比索洛尔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%
110.298530785323853228544385496853780.11
210.298564685550855980.08
单位质量响应值RSD%判断
8297.188318.560.19数据可信
供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178472-7847284.84086.233.4884.8486.223.48
282069-8206988.72888.73
381676-8167688.30488.30
482577-8257789.27889.28
575626-7562681.76381.76
678105-7810584.44384.44
10min189188-8918896.42594.883.4596.5795.023.45
288267-8826795.42995.58
390432-9043297.77097.92
490456-9045697.79697.94
583066-8306689.80689.94
685132-8513292.04092.18
15min190579-9057997.92996.872.5898.2397.172.58
289393-8939396.64796.95
391312-9131298.72299.03
491705-9170599.14699.46
585336-8533692.26192.55
689266-8926696.50996.80
20min191352-9135298.76597.242.6199.2397.702.61
289451-8945196.71097.18
391488-9148898.91299.39
492250-9225099.736100.21
585820-8582092.78493.22
689270-8927096.51496.97
30min191780-9178099.22797.602.3099.8698.232.30
289976-8997697.27797.91
391702-9170299.14399.78
492267-9226799.754100.40
586866-8686693.91594.51
689082-8908296.31196.93
45min192032-9203299.50097.392.60100.3098.182.60
290011-9001197.31598.11
391600-9160099.03399.84
491816-9181699.266100.08
585946-8594692.92093.67
689057-8905796.28497.06
极限191778-9177899.22597.102.47100.1998.052.47
289037-8903796.26297.22
391056-9105698.44599.41
491980-9198099.444100.42
586247-8624793.24694.15
688787-8878795.99296.93
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.631008441006411012591010021014961010480.34
213.711009881010181010030.03
单位质量响应值RSD%判断
7413.657367.100.45数据可信
供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174780-7478065.59468.004.3065.5968.004.30
281879-8187971.82171.82
377856-7785668.29368.29
478847-7884769.16269.16
572590-7259063.67363.67
679192-7919269.46469.46
10min190216-9021679.13479.574.0579.2479.684.05
294122-9412282.56082.68
393831-9383182.30582.42
490873-9087379.71179.83
583973-8397373.65873.76
691276-9127680.06480.18
15min195097-9509783.41684.484.6983.6684.734.69
2100559-10055988.20788.46
3102418-10241889.83790.09
496180-9618084.36684.61
590304-9030479.21179.44
693316-9331681.85382.10
20min198811-9881186.67488.644.1487.0589.024.13
2102406-10240689.82790.23
3106575-10657593.48493.88
4100489-10048988.14588.53
594476-9447682.87183.23
6103545-10354590.82691.21
30min1102539-10253989.94493.192.9790.4793.732.97
2107436-10743694.23994.79
3108631-10863195.28795.84
4105046-10504692.14392.68
5103272-10327290.58791.09
6110544-11054496.96597.50
45min1106992-10699293.85095.932.6394.5296.622.63
2110062-11006296.54297.25
3111333-11133397.65798.37
4106066-10606693.03793.73
5108040-10804094.76995.42
6113689-11368999.724100.42
极限1108490-10849095.16496.112.4195.9996.962.38
2108850-10885095.47996.35
3109844-10984496.35197.23
4105458-10545892.50493.35
5112149-11214998.37399.18
6112618-11261898.78599.65
比索洛尔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%
110.298530585359853148531885354853300.03
210.298529285324853080.03
单位质量响应值RSD%判断
8292.528290.380.02数据可信
供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180168-8016886.84585.633.9286.8485.643.92
280457-8045787.15887.16
374308-7430880.49780.50
476293-7629382.64782.65
580474-8047487.17687.18
682601-8260189.48089.48
10min187815-8781595.12995.862.9495.2796.002.94
291218-9121898.81598.96
385193-8519392.28892.42
485920-8592093.07693.21
589677-8967797.14697.29
691109-9110998.69798.85
15min189548-8954897.00698.702.6597.3199.002.66
293705-93705101.509101.82
388320-8832095.67695.96
489112-8911296.53496.83
592265-9226599.949100.26
693726-93726101.532101.85
20min189672-8967297.14099.162.6997.6199.622.69
294351-94351102.209102.69
388630-8863096.01296.46
489811-8981197.29197.74
592764-92764100.490100.96
693976-93976101.803102.29
30min189955-8995597.44799.092.9998.0799.722.99
294305-94305102.159102.81
387465-8746594.75095.36
490051-9005197.55198.17
