比索洛尔左氨氯地平片项目信息
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对照品来源中检院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%
110.078644985637856478565785635858050.42
210.088579685811858040.02
单位质量响应值RSD%判断
8520.858512.300.08数据可信
加速3月-供试品溶液-2023101321批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194015-9401599.15396.551.9199.1596.551.91
291198-9119896.18296.18
389902-8990294.81594.82
491906-9190696.92996.93
592848-9284897.92297.92
689429-8942994.31694.32
10min194962-94962100.15297.511.87100.3297.671.87
291534-9153496.53696.70
391271-9127196.25996.42
493064-9306498.15098.31
593600-9360098.71598.88
690306-9030695.24195.40
15min194918-94918100.10597.341.94100.4497.661.94
291452-9145296.45096.77
391161-9116196.14396.46
492791-9279197.86298.19
593467-9346798.57598.90
689960-8996094.87695.19
20min194767-9476799.94697.211.96100.4497.701.95
291152-9115296.13396.62
390923-9092395.89296.37
492894-9289497.97198.46
593356-9335698.45898.95
689955-8995594.87195.35
30min194487-9448799.65197.001.94100.3297.641.94
291167-9116796.14996.79
390932-9093295.90196.54
492640-9264097.70398.35
593080-9308098.16798.82
689515-8951594.40795.04
45min194454-9445499.61696.851.99100.4597.661.99
291113-9111396.09296.89
390323-9032395.25996.06
492441-9244197.49398.31
593051-9305198.13698.96
689580-8958094.47595.26
极限194474-9447499.63796.732.07100.6397.702.07
290695-9069595.65196.61
390649-9064995.60396.56
492323-9232397.36898.35
592934-9293498.01399.00
689207-8920794.08295.03
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715392854029536145392853827538650.30
214.695499054801548960.25
单位质量响应值RSD%判断
3661.793736.961.44数据可信
加速3月-供试品溶液-2023101321批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153864-5386491.94091.860.8791.9491.860.87
254050-5405092.25892.26
353551-5355191.40691.41
453144-5314490.71190.71
554527-5452793.07293.07
653765-5376591.77191.77
10min153709-5370991.67692.401.0391.8392.561.03
253833-5383391.88792.04
354031-5403192.22592.38
453843-5384391.90492.06
555223-5522394.26094.41
654171-5417192.46492.62
15min154236-5423692.57592.141.0892.8892.441.08
253682-5368291.62991.94
354171-5417192.46492.77
453625-5362591.53291.84
554902-5490293.71294.02
653260-5326090.90991.22
20min153870-5387091.95091.871.0092.4192.331.00
253135-5313590.69691.16
353947-5394792.08292.54
453349-5334991.06191.52
554655-5465593.29093.76
653980-5398092.13892.60
30min153645-5364591.56691.700.8192.1892.310.81
253178-5317890.76991.38
353743-5374391.73492.35
453789-5378991.81292.42
554482-5448292.99593.62
653491-5349191.30391.92
45min153827-5382791.87791.860.8692.6492.630.86
253663-5366391.59792.36
353572-5357291.44292.21
453433-5343391.20491.97
554717-5471793.39694.18
653690-5369091.64392.41
极限154169-5416992.46192.010.6593.3892.930.65
253409-5340991.16492.08
354102-5410292.34693.27
453717-5371791.68992.60
554332-5433292.73993.67
653712-5371291.68192.60
比索洛尔左氨氯地平片项目信息
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对照品来源中检院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%
110.078592685977859958600285987859770.04
210.088569385689856910.01
单位质量响应值RSD%判断
8537.938501.090.31数据可信
加速3月-供试品溶液-2023101322批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192129-9212997.13197.551.4397.1397.541.43
293708-9370898.79598.80
392690-9269097.72297.72
492389-9238997.40597.40
593940-9394099.04099.04
690278-9027895.17995.18
10min193091-9309198.14598.511.6198.3198.671.61
294806-9480699.953100.12
393390-9339098.46098.62
492907-9290797.95198.11
595311-95311100.485100.65
691105-9110596.05196.21
15min193035-9303598.08698.331.5098.4198.661.50
294540-9454099.673100.00
393330-9333098.39798.72
492904-9290497.94898.27
594846-9484699.995100.33
690945-9094595.88296.20
20min192699-9269997.73298.101.4198.2298.591.41
294232-9423299.34899.85
393054-9305498.10698.60
