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%
110.318615986192863068634686370862750.11
210.408643886413864260.03
单位质量响应值RSD%判断
8368.098310.190.50数据可信
加速6月-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%
5min190026-9002696.96798.230.8196.9798.230.81
292144-9214499.24999.25
390693-9069397.68697.69
491506-9150698.56198.56
591376-9137698.42198.42
691448-9144898.49998.50
10min191381-9138198.42799.480.9798.5999.640.97
293784-93784101.015101.18
391432-9143298.48298.64
492458-9245899.58799.75
592688-9268899.834100.00
692406-9240699.53199.69
15min191279-9127998.31799.461.0598.6499.791.05
293921-93921101.163101.50
391453-9145398.50498.83
492231-9223199.34299.67
592846-92846100.005100.34
692301-9230199.41899.75
20min191255-9125598.29199.321.0098.7899.821.00
293839-93839101.074101.58
391458-9145898.51099.00
492009-9200999.10399.60
592477-9247799.607100.10
692249-9224999.36299.86
30min191132-9113298.15899.170.9398.8199.830.93
293486-93486100.694101.36
391276-9127698.31498.97
492032-9203299.12899.79
592356-9235699.477100.14
692166-9216699.27299.93
45min191025-9102598.04399.040.8998.8699.870.89
293275-93275100.467101.31
391189-9118998.22099.04
491941-9194199.03099.86
592274-9227499.389100.22
692002-9200299.09699.92
极限190641-9064197.63098.770.9998.6199.770.99
293164-93164100.347101.35
390849-9084997.85498.84
491705-9170598.77699.77
592031-9203199.127100.12
691834-9183498.91599.91
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%
113.774925749309492304936749354493030.13
213.784934349448493960.16
单位质量响应值RSD%判断
3580.463584.620.09数据可信
加速6月-供试品溶液-2024010421批-左氨氯地平-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%
5min144260-4426078.00377.344.7778.0077.344.77
246533-4653382.00982.01
343884-4388477.34077.34
445648-4564880.44980.45
541192-4119272.59672.60
641802-4180273.67173.67
10min151569-5156990.88491.192.4091.0191.312.40
252563-5256392.63692.77
351829-5182991.34291.47
453035-5303593.46893.60
551990-5199091.62691.75
649453-4945387.15587.28
15min153257-5325793.85993.212.7894.1493.502.78
254395-5439595.86596.16
353884-5388494.96495.25
452689-5268992.85893.15
552946-5294693.31193.58
650175-5017588.42788.70
20min154158-5415895.44795.411.6595.8895.841.66
254892-5489296.74197.19
354024-5402495.21195.65
454778-5477896.54096.98
554506-5450696.06096.49
652448-5244892.43392.85
30min154128-5412895.39496.331.4695.9996.931.46
255803-5580398.34698.96
354844-5484496.65697.25
454661-5466196.33396.94
555045-5504597.01097.60
653481-5348194.25494.82
45min154848-5484896.66396.651.4197.4297.411.41
254807-5480796.59197.37
355045-5504597.01097.77
455464-5546497.74998.51
555501-5550197.81498.56
653393-5339394.09994.83
极限151049-5104989.96896.073.5790.8896.993.55
255682-5568298.13399.07
355076-5507697.06597.99
456087-5608798.84799.78
555749-5574998.25199.16
653427-5342794.15995.04
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%
110.318647986520865398648586511865070.03
210.408666986664866660.01
单位质量响应值RSD%判断
8390.598333.270.49数据可信
长期6月-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%
5min192591-9259199.45899.601.5099.4699.601.50
293605-93605100.547100.55
392331-9233199.17999.18
490333-9033397.03397.03
594384-94384101.384101.38
693104-93104100.009100.01
10min193368-93368100.293100.281.35100.46100.441.35
294196-94196101.182101.35
393111-93111100.017100.18
491089-9108997.84598.01
594762-94762101.790101.96
693585-93585100.526100.69
15min193409-93409100.337100.251.18100.67100.581.18
293979-93979100.949101.29
393126-93126100.033100.36
491339-9133998.11398.44
594586-94586101.601101.94
693540-93540100.478100.81
20min192974-9297499.870100.071.24100.37100.571.24
293704-93704100.654101.16
392913-9291399.804100.30
491136-9113697.89598.38
594534-94534101.545102.05
693690-93690100.639101.14
30min193248-93248100.164100.291.16100.83100.961.16
293794-93794100.750101.42
