Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Ph.Eur Compliant Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Ph.Eur Compliant Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Ph.Eur compliant silicon dioxide focuses on European Pharmacopoeia compliance and is produced via a dedicated refinement process for Ph.Eur standards. With a purity of ≥99.7%, it strictly complies with the latest version of Ph.Eur (European Pharmacopoeia) standards. Indicators such as heavy metals, microorganisms and bacterial endotoxins all meet Ph.Eur limit requirements. Featuring stable physical and chemical properties and integrating the dual functions of flow aiding and dispersion, it is suitable for pharmaceutical preparations recognized by Ph.Eur standards in Europe and around the world, aligning with the compliance trend of pharmaceutical raw materials in Europe.
2. Technical Parameters
Parameter | Details |
Product Name | Ph.Eur compliant silicon dioxide |
Appearance | White, odorless, tasteless fluffy powder, free of impurities, with good flowability |
Particle Size Range | 1-28μm (exclusive for Ph.Eur standards, customizable) |
Silicon Dioxide Content | ≥99.7% |
pH Value | 3.5-7.4 (5% suspension, the latest version of Ph.Eur standard) |
Typical Addition Level | 0.1%-3.8% (in accordance with Ph.Eur preparation formula requirements) |
Shelf Life | 24 months |
Packaging | 20/25kg Ph.Eur grade pharmaceutical sealed moisture-proof drums |
Sample | Free sample available (with Ph.Eur standard test report) |
3. Application
Its core advantage is compliance with the latest version of Ph.Eur (European Pharmacopoeia) standards, making it suitable for pharmaceutical preparations recognized by Ph.Eur standards in Europe and around the world, including oral solid preparations, topical ointments and biological preparations. Highlighting the basic functions of flow aiding and dispersion, it solves the pain points of caking and poor flowability of pharmaceutical powders. The impurity content strictly meets Ph.Eur requirements, and it can be directly used for pharmaceutical preparation filing in Europe, meeting the needs of pharmaceutical enterprises in the European market overseas.
4. Factory Advantages
We have a dedicated production line for Ph.Eur compliant silicon dioxide, certified by GMP and cGMP. A special Ph.Eur testing laboratory is set up, with production and testing strictly controlled in accordance with the latest version of Ph.Eur standards. With 36 detection items throughout the whole process, the focus is on the control of bacterial endotoxin indicators. We can provide specialized test reports in line with Ph.Eur standards, with sufficient production capacity and a delivery time of 7-10 days, complying with the procurement standards of European customers.
5. Shipping & Packaging
- Standard Packaging: 20/25kg Ph.Eur grade pharmaceutical sealed moisture-proof drums with double-layer PE inner liners for moisture and pollution prevention, marked with Ph.Eur logos.
- Storage & Transportation Requirements: Store in a cool, dry and sealed place, away from odorous substances. It is a non-hazardous chemical, supporting regular global transportation of Ph.Eur grade pharmaceutical raw materials and complying with European customs acceptance criteria.
- Labeling Specifications: Marked with Ph.Eur compliant, product name, Ph.Eur implementation standards with Chinese and English descriptions, complying with European acceptance specifications.
6. Frequently Asked Questions
Q: Does this product comply with the latest version of Ph.Eur pharmacopoeia standards?
A: Fully compliant. It strictly follows the latest version of Ph.Eur standards, all physical and chemical indicators and impurity limits meet the requirements, and a test report of the corresponding version can be provided for confirmation.
Q: Can it be used for the filing of pharmaceutical preparations in the European market?
A: Yes, it can. Combined with the specialized test report in line with Ph.Eur standards, it can be directly used as raw material certification for pharmaceutical preparation filing in Europe, meeting the requirements of European drug regulatory authorities.
7. Certifications & Honors
- ISO22000:2018
- ISO9001:2015
- FDA Certification
- SHC HALAL
- OU KOSHER
- Food Additive Production License
- National High-Tech Enterprise
Packaging and Shipping
Zhongqi (Guangdong) Silicon Materials Co., Ltd., with over 20 years of experience in the food-grade silica field, is a national high-tech enterprise and a Guangdong Province specialized and innovative enterprise. Trusted by numerous international food giants, it is a leader in high-end food-grade silica. Shandong Zhonglian Chemical Co., Ltd. is Zhongqi's sole officially authorized overseas sales subsidiary.
laboratory
The company has established a world-leading R&D and intelligent manufacturing system, built GMP-standardized workshops, constructed 10,000-ton intelligent production lines, established a national-level testing center equipped with cutting-edge international equipment, and built its own high-standard microbiological testing laboratory. From raw material screening to finished product delivery, the entire process strictly adheres to domestic and international food safety management certifications, achieving simultaneous leadership in both "quality" and "quantity."
Customer Visit
We are committed to silicon dioxide for 20 years, our product is well know in the world and cooperate with some Fortune 500 companies, such as the Nestlé，Yihai Kerry，COFCO，China Resources，Budweiser，Symrise, and so on.
HONOR
In 2021, the company was listed on the Guangdong Stock Exchange, marking the beginning of its international expansion. Today, Zhongqi Silicon Industry, with an open vision, empowers the global food industry's safety system with the power of "Made in China." Going forward, the company will continue to focus on molecular-level safety to ensure peace of mind and, with a global perspective, to create a purer quality of life. Because true strength lies in making invisible protections visible to the world.
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Jinan City, Shandong Province,China
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Guangzhou City, Guangdong Province
