Cleanchem – Impurity Reference Standards, Nitrosamines, APIs Supplier

Our Products

We provide well-characterized materials essential for identifying and analyzing trace-level substances in complex formulations. Our solutions support pharmaceutical quality control and regulatory documentation with high accuracy and reliability.

Purification Services

We offer advanced purification services tailored to meet the specific needs of pharmaceutical and chemical research. Our expertise ensures the highest purity levels through precise techniques, supporting your quality and compliance requirements.

Flash Chromatography Purification
Unknown Impurity Isolation & Identification
Fermentation Products Purification
Peptides & Proteins Purification

Unknown Impurity Profiling

We specialize in identifying, isolating and characterizing unknown impurities in pharmaceutical substances. Our advanced analytical techniques ensure regulatory compliance and product safety. Partner with us for accurate and efficient impurity profiling solutions.

Advanced Analytical Techniques
Accurate Structural Elucidation
Regulatory-Compliant Documentation
Ensure Purity & Compliance

Peptide CDMO

We offer comprehensive custom development and manufacturing services tailored for complex peptide projects. Our expertise ensures high-quality synthesis, scalability, and regulatory support for every stage of your product lifecycle.

Custom Synthesis Peptides
Peptide Coupling agent
Cosmetic Peptide
Peptide Intermediate

R&D Infrastructure of 20K Sq.Ft area
100+ Scientist
78K Products Catalog

About Cleanchem Laboratories

Cleanchem Laboratories is a research-driven CRO/CRAMS organization delivering advanced chemical solutions to the pharmaceutical and life-science industries. We specialize in unknown impurity identification, synthesis, and structural elucidation, supported by strong in-house R&D and analytical expertise. Our portfolio includes Impurity Reference Standards, Nitrosamines, metabolites, and custom-synthesized specialty compounds developed to meet global regulatory expectations. With a science-first approach, we partner closely with clients to solve complex development and compliance challenges. At Cleanchem, precision, reliability, and regulatory readiness are built into every molecule we deliver.

