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A certain pharmaceutical company in Beijing has formed a strong alliance with Southern Testing to jointly build a pharmaceutical excipient for sodium dihydrogen phosphate dihydrate
Date: 2025-12-02Read: 5

In the wave of high-quality development in the pharmaceutical industry, the stability and reliability of the supply chain are the cornerstone of enterprise innovation and development. A certain pharmaceutical company in Beijing has reached a deep strategic cooperation with Nanjing Chemical Reagent, relying on their respective professional accumulation in the pharmaceutical and chemical reagent fields to jointly promoteSouthern TestSodium dihydrogen phosphate dihydrate pharmaceutical excipient(CDE registration numbers: F202000001429 (A), F20200000164)This strong alliance not only provides a solid guarantee for drug production, but also establishes a new trend of coordinated development between the upstream and downstream of the pharmaceutical industry chain.


Nanjing reagentSodium dihydrogen phosphate dihydrate pharmaceutical excipient(CAS: 13472-35-0), Widely used in various pharmaceutical preparations, it plays a key role as a pH regulator, buffering agent, etc. The stability of its quality directly affects the safety, effectiveness, and quality controllability of the final drug. Registered with the National Center for Drug Evaluation (CDE), it meets the requirements of the 2025 edition of the Chinese Pharmacopoeia. Its core advantages are reflected in high purity and low impurities: purity ≥ 99.5%, key impurities (such as heavy metals and microorganisms) are strictly controlled below the pharmacopoeia limit, and it is suitable for various dosage forms such as oral preparations and injections; Stable and controllable: The production process adopts closed-loop management, with small differences between batches, ensuring stable formulation performance; Compliance acceleration: CDE registration has been completed, and customers can directly use it for formulation registration and application, significantly shortening the research and development cycle. This excipient is widely used in pH regulator, buffer, osmotic regulator and other scenarios - for example, to regulate the drug release rate in oral solid preparations and maintain the osmotic balance of body fluid in injections, which is one of the "basic core excipients" in preparation research and development.

With increasingly strict drug regulation, CDE registration of pharmaceutical excipients has become an important condition for formulation registration.Southern Test
Sodium dihydrogen phosphate dihydrate pharmaceutical excipientCompliance not only helps customers avoid registration risks, but also reduces the time cost of self verification for enterprises through the "get and use" nature of raw materials. This cooperation is not only a simple commercial procurement, but also a strategic choice for upstream and downstream enterprises in the industry chain to work together towards a common goal of "producing safer and more effective drugs".