP-1A04070
479,06 €
 N-Nitrosoiminodiacetic acid Solution (1 mL (1 mg/mL))
(2,2'-(nitrosoazanediyl)diacetic acid)
 F208U0 25081-31-6 479,06 €
USP-1A04080
438,17 €
 1-(2-Methoxyphenyl)-4-nitrosopiperazine Solution (1 mL (1 mg/mL))
(1-(2-Methoxyphenyl)-4-nitrosopiperazine)
 F205S0 2219339-64-5 438,17 €
USP-1A04090
642,64 €
 N-Nitroso Tetraxetan Triacetic Acid (10 mg)
(2,2',2''-(10-nitroso-1,4,7,10-tetraazacyclododecane-1,4,7-triyl)triacetic acid)
 F210J0 2892260-33-0 642,64 €
USP-1A04100
461,53 €
 4-Nitrosopiperazine-1-ethanol Solution (1 mL (1 mg/mL))
(2-(4-Nitrosopiperazin-1-yl)ethan-1-ol)
 F205T0 48121-20-6 461,53 €
USP-1A04130
461,53 €
 1-Benzhydryl-4-nitrosopiperazine Solution (1 mL (1 mg/mL))
(1-benzhydryl-4-nitrosopiperazine)
 F205U0 1698-25-5 461,53 €
USP-1A04140
455,69 €
 4-Nitroso-1-(4-fluorobenzoyl)piperazine Solution (1 mL (1 mg/mL))
((4-fluorophenyl)(4-nitrosopiperazin-1-yl)methanone)
 F205V0 2892260-28-3 455,69 €
USP-1A04170
461,53 €
 2-(4-Nitrosopiperazin-1-yl)pyrimidine Solution (1 mL (1 mg/mL))
(2-(4-nitrosopiperazin-1-yl)pyrimidine)
 F209K0 872826-80-7 461,53 €
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