Procipient® (Dimethyl Sulfoxide USP, PhEur):
DMSO的唯一等级适用于医疗保健和药物输送应用
Procipient® is the only grade of DMSO suitable for healthcare and drug delivery applications. Gaylord Chemical’s Procipient® 是一种活性药物成分和多功能赋形剂，广泛用于各种制药和生物技术应用，包括:
- Topical and Transdermal Dosage Forms
- Parenteral Drug Delivery & Medical Device Use
- Cryopreservation
- 加工各种医药产品
- Animal Healthcare formulations
- 提高原料药的溶解度
Gaylord Chemical’s Procipient® is manufactured under Good Manufacturing Practices (GMP) conditions following ICH Q7 guidelines, conforming to both the USP and Ph.Eur. monographs.
Procipient®得到了多个监管机构的支持, a Type II Drug Master File with US FDA, EDQM授予的CEP和加拿大卫生部的I类药物主文件.
It is the only DMSO product in the world with this level of regulatory support.
当需要最高纯度时，盖洛德是你的 best resource.
Procipient® Characteristics:
- Highly Purified DMSO with a minimum purity of 99.99%
- Extremely polar solvent
- Water-white odorless liquid
- 所有给药途径基本上都是无毒的
- Completely water miscible
- Chemically compatible with other excipients
- Low viscosity & density similar to water
Compliance
Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.)是一种多药典产品，其生产符合或超过美国药典和美国药典的规格.S. 药典和欧洲药典，根据制造和包装 Current Good Manufacturing Practices (cGMP) following ICH Q7 Guidelines for API.
由美国食品和药物管理局的II型药物主文件(DMF)支持, EDQM颁发的CEP和加拿大卫生部颁发的I型DMF, it is the only DMSO 世界上拥有这种监管支持水平的产品.
Our Procipient®(Dimethyl Sulfoxide USP, Ph.Eur)生产设施由美国FDA检查，具有可靠的检查历史.
Please contact us to request quality documentation and GMP Statements
Characteristics & Physical Properties
本品溶解度广，完全与水混溶. 这种有用的药物成分在化学上与广泛的有机和无机化合物相容.
本品具有显著降低水的冰点的能力. 本品的高极性是其多用途特性的原因.
- High Purity material having a minimum content of 99.99%
- Extremely Polar Solvent
- Odorless, clear water-white liquid
- Low viscosity (2.0 cP @ 25°C)
- Density similar to water (1.0955 g / mL @ 25°C).
- Low volatility: 189˚C boiling point
Extremely Low Toxicity
DMSO在所有给药途径中基本上都是无毒的. 口服和真皮给药以及皮下和肌肉内给药耐受性良好.
- DMSO has a well characterized ADME profile
- Not a reproductive toxic
- Not carcinogenic/mutagenic.
- Does not bio accumulate. 它在体内被氧化，产生的代谢产物随尿液排出体外.
有一份澳门星赌app下载二甲二甲磺酸肠外毒性的独立审查报告 upon request.
广泛用于不同剂型的多用途药物成分
Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) is used in topical and parenteral drug delivery. 批准产品中DMSO的详细信息可在美国.S. 食品和药物管理局-药物评价和研究中心的数据库 已批准药品的非活性成分搜索.
Topical and Transdermal Dosage Forms
Procipient®是外用和透皮产品中有用的赋形剂. DMSO continues to be evaluated as a penetration enhancer in transdermal formulations. DMSO已被描述在新技术生产无水乳剂的交付水解不稳定的药物, 或者为透皮输送系统提供储存器.
procicient是一种极好的渗透增强剂，是水溶性差的药物的强力溶剂.
DMSO的溶剂性质可能是有益的，因为在半固体产品中有时可以实现更高的原料药负载.
DMSO的低蒸气压使配方能够吸收，而没有辅料(如酒精)的皮肤冷却效应.
目前存在的人类和动物健康应用都使用DMSO.
Parenteral dosages
Procipient® is used as:
- An active pharmaceutical ingredient (API)
- An excipient to solubilize the drug product.
- A component in a drug delivery system.
澳门赌城app下载已被用来溶解聚合物沉淀原位形成可生物降解的植入物. 这样可以控制活性物质的释放. It may also aid in tissue regeneration.
这种给药途径的批准申请存在于Procipient，它提供API的溶解度.
在世界范围内，目前正在对小体积非注射产品和疫苗的许多创新应用进行评估.
Pharmaceutical Active
As an active pharmaceutical ingredient (API), 预剂是一种被注入膀胱的产品. 这种治疗方法可以减轻间质性膀胱炎患者的肿胀和疼痛. This product has been on the market since 1978.
这是DMSO在北美唯一被批准的适应症, DMSO在世界其他地区被用作局部产品的抗炎剂.
Cryopreservation
Procipient is a key ingredient in cryo-media.
DMSO is well known as a cryopreservation medium. 在这种作用下，Procipient能够长期储存细胞和生物组织. 它已被用于保存多种细胞类型, including human bone marrow, ovarian tissue, pancreatic and platelet cells, and hematopoietic stem and progenitor cells
DMSO Passes through cell membranes more readily than glycerol.
当与水结合时，DMSO表现出独特而有趣的热力学性质. The eutectic mixture remains liquid at minus 80°C, 因此，防止细胞损伤的冰形成，同时保持细胞的活力.
Processing Aid
Procipient作为一种加工助剂被广泛应用于不同的制药应用.
用澳门赌城app下载分散聚合物形成微胶囊的抗溶剂方法已被描述.
- Lyophilization / freeze drying
- 多肽和小分子的纯化介质
Animal Health
Procipient在动物保健药品中用作赋形剂. 目前，美国FDA批准了几种含有Procipient的受监管动物保健产品.
API Solubility
Procipient®(Dimethyl Sulfoxide USP, PhEur)为广泛的活性药物成分(API)提供出色的溶解度。. 聚合物和赋形剂的相容性数据-加上API溶解度测量列表-是 available here.
The Right DMSO for Drug Delivery Application