Argatroban Intermediate (Argatroban Impurity 13 HCl) CAS 74874-08-1 NT

Argatroban Intermediate (CAS 74874-08-1), also known as Argatroban Impurity 13 HCl, Argatroban Impurity D, or (2R,4R)-Ethyl 1-((S)-2-amino-5-(3-nitroguanidino)pentanoyl)-4-methylpiperidine-2-carboxylate Hydrochloride, is a protected dipeptide-like intermediate in the synthesis of Argatroban . Argatroban is a direct thrombin inhibitor approved for the prophylaxis and treatment of thrombosis in patients with heparin-induced thrombocytopenia (HIT) .

Chemical Characteristics:

• Features a piperidine ring with defined (2R,4R) stereochemistry and an L-arginine-derived side chain

• Contains a nitroamino (nitroguanidine) protecting group on the arginine moiety

• Hydrochloride salt form enhances stability and solubility

• Molecular formula: C₁₅H₂₉ClN₆O₅ 

• Molecular weight: 408.88 g/mol 

• Melting point: 174-177°C 

• Solubility: Soluble in DMSO and methanol 

• Stability: Hygroscopic; store under inert atmosphere 

Role in Argatroban Synthesis:

Argatroban is a synthetic direct thrombin inhibitor used as an anticoagulant. This compound serves as a key protected intermediate in the multi-step synthesis of the API, incorporating the nitroarginine side chain that is essential for the drug's thrombin-binding activity . As Argatroban Impurity 13 HCl (or Impurity D), it is also used as a reference standard for quality control and analytical method development .

Key Features:

• High Purity: ≥ 98% (HPLC), meeting rigorous quality standards 

• Key Intermediate: Essential for the synthesis of Argatroban API

• Impurity Reference Standard: Identified as Argatroban Impurity 13 HCl and Impurity D for QC applications 

• Well-characterized with available analytical data

• Hygroscopic nature requiring appropriate handling and storage

Applications:

• Pharmaceutical Manufacturing: As a key intermediate in the commercial synthesis of Argatroban API

• Quality Control: Serves as a reference standard for impurity profiling and analytical method development (AMV) in Argatroban production

• Regulatory Submissions: Used in ANDA and DMF filings for Argatroban-related drug products

Packaging: ___ (e.g.: 1g, 5g, 10g, 25kg per package, as per customer's request)

Storage: Store in a cool, dry, well-ventilated area, away from direct sunlight and moisture. Recommended storage temperature: 2-8°C (Refrigerator) under inert atmosphere; hygroscopic, protect from moisture . For long-term storage, keep sealed in a dry place at room temperature

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