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E-mail
3236925839@qq.com
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Phone
13813936700
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Address
No. 109, South Zhaoqiao Road, Nanjing Chemical Industry Park
Nanjing Chemical Reagent Co., Ltd
3236925839@qq.com
13813936700
No. 109, South Zhaoqiao Road, Nanjing Chemical Industry Park
Potassium sorbate pharmaceutical excipientAs an efficient and safe preservative, it is widely used in the fields of food, cosmetics, and medicine. In pharmaceutical excipients, it effectively extends the shelf life of drugs by inhibiting microbial growth, while avoiding allergic reactions that may be caused by traditional preservatives, becoming an important part of innovative drug formulations. However, pharmaceutical grade potassium sorbate has extremely strict requirements for purity, impurity control, and production processes. Through joint research and development, the two have broken through key technologies such as high-purity purification and microbial control, enabling the product to meet multiple national standards such as the Chinese Pharmacopoeia, USP, and EP, and meet the diverse needs of excipients for formulations.
Medicinal grade potassium sorbateNot just about "anti-corrosion", but also about "safety compliance"
Medicinal grade products need to meet stricter standards - the joint launch of potassium sorbate achieves breakthroughs in the following dimensions:
1. Purity, strict control of impurities
Through the joint optimization of the "low-temperature crystallization+molecular distillation" process, the product purity reaches over 99.9%, with heavy metal (lead, arsenic, etc.) content ≤ 0.5ppm and residual solvent ≤ 10ppm, far below the limits of the Chinese Pharmacopoeia 2025 edition and international pharmacopoeias such as USP and EP, eliminating drug safety hazards from the source.
2. Compliance first, accelerate declaration
Nanjing reagentMedicinal grade potassium sorbateThe registration of CDE pharmaceutical excipients has been completed (registration numbers: F20180000635, F20190001899 (A), F20250000201),It can be directly used for drug registration and application, helping pharmaceutical companies shorten their research and development cycle and reduce compliance risks.
3. Efficient anti-corrosion, stable compatibility
Within the pH range of 3-6, the inhibition rate against mold, yeast, and some Gram positive bacteria reaches 99.9%, and there are no compatibility taboos with most active ingredients of drugs (such as vitamins, antibiotics, and traditional Chinese medicine extracts), which does not affect the efficacy and stability of the formulation.
4. Full chain traceability, controllable quality
From raw material procurement to finished product delivery, a full chain traceability system of "raw materials production testing logistics" has been established. Each batch of products comes with a detailed quality report, supporting pharmaceutical companies to trace production process data at any time.
This cooperation is not only a complementarity of technical resources between the two parties, but also an optimization of the industry ecosystem. We hope to provide pharmaceutical companies with safer and more stable excipient solutions through this cooperation, while promoting the internationalization of the domestic pharmaceutical excipient industry.