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ABOUT US Cleanchem Laboratories

Cleanchem laboratories LLP is an independent reliable R&D based custom manufacturing company (CRAMS) delivering its numerous leading products to pharmaceutical, chemical, clinical research, speciality chemical, academic and government research institutions and healthcare industry. Cleanchem is fully research driven organization dealing with custom synthesis of Impurity reference standards, Metabolites, Agrochemical Impurities, NCE Building blocks, Speciality chemicals, intermediates, complex organic chemicals for biomedical and pharmaceutical research.(CoA).

Nitroso Impurities Genotoxic Impurities

N-Nitrosamines structurally characterized by a nitroso (NO) functional group covalently bonded to the nitrogen atom of an amine; Commonly, N-nitrosamines are formed by reaction of amines with a nitrosating agent under appropriate conditions (e.g., temperature, pH, concentration)

FDA has identified seven nitrosamine impurities that theoretically could be present in drug products:

  • N-Nitrosodimethylamine NDMA
  • N-nitrosodiethylamine (NDEA)
  • N-nitroso-N-methyl-4-aminobutanoic acid(NMBA)
  • N-nitrosoisopropylethyl amine (NIPEA)
  • N-nitrosodiisopropylamine (NDIPA)
  • N-nitrosodibutylamine (NDBA)
  • and N-nitrosomethylphenylamine (NMPA)
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SERVICESR&D Facility

Custom Synthesis (CRAMS)
Unknown Impurity Isolation
Chromatographic Purification
Analytical Services
FTE Services
Characterization & Identification
Custom Technology Development
Short Path Distillation [SPDU]

ADVANTAGES Products

Impurity Reference Standards
API Intermediates
Bile Salts
Fragrance & Flavoring agents
Genotoxic impurities
Building Blocks
Active Pharmaceutical Ingredients
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