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)0
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%
110.078385683843838148387183887838540.04
210.068362083663836420.04
单位质量响应值RSD%判断
8327.118314.310.11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%
5min188454-8845495.48491.424.1995.4891.424.19
288332-8833295.35295.35
380981-8098187.41787.42
480968-8096887.40387.40
582706-8270689.27989.28
686670-8667093.55893.56
10min193672-93672101.11796.933.65101.2897.093.65
293544-93544100.978101.14
387386-8738694.33194.48
485630-8563092.43592.58
588690-8869095.73995.89
689865-8986597.00797.16
15min194411-94411101.91497.903.29102.2498.223.29
293867-93867101.327101.65
389199-8919996.28896.59
486535-8653593.41293.71
589849-8984996.99097.30
690309-9030997.48697.80
20min194459-94459101.96698.083.14102.4698.553.14
293797-93797101.252101.75
389870-8987097.01297.48
486766-8676693.66294.12
589999-8999997.15297.62
690235-9023597.40697.89
30min194406-94406101.90998.122.91102.5898.762.91
293298-93298100.713101.38
390452-9045297.64198.27
486997-8699793.91194.52
589999-8999997.15297.78
690198-9019897.36798.01
45min193874-93874101.33597.842.74102.1798.642.74
292845-92845100.224101.06
390425-9042597.61298.40
486870-8687093.77494.54
589874-8987497.01797.81
689904-8990497.04997.85
极限193647-93647101.09097.332.85102.1098.292.86
292384-9238499.726100.73
389860-8986097.00297.95
486360-8636093.22494.15
589269-8926996.36497.32
689440-8944096.54897.51
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)0
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%
113.851045791043671047021050631044851046390.26
213.971041701048221044960.45
单位质量响应值RSD%判断
7555.167480.030.71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%
5min198414-9841484.86684.073.6484.8784.073.64
299698-9969885.97385.97
390844-9084478.33878.34
499997-9999786.23186.23
596241-9624182.99282.99
699729-9972986.00086.00
10min1107462-10746292.66891.593.2392.8191.733.23
2109725-10972594.62094.76
399871-9987186.12286.25
4108298-10829893.38993.53
5105681-10568191.13291.27
6106237-10623791.61291.76
15min1108858-10885893.87293.182.4194.1793.482.41
2111550-11155096.19396.49
3103639-10363989.37189.65
4108603-10860393.65293.95
5108586-10858693.63793.93
6107121-10712192.37492.67
20min1109923-10992394.79093.572.2795.2494.022.27
2111310-11131095.98696.45
3105064-10506490.60091.02
4110086-11008694.93195.39
5108604-10860493.65394.10
6106053-10605391.45391.90
30min1108239-10823993.33893.441.6993.9594.051.69
2110592-11059295.36795.99
3106387-10638791.74192.32
4110380-11038095.18495.80
5108138-10813893.25193.85
6106438-10643891.78592.39
45min1108063-10806393.18693.321.3093.9594.081.30
2108293-10829393.38594.16
3106640-10664091.95992.69
4110139-11013994.97795.75
5109419-10941994.35695.11
6106724-10672492.03292.79
极限1108623-10862393.66993.941.0694.5994.861.05
2109929-10992994.79595.73
3109378-10937894.32095.20
4110240-11024095.06495.99
5108344-10834493.42994.34
6107135-10713592.38693.29
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)0
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%
110.078391083968838068387383878838870.08
210.068353483400834670.12
单位质量响应值RSD%判断
8330.398296.920.29数据可信
供试品溶液-2024021621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%
5min193351-93351100.85696.932.44100.8696.932.44
287149-8714994.15594.16
391007-9100798.32498.32
489414-8941496.60396.60
589058-8905896.21896.22
688339-8833995.44195.44
10min193785-93785101.32598.012.11101.4998.172.11
288448-8844895.55995.72
391725-9172599.09999.26
490929-9092998.23998.40
590251-9025197.50797.67
689165-8916596.33396.49
15min194207-94207101.78197.972.29102.1298.292.29
288382-8838295.48895.80
391721-9172199.09599.42
490370-9037097.63597.96
590270-9027097.52797.85
689125-8912596.29096.61
20min193698-93698101.23197.842.08101.7498.322.09
288474-8847495.58796.06
391560-9156098.92199.42
490417-9041797.68698.17
590151-9015197.39997.88
689032-8903296.19096.67
30min193548-93548101.06997.492.25101.7498.142.25
287821-8782194.88195.52
391335-9133598.67899.34
490187-9018797.43898.09
589775-8977596.99397.64
688726-8872695.85996.50
45min193605-93605101.13097.462.22101.9798.282.22
288310-8831095.41096.20
391328-9132898.67099.49
490071-9007197.31298.13
589498-8949896.69397.50
688451-8845195.56296.36
极限193130-93130100.61797.182.06101.6398.162.06
287833-8783394.89495.85
390646-9064697.93498.92
489854-8985497.07898.05
589696-8969696.90797.88
688552-8855295.67196.63
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)0
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%
113.851042521042201037491041221042111041110.20
213.971038211036621037420.11
单位质量响应值RSD%判断
7517.047426.060.87数据可信
供试品溶液-2024021621批-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%
5min1106669-10666992.55291.011.3792.5591.011.37