492910-9291097.95498.44
594538-9453899.671100.17
690868-9086895.80196.28
30min192833-9283397.87397.901.4398.5298.551.43
294007-9400799.11199.77
392947-9294797.99398.65
492626-9262697.65598.31
594223-9422399.338100.00
690510-9051095.42496.06
45min192607-9260797.63597.741.4698.4598.561.46
294048-9404899.15499.98
392410-9241097.42798.24
492333-9233397.34698.16
594283-9428399.402100.23
690557-9055795.47396.27
极限191969-9196996.96297.431.5997.9498.401.59
293825-9382598.91999.91
392424-9242497.44298.42
492327-9232797.33998.32
593972-9397299.074100.07
689933-8993394.81695.77
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715501454898549505511855156550270.20
214.695476354850548060.12
单位质量响应值RSD%判断
3740.793730.840.19数据可信
加速3月-供试品溶液-2023101322批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157075-5707596.46196.321.3896.4696.321.39
256803-5680396.00196.00
356668-5666895.77395.77
458391-5839198.68598.69
557027-5702796.38096.38
656000-5600094.64494.64
10min154720-5472092.48193.781.3592.6493.941.35
255144-5514493.19893.36
355992-5599294.63194.79
456717-5671795.85696.02
555432-5543293.68493.84
654939-5493992.85193.01
15min154669-5466992.39593.811.5592.7194.131.55
255092-5509293.11093.43
356501-5650195.49195.81
456610-5661095.67596.00
555447-5544793.71094.03
654736-5473692.50892.82
20min154498-5449892.10693.401.7292.5793.871.72
254348-5434891.85292.32
356208-5620894.99695.47
456601-5660195.66096.14
555306-5530693.47193.94
654635-5463592.33792.80
30min154989-5498992.93693.611.2893.5694.241.28
254722-5472292.48493.11
356389-5638995.30295.94
456099-5609994.81295.45
555360-5536093.56394.19
654768-5476892.56293.18
45min155031-5503193.00793.101.1693.7893.881.16
254390-5439091.92392.70
355446-5544693.70894.50
456030-5603094.69595.50
555231-5523193.34594.13
654388-5438891.92092.69
极限154454-5445492.03193.251.7792.9694.181.76
254884-5488492.75893.69
355941-5594194.54595.49
456496-5649695.48396.44
555404-5540493.63794.58
653855-5385591.01991.95
比索洛尔左氨氯地平片项目信息
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对照品来源中检院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%
110.078542185450854828556285500854830.07
210.088652886478865030.05
单位质量响应值RSD%判断
8488.888581.650.77数据可信
加速3月-供试品溶液-2023101323批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191731-9173196.53596.632.2196.5496.632.21
290195-9019594.91994.92
394658-9465899.61599.62
489118-8911893.78593.79
593384-9338498.27598.27
691846-9184696.65696.66
10min192621-9262197.47297.162.0697.6397.322.06
290792-9079295.54795.71
395035-95035100.012100.18
489726-8972694.42594.58
593519-9351998.41798.58
692255-9225597.08797.25
15min192705-9270597.56097.302.1697.8897.622.16
290941-9094195.70496.02
395180-95180100.165100.50
489606-8960694.29994.61
593861-9386198.77799.10
692441-9244197.28297.61
20min192184-9218497.01296.772.2797.5097.252.27
290915-9091595.67696.15
395314-95314100.306100.81
489442-8944294.12694.60
593142-9314298.02098.51
690713-9071395.46495.95
30min192368-9236897.20597.012.4397.8597.662.43
289951-8995194.66295.30
395420-95420100.417101.08
489476-8947694.16294.79
593657-9365798.56299.22
692226-9222697.05697.70
45min191870-9187096.68196.792.1697.4997.602.16
290481-9048195.22096.01
394645-9464599.602100.44
489121-8912193.78894.57
593366-9336698.25699.08
692348-9234897.18497.99
极限191469-9146996.25996.502.3897.2397.482.38
290334-9033495.06596.02
394507-9450799.456100.46
488415-8841593.04593.99
593445-9344598.33999.32
692044-9204496.86497.83
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715497554839549915488554925549230.12
214.695567955640556600.05
单位质量响应值RSD%判断
3733.723788.971.04数据可信
加速3月-供试品溶液-2023101323批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155219-5521992.69692.351.4992.7092.351.49
254152-5415290.90490.90
354405-5440591.32991.33
455997-5599794.00294.00
