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項目編號
Project ID |
服務內容
Content |
方法或設備
Method or Instrument |
|
HB-S-C201 |
分析方法的建立和驗證
Analytical method development and validation |
GC, HPLC, GC-MS/MS, LC-MS/MS, Beckman ProteomeLab PA800CE System毛細管電泳, nano Acquity UPLC, UV-VIS Spectrometry, etc. |
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HB-S-C202 |
固態穩定性測試、 貯存穩定性測試、加速穩定性試驗（ICH）
Solid state stability testing: storage stability testing; accelerated stability testing |
Stability chamber, 恒溫恒濕箱HPLC, GC-MS/MS, LC-MS/MS, etc. |
|
HB-S-C203 |
活性組分標準物質表征
API reference standard qualifications |
GC, LC, GC-MS/MS, LC-MS/MS, NMR, UV/VIS, FT-IR傅立葉紅外光譜儀, LTQ-MS (linear ion trap MS) 線性離子阱液質聯用, X-Ray diffraction X光-衍射儀, etc. |
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HB-S-C204 |
雜質結構鑒定與表征
Impurity structural characterization and confirmation |
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HB-S-C205 |
藥物活性成分及藥物產品GMP批次質量控制與確認
API and drug product GMP batch QC confirmation |
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HB-S-C206 |
藥物活性成分光譜學結構確認
Spectroscopic structure confirmation for API |
UV/VIS, IR, MS, NMR, XRD |
|
HB-S-C207 |
元素分析
Elemental analysis |
元素分析儀
Elemental Analysis Vario EL-III Elemental analyzer |
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HB-S-C208 |
重金屬分析
Heavy metal analysis (coming soon) |
ICP or AA原子吸收分光光度計
Atomic Absorption Spectrometry |
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HB-S-C209 |
篩選和選擇成鹽類型
Salt screen and selection |
HPLC, LC-MS/MS, NMR, UV/VIS, FT-IR傅立葉變換紅外光譜儀, X-Ray diffraction (XRD) X光-衍射儀, DSC差示掃描量熱儀，TGA熱重分析儀，DVS, (dynamic vapor sorption)動態濕氣吸附分析儀 |
|
HB-S-C210 |
多晶型篩選及選擇
Polymorph screen and selection |
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HB-S-C211 |
殘留溶劑和配對離子篩選
Residual solvents and counter-ion screen |
GC, LC, GC-MS/MS, LC-MS/MS, NMR, UV/VIS, FT-IR傅立葉紅外光譜儀, LTQ-MS (linear ion trap MS) 線性離子阱液質聯用, X-Ray diffraction X光-衍射儀, etc. |
|
HB-S-C212 |
含量均一性測試
Content uniformity |
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HB-S-C213 |
片劑、膠囊、液劑及懸浮液劑型開發
Tablets, capsules, solution and suspension formulation development |
|
HB-S-C214 |
制劑優化及工藝過程優化
Formulation optimization and process optimization |
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HB-S-C215 |
可溶性測試
Solubility screen (different pHs, solvents or conditions) |
HPLC, LC-MS/MS, etc. |
|
HB-S-C216 |
不同條件下溶液物化穩定性
Physi-chemical solution stability at different conditions |
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HB-S-C217 |
藥物制劑添加劑兼容性試驗
Drug recipient compatibility testing |
HPLC, LC-MS/MS, etc. |
|
HB-S-C218 |
溶出度測試
Dissolution testing |
Dissolution Apparatus
溶出度測試儀 |
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HB-S-C219 |
崩解度測試
Disintegration testing |
Disintegration Apparatus
崩解度測試儀 |
