Neostigmine Methylsulphate is a synthetic reversible acetylcholinesterase inhibitor and cholinergic pharmaceutical active pharmaceutical ingredient (API). It increases the availability of acetylcholine by reducing its enzymatic breakdown, thereby enhancing cholinergic transmission.
Neostigmine Methylsulphate is an important pharmaceutical form of neostigmine used in formulations associated with neuromuscular transmission and reversal of non-depolarizing neuromuscular blockade. It is also relevant to pharmaceutical research involving cholinergic and neuromuscular pharmacology.
Neostigmine Methylsulphate is a well-characterized anticholinesterase pharmaceutical API used in pharmaceutical formulation development, manufacturing, analytical testing and research.
The compound is the methyl sulfate salt of neostigmine and is chemically distinct from Neostigmine Bromide. Neostigmine Methylsulphate has the molecular formula C₁₃H₂₂N₂O₆S and molecular weight 334.39 g/mol.
CAS Number: 51-60-5
Molecular Formula: C₁₃H₂₂N₂O₆S
Molecular Weight: 334.39 g/mol
Chemical Name: 3-[(Dimethylcarbamoyl)oxy]-N,N,N-trimethylbenzenaminium methyl sulfate
Drug Class: Cholinesterase Inhibitor
Therapeutic Class: Anticholinesterase / Cholinergic Agent
Therapeutic Area: Neurology / Anesthesiology
Molecule Type: Synthetic Small Molecule
Salt Form: Methylsulphate
Synonyms: Neostigmine Methylsulphate, Neostigmine Methylsulfate, Neostigmine Methosulfate
Neostigmine Methylsulphate acts as a reversible acetylcholinesterase inhibitor.
Its mechanism includes:
Neostigmine Methylsulphate API is relevant to:
Neostigmine Methylsulphate increases acetylcholine concentrations at the neuromuscular junction through inhibition of acetylcholinesterase.
This enhances neuromuscular transmission and makes the API particularly relevant to pharmaceutical preparations used for reversal of non-depolarizing neuromuscular blocking agents.
Neostigmine Methylsulphate belongs to the reversible cholinesterase inhibitor class. By slowing the breakdown of acetylcholine, it enhances acetylcholine-mediated activity at cholinergic sites.
Neostigmine Methylsulphate is generally described as a white crystalline powder and is hygroscopic.
It is very soluble in water and freely soluble in ethanol.
A controlled Neostigmine Methylsulphate API manufacturing process may involve:
Typical Neostigmine Methylsulphate API testing may include:
Store Neostigmine Methylsulphate API in a tightly closed container protected from light and moisture.
Because the material is hygroscopic, appropriate moisture protection should be maintained during storage and handling.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 3.0 – 5.0 |
| Water Content | NMT 1.0% |
| Melting Point | 145 – 149°C |