Rasagiline Mesylate is the methanesulfonate salt of the selective monoamine oxidase-B inhibitor rasagiline. It is identified by CAS 161735-79-1, molecular formula C₁₂H₁₃N·CH₄O₃S, and molecular weight 267.34 g/mol.
Rasagiline is an R-configured propargylamine derivative used in pharmaceutical products for the treatment of idiopathic Parkinson's disease.
Rasagiline Mesylate is a selective MAO-B inhibitor. The pharmaceutical substance is the R-enantiomer, making enantiomeric purity an important quality attribute.
The material is described as a white to off-white powder and is freely soluble in water and ethanol, with limited solubility in isopropanol.
| Parameter | Details |
|---|---|
| Product | Rasagiline Mesylate |
| CAS | 161735-79-1 |
| Formula | C₁₂H₁₃N·CH₄O₃S |
| Molecular Weight | 267.34 g/mol |
| Free Base CAS | 136236-51-6 |
| Free Base MW | 171.24 g/mol |
| Development Code | TVP-1012 |
| Drug Class | MAO-B inhibitor |
| Configuration | R |
| Defined Stereocenters | 1 |
| Appearance | White to almost-white powder/crystal |
| Melting Point | 155–159°C |
| Specific Rotation | +20.0° to +22.0° (c=2, ethanol) |
| Solubility | Freely soluble in water and ethanol |
The current TCI specification reports HPLC purity of NLT 98.0 area%, melting point 155–159°C, and specific rotation +20.0° to +22.0° (c=2, ethanol).
Rasagiline Mesylate API is used in pharmaceutical development for:
Current U.S. labeling identifies rasagiline, administered as the mesylate salt, for treatment of idiopathic Parkinson's disease.
Rasagiline Mesylate requires control of both chemical purity and stereochemical purity.
The 2026 USP-NF proposed monograph includes separate analytical procedures for:
The proposed USP monograph specifically identifies chiral analysis for the Rasagiline S-enantiomer and LC-MS testing for Related Compound B.
Manufacturing Rasagiline Mesylate requires controlled synthesis of the R-configured active moiety, salt formation with methanesulfonic acid, purification and validated chromatographic testing. Enantiomeric purity is particularly important because the pharmaceutical substance has one defined stereocenter.
TCI recommends storage of its Rasagiline Mesylate material in a frozen condition below 0°C and identifies it as heat sensitive.
For commercial pharmaceutical API, the final storage condition should follow the validated stability data and approved specification for the specific material.
Typical documentation can include:
Rasagiline Mesylate requires control of assay, related substances and especially enantiomeric purity. Validated chromatographic methods and appropriate storage conditions help maintain consistent quality for pharmaceutical manufacturing and development.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.50% |
| Residue on Ignition | NMT 0.20% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |
| Melting Point | 155–159°C |