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4000
标示量(mg)2.5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%
110.234365343739435714366543489436230.22
210.274353743635435860.16
单位质量响应值RSD%判断
4264.224244.010.34数据可信
供试品溶液-23122802批-比索洛尔-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%
5min146486-4648698.15096.802.8698.1596.802.86
245436-4543695.93395.93
347659-47659100.626100.63
446214-4621497.57597.58
545537-4553796.14696.15
643738-4373892.34792.35
10min146604-4660498.39997.102.5598.5697.262.55
245626-4562696.33496.49
347517-47517100.326100.49
446408-4640897.98598.15
545728-4572896.54996.71
644053-4405393.01393.17
15min146352-4635297.86796.902.3998.1997.222.39
245675-4567596.43796.76
347289-4728999.845100.18
446255-4625597.66297.99
545807-4580796.71697.04
643981-4398192.86193.17
20min146453-4645398.08096.722.6698.5797.202.66
245431-4543195.92296.40
347390-47390100.058100.56
446105-4610597.34597.83
545720-4572096.53297.01
643745-4374592.36292.83
30min146407-4640797.98396.662.6798.6497.312.67
245556-4555696.18696.83
347332-4733299.936100.60
446119-4611997.37598.03
545601-4560196.28196.92
643676-4367692.21792.83
45min146303-4630397.76396.402.5598.5897.212.55
245344-4534495.73896.54
347175-4717599.604100.44
445868-4586896.84597.66
545565-4556596.20597.01
643688-4368892.24293.01
极限146178-4617897.49996.282.5798.4897.242.57
245195-4519595.42496.38
347130-4713099.509100.51
445959-4595997.03798.01
545487-4548796.04097.00
643640-4364092.14193.07
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4000
标示量(mg)2.5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%
110.234347543745436174356043670436130.24
210.274357843482435300.16
单位质量响应值RSD%判断
4263.254238.560.42数据可信
供试品溶液-23122803批-比索洛尔-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%
5min146933-4693399.16997.821.4299.1797.821.42
245624-4562496.40396.40
345759-4575996.68896.69
446420-4642098.08598.08
547186-4718699.70399.70
645846-4584696.87296.87
10min146995-4699599.30098.111.5499.4698.271.54
245757-4575796.68496.84
346084-4608497.37597.54
446419-4641998.08298.25
547539-47539100.449100.62
645785-4578596.74396.90
15min146999-4699999.30897.711.2299.6498.041.22
245471-4547196.07996.40
346167-4616797.55097.87
446422-4642298.08998.42
546631-4663198.53098.86
645762-4576296.69497.02
20min146831-4683198.95397.911.5599.4598.401.55
245508-4550896.15896.64
345973-4597397.14097.63
446301-4630197.83398.32
547493-47493100.352100.85
645916-4591697.02097.50
30min146837-4683798.96697.641.6199.6398.291.61
245525-4552596.19396.84
345587-4558796.32496.97
446190-4619097.59998.25
547354-47354100.058100.72
645760-4576096.69097.34
45min146783-4678398.85297.691.6199.6898.511.61
245357-4535795.83896.64
345925-4592597.03997.85
446364-4636497.96698.78
547335-47335100.018100.85
645645-4564596.44797.25
极限146743-4674398.76797.471.5799.7698.451.57
245381-4538195.88996.85
345604-4560496.36097.33
446317-4631797.86798.85
547160-4716099.648100.65
645581-4558196.31297.28
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4000
标示量(mg)2.5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%
110.234361243767435274349143595435980.25
210.274341643548434820.22
单位质量响应值RSD%判断
4261.784233.890.47数据可信
供试品溶液-23122803批-比索洛尔-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%
5min146833-4683399.02997.171.7099.0397.171.70
246294-4629497.88997.89
345212-4521295.60195.60
445516-4551696.24496.24
546777-4677798.91198.91
645099-4509995.36295.36
10min147334-47334100.08897.931.51100.2598.091.51
246477-4647798.27698.44
345751-4575196.74196.90
445797-4579796.83897.00
546877-4687799.12299.29
645636-4563696.49896.66
15min147162-4716299.72597.401.59100.0697.731.59
246075-4607597.42697.75
345316-4531695.82196.14
445459-4545996.12496.45
546682-4668298.71099.04
645687-4568796.60696.93
20min146923-4692399.21997.111.6999.7297.601.69
