High-quality chemical precursors are necessary for the synthesis of amisulpride. An important stage in the manufacturing of this significant antipsychotic medication is the synthesis of amisulpride intermediates, CAS 71675-85-9. The final active pharmaceutical ingredient (API) is directly derived from this compound. Its purity and steady supply are therefore important for the manufacturing of pharmaceuticals. In this supply chain, reliable amisulpride intermediate suppliers are very important.
An Overview of Intermediates of Amisulpride
For chemists and engineers. This information guarantees appropriate application, synthesis, and handling.
Identification of Chemicals
Its CAS number specifically identifies the main compound of interest.
– 71675-85-9 is the CAS number.
– C₁₇H₂₇N₃O₄S is the molecular formula.
– 369.48 g/mol is the molecular weight.
There are numerous synonyms for this compound as well. For instance, 4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl], its IUPAC name, is frequently used to refer to it. 5-(ethylsulfonyl)-2-methoxybenzamide. It may be referred to as Aminosultopride or Amisulpride API in commercial settings, though this can be confusing because it is an intermediate and not the final API.
Amisulpride Intermediates’ Chemical Characteristics and Properties CAS 71675-85-9
The handling, storage, and quality control parameters of amisulpride intermediates CAS 71675-85-9 are determined by their physical and chemical characteristics. Manufacturers of amisulpride intermediates are required to follow stringent guidelines to guarantee the safety and effectiveness of the finished medication.
Physical attributes
This substance usually manifests as a crystalline powder that ranges from white to off-white. Its solid form makes transportation and handling easier. One important measure of purity is the melting point. Any departures from this range could indicate the existence of contaminants.
The main requirements for a pharmaceutical-grade amisulpride intermediate are listed in the table below.
|
Parameter |
Specification |
Test Method |
|
Appearance |
White to off-white crystalline powder |
Visual Inspection |
|
CAS Number |
71675-85-9 |
– |
|
Molecular Formula |
C₁₇H₂₇N₃O₄S |
– |
|
Molecular Weight |
369.48 g/mol |
– |
|
Melting Point |
125-129°C |
Capillary Method |
|
Purity (HPLC) |
≥98% |
High-Performance Liquid Chromatography |
|
Water Content |
≤0.5% |
Karl Fischer Titration |
|
Residue on Ignition |
≤0.1% |
USP <281> |
|
Heavy Metals |
≤20 ppm |
USP <231> |
Quality and Purity
No pharmaceutical intermediate can compromise on high purity. According to High-Performance Liquid Chromatography (HPLC), this compound’s standard purity level is ≥98%. Each component in a mixture is identified, separated, and quantified using this analytical method. Each batch of amisulpride intermediate bulk suppliers must include a Certificate of Analysis (CoA) attesting to the product’s compliance with this pharmaceutical grade standard. To avoid deterioration, the compound should be stored between 2 and 8°C and shielded from light.
Security and Management
When handling any chemical, safety is the top priority. Because of its Acute Toxicity 4 (Oral) classification, this amisulpride intermediate is dangerous if swallowed. Employees must thus wear the proper personal protective equipment (PPE). This includes eye protection, a dust mask to stop inhalation, and gloves that can withstand chemicals. Every handling operation should take place in an area with adequate ventilation.
Amisulpride Intermediate Synthesis Routes
A number of steps are involved in the chemical synthesis of amisulpride and its precursors. For industrial production, the entire procedure needs to be scalable and effective. Optimizing these pathways is a common focus of custom synthesis services for amisulpride intermediates.
Important Synthetic Pathways
Usually, more fundamental raw materials are used to produce amisulpride intermediates. Two important precursors, methyl 4-amino-5-ethylsulfonyl-2-methoxybenzoate (CAS 80036-89-1) and 2-(Aminomethyl)-1-ethylpyrrolidine (CAS 26116-12-1), react in one typical pathway.
It is possible to deconstruct the entire pathway of amisulpride synthesis intermediates:
5-aminosalicylic acid acetylation: This first stage shields the amino group for ensuing reactions.
The benzene ring gains the required functional groups through the processes of methylation and nitration.
The important ethylsulfonyl group is introduced by the diazotization and sulfonylation process.
Amide Formation: To create the target molecule, CAS 71675-85-9, the advanced benzoic acid derivative must be coupled with the pyrrolidine side chain in the last step.
Industrial Difficulties
There are many obstacles to overcome when scaling a synthesis from laboratory to industrial production.
Reaction Time Optimization: To increase throughput without compromising quality, every stage needs to be optimized. Reaction times that are too long can be expensive.
Yield Improvement: Economic viability depends on maximizing the yield at every stage. In bulk amisulpride intermediate production, even a small percentage increase in yield can result in sizable savings.
Impurity Control: To reach the necessary ≥98% purity, it is important to regulate the production of byproducts.
Creative Methods
To increase the sustainability and efficiency of chemical manufacturing, constant innovation is required.
Alternative Oxidizing Agents: To enhance the synthesis’s environmental profile and safety, scientists are investigating more environmentally friendly and selective oxidizing agents.
Improved Methods of Purification: Purity and yield can be increased by using sophisticated purification techniques like continuous crystallization or preparative chromatography. These techniques assist amisulpride intermediate exporters in meeting the demanding international quality standards.
Amisulpride Intermediate Applications
The pharmaceutical industry is the main application for amisulpride intermediates CAS 71675-85-9. Its function encompasses both specialized research applications and large-scale manufacturing.
Relevance to Pharmaceuticals
The primary function of this compound is to act as the direct precursor in the synthesis of amisulpride. Amisulpride is an atypical antipsychotic drug. It mainly treats dysthymia and schizophrenia. The medication works as a selective antagonist of the dopamine D2/D3 receptor. It increases dopamine release and reduces negative symptoms of schizophrenia by blocking presynaptic D2/D3 autoreceptors at low doses. It lessens the positive symptoms of schizophrenia by blocking postsynaptic receptors at higher dosages. The effectiveness and safety of the finished API are directly impacted by the quality of the amisulpride intermediate.
Investigation and Creation
These intermediates are useful resources for research and development in addition to manufacturing. Researchers use them to investigate neuropsychiatric conditions. Quality control laboratories use the compound as a reference standard. Scientists also develop new analytical techniques with it to identify amisulpride and its metabolites in biological materials. High-purity amisulpride intermediates are necessary for this continuing study.
Commonly Asked Questions (FAQs)
What is the intermediate molecular weight of amisulpride?
369.48 g/mol is the molecular weight.
What are this compound’s storage requirements?
The compound should be kept out of direct sunlight and between 2 and 8°C.
What is the main use for intermediates of amisulpride?
Its main use is in the chemical synthesis of antipsychotic drugs, particularly amisulpride.
What safety measures should be taken when working with this compound?
Wear eye protection, a dust mask, and gloves when handling. You must also refrain from eating.
How pure are the intermediates of amisulpride?
According to HPLC, a pharmaceutical grade intermediate has a purity level of ≥98%.
