規格需求表-國家衛生研究院.docVIP

█財物採購（█買受、訂製□租賃□租購）： █履約期限及分批驗收： 。DBPR110原料藥與分析報告(Certificate of Analysis)。實際交貨期程及批次與廠商協商後議定。 DBPR110原料藥驗收合格後之次日起15個日曆天交付DBPR110原料藥生產文件，包括製程開發報告、生產批次紀錄、原始資料數據(raw data)。█履約、驗收地點：。█付款方式：付款次數與方式經與廠商協商後，於合約中訂定之。 █驗收標準： █智慧財產權：本院取得全部權利，未經本院同意不得對第三者揭露本合約內容。 需求或規格： Specification/ acceptance criteria Appearance White to off-white powder Identification: FT-IR Consistent with structure Identification: 1H NMR Consistent with structure Identification: 13C NMR Consistent with structure Identification: MS Consistent with structure Identification: Elemental Analysis Consistent with structure Purity: HPLC (%w/w) DBPR110 Max. Individual Impurity (including isomers) Total Impurities NLT 99.5% NMT 0.5% NMT 0.5% Residual Solvents Complies to ICH guidance Water Content: Karl Fischer (USP 921) NMT 1.0% Specific Rotation(Concentration (w/v % (g/mL): 0.1, CHCl3) To be determined Differential Scanning Calorimetry Onset Enthalpy Report Report Heavy Metals (USP 231) NMT 20 ppm Residue on Ignition (USP 281) NMT 0.1% X-ray Powder Diffraction (USP 941) Crystalline 檢附分析報告(Certificate of Analysis) 生產文件：生產批次紀錄、原始資料數據(raw data) DBPR110原料藥製備 2公斤，包含執行安定性試驗所需數量。 成品分析(release tests)須符合GLP規範。 DBPR110原料藥規格，得依本院生技與藥物研究所需求與廠商討論後修訂： Tests Specification/ acceptance criteria Appearance White to off-white powder Identification: FT-IR Conforms to standard Identification: 1H NMR Conforms to standard Identification: 13C NMR Conforms to standard Identification: MS Conforms to standard Identification: HPLC Conforms to standard Assay and Purity: HPLC (dried basis, %w/w) DBPR110 Max. Individual Impurity (including isomers) Total Impurities NLT 97.0% and NMT 103.0% NMT 1.0% NMT 3.0% Residual Solvents Complies to ICH guidance Water Content: Karl Fischer (USP 921) NMT 1.0% Specific Rotation(Concentration (w/v % (g/mL): 0.1, CHCl3) To be determined Differential Scanning Calorimetry Onset Enthalpy Report Report Heavy Metals (USP 231) NMT 20 ppm Residue on Ignition (U