555925-5592593.88193.88
654396-5439691.31491.31
10min153423-5342389.68192.302.1589.8492.452.15
254294-5429491.14391.29
354353-5435391.24291.39
456562-5656294.95095.11
556018-5601894.03794.19
655250-5525092.74892.90
15min156481-5648194.81493.181.8595.1293.491.85
254714-5471491.84892.15
354013-5401390.67190.98
456298-5629894.50794.82
556353-5635394.59994.91
655182-5518292.63492.94
20min154460-5446091.42289.882.1691.8890.342.15
252631-5263188.35188.81
353438-5343889.70690.16
454823-5482392.03192.50
554095-5409590.80991.28
651802-5180286.96087.42
30min154959-5495992.25990.072.3692.8790.682.35
252740-5274088.53489.14
352484-5248488.10488.71
454508-5450891.50292.13
554911-5491192.17992.80
652322-5232287.83288.44
45min154381-5438191.28990.821.6792.0691.591.67
253287-5328789.45290.20
352961-5296188.90589.66
454929-5492992.20992.99
555233-5523392.71993.49
653830-5383090.36491.12
极限155162-5516292.60091.101.2893.5292.011.28
253707-5370790.15791.06
353457-5345789.73890.64
454385-5438591.29692.23
554975-5497592.28693.22
653917-5391790.51091.41
比索洛尔左氨氯地平片项目信息
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对照品来源中检院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%
110.078587785862858948589585919858890.03
210.088543385438854360.01
单位质量响应值RSD%判断
8529.208475.790.45数据可信
加速3月-供试品溶液-2024010421批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191879-9187997.06297.780.7497.0697.780.74
292328-9232897.53697.54
393087-9308798.33898.34
492441-9244197.65597.66
593641-9364198.92398.92
691970-9197097.15897.16
10min192978-9297898.22398.680.7398.3898.840.72
292931-9293198.17398.34
394188-9418899.50199.66
493307-9330798.57098.73
594316-9431699.63699.80
692762-9276297.99498.16
15min192669-9266997.89698.630.9398.2298.960.93
292817-9281798.05298.38
394205-9420599.51999.85
493491-9349198.76499.09
594543-9454399.876100.21
692470-9247097.68698.01
20min192667-9266797.89498.420.5798.3898.910.57
292983-9298398.22898.72
393803-9380399.09499.59
493103-9310398.35598.85
593798-9379899.08999.59
692613-9261397.83798.33
30min192395-9239597.60798.140.7598.2698.800.75
292610-9261097.83498.49
393563-9356398.84199.50
492874-9287498.11398.77
593867-9386799.16299.82
692086-9208697.28097.93
45min192465-9246597.68198.010.8098.5098.830.80
292401-9240197.61398.43
393290-9329098.55299.38
492781-9278198.01498.83
593917-9391799.215100.04
691818-9181896.99797.81
极限192004-9200497.19497.670.7198.1798.660.71
292411-9241197.62498.60
392852-9285298.08999.08
491927-9192797.11298.09
593582-9358298.86199.85
691981-9198197.16998.14
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715566455652556655562555537556290.10
214.695491554875548950.06
单位质量响应值RSD%判断
3781.713736.900.85数据可信
加速3月-供试品溶液-2024010421批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153921-5392190.56491.931.3690.5691.931.36
255218-5521892.74392.74
355459-5545993.14793.15
453689-5368990.17590.17
555092-5509292.53192.53
655034-5503492.43492.43
10min154496-5449691.53092.701.3191.6892.851.31
255452-5545293.13693.29
356244-5624494.46694.62
454386-5438691.34591.50
554918-5491892.23992.39
655652-5565293.47293.63
15min154528-5452891.58493.301.5091.8993.601.49
256474-5647494.85295.16
356227-5622794.43794.75
454565-5456591.64691.95
555859-5585993.81994.13
655630-5563093.43593.74
20min154366-5436691.31293.151.3791.7793.621.37
256352-5635294.64795.12
356099-5609994.22294.69
454799-5479992.03992.49
555647-5564793.46393.93
655508-5550893.23093.70
30min155065-5506592.48691.982.5093.0992.602.48
252379-5237987.97488.60
356382-5638294.69895.32
454685-5468591.84792.46
555651-5565193.47094.09
654422-5442291.40692.03
45min154787-5478792.01991.053.1792.7891.823.14
254049-5404990.77991.55
351101-5110185.82886.61
453976-5397690.65791.42
556066-5606694.16794.94
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