{"id":51851,"date":"2024-12-20T11:03:34","date_gmt":"2024-12-20T03:03:34","guid":{"rendered":"http:\/\/www.newtopchem.com\/archives\/51851"},"modified":"2024-12-20T12:12:39","modified_gmt":"2024-12-20T04:12:39","slug":"uses-and-safety-evaluations-of-cyclohexylamine-in-pharmaceutical-manufacturing-processes","status":"publish","type":"post","link":"http:\/\/www.newtopchem.com\/archives\/51851","title":{"rendered":"Uses and Safety Evaluations of Cyclohexylamine in Pharmaceutical Manufacturing Processes","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

Uses and Safety Evaluations of Cyclohexylamine in Pharmaceutical Manufacturing Processes<\/h3>\n

Abstract<\/h4>\n

Cyclohexylamine (CHA) is a versatile organic compound widely used in various industries, including pharmaceutical manufacturing. This paper provides an extensive overview of the applications of cyclohexylamine in pharmaceutical processes, along with comprehensive safety evaluations. The article covers product parameters, potential hazards, regulatory guidelines, and risk mitigation strategies. Literature from both international and domestic sources has been reviewed to ensure a robust understanding of the topic.<\/p>\n

1. Introduction<\/h4>\n

Cyclohexylamine (CHA), also known as hexahydroaniline or amino cyclohexane, is a colorless liquid with a fishy odor. It is primarily used as an intermediate in the synthesis of pharmaceuticals, rubber chemicals, dyes, and resins. In the pharmaceutical industry, CHA serves multiple purposes, including as a raw material for synthesizing active pharmaceutical ingredients (APIs) and as a catalyst or reagent in chemical reactions.<\/p>\n

2. Product Parameters of Cyclohexylamine<\/h4>\n

Understanding the physical and chemical properties of cyclohexylamine is crucial for its safe handling and application in pharmaceutical manufacturing. Below is a detailed table summarizing the key parameters:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Parameter<\/th>\nValue<\/th>\n<\/tr>\n<\/thead>\n
Chemical Formula<\/td>\nC6H11NH2<\/td>\n<\/tr>\n
Molecular Weight<\/td>\n101.16 g\/mol<\/td>\n<\/tr>\n
Appearance<\/td>\nColorless liquid<\/td>\n<\/tr>\n
Odor<\/td>\nFishy<\/td>\n<\/tr>\n
Boiling Point<\/td>\n134-135\u00b0C<\/td>\n<\/tr>\n
Melting Point<\/td>\n-7.9\u00b0C<\/td>\n<\/tr>\n
Density<\/td>\n0.861 g\/cm\u00b3 at 20\u00b0C<\/td>\n<\/tr>\n
Solubility in Water<\/td>\nSlightly soluble<\/td>\n<\/tr>\n
Flash Point<\/td>\n44\u00b0C<\/td>\n<\/tr>\n
Autoignition Temperature<\/td>\n415\u00b0C<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

3. Applications in Pharmaceutical Manufacturing<\/h4>\n

Cyclohexylamine finds diverse applications in pharmaceutical manufacturing due to its unique properties. Some of the key uses include:<\/p>\n

3.1 Synthesis of Active Pharmaceutical Ingredients (APIs)<\/h5>\n

CHA is a critical building block for synthesizing APIs. For instance, it is used in the production of drugs like chlorpheniramine maleate, which is an antihistamine commonly prescribed for allergic reactions.<\/p>\n

3.2 Catalyst and Reagent<\/h5>\n

In many organic syntheses, CHA acts as a catalyst or reagent. Its ability to form stable complexes with metal ions makes it valuable in catalytic reactions, enhancing reaction rates and selectivity.<\/p>\n

3.3 pH Adjuster<\/h5>\n

Cyclohexylamine can be employed as a pH adjuster in pharmaceutical formulations. Its basic nature allows it to neutralize acidic components, ensuring optimal conditions for drug stability and efficacy.<\/p>\n

4. Safety Evaluations<\/h4>\n

Given its reactive nature and potential health risks, conducting thorough safety evaluations is imperative. Key aspects include toxicity, exposure limits, and environmental impact.<\/p>\n

4.1 Toxicity<\/h5>\n

Studies have shown that cyclohexylamine exhibits moderate toxicity. Prolonged exposure can cause irritation to the skin, eyes, and respiratory tract. Inhalation of vapors may lead to central nervous system depression. According to the U.S. Environmental Protection Agency (EPA), chronic exposure can result in liver and kidney damage.<\/p>\n

4.2 Exposure Limits<\/h5>\n

Regulatory bodies such as OSHA (Occupational Safety and Health Administration) and ACGIH (American Conference of Governmental Industrial Hygienists) have established permissible exposure limits (PELs) for cyclohexylamine. The following table summarizes these limits:<\/p>\n\n\n\n\n\n\n
Organization<\/th>\nLimit Type<\/th>\nValue<\/th>\n<\/tr>\n<\/thead>\n
OSHA<\/td>\nTime-Weighted Average (TWA)<\/td>\n10 ppm (30 mg\/m\u00b3)<\/td>\n<\/tr>\n
ACGIH<\/td>\nThreshold Limit Value (TLV)<\/td>\n5 ppm (15 mg\/m\u00b3)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
4.3 Environmental Impact<\/h5>\n

Cyclohexylamine can pose environmental risks if improperly managed. It is moderately toxic to aquatic life and can persist in water bodies. Proper disposal methods and containment strategies are essential to mitigate ecological harm.<\/p>\n

5. Regulatory Guidelines and Compliance<\/h4>\n

To ensure safe usage, pharmaceutical manufacturers must adhere to stringent regulatory guidelines. These include:<\/p>\n

5.1 International Regulations<\/h5>\n