FAQ

LCZ696 Intermediate N-3 (CAS No.: 1012341-50-2) is a chemical intermediate primarily used in pharmaceutical synthesis, particularly in the production of sacubitril/valsartan (Entresto®), a medication for heart failure. While specific toxicity data for this intermediate may not be widely published in open sources, general principles of chemical safety and risk assessment can be applied based on its classification and intended use.

1. Chemical Classification and Properties

• CAS No.: 1012341-50-2
• Chemical Name: (2R,4S)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid
• Molecular Formula: C₂₃H₂₉NO₄
• Molecular Weight: 383.48 g/mol
• Function: Pharmaceutical intermediate for LCZ696 (sacubitril/valsartan).

2. Potential Hazards

• Toxicological Risk: As a chemical intermediate, it is not intended for direct human exposure or consumption. Its toxicity would depend on factors such as route of exposure (inhalation, ingestion, dermal), dose, and duration. Intermediates are typically handled under controlled laboratory or industrial conditions with appropriate safety measures.
• Environmental and Health Regulations: Chemicals used in pharmaceutical manufacturing are subject to strict regulatory oversight (e.g., by the FDA, EMA, or equivalent agencies) to ensure safety throughout the supply chain. However, intermediates like this one may not be individually listed in consumer safety databases unless they pose specific risks.
• Handling Precautions: Workers in pharmaceutical or chemical facilities where this intermediate is used would follow standard operating procedures (SOPs) and wear personal protective equipment (PPE) to minimize exposure risks.

3. Risk Assessment

• Absence of Public Toxicity Data: The lack of widely available toxicity data for this specific intermediate suggests it is not a commonly encountered household or environmental chemical. Its risk profile is likely managed through controlled industrial processes.
• Comparison to Final Drug Product: The final drug (sacubitril/valsartan) has undergone extensive clinical trials and regulatory review to establish safety and efficacy. The intermediate’s risk is mitigated by its incorporation into a formulated medication with established safety guidelines.

4. Safety Recommendations

• Industrial Use: Follow Material Safety Data Sheets (MSDS) and SOPs provided by the manufacturer or supplier. Ensure proper ventilation, PPE, and waste disposal practices.
• Regulatory Compliance: Adhere to local and international regulations for chemical handling, storage, and transport.
• Medical Inquiries: For patients or healthcare providers, concerns about exposure should be directed to toxicology experts or regulatory bodies (e.g., Poison Control Centers, FDA).