393330-93330100.252100.92
491398-9139898.17798.83
594582-94582101.597102.27
693843-93843100.803101.47
45min193178-93178100.089100.091.19100.92100.921.19
293800-93800100.757101.60
393036-9303699.936100.77
491158-9115897.91998.73
594398-94398101.399102.25
693510-93510100.445101.28
极限193227-93227100.14199.771.29101.14100.781.29
293181-93181100.092101.10
392819-9281999.703100.70
490603-9060397.32398.30
594067-94067101.044102.06
693417-93417100.345101.35
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%
113.774948749465494614944449493494700.05
213.784950249528495150.04
单位质量响应值RSD%判断
3592.593593.250.02数据可信
长期6月-供试品溶液-2024010421批-左氨氯地平-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%
5min146093-4609380.99977.992.2681.0077.992.26
244061-4406177.42877.43
344937-4493778.96778.97
443372-4337276.21776.22
543580-4358076.58376.58
644238-4423877.73977.74
10min152629-5262992.48491.971.0692.6292.101.06
253042-5304293.21093.34
352779-5277992.74892.88
451971-5197191.32891.46
551678-5167890.81390.94
651909-5190991.21991.35
15min154424-5442495.63994.801.3995.9395.091.39
254904-5490496.48296.77
354289-5428995.40195.69
453919-5391994.75195.03
553214-5321493.51293.79
652943-5294393.03693.32
20min154802-5480296.30395.224.2196.7595.664.20
255783-5578398.02798.47
355529-5552997.58098.03
449651-4965187.25187.69
554331-5433195.47595.91
655014-5501496.67597.11
30min154680-5468096.08895.751.2596.7096.351.25
255368-5536897.29897.91
355091-5509196.81197.42
454206-5420695.25695.84
553959-5395994.82195.42
653609-5360994.20694.80
45min155085-5508596.80096.491.6197.5797.251.61
256335-5633598.99799.77
353947-5394794.80095.57
453979-5397994.85795.60
555108-5510896.84197.59
654993-5499396.63997.39
极限155111-5511196.84695.641.2797.7896.561.27
254779-5477996.26297.20
355044-5504496.72897.66
453735-5373594.42895.33
553461-5346193.94694.86
654414-5441495.62196.54
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%
110.318641486383864018642286295863830.06
210.408644186378864100.06
单位质量响应值RSD%判断
8378.568308.650.60数据可信
中间条件6月-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%
5min191996-9199699.03799.001.0099.0499.001.01
291932-9193298.96898.97
391152-9115298.12898.13
490756-9075697.70297.70
593130-93130100.257100.26
692825-9282599.92999.93
10min192815-9281599.91899.951.09100.08100.111.09
292848-9284899.954100.12
392264-9226499.32599.49
491320-9132098.30998.47
593603-93603100.767100.93
694208-94208101.418101.58
15min192785-9278599.88699.881.03100.22100.211.03
292612-9261299.700100.03
392068-9206899.11499.44
491492-9149298.49498.82
593946-93946101.136101.47
693772-93772100.949101.28
20min192489-9248999.56799.600.99100.07100.100.99
292380-9238099.45099.95
392093-9209399.14199.64
491160-9116098.13798.63
593159-93159100.289100.79
693828-93828101.009101.51
30min192261-9226199.32299.440.9499.99100.100.95
292214-9221499.27199.93
391853-9185398.88399.54
491190-9119098.16998.82
593057-93057100.179100.85
693634-93634100.800101.47
45min192147-9214799.19999.360.82100.03100.190.83
292331-9233199.397100.23
391941-9194198.97799.80
491128-9112898.10298.92
593086-93086100.210101.05
693139-93139100.267101.11
极限192163-9216399.21699.160.93100.21100.160.93
292151-9215199.203100.20
391608-9160898.61999.61
490770-9077097.71798.70
592846-9284699.952100.96
693112-93112100.238101.25
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%
113.774934749372493384933249267493310.08
213.784873948515486270.33
单位质量响应值RSD%判断
3582.503528.811.07数据可信
中间条件6月-供试品溶液-2024010421批-左氨氯地平-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%
5min144292-4429278.65479.591.3478.6579.591.34
245662-4566281.08781.09
343984-4398478.10778.11
445064-4506480.02580.02
544890-4489079.71679.72
645017-4501779.94279.94
10min151972-5197292.29293.972.4592.4294.102.45
254119-5411996.10596.24
351427-5142791.32491.45
451848-5184892.07292.21