246149-4614997.58398.07
345116-4511695.39895.88
445254-4525495.69096.17
546692-4669298.73199.23
645413-4541396.02696.51
30min146849-4684999.06396.931.7699.7397.581.76
246085-4608597.44798.10
344951-4495195.04995.69
445361-4536195.91696.56
546645-4664598.63199.29
645146-4514695.46296.10
45min146681-4668198.70896.681.6199.5497.501.61
245900-4590097.05697.87
345091-4509195.34696.14
445185-4518595.54496.35
546461-4646198.24299.07
645020-4502095.19596.00
极限146470-4647098.26196.301.5399.2597.271.53
245706-4570696.64697.62
344996-4499695.14596.10
444881-4488194.90195.86
546224-4622497.74198.73
644977-4497795.10496.06
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4000
标示量(mg)2.5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%
110.238481384953847498488684745848290.11
210.278484884945848960.09
单位质量响应值RSD%判断
8292.188266.410.23数据可信
供试品溶液-2024010421批-比索洛尔-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%
5min195482-95482103.586102.522.16103.59102.522.16
293378-93378101.304101.30
393607-93607101.552101.55
491565-9156599.33799.34
597241-97241105.495105.49
695739-95739103.865103.87
10min196773-96773104.987103.652.14105.16103.822.14
294446-94446102.462102.63
394032-94032102.013102.18
493408-93408101.336101.50
598896-98896107.290107.47
695669-95669103.789103.96
15min196203-96203104.369103.102.18104.72103.442.18
294036-94036102.018102.36
393472-93472101.406101.74
492744-92744100.616100.95
598392-98392106.743107.10
695338-95338103.430103.78
20min196071-96071104.225102.842.23104.75103.362.23
293744-93744101.701102.21
393266-93266101.182101.69
492480-92480100.330100.83
598240-98240106.578107.11
694957-94957103.017103.54
30min195647-95647103.765102.602.19104.46103.292.19
293869-93869101.836102.52
393154-93154101.061101.74
491993-9199399.801100.47
597883-97883106.191106.90
694882-94882102.935103.63
45min195809-95809103.941102.382.09104.81103.242.09
293443-93443101.374102.22
392813-92813100.691101.54
492124-9212499.943100.78
597340-97340105.602106.49
694683-94683102.719103.58
极限195030-95030103.096101.732.10104.14102.752.11
292678-92678100.544101.56
392366-92366100.206101.22
491541-9154199.311100.31
596858-96858105.079106.14
694127-94127102.116103.15
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4000
标示量(mg)2.5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%
110.238481784968849238488284965849110.08
210.278524785224852360.02
单位质量响应值RSD%判断
8300.208299.510.01数据可信
供试品溶液-2024010421批-比索洛尔-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%
5min193922-93922101.641100.171.45101.64100.171.45
291447-9144798.96398.96
391733-9173399.27299.27
494578-94578102.351102.35
591745-9174599.28599.29
691930-9193099.48699.49
10min194186-94186101.927100.881.40102.10101.051.41
291924-9192499.47999.64
392785-92785100.411100.58
495388-95388103.228103.40
592428-92428100.024100.19
692609-92609100.220100.39
15min193835-93835101.547100.791.50101.89101.131.50
291913-9191399.46799.80
392766-92766100.390100.72
495620-95620103.479103.82
592096-9209699.665100.00
692606-92606100.217100.55
20min193861-93861101.575100.681.36102.08101.181.36
291786-9178699.33099.83
392508-92508100.111100.61
495190-95190103.013103.53
592381-9238199.974100.47
692467-92467100.067100.57
30min193838-93838101.550100.761.28102.23101.441.29
292093-9209399.662100.32
392561-92561100.168100.84
495215-95215103.040103.73
592519-92519100.123100.79
692446-92446100.044100.71
45min194057-94057101.787100.641.31102.63101.481.31
292048-9204899.613100.44
392263-9226399.846100.68
494968-94968102.773103.63
592368-9236899.960100.79
692300-9230099.886100.72
极限193681-93681101.380100.291.38102.40101.301.38
291243-9124398.74299.74
392077-9207799.645100.64
494722-94722102.507103.54
592082-9208299.650100.65
692260-9226099.843100.84
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