593040-93040100.789101.43
694029-94029101.860102.51
45min189829-8982997.31099.402.7198.10100.202.71
294584-94584102.461103.28
388981-8898196.39297.16
489800-8980097.27998.06
593379-93379101.156101.97
693953-93953101.778102.60
极限190228-9022897.74399.362.6698.69100.322.67
294458-94458102.325103.32
388663-8866396.04796.97
489915-8991597.40498.34
592895-92895100.632101.61
694179-94179102.023103.01
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.63100186100078100070101062996401002070.53
213.71997261004311000780.50
单位质量响应值RSD%判断
7351.947299.640.51数据可信
供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180376-8037671.12565.054.7671.1265.054.76
273541-7354165.07665.08
371993-7199363.70763.71
472891-7289164.50164.50
571227-7122763.02963.03
671046-7104662.86962.87
10min192688-9268882.02075.095.0182.1475.205.01
285829-8582975.95076.06
380887-8088771.57771.68
484898-8489875.12675.23
582001-8200172.56372.67
682854-8285473.31873.42
15min1100998-10099889.37380.476.1289.6380.706.11
292670-9267082.00482.24
387087-8708777.06377.29
491378-9137880.86081.09
586454-8645476.50376.73
687041-8704177.02377.25
20min1104211-10421192.21684.734.8192.6285.104.81
296794-9679485.65386.02
392878-9287882.18882.54
496064-9606485.00785.37
592830-9283082.14582.50
691722-9172281.16581.52
30min1107660-10766095.26889.954.1095.8390.464.11
2103274-10327491.38791.90
396725-9672585.59286.08
4104512-10451292.48392.99
598908-9890887.52488.01
698805-9880587.43387.92
45min1110449-11044997.73694.363.3198.4595.023.31
2108069-10806995.63096.30
3106664-10666494.38795.02
4109745-10974597.11397.78
5102903-10290391.05991.70
6101968-10196890.23290.87
极限1109431-10943196.83695.322.8997.7296.142.89
2108358-10835895.88696.71
3106940-10694094.63195.42
4112485-11248599.538100.36
5105435-10543593.29994.09
6103667-10366791.73592.52
比索洛尔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%
110.298467884965848468480084818848210.13
210.298461984691846550.07
单位质量响应值RSD%判断
8243.058226.920.14数据可信
供试品溶液-2024021621批-比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191910-91910100.24798.961.55100.2598.961.55
289215-8921597.30897.31
391754-91754100.077100.08
490432-9043298.63598.64
592101-92101100.456100.46
688972-8897297.04397.04
10min192510-92510100.90299.631.42101.0799.801.43
289732-8973297.87298.03
392193-92193100.556100.72
491142-9114299.41099.57
592604-92604101.004101.17
689894-8989498.04998.21
15min192506-92506100.89899.831.08101.23100.161.08
291066-9106699.32799.65
392046-92046100.396100.73
491072-9107299.33399.66
592450-92450100.836101.17
689999-8999998.16398.49
20min191538-9153899.84298.951.23100.3599.451.23
289456-8945697.57198.06
391742-91742100.064100.57
490574-9057498.79099.29
591672-9167299.988100.49
689324-8932497.42797.92
30min191474-9147499.77298.771.45100.4499.431.45
289061-8906197.14097.79
391610-9161099.920100.59
490383-9038398.58299.24
591867-91867100.201100.87
688928-8892896.99597.65
45min190826-9082699.06598.111.3599.9098.941.35
288632-8863296.67297.49
391077-9107799.339100.17
489712-8971297.85098.67
591030-9103099.288100.13
688430-8843096.45297.26
极限190217-9021798.40197.551.3299.4098.541.32
287928-8792895.90496.88
390498-9049898.70799.71
489074-8907497.15498.14
590645-9064598.86899.87
688276-8827696.28497.26
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.63100706100252993459996499498999530.56
213.719970799969998380.19
单位质量响应值RSD%判断
7333.317282.130.50数据可信
供试品溶液-2024021621批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103282-10328291.62089.683.4691.6289.683.46
2104511-10451192.71092.71
398570-9857087.44087.44
499698-9969888.44188.44
596091-9609185.24185.24
6104417-10441792.62792.63
10min1104938-10493893.08993.462.4693.2493.602.46
2109244-10924496.90997.06
3102723-10272391.12491.27
4102383-10238390.82390.97
5106688-10668894.64294.78
6106136-10613694.15294.31
15min1105697-10569793.76394.372.6994.0794.682.69
