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实验室服务项目简介7-化学制造与控制

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化学制造与控制

Chemistry Manufacture and Control (Negotiable price depending on project)

项目编号

Project ID

服务内容

Content

方法或设备

Method or Instrument

HB-S-C201

分析方法的建立和验证

Analytical method development and validation

GC, HPLC, GC-MS/MS, LC-MS/MS, Beckman ProteomeLab PA800CE System毛细管电泳, nano Acquity UPLC, UV-VIS Spectrometry, etc.

HB-S-C202

固态稳定性测试、 贮存稳定性测试、加速稳定性试验(ICH

Solid state stability testing: storage stability testing; accelerated stability testing

Stability chamber, 恒温恒湿箱HPLC, GC-MS/MS, LC-MS/MS, etc.

HB-S-C203

活性组分标准物质表征

API reference standard qualifications

GC, LC, GC-MS/MS, LC-MS/MS, NMR, UV/VIS, FT-IR傅立叶红外光谱仪, LTQ-MS (linear ion trap MS) 线性离子阱液质联用, X-Ray diffraction X-衍射仪, etc.

HB-S-C204

杂质结构鉴定与表征

Impurity structural characterization and confirmation

HB-S-C205

药物活性成分及药物产品GMP批次质量控制与确认

API and drug product GMP batch QC confirmation

HB-S-C206

药物活性成分光谱学结构确认

Spectroscopic structure confirmation for API

UV/VIS, IR, MS, NMR, XRD

HB-S-C207

元素分析

Elemental analysis

元素分析仪

Elemental Analysis Vario EL-III  Elemental analyzer

HB-S-C208

重金属分析

Heavy metal analysis (coming soon)

ICP or AA原子吸收分光光度计

Atomic Absorption Spectrometry

HB-S-C209

筛选和选择成盐类型

Salt screen and selection

 HPLC, LC-MS/MS, NMR, UV/VIS, FT-IR傅立叶变换红外光谱仪, X-Ray diffraction (XRD) X-衍射仪, DSC差示扫描量热仪,TGA热重分析仪,DVS, (dynamic vapor sorption)动态湿气吸附分析仪

HB-S-C210

多晶型筛选及选择

Polymorph screen and selection

HB-S-C211

残留溶剂和配对离子筛选

Residual solvents and counter-ion screen

GC, LC, GC-MS/MS, LC-MS/MS, NMR, UV/VIS, FT-IR傅立叶红外光谱仪, LTQ-MS (linear ion trap MS) 线性离子阱液质联用, X-Ray diffraction X-衍射仪, etc.

HB-S-C212

含量均一性测试

Content uniformity

HB-S-C213

片剂、胶囊、液剂及悬浮液剂型开发

Tablets, capsules, solution and suspension formulation development

HB-S-C214

制剂优化及工艺过程优化

Formulation optimization and process optimization

HB-S-C215

可溶性测试

Solubility screen (different pHs, solvents or conditions)

HPLC, LC-MS/MS, etc.

HB-S-C216

不同条件下溶液物化稳定性

Physi-chemical solution stability at different conditions

HB-S-C217

药物制剂添加剂兼容性试验

Drug recipient compatibility testing

HPLC, LC-MS/MS, etc.

HB-S-C218

溶出度测试

Dissolution testing

Dissolution Apparatus

溶出度测试仪

HB-S-C219

崩解度测试

Disintegration testing

Disintegration Apparatus

崩解度测试仪


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