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Our Products

N-Nitroso Adagrasib Impurity 1

Cat No: CL-ADGR-05

CAS No: NA

M. F: C29H33ClN8O2

M. W: 561.1

Inv.Status: In Stock

N-Nitroso Apixaban Impurity 1

Cat No: CL-AXB-NO-01

CAS No: NA

M. F: C25H26N6O6

M. W: 506.52

Inv.Status: In Stock

N-Nitroso Apixaban Impurity 2

Cat No: CL-AXB-NO-02

CAS No: NA

M. F: C25H27N7O5

M. W: 505.54

Inv.Status: In Stock

N-Nitroso Argatroban

Cat No: CL-AGTB-NO-01

CAS No: NA

M. F: C23H35N7O6S

M. W: 537.6

Inv.Status: In Stock

N-Nitroso Brexpiprazole Impurity 2

Cat No: CL-BXP-NO-01

CAS No: NA

M. F: C17H22N4O3

M. W: 330.39

Inv.Status: In Stock

N-Nitroso Brimonidine

Cat No: CL-BND-NO-01

CAS No: NA

M. F: C11H9BrN6O

M. W: 321.13

Inv.Status: In Stock

N-Nitroso Desmethyl Diltiazem

Cat No: CL-DTZ-NO-03

CAS No: 3036581-85-5

M. F: C21H23N3O5S

M. W: 429.49

Inv.Status: In Stock

N-Nitroso Gemigliptin Impurity 1

Cat No: CL-GMGP-NO-01

CAS No: NA

M. F: C9H6F6N4O

M. W: 300.16

Inv.Status: In Stock

N-Nitroso Meglumine D3

Cat No: CL-MEGU-NO-02

CAS No: NA

M. F: C7H13D3N2O6

M. W: 227.23

Inv.Status: In Stock

N-Nitroso Rasagiline Impurity 1

Cat No: CL-RSG-NO-02

CAS No: NA

M. F: C12H13ClN2O

M. W: 236.7

Inv.Status: Custom Synthesis

N-Nitroso Rasagiline Impurity 6

Cat No: CL-RSG-NO-07

CAS No: NA

M. F: C12H13ClN2O

M. W: 236.7

Inv.Status: Custom Synthesis

N-Nitroso Rizatriptan Impurity 11

Cat No: CL-RZT-NO-16

CAS No: NA

M. F: C5H11ClN2O

M. W: 150.61

Inv.Status: Custom Synthesis

N-Nitroso Tetracaine Impurity C

Cat No: CL-TETR-NO-03

CAS No: NA

M. F: C12H16N2O3

M. W: 236.27

Inv.Status: In Stock

N-Nitroso Theophylline Impurity D

Cat No: CL-TYLL-NO-02

CAS No: NA

M. F: C6H9N5O2

M. W: 183.2

Inv.Status: In Stock

N-Nitroso Tranexamic acid EP Impurity A

Cat No: CL-TXA-NO-02

CAS No: NA

M. F: C16H26N2O5

M. W: 326.39

Inv.Status: In Stock

N-Nitroso Trientine

Cat No: CL-TRT-NO-01

CAS No: NA

M. F: C6H16N6O2

M. W: 204.23

Inv.Status: In Stock

N-Nitroso Voglibose

Cat No: CL-VGB-NO-01

CAS No: NA

M. F: C10H20N2O8

M. W: 296.28

Inv.Status: In Stock

N-Nitroso Vonoprazan Impurity 11

Cat No: CL-VPZ-NO-12

CAS No: NA

M. F: C17H12D3FN4O3S

M. W: 377.41

Inv.Status: In Stock

All Products

Services We Provide

Purification Services

We offer specialized purification services including Preparative HPLC, Flash Chromatography, Resin and Silica-based Chromatography to support Unknown Impurity projects for pharmaceutical and chemical organizations. Our advanced techniques enable efficient separation, isolation, and refinement of impurities and active ingredients. Trusted for quality and precision, our purification solutions support R&D, regulatory compliance, and commercial production needs. Explore All Services

Analytical Services

We offer comprehensive analytical services to support the qualification and quality assessment of your pharmaceutical and chemical products. Our advanced techniques ensure precise identification, quantification, and characterization of impurities, raw materials, and finished products. Backed by expert scientists and state-of-the-art instrumentation, we help you meet regulatory standards and ensure product consistency. Partner with us to strengthen your quality control and streamline compliance with global guidelines. Explore All Services

Custom Synthesis

We specialize in the development and supply of impurities and working standards as per EP, USP, BP, IP, and other international pharmacopeial guidelines. Our portfolio includes process-related impurities, degradation products, Nitrosamines & NDSRI, ensuring regulatory compliance and analytical accuracy. Each standard is thoroughly characterized and supported by comprehensive documentation. Trusted by global clients, we deliver high-purity materials for R&D, quality control, and regulatory submissions. Explore All Services

Unknown Impurity Isolation And Characterization

Unknown impurities can significantly impact product quality, safety, and regulatory compliance. Cleanchem Lab offers comprehensive impurity isolation and characterization services designed to identify trace-level unknown compounds in pharmaceutical and chemical products. Explore All Services

Industries We Serve

Pharmaceutical Industries

Pioneering Excellence in Pharmaceutical Reference Standards, Impurities & NDSRI.

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Chemical Industries

Custom Synthesized Products at their Finest

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Agrochemical Industries

Advancing Agriculture with Reference Standards

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Biotech Industries

Driving innovation and discovery with cutting-edge solutions.

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Food Industries

Redefining Quality by characterising Food Grade Dyes, Stabilisers & Preservatives.

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Cosmetics and Personal Care

Pharmaceutical Ingredients (APIs) for cosmetics and personal care products

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Our Expertise

Pharmaceutical Reference Standards

Pharmaceutical Reference Standards Suppliers in India

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Working Standards

A drug substance or chemical material that conforms to established standards of quality and purity, confirmed by comparison with an official reference standard. It is designated as a Reference Working Substance for use in routine quality control analysis, and can be taken from any approved manufacturing batch.

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Impurity Reference Standards

Impurity Standards Suppliers And Manufacturers in India: Ensuring Drug Quality and Safety

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Nitrosamines and NDSRIs

Nitrosamines are chemical impurities classified as probable human carcinogens, formed during drug manufacturing or storage, requiring strict regulatory control to ensure patient safety.

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API Intermediates

API intermediates are chemical compounds formed during the synthesis of active pharmaceutical ingredients, serving as essential building blocks in the production of high-quality medicines

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Custom Synthesized Compounds

Cleanchem delivers high-quality, cost-effective custom-synthesized complex organic molecules ranging from milligram to kilogram scale. Our team of highly experienced Ph.D. scientists specializes in designing efficient and innovative synthetic routes for both new and known compounds. With deep expertise in synthetic organic chemistry, our scientists have extensive experience in developing and producing a wide range of high-purity organic molecules tailored to customer requirements.

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