Drug Impurities

Your Trusted Partner for Drug Impurities

Impurities in drugs directly impact the safety, efficacy, and stability of pharmaceutical products. Impurity research is a critical component of drug development and quality control, essential for successful regulatory approval and patient safety. Protheragen is dedicated to providing a comprehensive range of drug impurity reference standards with the highest purity and complete documentation, serving global new drug development, generic drug manufacturing, quality control, and regulatory submissions.

10+ Years of Industry Experience

60,000+ Premium Products

Our Core Capabilities

Drug Impurities Supply

As an ISO9001 certified supplier of pharmaceutical ingredients, Protheragen operates under a stringent quality management system to ensure high standards in every product we deliver.

Comprehensive Impurity Library

Our portfolio covers process-related impurities, degradation products, genotoxic impurities (GTIs), elemental impurities, residual solvents, and chiral impurities. Each product undergoes rigorous QC verification to ensure precision and reliability of your research data.

Advanced Analytical Technologies

Equipped with state-of-the-art instruments including HPLC, GC, MS, and NMR, we deliver accurate identification and quantification. From impurity analysis and forced degradation studies to structural elucidation, we provide integrated research services throughout the entire drug development lifecycle.

Extensive Preparation Experience

Our highly skilled scientists excel in rapid enrichment, purification, and synthesis of high-purity drug impurities, delivering tailored solutions for complex impurity challenges.

End-to-End Services

We offer comprehensive impurity research services while adhering to strict data security and confidentiality protocols, protecting your sensitive information and intellectual property at every stage.

Customer Testimonials

Our commitment to quality, purity, and regulatory compliance makes us a trusted partner for pharmaceutical companies worldwide.

Sam, Director of R&D

Protheragen has been instrumental in our generic drug development. Their impurity reference standards are consistently high-purity, and the complete documentation package significantly streamlined our ANDA submission.

Sam, Director of R&D

James, Senior Scientist

We faced challenges identifying a novel degradation impurity in our lead compound. Protheragen's team not only isolated and characterized the impurity but also provided synthesis support.

James, Senior Scientist

Michael, Procurement Manager

The breadth of Protheragen's impurity catalog is impressive. We've sourced over 20 impurities from them, from common pharmacopeial standards to rare metabolites. Delivery is always on time, and customer service is excellent.

Michael, Procurement Manager

Our Impurity Platforms

Separation & Purification Platform

Preparative HPLC (UV, ELSD, CAD), supporting normal-phase and reverse-phase modes.

Analytical Characterization Platform

MS, NMR, HPLC, GC, CD, XRD.

Synthetic Chemistry Platform

Parallel synthesizers, microwave synthesizers, HPLC, LC-MS.

Featured Impurity Products

With over 60,000 high-purity impurity reference standards, our portfolio delivers the accuracy and reliability you need for pharmaceutical development and quality control.

Genotoxic Impurities

Product Name	Cat Number	CAS Number	API
Cabotegravir Impurity 26	PIMP22313	740054-23-3	Cabotegravir
Hydrocortisone Acetate Impurity 44	PIMP34653	/	Hydrocortisone Acetate
Loratadine Impurity 81	PIMP41029	/	Loratadine
Omeprazole Impurity 3	PIMP48592	142885-96-9	Omeprazole
Terbinafine Impurity 14	PIMP61476	126764-17-8	Terbinafine
Sumatriptan Hydrazine Impurity	PIMP60111	88933-16-8	Sumatriptan Hydrazine
Chlordiazepoxide EP Impurity A	PIMP20282	963-39-3	Chlordiazepoxide
Bisoprolol Epoxide Impurity	PIMP15989	66722-57-4	Bisoprolol Epoxide
Alprazolam EP Impurity E	PIMP09701	719-59-5	Alprazolam
Chlordiazepoxide EP Impurity B	PIMP20283	5958-24-7	Chlordiazepoxide
Metoprolol Hydroxy Epoxide Impurity	PIMP44332	104857-48-9	Metoprolol Hydroxy Epoxide
Chlordiazepoxide Impurity D	PIMP20284	70988-37-3	Chlordiazepoxide
Metoprolol Methoxy Epoxide Impurity	PIMP44325	56718-70-8	Metoprolol Methoxy Epoxide

