Industrial Purity 3-[(1S)-1-(Dimethylamino)Ethyl]Phenol Coa Specs
- Chiral Integrity: Strict control over enantiomeric excess to meet pharmaceutical intermediate standards.
- Documentation: Comprehensive Certificate of Analysis (COA) including residual solvents and heavy metals.
- Scalability: Optimized manufacturing process designed for bulk procurement and consistent supply.
In the landscape of pharmaceutical intermediates, consistent quality and documented purity are paramount for regulatory compliance. 3-[(1S)-1-(Dimethylamino)ethyl]phenol, frequently identified in technical literature as Rivastigmine Related Compound C, serves as a critical chiral building block in the synthesis of acetylcholinesterase inhibitors. For process chemists and procurement officers, understanding the specific Certificate of Analysis (COA) specifications is essential to ensure downstream reaction success. As a premier global manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. prioritizes transparency in technical data to support large-scale production requirements.
The compound, with CAS number 139306-10-8, presents specific challenges regarding chiral resolution and stability. Sourcing material that meets strict assay limits prevents costly purification steps later in the synthesis route. When evaluating suppliers, buyers must look beyond basic identity confirmation and focus on impurity profiles, particularly regarding the R-enantiomer and related phenolic byproducts.
Understanding Isomer Assay Limits ≤0.5%
The pharmacological activity of the final drug product often depends heavily on the stereochemical purity of the intermediate. For (S)-3-[1-(Dimethylamino)ethyl]phenol, the presence of the opposite enantiomer can complicate crystallization and reduce overall yield. Industrial grade specifications typically demand an enantiomeric excess (ee) of greater than 99.0%, with the opposing isomer limited to ≤0.5%.
Advanced chiral HPLC methods are required to validate these claims. A robust COA will detail the column type, mobile phase composition, and retention times for both the major and minor enantiomers. Process chemists should verify that the testing methodology aligns with pharmacopeial standards, such as EP or USP monographs where applicable. At NINGBO INNO PHARMCHEM CO.,LTD., our quality control laboratories utilize validated chiral stationary phases to guarantee that every batch meets these stringent stereochemical requirements before release.
Furthermore, chemical purity via standard HPLC should exceed 98.5% to 99.0% for most industrial applications. Impurities such as unreacted starting materials or over-alkylated byproducts must be quantified. When sourcing high-purity 3-[(1S)-1-(Dimethylamino)ethyl]phenol, buyers should request chromatograms alongside the final report to verify peak separation and integration accuracy.
Required COA Documentation for GMP Compliance
For pharmaceutical manufacturers operating under Good Manufacturing Practice (GMP) guidelines, the Certificate of Analysis is more than a summary of results; it is a legal document tracing the quality history of the material. A compliant COA for this intermediate must include specific data points beyond simple identity and assay.
Key parameters include:
- Residual Solvents: Compliance with ICH Q3C guidelines is mandatory. Common solvents used in the manufacturing process, such as methanol, ethanol, or toluene, must be quantified via Headspace GC.
- Heavy Metals: Limits for lead, cadmium, mercury, and arsenic should be clearly stated, typically below 10 ppm for each, depending on the daily dose of the final drug product.
- Water Content: Karl Fischer titration results ensure the material is sufficiently dry, typically ≤0.5%, to prevent hydrolysis during storage or subsequent reactions.
- Appearance: Visual inspection confirming the material is a white to off-white solid, free from foreign matter.
Transparency in these areas reduces the risk of regulatory audits failing due to supplier documentation gaps. Industrial purity is defined not just by the main peak area, but by the control of these critical quality attributes. Buyers should ensure their supplier can provide trend data over multiple batches to demonstrate process consistency.
Stability Data and Storage Conditions Overview
Proper handling and storage are critical to maintaining the integrity of 3-[(1S)-1-(Dimethylamino)ethyl]phenol. The compound is sensitive to oxidation and moisture, which can lead to discoloration and degradation over time. Based on physical property data, the material exhibits a melting point range of 87-88°C and a boiling point of approximately 241°C.
Recommended Storage Protocols:
- Temperature: Store in a cool, dry place. While room temperature is acceptable for short durations, long-term storage at +5°C is recommended to maximize shelf life.
- Atmosphere: Keep containers tightly sealed under an inert atmosphere (nitrogen or argon) to prevent oxidative degradation.
- Light Protection: The material should be kept in a dark place, as exposure to UV light may promote decomposition.
Safety data indicates the substance is a combustible solid (GHS02). Hazard statements include H228, requiring appropriate precautions during handling and transport. Precautionary statements such as P280 (wear protective gloves/eye protection) and P370+P378 (in case of fire) must be adhered to within the facility.
| Property | Specification | Test Method |
|---|---|---|
| CAS Number | 139306-10-8 | N/A |
| Molecular Formula | C10H15NO | N/A |
| Molecular Weight | 165.23 g/mol | N/A |
| Appearance | White to Off-White Solid | Visual |
| Melting Point | 87-88°C | DSC / Capillary |
| Assay (HPLC) | ≥ 98.5% | HPLC |
| Enantiomeric Excess | ≥ 99.0% | Chiral HPLC |
| Water Content | ≤ 0.5% | Karl Fischer |
Understanding these physical and chemical properties allows process engineers to design appropriate handling systems. For instance, the solubility profile indicates slight solubility in DMSO and Methanol, which informs solvent selection for reaction setups. Bulk procurement strategies should account for these storage requirements to ensure the bulk price reflects value without compromising quality due to degradation during transit or warehousing.
In conclusion, securing a reliable supply chain for chiral intermediates requires a partner dedicated to technical excellence and regulatory compliance. By focusing on rigorous COA specs, stability data, and chiral purity, manufacturers can mitigate risk in their production lines. NINGBO INNO PHARMCHEM CO.,LTD. remains committed to delivering high-quality intermediates that meet the demanding standards of the global pharmaceutical industry.