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Country: China (Mainland)
Business Type:Lab/Research institutions
Tel: +86-173-20513646
Tel: +86 17320513646
Mobile: 17320513646
Tel: +86-173-20513646
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Province/state: Hu Bei
City: Wuhan
Street: Company address: Room 005, 15th Floor, Building D2, Phase III, Software New Town, No. 8 Huacheng Avenue, East Lake High-tech Development Zone, Wuhan, Hubei Province, China
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Our products are mainly impurity reference and standard products for drug development。Our laboratory area is more than 5000 square meters, and our liquid phase and mass spectrometry more than 20 units。
N-Nitroso rac-Proline
Product Information
Product Code:N031288
English Name:N-Nitroso rac-Proline
English Alias:1-nitrosopyrrolidine-2-carboxylic acid
CAS No.:2571-28-0
Molecular Formula:CHNO
Molecular Weight:144.13
Advantages
High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for precise analysis of N-nitroso impurities.
Stability Assurance:Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in acetonitrile-water solution within 6 months.
Applications
Quality Control Testing:Used for UPLC-MS/MS detection of N-nitroso impurities in proline-containing drugs, food additives, and cosmetics, controlling content to meet international regulatory standards (e.g., ≤10 μg/kg in food).
Biological Sample Analysis:Detects N-Nitroso rac-Proline in human urine, blood, and other biological samples to assess in-vivo exposure levels of nitrosocompounds, with an LOD of 0.01 ng/mL.
Process Optimization Research:Monitors N-Nitroso rac-Proline formed by nitrosation side reactions during proline derivative synthesis or fermentation, reducing generation by >70% by adjusting reaction pH (6-7) and avoiding nitrite exposure.
Background Description
N-nitroso compounds (NOCs) are widespread potential carcinogens. N-Nitroso rac-Proline, as a nitrosated derivative of proline, may form during food processing (e.g., pickling, fermentation), drug synthesis, or in-vivo metabolic processes. Its nitrosamide group is genotoxic, capable of inducing DNA damage and increasing cancer risk. With stricter regulations on NOCs by WHO and FDA, studying such impurities is crucial for ensuring food safety, drug safety, and human health.
Research Status
Detection Technology:UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 2.5 minutes, with LOD of 0.003 ng/mL for trace nitrosamine analysis.
Formation Mechanism:Formed by reaction of proline with sodium nitrite under acidic conditions (pH<4) or indirectly via microbial metabolism of nitrites. Adding antioxidants (e.g., vitamin C) and optimizing fermentation processes inhibit its formation.
Safety Evaluation:Animal studies show carcinogenicity, with a permitted daily intake (TTC value) determined as 1.5 μg/day. Current population cohort studies analyze the correlation between its exposure levels and cancer incidence.