Ensuring Quality: A Deep Dive into Alpha-Methyldopa Sesquihydrate Specifications
For pharmaceutical companies sourcing Active Pharmaceutical Ingredients (APIs) and intermediates, understanding product specifications is paramount. Alpha-Methyldopa Sesquihydrate (CAS 41372-08-1) is no exception. As a key component in antihypertensive medications, its quality directly impacts patient safety and treatment efficacy. This guide delves into the critical specifications you should look for when you intend to buy Alpha-Methyldopa Sesquihydrate from a reliable manufacturer.
The Importance of Purity and Appearance
The most fundamental quality parameter for any pharmaceutical ingredient is its purity. For Alpha-Methyldopa Sesquihydrate, purity levels typically exceed 99.0%. This ensures that the molecule's intended pharmacological activity is not compromised by impurities, which could lead to adverse effects or reduced potency in the final drug product. Appearance is also a key indicator; the compound is generally described as a white to yellowish-white fine powder. Any significant deviation from this description warrants further investigation.
Key Specifications for Procurement Professionals:
- Assay/Purity: As mentioned, high purity (e.g., ≥99.0%) is crucial. Suppliers should provide detailed analytical data, often from High-Performance Liquid Chromatography (HPLC), confirming this.
- CAS Number: Confirming the CAS number 41372-08-1 ensures you are sourcing the correct chemical entity.
- Molecular Formula: C10H13NO4·1.5H2O is the correct molecular formula for Alpha-Methyldopa Sesquihydrate.
- Loss on Drying/Water Content: As a sesquihydrate, the water content is specific. Manufacturers should provide data on loss on drying or Karl Fischer titration results.
- Heavy Metals and Residues: Strict limits on heavy metals and residual solvents are mandatory for pharmaceutical ingredients. Reputable suppliers will have data confirming compliance with these limits.
- Particle Size Distribution: For certain formulation processes, particle size can be an important factor. If relevant to your application, inquire about the particle size distribution data.
Sourcing from Trustworthy Suppliers
When you decide to purchase Alpha-Methyldopa Sesquihydrate, selecting a supplier with a robust quality management system is essential. A leading manufacturer and Alpha-Methyldopa Sesquihydrate supplier in China will not only meet these specifications but also offer comprehensive documentation, including Certificates of Analysis (CoA), MSDS, and potentially GMP compliance information. This diligence ensures that your procurement aligns with regulatory requirements and supports the development of safe and effective medications.
By focusing on these critical quality parameters, pharmaceutical buyers can confidently source Alpha-Methyldopa Sesquihydrate, ensuring the integrity of their cardiovascular drug products. When seeking to buy Alpha-Methyldopa Sesquihydrate, partner with suppliers who prioritize transparency and quality assurance.
Perspectives & Insights
Future Origin 2025
“This diligence ensures that your procurement aligns with regulatory requirements and supports the development of safe and effective medications.”
Core Analyst 01
“By focusing on these critical quality parameters, pharmaceutical buyers can confidently source Alpha-Methyldopa Sesquihydrate, ensuring the integrity of their cardiovascular drug products.”
Silicon Seeker One
“When seeking to buy Alpha-Methyldopa Sesquihydrate, partner with suppliers who prioritize transparency and quality assurance.”