地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161705760170412217046411705737170831417057150.10
210.091746065174853217472980.10
单位质量响应值RSD%判断
167885.33173171.262.20数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2025031021批-pH6.8(内含0.5%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11348325-134832579.00791.906.9979.0191.906.99
21599599-159959993.73193.73
31599088-159908893.70193.70
41620954-162095494.98394.98
51595238-159523893.47693.48
61647397-164739796.53296.53
10min11504407-150440788.15395.044.2989.0396.064.31
21647076-164707696.51397.55
31572809-157280992.16193.20
41661362-166136297.35098.41
51657465-165746597.12298.16
61688616-168861698.947100.02
15min11531609-153160989.74794.852.9391.6096.932.98
21619574-161957494.90297.02
31606020-160602094.10896.17
41656296-165629697.05499.19
51641430-164143096.18298.30
61657570-165757097.12899.30
20min11566025-156602591.76494.912.7094.6298.042.73
21633380-163338095.71198.88
31593784-159378493.39196.50
41659013-165901397.213100.43
51588827-158882793.10096.29
61677262-167726298.282101.53
30min11567329-156732991.84092.136.3795.7196.326.16
21634397-163439795.770100.00
31398481-139848181.94686.09
41635496-163549695.835100.13
51526449-152644989.44593.67
61671691-167169197.956102.30
极限11591241-159124193.24294.442.5998.1499.652.61
21604129-160412993.99799.29
31565564-156556491.73796.80
41649107-164910796.632101.99
51585397-158539792.89998.11
61674699-167469998.132103.56
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161743683174587917404901737971173799317412030.21
210.091722028171840917202180.15
单位质量响应值RSD%判断
171378.25170487.410.37数据可信
供试品溶液-2025031021批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11632007-163200795.38289.309.0195.3889.309.01
21638203-163820395.74495.74
31604765-160476593.79093.79
41317924-131792477.02577.03
51391507-139150781.32681.33
61583483-158348392.54692.55
10min11666864-166686497.41994.196.7498.4895.186.76
21733029-1733029101.286102.35
31642436-164243695.99197.03
41443352-144335284.35685.21
51517632-151763288.69789.60
61666008-166600897.36998.40
15min11684036-168403698.42294.665.06100.5696.695.11
21674221-167422197.849100.04
31646869-164686996.25098.36
41475337-147533786.22588.02
51569583-156958391.73393.62
61667415-166741597.45199.56
20min11650211-165021196.44692.964.7699.6896.054.79
21612465-161246594.24097.52
31638659-163865995.77098.95
41442106-144210684.28387.03
51596850-159685093.32796.24
61602792-160279293.67496.87
30min11605659-160565993.84293.773.4698.1597.893.55
21645308-164530896.159100.48
31645037-164503796.143100.39
41497294-149729487.50891.20
51604733-160473393.78897.73
61628140-162814095.15699.39
极限11620417-162041794.70494.062.52100.0599.222.63
21628861-162886195.198100.59
31643299-164329996.042101.35
41530694-153069489.46194.12
51627785-162778595.135100.12
61605022-160502293.80599.10
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161768612176650717645011763374176574217657470.12
210.091737436173695817371970.02
单位质量响应值RSD%判断
173794.00172170.170.67数据可信
供试品溶液-2025031121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11270025-127002573.34875.451.6973.3575.451.69
21333160-133316076.99476.99
31307789-130778975.52975.53
41304421-130442175.33475.33
51324137-132413776.47376.47
61298889-129888975.01575.01
10min11451320-145132083.81886.071.9084.6386.901.89
21466732-146673284.70885.56
31491807-149180786.15687.00
41530851-153085188.41189.25
51505689-150568986.95887.81
61495036-149503686.34387.18
15min11526945-152694588.18688.250.8389.9390.040.82
21513657-151365787.41889.21
31513616-151361687.41689.21
41544175-154417589.18191.00
51537689-153768988.80690.62
61532585-153258588.51190.30
20min11529747-152974788.34789.761.4091.0792.541.38
21529697-152969788.34491.11
31567354-156735490.51993.29
41574346-157434690.92393.73
51577014-157701491.07793.88
61547617-154761789.37992.16
30min11539547-153954788.91391.171.5992.6294.951.57
21563388-156338890.29094.04
31582125-158212591.37295.15
41581412-158141291.33195.15
51612555-161255593.13096.94
61593198-159319892.01295.78
极限11591793-159179391.93193.271.3596.6398.061.30
21626702-162670293.94798.70
31647038-164703895.12199.91
41595934-159593492.17097.01
51626197-162619793.91898.77
61602056-160205692.52397.32