553996-5399695.88696.02
654150-5415096.16096.29
15min153517-5351795.03697.161.5295.3297.451.52
255472-5547298.50898.80
354273-5427396.37896.66
454273-5427396.37896.67
555079-5507997.81098.10
655656-5565698.83499.13
20min153469-5346994.95198.902.3895.3999.352.38
256322-56322100.017100.48
355240-5524098.09698.54
455308-5530898.21698.66
556675-56675100.644101.10
657136-57136101.463101.92
30min155046-5504697.75199.121.6598.3599.731.64
254911-5491197.51198.14
355114-5511497.87298.48
456375-56375100.111100.72
556301-5630199.980100.60
657144-57144101.477102.10
45min154760-5476097.243100.021.6298.01100.801.62
257336-57336101.818102.61
355874-5587499.22199.99
456384-56384100.127100.91
556914-56914101.068101.86
656676-56676100.646101.44
极限153871-5387195.665100.092.5596.59101.042.54
257423-57423101.972102.93
355688-5568898.89199.83
456493-56493100.321101.27
556841-56841100.939101.90
657875-57875102.775103.74
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%
110.318652986516867518653386511865680.12
210.408689586867868810.03
单位质量响应值RSD%判断
8396.518353.940.36数据可信
中间条件6月-供试品溶液-2024010421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%
5min189052-8905295.50497.512.5295.5097.522.53
292475-9247599.17599.18
389417-8941795.89695.90
491447-9144798.07398.07
594490-94490101.336101.34
688674-8867495.09995.10
10min190541-9054197.10199.282.4897.2699.442.48
293686-93686100.474100.64
391200-9120097.80897.97
493726-93726100.517100.68
596063-96063103.023103.19
690209-9020996.74596.90
15min190723-9072397.29699.042.3197.6299.372.31
293467-93467100.239100.57
391120-9112097.72298.05
493334-93334100.097100.43
595559-95559102.483102.82
689885-8988596.39896.72
20min190448-9044897.00198.992.4697.4899.482.46
293786-93786100.581101.08
391234-9123497.84498.33
492824-9282499.550100.05
595761-95761102.699103.21
689737-8973796.23996.72
30min190210-9021096.74698.932.5797.3999.582.56
293689-93689100.477101.14
390934-9093497.52398.17
492916-9291699.648100.31
595921-95921102.871103.55
689793-8979396.29996.94
45min189731-8973196.23398.202.5297.0499.022.52
292580-9258099.288100.12
390431-9043196.98397.79
492010-9201098.67799.51
595445-95445102.361103.21
689218-8921895.68296.48
极限190355-9035596.90298.462.4297.8799.442.42
293085-9308599.830100.83
390450-9045097.00497.98
492427-9242799.124100.12
595277-95277102.180103.20
689230-8923095.69596.66
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%
113.774957249511494464951949411494920.13
213.784970749754497300.07
单位质量响应值RSD%判断
3594.193608.850.29数据可信
中间条件6月-供试品溶液-2024010421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%
5min153778-5377894.27895.382.4094.2895.382.40
254949-5494996.33196.33
354507-5450795.55695.56
454367-5436795.31195.31
556396-5639698.86898.87
652442-5244291.93691.94
10min155598-5559897.46999.371.6497.6399.531.63
257708-57708101.168101.33
355989-5598998.15498.31
456327-5632798.74798.91
557879-57879101.468101.63
656598-5659899.22299.38
15min155352-5535297.03899.101.5497.3699.421.54
257469-57469100.749101.08
356695-5669599.39299.71
456702-5670299.40499.73
557321-57321100.489100.82
655628-5562897.52197.84
20min156290-5629098.68298.711.0999.1699.201.09
255894-5589497.98898.48
356315-5631598.72699.21
456035-5603598.23598.72
557482-57482100.772101.27
655828-5582897.87298.35
30min154875-5487596.20198.091.7496.8598.751.74
255967-5596798.11698.78
356010-5601098.19198.84
455480-5548097.26297.91
557755-57755101.250101.92
655642-5564297.54698.19
45min154360-5436095.29897.852.5096.1098.672.49
256947-5694799.834100.66
355773-5577397.77698.59
455198-5519896.76897.58
557956-57956101.603102.44
654674-5467495.84996.66
极限155530-5553097.35098.471.8298.3199.451.82
257481-57481100.770101.76
355550-5555097.38598.36
455759-5575997.75198.73
557460-57460100.733101.74
655241-5524196.84397.81
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