Process-Related Impurities

Product Name	Cat Number	CAS Number	API
Bupivacaine Impurity 40	PIMP15433	2199805-25-7	Bupivacaine
Calcitonin Impurity 20	PIMP16979	/	Calcitonin
Chlorhexidine Impurity 25	PIMP19698	102-02-3	Chlorhexidine
Cabotegravir Impurity 23	PIMP22310	/	Cabotegravir
Diclofenac Sodium Impurity 44	PIMP23106	/	Diclofenac Sodium
Diphenhydramine Impurity 13	PIMP23599	26926-47-6	Diphenhydramine
Doxofylline Impurity 1	PIMP25349	1429636-74-7	Doxofylline
Deoxycholic Acid Impurity 27	PIMP25641	3245-38-3	Deoxycholic Acid
Dextromethorphan Impurity 24	PIMP26083	367520-36-3	Dextromethorphan
Glycine Impurity 9	PIMP26482	14486-03-4	Glycine
Ibuprofen Impurity 49	PIMP37353	/	Ibuprofen
Bromhexine Impurity 112	PIMP43602	/	Bromhexine
Minoxidil Impurity 9	PIMP43680	116436-03-4	Minoxidil
Minoxidil Impurity 33	PIMP43704	35139-68-5	Minoxidil
Methylene Blue Impurity 26	PIMP44703	61613-22-7	Methylene Blue
Sildenafil Impurity 180	PIMP59120	247583-72-8	Sildenafil

Degradation Products

Product Name	Cat Number	CAS Number	API
Carbocisteine Impurity 29	PIMP16956	/	Carbocisteine
Glycine Impurity 6	PIMP26479	/	Glycine
Edaravone Impurity 26	PIMP26631	852539-02-7	Edaravone
Edaravone Impurity 30	PIMP26634	/	Edaravone
Esomeprazole Impurity 66	PIMP27964	/	Esomeprazole
Folic Acid Impurity 18	PIMP30707	694514-39-1	Folic Acid
Ibuprofen Impurity 81	PIMP37386	/	Ibuprofen
Minoxidil Impurity 16	PIMP43687	/	Minoxidil
Minoxidil Impurity 30	PIMP43701	/	Minoxidil
Minoxidil Impurity 47	PIMP43717	/	Minoxidil
Etelcalcetide Impurity 18	PIMP28053	/	Etelcalcetide
Nicorandil Impurity 33	PIMP46201	/	Nicorandil
Nicorandil Impurity 34	PIMP46202	/	Nicorandil
Semaglutide Impurity 5	PIMP61119	/	Semaglutide

Nitrosamine Impurities

Product Name	Cat Number	CAS Number	API
Valsartan Nitroso Impurity 161	PIMP67782	2407652-86-0	Valsartan Nitroso
Valsartan Nitroso Impurity 163	PIMP67784	2851532-34-6	Valsartan Nitroso
N-Nitroso Metformin EP Impurity A	PIMP44753	/	N-Nitroso Metformin
N-Nitroso-Ranitidine-2	PIMP56805	/	/
N-Nitroso-Ranitidine-1	PIMP56804	/	/
N-Nitroso Metformin EP Impurity E	PIMP44754	/	N-Nitroso Metformin
Metformin Nitroso Impurity 52	PIMP44752	/	Metformin Nitroso
N-Nitroso Metformin EP Impurity B	PIMP44755	/	N-Nitroso Metformin
N-Nitrosodiethylamine-D10	PIMP07156	1219794-54-3	/
N-Nitrosodimethylamine-D6	PIMP07130	17829-05-9	/
Molsidomine EP Impurity B	PIMP47838	59-89-2	Molsidomine
Valsartan Nitroso Impurity 149	PIMP67770	/	Valsartan Nitroso

Pharmacopoeial Impurities

Product Name	Cat Number	CAS Number	API
Diclofenac Impurity N	PIMP23083	84-66-2	Diclofenac
Desloratadine EP Impurity C	PIMP23868	79794-75-5	Desloratadine
Acemetacin EP Impurity B	PIMP36132	53-86-1	Acemetacin
Omeprazole EP Impurity E	PIMP48566	176219-04-8	Omeprazole
Fenoterol hydrobromide EP impurity A	PIMP30326	/	Fenoterol hydrobromide
Fenoterol hydrobromide EP impurity B	PIMP30327	699525-61-6	Fenoterol hydrobromide