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161708897170982917092831710126170959917095470.03
210.091791621179280717922140.05
单位质量响应值RSD%判断
168262.50177622.793.83数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2025031121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11368953-136895379.13576.572.4879.1476.572.48
21323779-132377976.52476.52
31346023-134602377.81077.81
41310003-131000375.72875.73
51326550-132655076.68476.68
61272248-127224873.54573.55
10min11517266-151726687.70986.412.8588.5987.262.82
21501179-150117986.77987.63
31411386-141138681.58882.45
41499919-149991986.70687.55
51531597-153159788.53789.39
61507322-150732287.13487.95
15min11592451-159245192.05589.083.1493.9190.893.10
21552738-155273889.75991.57
31530806-153080688.49290.26
41571229-157122990.82892.63
51546087-154608789.37591.21
61452533-145253383.96785.75
20min11599126-159912692.44189.982.2195.3292.782.19
21554471-155447189.86092.67
31504043-150404386.94489.70
41551911-155191189.71292.53
51588629-158862991.83494.66
61541038-154103889.08391.80
30min11593415-159341592.11190.482.7796.0194.282.67
21593026-159302692.08895.90
31510244-151024487.30391.02
41558918-155891890.11793.93
51519285-151928587.82691.67
61616564-161656493.44997.16
极限11674135-167413596.77793.222.62101.7098.032.52
21601944-160194492.60497.44
31618418-161841893.55698.25
41631720-163172094.32599.14
51545531-154553189.34394.17
61603909-160390992.71797.46
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161686729168340016834911684473167893216834050.17
210.091677363167866616780140.06
单位质量响应值RSD%判断
165689.47166304.660.27数据可信
供试品溶液-2025031221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11351071-135107181.31082.472.2281.3182.472.22
21387569-138756983.50783.51
31398752-139875284.18084.18
41321697-132169779.54279.54
51365019-136501982.15082.15
61397612-139761284.11184.11
10min11514544-151454491.14890.810.8392.0591.720.83
21500293-150029390.29191.22
31516340-151634091.25692.19
41512081-151208191.00091.88
51487935-148793589.54790.46
61521877-152187791.59092.52
15min11570169-157016994.49692.991.7896.4194.921.76
21539287-153928792.63794.57
31553368-155336893.48595.43
41492902-149290289.84691.74
51555570-155557093.61795.53
61559825-155982593.87395.83
20min11563753-156375394.11093.501.8097.0896.461.78
21570721-157072194.52997.49
31568882-156888294.41897.41
41501312-150131290.35293.25
51543052-154305292.86495.81
61574106-157410694.73397.73
30min11583247-158324795.28394.031.2799.2998.031.24
21589072-158907295.63499.64
31556394-155639493.66797.70
41544037-154403792.92396.82
51541581-154158192.77596.76
61560557-156055793.91797.97
极限11619864-161986497.48796.361.68102.56101.401.65
21608165-160816596.783101.86
31621011-162101197.556102.63
41548394-154839493.18598.12
51603538-160353896.504101.51
61605440-160544096.619101.71
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161680546168250316807101680203167933916806600.07
210.091713093171218817126400.04
单位质量响应值RSD%判断
165419.29169736.371.83数据可信
供试品溶液-2025031221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11358570-135857081.00380.800.9581.0080.800.95
21367275-136727581.52281.52
31365917-136591781.44181.44
41348571-134857180.40780.41
51332759-133275979.46479.46
61357659-135765980.94980.95
10min11478168-147816888.13489.020.8089.0389.910.79
21514074-151407490.27591.18
31487939-148793988.71789.62
41495236-149523689.15290.05
51491021-149102188.90189.78
61491341-149134188.92089.82
15min11500909-150090989.49090.901.2691.3792.781.23
21517519-151751990.48192.39
31524269-152426990.88392.77
41525727-152572790.97092.85
51519461-151946190.59692.47
61558967-155896792.95294.84
20min11529624-152962491.20290.811.3394.0893.711.30
21535545-153554591.55594.47
31530566-153056691.25894.16
41511732-151173290.13593.03
51487633-148763388.69991.58
61543220-154322092.01394.93
30min11541319-154131991.90091.891.2495.7995.801.21
21532869-153286991.39695.33
31542513-154251391.97195.89
41542900-154290091.99495.89
51514378-151437890.29394.16
61573109-157310993.79597.74
极限11580003-158000394.20694.112.2999.1199.042.20
21625504-162550496.919101.87
31608946-160894695.932100.87
41536350-153635091.60396.52
51538923-153892391.75796.62
61580462-158046294.23399.22
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