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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. |
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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. |
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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光-衍射仪, etc. |
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HB-S-C204 |
杂质结构鉴定与表征
Impurity structural characterization and confirmation |
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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 |
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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 |
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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 |
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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光-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 |
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HB-S-C210 |
多晶型筛选及选择
Polymorph screen and selection |
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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光-衍射仪, etc. |
|
HB-S-C212 |
含量均一性测试
Content uniformity |
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HB-S-C213 |
片剂、胶囊、液剂及悬浮液剂型开发
Tablets, capsules, solution and suspension formulation development |
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HB-S-C214 |
制剂优化及工艺过程优化
Formulation optimization and process optimization |
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HB-S-C215 |
可溶性测试
Solubility screen (different pHs, solvents or conditions) |
HPLC, LC-MS/MS, etc. |
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HB-S-C216 |
不同条件下溶液物化稳定性
Physi-chemical solution stability at different conditions |
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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 |
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HB-S-C219 |
崩解度测试
Disintegration testing |
Disintegration Apparatus
崩解度测试仪 |