Chiral Impurities

Product Name	Cat Number	CAS Number	API
Cabotegravir Impurity 3	PIMP22290	/	Cabotegravir
Deoxycholic Acid Impurity 43	PIMP25657	/	Deoxycholic Acid
Minoxidil Impurity 86	PIMP43755	1035654-75-1	Minoxidil
Atipamezole Impurity 1	PIMP13644	917220-61-2	Atipamezole

Metabolites

Product Name	Cat Number	CAS Number	API
Carbocisteine Impurity 27	PIMP16954	7728-98-5	Carbocisteine
Dextromethorphan EP Impurity B	PIMP26061	125-73-5	Dextromethorphan
Cholesterol Impurity 41	PIMP34745	144300-24-3	Cholesterol

Please note: The above products are only a small part of our drug impurities. For a complete list of impurities, please visit Protheragen Impurity.

Comprehensive Impurity Research Services

Protheragen Impurity provides comprehensive impurity research services covering the entire drug development lifecycle, helping pharmaceutical companies identify, quantify, and control impurities to ensure regulatory compliance and patient safety.

Impurity Research

Impurity Identification and Characterization

Custom Impurity Synthesis & Isolation

Genotoxic Impurity Risk Assessment

Impurity Testing and Quantification

Residual Solvent & Elemental Impurity Analysis

Nitrosamine Impurity Analysis

Forced Degradation Study & Impurity Analysis

Impurity Identification and Characterization

Identify unknown impurities and elucidate their structures using HPLC, LC-MS, GC-MS, and NMR. Support regulatory submissions with complete documentation including structural confirmation and risk assessment.

Custom Impurity Synthesis & Isolation

Synthesize and isolate high-purity impurities including degradation products, process impurities, metabolites, and genotoxic impurities. Capabilities range from milligram to gram scale.

Genotoxic Impurity Risk Assessment

Assess GTIs through (Q)SAR prediction, Ames test, and in vitro/in vivo genotoxicity studies based on ICH M7 guidelines. Provide comprehensive risk assessment reports.

Impurity Testing and Quantification

Precisely detect and quantify known and unknown impurities in APIs and drug products using validated analytical methods. Deliver accurate quantification results for quality control.

Residual Solvent & Elemental Impurity Analysis

Analyze residual solvents per ICH Q3C and elemental impurities per ICH Q3D using ICP-MS, GC-MS, and HPLC. Support assessment against applicable PDE limits.

Nitrosamine Impurity Analysis

Detect and quantify nitrosamine impurities (NDMA, NDEA, etc.) using highly sensitive LC-MS and GC-MS methods. Assess formation risks and support mitigation strategies.

Forced Degradation Study & Impurity Analysis

Conduct hydrolytic, oxidative, photolytic, and thermal stress studies to identify degradation products, predict drug stability, and support shelf-life determination.

How We Work

Protheragen follows a streamlined, client-focused process to ensure efficient project execution, transparent communication, and high-quality deliverables at every stage.

01
Consultation & Service Design

We discuss your project requirements (impurity type, quantity, purity, testing specifications) and design a tailored service plan including synthesis, isolation, risk assessment, or method development tailored to your specific project goals.

02
Synthesis, Testing & Characterization

Our team performs custom synthesis, impurity isolation, or forced degradation studies. All products and samples are rigorously tested using HPLC, LC-MS, NMR, and other techniques to ensure accuracy and purity.

03
Documentation & Delivery

We provide complete deliverables including COA, structural elucidation data, test reports, and method validation documents. Products are shipped under appropriate conditions with ongoing technical support.

Frequently Asked Questions

01 What documentation do you provide with each impurity standard?

We provide a complete documentation package including Certificate of Analysis (CoA), structural confirmation data (NMR, HPLC, LC-MS), and stability study reports.
02 Do you offer custom synthesis for impurities not listed in your catalog?

Yes. With extensive synthesis experience, we can develop custom synthesis routes for novel impurities, degradation products, metabolites, and reference standards. Please contact us with your specific requirements.
03 What is your minimum order quantity (MOQ)?

We offer flexible MOQs to accommodate all project stages, from milligram quantities for early research to gram quantities for validation and commercial use.