Boc-2-methyl-pyrrolidine-2-carboxylic acid | Quality China Suppliers & Factory Products
Basic Information
Product Description
(2S)-1-(tert-Butoxycarbonyl)-2-methylpyrrolidine-2-carboxylic acid
CAS No.: 103336-06-7
Critical intermediate for Daridorexant (Insomnia treatment).
(2S)-1-(tert-Butoxycarbonyl)-2-methylpyrrolidine-2-carboxylic acid (also known as N-BOC-2-methyl-L-proline, Molecular Formula: C₁₀H₁₇NO₄) is a key chiral intermediate for pharmaceutical synthesis. Its chemical structure is characterized by a methyl substituent at the 2-position of the pyrrolidine ring and a tert-butoxycarbonyl (BOC) protecting group on the pyrrolidine nitrogen atom. Under ambient temperature and pressure, it exists as a white to pale yellow solid, slightly soluble in water but soluble in polar organic solvents such as acetonitrile and methanol.
Quality Standard: Strict quality control specifications are established: appearance compliance is verified by visual inspection; related substances (individual impurity ≤ 0.5%, total impurities ≤ 2.0%) and purity (≥ 98.0%) are determined by HPLC; enantiomeric excess (≥ 99.0%) is detected by chiral HPLC; moisture content is controlled to ≤ 1.0% via Karl Fischer titration (Method 1 of ChP 2020 Edition, Part IV).
The recommended storage condition is sealed preservation at room temperature, with a retest period of 24 months. These requirements ensure batch-to-batch consistency and stability for industrial pharmaceutical synthesis.
Product Specification
| Item | Limit | Basis for Test Method |
|---|---|---|
| Appearance | White to pale yellow solid | ChP 2020 Edition, Part IV, General Notices, Article 15 |
| Related Substances - Individual Unknown Impurity | ≤0.5% | ChP 2020 Edition, Part IV, General Rule 0512 (HPLC Method) |
| Related Substances - Total Impurities | ≤2.0% | |
| Purity | ≥98.0% | |
| Enantiomeric Excess | ≥99.0% | Chiral HPLC |
| Moisture | ≤0.5% | ChP 2020 Edition, Part IV, General Rule 0832 |