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%
19.948387083780838058385383738838090.07
210.058385683715837860.12
单位质量响应值RSD%判断
8431.498336.920.80数据可信
供试品溶液-2024110221批-比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189738-8973896.13995.482.8596.1495.482.85
288391-8839194.69694.70
388123-8812394.40994.41
492284-9228498.86798.87
591091-9109197.58997.59
685083-8508391.15291.15
10min191545-9154598.07598.751.5898.2498.911.58
290934-9093497.42197.58
391103-9110397.60297.76
494572-94572101.318101.48
593319-9331999.976100.14
691576-9157698.10998.26
15min192262-9226298.84399.711.3399.17100.041.33
291662-9166298.20198.52
392086-9208698.65598.97
494659-94659101.411101.75
593648-93648100.328100.66
694115-94115100.829101.14
20min192122-9212298.69399.991.4999.18100.481.49
291626-9162698.16298.65
392575-9257599.17999.66
494853-94853101.619102.12
594145-94145100.861101.36
694653-94653101.405101.89
30min192209-9220998.787100.161.4499.44100.821.43
292072-9207298.64099.29
392654-9265499.26399.91
494453-94453101.191101.86
594338-94338101.068101.73
695219-95219102.011102.66
45min192403-9240398.995100.261.4599.81101.081.45
292086-9208698.65599.47
392753-9275399.369100.18
494513-94513101.255102.10
594342-94342101.072101.90
695420-95420102.227103.05
极限192528-9252899.128100.371.40100.11101.361.40
292583-9258399.187100.16
392617-9261799.224100.20
494334-94334101.063102.07
594411-94411101.146102.15
695656-95656102.480103.47
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%
113.224936049498500884962850104497360.69
213.254919449795494940.86
单位质量响应值RSD%判断
3762.183735.400.51数据可信
供试品溶液-2024110221批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122105-2210537.23039.828.0837.2339.828.08
223309-2330939.25839.26
325950-2595043.70643.71
421103-2110335.54335.54
523758-2375840.01440.01
625632-2563243.17143.17
10min140023-4002367.40968.084.7067.4768.144.70
239085-3908565.82965.89
343543-4354373.33773.41
439209-3920966.03866.10
538777-3877765.31065.38
641882-4188270.54070.61
15min147096-4709679.32178.525.1779.5078.705.17
245287-4528776.27476.45
349615-4961583.56483.76
444576-4457675.07775.25
543938-4393874.00274.18
649207-4920782.87783.07
20min149517-4951783.39981.173.4583.7181.483.45
246117-4611777.67277.97
350180-5018084.51584.85
446818-4681878.85379.15
547307-4730779.67779.98
649231-4923182.91783.24
30min149665-4966583.64883.824.0184.0984.274.01
248879-4887982.32482.76
351138-5113886.12986.60
447592-4759280.15780.58
548338-4833881.41381.84
652998-5299889.26289.73
45min150227-5022784.59582.144.3585.1882.724.34
245838-4583877.20277.77
349620-4962083.57284.19
447561-4756180.10480.66
547696-4769680.33280.90
651667-5166787.02087.63
极限152421-5242188.29086.352.3189.0287.082.30
249714-4971483.73184.43
351067-5106786.00986.77
452234-5223487.97588.67
550044-5004484.28684.99
652135-5213587.80888.57
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%
19.948378883832838418383183788838160.04
210.058344483397834200.04
单位质量响应值RSD%判断
8432.198300.501.12数据可信
供试品溶液-2024110321批-比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186715-8671593.10295.113.1293.1095.113.12
286552-8655292.92792.93
385549-8554991.85091.85
491096-9109697.80697.81
589171-8917195.73995.74
692408-9240899.21499.21
10min190360-9036097.01598.352.3797.1798.502.37
290102-9010296.73896.89
389121-8912195.68595.84
493886-93886100.801100.96
591662-9166298.41398.57
694473-94473101.431101.60
15min191177-9117797.89399.092.3998.2199.412.39
291095-9109597.80498.12
389365-8936595.94796.26
494500-94500101.460101.79
592475-9247599.28699.61
695116-95116102.122102.46
20min191639-9163998.38999.602.2098.87100.092.20
291786-9178698.54699.03
390429-9042997.08997.56
494760-94760101.739102.24
592250-9225099.04599.53
695738-95738102.789103.29
30min192881-9288199.722100.672.22100.37101.322.22
292619-9261999.441100.08
391278-9127898.00198.64
495647-95647102.692103.36
593303-93303100.175100.83
696850-96850103.983104.66
45min193180-93180100.043100.892.21100.85101.722.21
293177-93177100.040100.85
391605-9160598.35299.15
495893-95893102.956103.80
592885-9288599.726100.55
697089-97089104.240105.09
极限193591-93591100.484101.082.43101.46102.072.43
293121-9312199.980100.96
391034-9103497.73998.70
495966-95966103.034104.05
593638-93638100.535101.52
697521-97521104.704105.73