2108898-10889896.60296.92
3102386-10238690.82591.12
4103943-10394392.20792.51
5107829-10782995.65495.95
6109565-10956597.19497.51
20min1104509-10450992.70993.633.0093.1794.102.99
2110300-11030097.84698.32
3102274-10227490.72691.18
4102245-10224590.70091.15
5106561-10656194.52994.99
6107420-10742095.29195.76
30min1104060-10406092.31093.472.4992.9394.082.49
2109008-10900896.70097.34
3102977-10297791.35091.95
4102445-10244590.87891.48
5106246-10624694.25094.87
6107438-10743895.30795.94
45min1103159-10315991.51192.953.1092.2893.723.09
2108138-10813895.92896.73
3100455-10045589.11289.86
4102481-10248190.91091.66
5106066-10606694.09094.86
6108367-10836796.13196.92
极限1102884-10288491.26792.484.0292.1993.404.01
2107757-10775795.59096.55
398678-9867887.53688.44
4100560-10056089.20690.11
5106436-10643694.41895.35
6109168-10916896.84297.79
比索洛尔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%
110.298470884725847158475684857847520.08
210.298444584514844800.06
单位质量响应值RSD%判断
8236.358209.910.23数据可信
供试品溶液-2024021621批-比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187578-8757895.66097.251.7495.6697.241.74
289520-8952097.78297.78
388971-8897197.18297.18
491809-91809100.282100.28
587774-8777495.87495.87
688525-8852596.69596.69
10min187986-8798696.10698.251.8796.2798.411.87
290022-9002298.33098.49
390392-9039298.73498.90
492901-92901101.475101.64
588951-8895197.16097.32
689434-8943497.68897.85
15min188988-8898897.20197.901.8197.5298.221.81
289697-8969797.97598.30
390053-9005398.36498.69
492549-92549101.090101.43
588067-8806796.19596.52
688392-8839296.54996.87
20min187683-8768395.77597.381.8896.2697.871.88
289504-8950497.76498.25
389587-8958797.85598.35
492132-92132100.635101.14
587906-8790696.01996.50
688109-8810996.24096.73
30min186977-8697795.00496.922.0495.6597.582.03
289273-8927397.51298.16
389325-8932597.56998.22
491806-91806100.279100.95
587279-8727995.33495.98
687750-8775095.84896.49
45min186821-8682194.83496.631.8795.6397.441.87
288668-8866896.85197.67
388555-8855596.72897.54
491472-9147299.914100.75
587184-8718495.23096.03
688070-8807096.19897.00
极限186377-8637794.34995.941.6195.3196.921.61
288179-8817996.31797.29
387493-8749395.56896.54
490445-9044598.79299.80
587063-8706395.09896.06
687466-8746695.53896.50
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.6310069710062499843994041003431001820.55
213.711000861003961002410.22
单位质量响应值RSD%判断
7350.117311.520.38数据可信
供试品溶液-2024021621批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100995-10099589.30991.322.6689.3191.332.66
2103629-10362991.63891.64
3102473-10247390.61690.62
4100269-10026988.66788.67
5104361-10436192.28592.29
6107912-10791295.42595.43
10min1104743-10474392.62393.791.9492.7793.941.94
2105309-10530993.12493.28
3107357-10735794.93595.09
4102988-10298891.07191.22
5108250-10825095.72495.88
6107730-10773095.26495.42
15min1102670-10267090.79092.601.9191.0992.911.91
2104951-10495192.80793.11
3107782-10778295.31095.62
4103111-10311191.18091.48
5103537-10353791.55791.87
6106254-10625493.95994.28
20min1104275-10427592.20994.102.4092.6694.562.40
2104352-10435292.27792.74
3108523-10852395.96696.43
4103687-10368791.68992.14
5109121-10912196.49496.96
6108529-10852995.97196.45
30min1104579-10457992.47893.272.0393.0993.892.03
2103689-10368991.69192.31
3107274-10727494.86195.49
4102594-10259490.72391.33
5107744-10774495.27795.90
6106972-10697294.59495.23
45min1104098-10409892.05393.092.5592.8193.872.54
2102498-10249890.63891.41
3106859-10685994.49495.28
4102447-10244790.59391.35
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极限1101132-10113289.43092.002.7290.3592.932.71
2103420-10342091.45392.37
3105858-10585893.60994.55
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5107181-10718194.77995.72
6106214-10621493.92494.88
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