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- 产品名称:Lifecore
- 产品型号:Lifecore
- 产品展商:Lifecore
- 产品文档:无相关文档
- 发布时间:2018-09-11
- 在线询价
简单介绍
Lifecore对质量和服务的承诺确保我们的产品达到或超过美国食品**管理局,欧洲共同体和其他国际机构制定的*高标准。Lifecore设施是ISO 13485和GMP认证,具有质量体系保证和合规性的国际标志。
产品描述
Lifecore Pharmaceutical Grade Sodium Hyaluronate
Hyaluronan in Nature
Hyaluronan (also known as sodium hyaluronate or hyaluronic acid) is a polysaccharide composed of repeating disaccharide units of glucuronate and N-acetyl glucosamine (linked by ß 1-3 and ß 1-4 glycosidic bonds) and counter ions. Hyaluronan is a physiological substance that is widely distributed in the extracellular matrix of connective tissues in both animals and humans. It is found in high concentration in the aqueous humor of the eye, synovial fluid, skin, and umbilical cord.
Primary medical applications include: Ophthalmology, Orthopedics, Aesthetics, Tissue Engineering, and Veterinary Medicine
Lifecore's Pharmaceutical Grade Sodium Hyaluronate
Lifecore’s sodium hyaluronate is produced by an efficient microbial fermentation and purified by a highly effective purification process. It is produced in large batches to promote consistency in supply and customer convenience. Pharmaceutical grade sodium hyaluronate is available as a powder in a broad range of molecular weights for use in various medical applications (150KDa – 1.8MDa). Sterile pharmaceutical grade sodium hyaluronate is available in select molecular weights – please inquire.
Why Choose Lifecore for Your Sodium Hyaluronate Needs?
Lifecore Biomedical offers quality, regulatory and technical support, including:
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Certificate of Suitability (CEP) to the Sodium Hyaluronate Monograph of the European Pharmacopoeia
- complies with the EU Pharmacopoeia monograph for NaHy
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Compliance to the Japanese Pharmacopoeia
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ISO 13485 Certified Quality System
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ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) compliance
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CE Mark Certification on Lifecore’s Hyaluronan Based Products
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Drug and Device Master Files
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GMP Certification
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21 CFR 210, 211, 820, drug and device compliance
Lifecore公司(纳斯达克股票代码:LNDC)的全资子公司Lifecore Biomedical,LLC 致力于开发技术先进的透明质酸产品,与人体长期兼容。自1986年以来,全球有超过5000万名患者受益于Lifecore透明质酸钠产品的**。
Lifecore对质量和服务的承诺确保我们的产品达到或超过美国食品**管理局,欧洲共同体和其他国际机构制定的*高标准。Lifecore设施是ISO 13485和GMP认证,具有质量体系保证和合规性的国际标志。