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%
19.808354583645835878361383526835830.06
29.888358483634836090.05
单位质量响应值RSD%判断
8528.888462.450.56数据可信
供试品溶液-2024110421批-比索洛尔-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min194655-94655100.075100.571.65100.08100.571.65
293250-9325098.59098.59
397420-97420102.998103.00
496589-96589102.120102.12
594207-9420799.60199.60
694619-94619100.037100.04
10min196513-96513102.039102.131.68102.21102.291.68
294679-94679100.100100.26
398511-98511104.152104.32
498429-98429104.065104.24
595054-95054100.497100.66
696383-96383101.902102.07
15min196709-96709102.247102.191.67102.58102.531.66
294759-94759100.185100.52
398578-98578104.223104.57
498431-98431104.067104.41
595136-95136100.584100.92
696307-96307101.822102.16
20min196505-96505102.031102.071.71102.54102.581.70
294633-94633100.052100.55
398581-98581104.226104.74
498401-98401104.036104.55
595158-95158100.607101.11
695967-95967101.462101.97
30min196383-96383101.902101.971.72102.58102.641.73
294470-9447099.879100.54
398512-98512104.153104.85
498296-98296103.925104.62
595100-95100100.546101.21
695904-95904101.396102.07
45min196372-96372101.890101.671.71102.74102.521.70
294172-9417299.564100.40
398089-98089103.706104.57
497985-97985103.596104.46
594725-94725100.149100.99
695623-95623101.099101.94
极限195675-95675101.153101.371.63102.17102.391.63
294164-9416499.556100.55
397709-97709103.304104.34
497784-97784103.383104.42
594462-9446299.871100.87
695489-95489100.957101.97
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%
113.924965349700496394989449695497160.21
213.884992349474496980.64
单位质量响应值RSD%判断
3571.553580.550.18数据可信
供试品溶液-2024110421批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152425-5242592.56192.700.8492.5692.700.83
252907-5290793.41293.41
352942-5294293.47393.47
452623-5262392.91092.91
552356-5235692.43992.44
651760-5176091.38691.39
10min153995-5399595.33395.860.9595.4996.020.94
254057-5405795.44295.60
354120-5412095.55395.71
454852-5485296.84697.00
553743-5374394.88895.04
655011-5501197.12697.28
15min154525-5452596.26895.952.7796.5896.262.76
255407-5540797.82698.14
355233-5523397.51897.83
454562-5456296.33496.65
551360-5136090.68090.99
654968-5496897.05097.36
20min154083-5408395.48897.001.1595.9697.471.14
255237-5523797.52598.00
355202-5520297.46497.94
454367-5436795.98996.47
554921-5492196.96897.43
655811-5581198.53999.01
30min154853-5485396.84796.960.8797.4897.600.87
254379-5437996.01196.65
355233-5523397.51898.16
454366-5436695.98896.62
555542-5554298.06498.69
655139-5513997.35297.99
45min154536-5453696.28895.641.7997.0896.441.78
252904-5290493.40694.21
355150-5515097.37298.17
453001-5300193.57894.37
554832-5483296.81097.60
654590-5459096.38397.19
极限153364-5336494.21895.931.0095.1796.890.99
254484-5448496.19697.15
354955-5495597.02897.99
454273-5427395.82396.78
554657-5465796.50197.45
654267-5426795.81396.78
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%
19.808362783559836998355283643836160.08
29.888374083802837710.06
单位质量响应值RSD%判断
8532.248478.850.45数据可信
供试品溶液-2024110421批-比索洛尔-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min191817-9181796.96199.603.1896.9699.603.18
295020-95020100.344100.34
395538-95538100.891100.89
492948-9294898.15698.16
599328-99328104.893104.89
691224-9122496.33596.34
10min192346-9234697.520100.513.1997.68100.673.19
295917-95917101.291101.46
396607-96607102.020102.19
494223-9422399.50299.67
5100039-100039105.644105.82
691914-9191497.06497.22
15min192277-9227797.447100.653.2297.77100.983.22
296125-96125101.511101.85
396639-96639102.053102.39
494551-9455199.848100.18
5100208-100208105.822106.17
692037-9203797.19497.52
20min192209-9220997.375100.393.1597.86100.893.15
295768-95768101.134101.64
396457-96457101.861102.37
494053-9405399.32399.82
599926-99926105.525106.05
691969-9196997.12297.61
30min192008-9200897.163100.423.1997.81101.083.19
295781-95781101.147101.82
396208-96208101.598102.28
494466-9446699.759100.42
5100068-100068105.675106.38
692004-9200497.15997.80
45min191850-9185096.996100.073.1997.81100.903.19
295325-95325100.666101.51
395986-95986101.364102.21
494083-9408399.354100.18
599725-99725105.312106.19
691591-9159196.72397.53
极限191567-9156796.69799.803.1297.67100.813.12
294933-94933100.252101.26
395636-95636100.994102.01
493745-9374598.99799.99
599481-99481105.055106.11
691691-9169196.82897.80
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%
113.924962949467494914990149859496690.41
213.884973549395495650.49
单位质量响应值RSD%判断
3568.183570.970.06数据可信
供试品溶液-2024110421批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min150687-5068789.65491.241.6289.6591.241.62
252529-5252992.91292.91
350725-5072589.72289.72
451347-5134790.82290.82
552568-5256892.98192.98
651650-5165091.35891.36
10min153152-5315294.01495.012.8694.1695.162.85
255507-5550798.18098.33
353882-5388295.30695.46
454362-5436296.15596.31
551007-5100790.22090.38
654365-5436596.16096.31
15min153550-5355094.71896.051.5295.0296.361.51
255178-5517897.59897.92
354326-5432696.09196.40
453161-5316194.03094.34
555140-5514097.53197.84
654459-5445996.32696.64
20min153601-5360194.80996.091.2795.2796.561.27
255295-5529597.80598.29
354157-5415795.79296.26
453556-5355694.72995.20
554762-5476296.86297.33
654593-5459396.56397.04
30min153354-5335494.37296.081.6094.9996.711.60
254884-5488497.07897.72
353757-5375795.08595.71
453880-5388095.30295.93
555736-5573698.58599.21
654300-5430096.04596.68
45min152957-5295793.66995.551.7194.4596.341.70
254068-5406895.63596.44
353423-5342394.49495.28
454184-5418495.84096.62
555662-5566298.45499.25
653835-5383595.22296.02
极限152880-5288093.53395.611.5394.4796.561.52
254727-5472796.80097.77
353524-5352494.67295.62
454068-5406895.63596.58
555177-5517797.59698.55
653949-5394995.42496.38
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