In the realm of pharmaceutical manufacturing, a deep understanding of the chemical and physical properties of intermediates is fundamental for successful process development and quality assurance. (S)-(-)-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)propanamine (CAS: 132335-44-5), a key intermediate for Duloxetine hydrochloride, is no exception. As a dedicated pharmaceutical chemical supplier, we aim to provide clarity on these essential characteristics.

The molecular formula for this compound is C9H15NOS, with a molecular weight of approximately 185.29 g/mol. Its structure is characterized by a thiophene ring attached to a propanol backbone, with a dimethylamino group. The presence of the hydroxyl group and the chiral center at the C1 position are critical for its role in the stereospecific synthesis of Duloxetine.

Key physical properties that manufacturers need to be aware of include its appearance, typically an off-white to white powder. The melting point, reported to be in the range of 78-80°C, is an important parameter for identification and quality control. Its density is approximately 1.111 g/cm³, and it has a boiling point around 290°C. The flash point of 129°C and a refractive index of 1.553 also provide valuable data for safe handling and processing.

For API manufacturers aiming to buy this intermediate, understanding its specification sheet is crucial. High purity, generally ≥98.0%, is a standard requirement. This purity is often determined by methods like Gas Chromatography (GC) or High-Performance Liquid Chromatography (HPLC). Critical impurities must be kept to a minimum. Specifications commonly include:

  • Water Content: ≤0.5%
  • Loss on Drying: ≤0.5%
  • Sulphated Ash: ≤0.1%
  • Heavy Metals: ≤20 ppm
  • Single Impurity: ≤0.1%

These parameters ensure that the intermediate is suitable for use in pharmaceutical synthesis, where even trace impurities can affect the final API’s quality, safety, and efficacy. Manufacturers seeking a reliable supplier, particularly from China, should confirm that these specifications are consistently met. Proper storage conditions – cool, dry, and away from light – are also important for maintaining the compound’s stability and chemical integrity, thus preserving its quality for downstream applications.

By understanding these detailed chemical and physical properties, pharmaceutical professionals can make informed decisions when sourcing (S)-(-)-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)propanamine, ensuring the success of their API manufacturing processes.