Ensuring Quality: Specifications of (3S)-3-[4-...phenoxy]oxolane for Pharma
In the pharmaceutical industry, the quality of raw materials directly dictates the safety and efficacy of the final drug product. For intermediates like (3S)-3-[4-[(5-Bromo-2-chlorophenyl)methyl]phenoxy]oxolane (CAS: 915095-89-5), a vital component in the synthesis of Empagliflozin, adhering to strict specifications is non-negotiable. Pharmaceutical manufacturers and research scientists must understand these critical parameters to ensure successful drug development and production.
The primary specification for (3S)-3-[4-[(5-Bromo-2-chlorophenyl)methyl]phenoxy]oxolane is its purity. Reputable suppliers, such as ourselves, guarantee a minimum purity of ≥99.0%, as determined by analytical methods like HPLC. This high level of purity is essential to minimize the introduction of unwanted compounds into the synthesis process, which could complicate purification or affect the final API’s therapeutic profile.
Beyond overall purity, the control of specific and non-specific impurities is equally critical. Our product adheres to stringent limits, with total impurities not exceeding 0.50%. Specific impurities are carefully monitored to meet pharmacopoeial standards such as those found in the European Pharmacopoeia (EP), United States Pharmacopeia (USP), or British Pharmacopoeia (BP). These detailed impurity profiles are crucial for regulatory submissions and risk assessments by pharmaceutical companies.
The physical characteristics of the intermediate are also important for practical handling and processing. (3S)-3-[4-[(5-Bromo-2-chlorophenyl)methyl]phenoxy]oxolane is typically supplied as a white powder. This form offers good flowability and is generally stable under appropriate storage conditions. To maintain its quality, it is recommended to keep the product in a cool, dry place, protected from strong light and heat. These storage conditions help prevent degradation and ensure the intermediate remains within its specified parameters for an extended shelf life.
For procurement managers seeking to buy this pharmaceutical intermediate, requesting a detailed specification sheet and a Certificate of Analysis (CoA) for each batch is standard practice. These documents provide verified data on purity, impurity levels, loss on drying, water content, heavy metals, and inorganic salt content. Partnering with a manufacturer that transparently provides this information ensures confidence in the material's quality and its suitability for your demanding pharmaceutical applications.
Perspectives & Insights
Nano Explorer 01
“These documents provide verified data on purity, impurity levels, loss on drying, water content, heavy metals, and inorganic salt content.”
Data Catalyst One
“Partnering with a manufacturer that transparently provides this information ensures confidence in the material's quality and its suitability for your demanding pharmaceutical applications.”
Chem Thinker Labs
“In the pharmaceutical industry, the quality of raw materials directly dictates the safety and efficacy of the final drug product.”