地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121701450170345017034591701328170118817021750.07
210.241700673170204017013560.06
单位质量响应值RSD%判断
168199.11166148.050.87数据可信
供试品溶液-ACSB24025批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12485-24850.0370.0316.300.040.0315.50
22161-21610.0320.03
32585-25850.0390.04
41722-17220.0260.03
51806-18060.0270.03
62065-20650.0310.03
15min13395-33950.0510.057.720.050.057.91
23398-33980.0510.05
33735-37350.0560.06
43092-30920.0460.05
53076-30760.0460.05
63199-31990.0480.05
30min13541-35410.0530.057.140.050.057.91
23310-33100.0490.05
33788-37880.0570.06
43265-32650.0490.05
53243-32430.0480.05
63180-31800.0480.05
45min13612-36120.0540.0512.120.050.0615.22
23445-34450.0510.05
33819-38190.0570.06
43275-32750.0490.05
53114-31140.0470.05
64347-43470.0650.07
60min13401-34010.0510.057.220.050.057.91
23369-33690.0500.05
33700-37000.0550.06
43111-31110.0460.05
53049-30490.0460.05
63142-31420.0470.05
90min13263-32630.0490.054.570.050.058.45
23185-31850.0480.05
33272-32720.0490.05
43030-30300.0450.05
53061-30610.0460.05
62955-29550.0440.04
120min12954-29540.0440.059.790.040.0412.18
22996-29960.0450.05
33365-33650.0500.05
42818-28180.0420.04
53605-36050.0540.05
62928-29280.0440.04
极限13028-30280.0450.044.880.050.0412.18
22889-28890.0430.04
33217-32170.0480.05
43022-30220.0450.05
52886-28860.0430.04
62826-28260.0420.04
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121714489171401917148651707330170724617115900.24
210.241763806176423217640190.02
单位质量响应值RSD%判断
169129.45172267.481.30数据可信
供试品溶液-ACSB24025批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11525-15250.0220.0336.660.020.0346.92
21347-13470.0200.02
31660-16600.0240.02
43140-31400.0460.05
51509-15090.0220.02
62464-24640.0360.04
15min12743-27430.0400.0410.130.040.049.80
22534-25340.0370.04
32949-29490.0430.04
42937-29370.0430.04
52966-29660.0430.04
63424-34240.0500.05
30min13083-30830.0450.0532.630.050.0628.82
26057-60570.0890.09
33102-31020.0450.05
43173-31730.0460.05
53222-32220.0470.05
63354-33540.0490.05
45min13056-30560.0450.055.330.040.0412.18
23451-34510.0500.05
33091-30910.0450.05
43036-30360.0440.04
53014-30140.0440.04
63257-32570.0480.05
60min13077-30770.0450.055.720.050.058.45
23242-32420.0470.05
33188-31880.0470.05
42875-28750.0420.04
53112-31120.0460.05
63403-34030.0500.05
90min12707-27070.0400.044.770.040.0411.92
23101-31010.0450.05
32813-28130.0410.04
42936-29360.0430.04
53067-30670.0450.05
62919-29190.0430.04
120min12951-29510.0430.0519.880.040.0418.85
22903-29030.0420.04
32810-28100.0410.04
42579-25790.0380.04
52980-29800.0440.04
64279-42790.0630.06
极限12618-26180.0380.047.230.040.049.80
23021-30210.0440.04
32875-28750.0420.04
42637-26370.0390.04
52908-29080.0430.04
63150-31500.0460.05
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121727900172793017265261720294171848917242280.27
210.241753554175374017536470.01
单位质量响应值RSD%判断
170378.26171254.590.37数据可信
供试品溶液-ACSB24005批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12391-23910.0350.0413.790.030.0415.82
22839-28390.0420.04
32531-25310.0370.04
42587-25870.0380.04
52544-25440.0370.04
63429-34290.0500.05
15min13156-31560.0460.056.000.050.050.00
23385-33850.0490.05
33402-34020.0500.05
43418-34180.0500.05
53093-30930.0450.05
63603-36030.0530.05
30min13501-35010.0510.057.070.050.058.45
23324-33240.0490.05
33420-34200.0500.05
43600-36000.0530.05
53009-30090.0440.04
63699-36990.0540.05
45min13380-33800.0490.053.120.050.050.00
23203-32030.0470.05
33200-32000.0470.05
43281-32810.0480.05
53288-32880.0480.05
63483-34830.0510.05
60min13125-31250.0460.053.500.050.050.00
23100-31000.0450.05
33223-32230.0470.05
43094-30940.0450.05
53316-33160.0480.05
63330-33300.0490.05
90min13108-31080.0450.045.170.050.0511.07
23269-32690.0480.05
33148-31480.0460.05
42804-28040.0410.04
52998-29980.0440.04
63081-30810.0450.05
120min14928-49280.0720.0524.550.070.0427.22
22937-29370.0430.04
32986-29860.0440.04
42857-28570.0420.04
52921-29210.0430.04
63020-30200.0440.04
极限13356-33560.0490.047.910.050.0412.18
23192-31920.0470.05
33117-31170.0460.05
42906-29060.0420.04
52768-27680.0400.04
62869-28690.0420.04
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