ADPEN Laboratories

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制药测试

ADPEN 实验室是质量和卓越的标准, 我们的知识和经验使我们能够为制药公司、医疗器械制造商和研究型大学的持续经营提供帮助。Pharmaceutical_Large

分析服务

ADPEN 提供 QC 和研究分析服务, 如下所示:

  • 原材料测试
  • 最终产品测试
  • 残留溶剂测试
  • 药典测试
  • 临床研究支持
  • 方法开发
  • 方法验证
  • 方法转移
  • 过程验证
  • 清洗验证
  • 小和大分子
  • 内容一致性
  • 存储稳定性 ICH、存储和测试
  • 解体
  • 溶解
  • 临床试验分析支持
  • 识别和隔离
  • 退化研究
  • 中央实验室服务
  • Bioequivalency 仿制药
  • 杂质表征
  • 控制药物 (附表一 V)
  • 化验鉴定
  • 蛋白质和 RNA 分析
  • 颜料的色度分析
  • 液相色谱、气相色谱/ms
  • 紫外/可见光、FTIR 和电泳

ADPEN 在 FDA 注册 (注册号: 1064435), 并有一个 DEA 许可证 (RA0270114) 处理受控药物的滥用。ADPEN 是您在质量控制、研发和方法验证方面的合作伙伴。ADPEN 是一个真正独立的实验室, 你可以信任。ADPEN 已经提供了20年的分析服务, 从主要的跨国世界级公司到规模较小的独立初创公司。  我们的服务和能力包括从复杂的分析测试和方法开发到产品发布测试、方法验证、稳定性测试、质量控制和复合识别。

仪表

我们有多种仪器可供使用。

周转时间

ADPEN 以更快的速度提供分析结果:

  • 关键服务 (少于 3-5 天) *
  • 拉什服务 (5-7 天) *
  • 正常服务 (10-12 天) *
  • 有信用卡付款, 请查询。

* 工作日的周转时间。对于常规分析, 时间可能会因工作量和使用的方法而异。对于需要仪器优化或仪器实验室或设置的非例行分析或研究分析, 大约10至15个工作日。多重分析可能需要额外的时间。紧急或紧急服务需要特殊定价和事先实验室批准。

ISO/IEC 17025 ACCREDITED

ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”. ISO/IEC 17025 is a general umbrella term used to refer to the specific standard; the current version of this standard is ISO/IEC 17025:2017. The standard contains two main sections: management requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also gives requirements related to quality management such as document control and corrective action. This standard is the basis for accreditation from an accrediting body.

ADPEN has also been inspected by the US-EPA and US-FDA multiple times with no observations.

Agroscience Links

  • 5-Batch Analytical Services
  • Analytical Testing Brochure
  • Pesticide Residue Analytical Services

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What Our Clients Say About ADPEN

“This is an outstanding job, and I really appreciate your help. Looking forward for other projects with less stressful timelines.” M.S.

Get in Touch With Us

ADPEN Laboratories, Inc.
11757 Central Parkway
Jacksonville, FL 32224 USA

Phone: 1.904.645.9169
Fax: (904) 641-8423
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