富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.218837788430883458856888578884600.13
210.208794588225880850.23
单位质量响应值RSD%判断
8664.058635.780.24数据可信
供试品溶液-25053001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%
5min192072-9207295.60796.331.7795.6196.331.77
290427-9042793.89993.90
393716-9371697.31497.31
494737-9473798.37498.37
593980-9398097.58897.59
691683-9168395.20395.20
10min193751-9375197.35097.101.6897.5197.261.68
291216-9121694.71894.87
394193-9419397.80997.97
495044-9504498.69398.86
594853-9485398.49598.66
691995-9199595.52795.69
15min193204-9320496.78296.711.5097.1097.031.50
291188-9118894.68995.00
393944-9394497.55197.88
494632-9463298.26598.59
594112-9411297.72598.05
691719-9171995.24095.56
20min192983-9298396.55396.541.5997.0497.031.59
290759-9075994.24494.72
393771-9377197.37197.86
494421-9442198.04698.54
594235-9423597.85398.34
691676-9167695.19695.67
30min192879-9287996.44596.391.5197.0997.031.52
290602-9060294.08194.71
393372-9337296.95797.61
494564-9456498.19598.85
593640-9364097.23597.89
691891-9189195.41996.05
45min192211-9221195.75195.821.5496.5696.631.54
290206-9020693.66994.46
393125-9312596.70097.51
493992-9399297.60198.42
593092-9309296.66697.48
691067-9106794.56395.36
极限191840-9184095.36696.241.6796.3397.201.65
295068-9506898.71899.66
392428-9242895.97796.95
493620-9362097.21498.20
592591-9259196.14697.12
690544-9054494.02094.97
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.218802287809873918777688174878340.34
210.208852088361884400.13
单位质量响应值RSD%判断
8602.748670.590.56数据可信
供试品溶液-25053002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%
5min196693-96693100.56196.882.45100.5696.882.44
294512-9451298.29398.29
390597-9059794.22194.22
492808-9280896.52096.52
593336-9333697.07097.07
690967-9096794.60694.61
10min197751-97751101.66198.072.36101.8398.242.36
295430-9543099.24799.41
391594-9159495.25895.41
493848-9384897.60297.76
594812-9481298.60598.77
692376-9237696.07196.23
15min197689-97689101.59797.842.39101.9398.172.39
295263-9526399.07499.40
391299-9129994.95195.27
493627-9362797.37297.70
594184-9418497.95198.28
692404-9240496.10096.42
20min197116-97116101.00197.762.06101.5198.252.07
294905-9490598.70199.20
392354-9235496.04896.52
493265-9326596.99697.48
594516-9451698.29798.79
691837-9183795.51195.99
30min197374-97374101.26997.412.43101.9498.062.43
294708-9470898.49699.16
390935-9093594.57295.21
492958-9295896.67697.32
594051-9405197.81398.47
691952-9195295.63096.27
45min196460-96460100.31896.802.33101.1697.612.33
294312-9431298.08598.91
390394-9039494.01094.80
492252-9225295.94296.75
593468-9346897.20798.02
691555-9155595.21796.01
极限196386-96386100.24296.352.47101.2597.322.47
293905-9390597.66198.65
390182-9018293.78994.74
491845-9184595.51996.49
592804-9280496.51697.49
690719-9071994.34895.30
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.218848288182885138838588353883830.15
210.208784187474876580.30
单位质量响应值RSD%判断
8656.518593.920.52数据可信
供试品溶液-25053003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%
5min193751-9375197.63096.171.4997.6396.171.49
290635-9063594.38594.39
393727-9372797.60597.61
490840-9084094.59994.60
592256-9225696.07396.07
692878-9287896.72196.72
10min192406-9240696.23096.991.4796.3997.141.47
291740-9174095.53695.69
394766-9476698.68798.85
491647-9164795.43995.60
594155-9415598.05198.21
694080-9408097.97398.13
15min192210-9221096.02696.741.4696.3597.061.46
291502-9150295.28895.60
394494-9449498.40498.73
491427-9142795.21095.53
593979-9397997.86898.19
693784-9378497.66597.99
20min191667-9166795.46096.411.6095.9496.901.60
291082-9108294.85195.33
394217-9421798.11698.61
491051-9105194.81995.29
593984-9398497.87398.36
693486-9348697.35497.84
30min191641-9164195.43396.121.4196.0896.761.41
290812-9081294.57095.20
393890-9389097.77598.43
491066-9106694.83495.47
593412-9341297.27797.93
692972-9297296.81997.47
45min191130-9113094.90195.861.5595.7096.661.55
290729-9072994.48395.27
393328-9332897.19098.01
490674-9067494.42695.22
593997-9399797.88698.70
692457-9245796.28397.09
极限190850-9085094.60995.211.2895.5796.171.28
290069-9006993.79694.74
392597-9259796.42997.41
490262-9026293.99794.95
592441-9244196.26697.24
692339-9233996.16097.13
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.218845288239882388815288029882220.18
210.208773987885878120.12
单位质量响应值RSD%判断
8640.748609.020.27数据可信
供试品溶液-25053003批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min195019-9501998.95496.001.7598.9596.001.75
290997-9099794.76594.77
392600-9260096.43496.43
491773-9177395.57395.57
592284-9228496.10596.11
690411-9041194.15594.15
10min195943-9594399.91697.241.56100.0897.401.56
292091-9209195.90496.06
393881-9388197.76997.93
492771-9277196.61396.77
593462-9346297.33297.49
692073-9207395.88696.04
15min195757-9575799.72297.261.50100.0597.581.49
292277-9227796.09896.42
393997-9399797.88998.21
492692-9269296.53096.85
593647-9364797.52597.85
691999-9199995.80996.13
20min195463-9546399.41697.231.2799.9197.721.27
292618-9261896.45396.93
393642-9364297.52098.01
492582-9258296.41696.90
593624-9362497.50197.99
692264-9226496.08596.56
30min195440-9544099.39296.951.43100.0697.601.43
291859-9185995.66396.30
393402-9340297.27097.92
492862-9286296.70797.35
593180-9318097.03897.69
691816-9181695.61896.25
45min195313-9531399.26096.721.48100.0997.531.48
291700-9170095.49796.30
393532-9353297.40598.22
492376-9237696.20197.00
592627-9262796.46397.27
691706-9170695.50396.30
极限195077-9507799.01496.571.50100.0197.541.50
291764-9176495.56496.52
393543-9354397.41798.39
492114-9211495.92896.89
592617-9261796.45297.42
691263-9126395.04296.00
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