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%
113.224963149768495404928149140494720.52
213.254970349402495520.43
单位质量响应值RSD%判断
3742.213739.770.05数据可信
供试品溶液-2024110321批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127190-2719045.88947.355.9845.8947.345.98
227689-2768946.73246.73
327845-2784546.99546.99
427098-2709845.73445.73
527089-2708945.71945.72
631409-3140953.01053.01
10min137407-3740763.13363.033.1463.2163.113.14
237122-3712262.65262.73
337815-3781563.82263.90
436045-3604560.83460.91
536356-3635661.35961.44
639318-3931866.35866.45
15min141037-4103769.26071.812.4369.4471.992.43
242017-4201770.91471.10
343006-4300672.58372.77
442538-4253871.79371.97
542541-4254171.79871.98
644139-4413974.49574.69
20min144537-4453775.16777.932.5375.4678.232.53
245906-4590677.47777.78
347827-4782780.71981.02
446052-4605277.72478.02
545579-4557976.92577.22
647153-4715379.58279.90
30min146179-4617977.93881.752.9978.3682.182.99
247823-4782380.71281.14
349259-4925983.13683.58
447893-4789380.83181.26
549153-4915382.95783.38
650306-5030684.90385.36
45min149491-4949183.52884.612.1884.0885.182.17
251187-5118786.39086.95
351400-5140086.75087.33
449307-4930783.21783.78
548763-4876382.29982.86
650632-5063285.45386.05
极限151301-5130186.58286.312.5487.2787.022.53
251391-5139186.73487.44
350708-5070885.58286.30
450140-5014084.62385.32
549836-4983684.11084.81
653470-5347090.24390.98
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%
19.948357983483834768354683441835050.07
210.058368283709836960.03
单位质量响应值RSD%判断
8400.918327.960.62数据可信
供试品溶液-2024110321批-比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188655-8865595.20296.782.4695.2096.782.45
291514-9151498.27398.27
390830-9083097.53897.54
493256-93256100.143100.14
587042-8704293.47093.47
689423-8942396.02796.03
10min192501-9250199.33299.851.5799.49100.011.57
293034-9303499.905100.07
392872-9287299.73199.89
495647-95647102.711102.88
591235-9123597.97398.13
692623-9262399.46399.62
15min193615-93615100.529100.431.18100.85100.761.18
293228-93228100.113100.44
393329-93329100.222100.55
495443-95443102.492102.83
592035-9203598.83299.15
693483-93483100.387100.71
20min193385-93385100.282100.741.24100.77101.231.24
293919-93919100.855101.35
393653-93653100.570101.07
495896-95896102.978103.49
592365-9236599.18699.67
693626-93626100.541101.03
30min193954-93954100.893101.301.21101.55101.961.21
294146-94146101.099101.76
394219-94219101.177101.84
496516-96516103.644104.32
593143-93143100.022100.67
694025-94025100.969101.63
45min194584-94584101.569101.481.06102.40102.321.05
294057-94057101.003101.84
393889-93889100.823101.66
496466-96466103.590104.44
593956-93956100.895101.71
694067-94067101.014101.84
极限194708-94708101.702101.761.09102.70102.761.10
294530-94530101.511102.51
394291-94291101.255102.25
496814-96814103.964104.99
594097-94097101.046102.03
694131-94131101.083102.08
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%
113.224988449920493654997049320496920.65
213.255073550403505690.47
单位质量响应值RSD%判断
3758.853816.531.08数据可信
供试品溶液-2024110321批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127452-2745245.76344.259.8845.7644.259.88
222392-2239237.32837.33
325466-2546642.45242.45
425736-2573642.90242.90
529916-2991649.87149.87
628303-2830347.18247.18
10min137004-3700461.68660.347.1661.7660.427.16
232509-3250954.19354.26
337342-3734262.25062.32
436997-3699761.67561.75
539571-3957165.96666.05
633756-3375656.27256.35
15min142636-4263671.07568.517.7171.2568.697.71
234814-3481458.03658.19
342058-4205870.11270.29
441098-4109868.51168.69
543345-4334572.25772.45
642636-4263671.07571.25
20min144909-4490974.86475.064.3475.1675.344.35
241360-4136068.94869.20
345938-4593876.58076.87
445393-4539375.67175.96
547151-4715178.60278.92
645394-4539475.67375.96
30min146621-4662177.71878.682.9178.1479.092.92
244975-4497574.97475.34
348861-4886181.45281.87
448368-4836880.63181.05
547173-4717378.63879.08
647172-4717278.63779.05
45min151048-5104885.09882.503.4285.6583.043.43
246653-4665377.77278.26
349286-4928682.16182.72
448966-4896681.62782.18
551360-5136085.61886.19
649620-4962082.71883.27
极限152786-5278687.99584.182.4588.6984.862.44
249910-4991083.20183.82
349609-4960982.69983.39
449693-4969382.83983.52
549936-4993683.24483.96
651053-5105385.10685.79
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