2102855-10285589.24389.24
3104463-10446390.63890.64
4104397-10439790.58190.58
5104527-10452790.69490.69
6106450-10645092.36292.36
10min1112406-11240697.53096.271.2097.6896.421.20
2109437-10943794.95495.10
3111701-11170196.91897.07
4109656-10965695.14495.29
5110238-11023895.64995.80
6112256-11225697.40097.55
15min1112525-11252597.63396.231.1397.9596.541.12
2110582-11058295.94796.25
3110617-11061795.97896.29
4108818-10881894.41794.73
5111499-11149996.74397.05
6111374-11137496.63596.95
20min1112342-11234297.47496.031.1997.9596.501.19
2110936-11093696.25596.72
3110466-11046695.84796.32
4109113-10911394.67395.14
5109327-10932794.85895.33
6111876-11187697.07097.55
30min1112134-11213497.29495.781.1297.9496.411.12
2110291-11029195.69596.32
3110263-11026395.67196.30
4108312-10831293.97894.60
5110477-11047795.85696.49
6110841-11084196.17296.81
45min1112135-11213597.29595.850.9598.1096.640.95
2110189-11018995.60696.39
3110633-11063395.99296.78
4108963-10896394.54395.32
5110073-11007395.50696.30
6110813-11081396.14896.95
极限1111631-11163196.85896.131.1497.8297.081.13
2111645-11164596.87097.82
3109806-10980695.27496.23
4108721-10872194.33395.27
5111076-11107696.37697.32
6111846-11184697.04498.00
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)0
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%
110.078355883480834738346083475834890.05
210.068367883738837080.06
单位质量响应值RSD%判断
8290.868320.870.26数据可信
供试品溶液-2024021621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%
5min190162-9016297.50294.473.0597.5094.463.05
289395-8939596.67296.67
382663-8266389.39289.39
488238-8823895.42195.42
586877-8687793.94993.95
686796-8679693.86293.86
10min192874-92874100.43597.252.38100.6097.412.38
291688-9168899.15299.31
386877-8687793.94994.10
489996-8999697.32297.48
588685-8868595.90596.06
689469-8946996.75296.91
15min193505-93505101.11798.222.24101.4598.542.25
292890-92890100.452100.78
388182-8818295.36195.67
490425-9042597.78698.11
589404-8940496.68297.00
690560-9056097.93298.25
20min193931-93931101.57898.472.21102.0898.952.21
293051-93051100.626101.12
388702-8870295.92396.39
490382-9038297.74098.22
589766-8976697.07497.55
690512-9051297.88098.36
30min194096-94096101.75698.992.16102.4299.642.16
293828-93828101.466102.13
389231-8923196.49597.12
490923-9092398.32598.97
590333-9033397.68798.33
690816-9081698.20998.85
45min194325-94325102.00498.912.20102.8499.722.20
293532-93532101.146101.98
389276-8927696.54497.33
490581-9058197.95598.77
590064-9006497.39698.20
690997-9099798.40599.21
极限194110-94110101.77198.642.20102.7899.622.20
293222-93222100.811101.81
389121-8912196.37697.32
490411-9041197.77198.75
589671-8967196.97197.94
690746-9074698.13399.11
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)0
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%
113.851037371037781040451038111037591038260.13
213.971040091041031040560.07
单位质量响应值RSD%判断
7496.467448.530.46数据可信
供试品溶液-2024021621批-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%
5min159097-5909751.26852.415.3151.2752.415.30
256909-5690949.37049.37
359060-5906051.23651.24
466159-6615957.39557.39
561705-6170553.53153.53
659542-5954251.65451.65
10min176531-7653166.39367.644.6966.4867.734.69
275511-7551165.50865.59
377233-7723367.00267.09
485215-8521573.92674.02
577707-7770767.41367.50
675611-7561165.59465.68
15min181042-8104270.30673.373.7970.5073.573.79
282410-8241071.49371.68
384407-8440773.22573.42
490366-9036678.39578.61
585119-8511973.84374.04
684100-8410072.95973.15
20min184800-8480073.56675.883.5573.8876.203.55
284074-8407472.93673.25
386695-8669575.21075.53
492717-9271780.43480.78
588515-8851576.78977.11
687986-8798676.33076.65
30min186735-8673575.24578.003.8175.6878.453.81
287465-8746575.87876.31
389829-8982977.92978.37
496277-9627783.52384.01
590477-9047778.49178.94
688683-8868376.93577.38
45min188544-8854476.81479.723.3177.3880.303.32
288726-8872676.97277.53
392418-9241880.17580.75
496741-9674183.92584.55
592977-9297780.66081.24
691977-9197779.79280.36
极限1100721-10072187.37890.623.6588.0791.333.65
2100893-10089387.52788.21
3108819-10881994.40395.11
4109441-10944194.94395.71
5103372-10337289.67890.40
6103497-10349789.78690.49
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)0
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%
110.078378883878838048406483848838760.14
210.068369983828837640.11
单位质量响应值RSD%判断
8329.298326.440.03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%
5min192989-92989100.29397.763.78100.2997.763.78
291693-9169398.89598.90
387985-8798594.89694.90
491116-9111698.27398.27
594707-94707102.146102.15
685347-8534792.05192.05
10min192699-9269999.98098.033.45100.1598.203.45
291696-9169698.89899.06
387670-8767094.55694.71
491333-9133398.50798.67
595136-95136102.609102.78
686834-8683493.65593.81
15min194175-94175101.57298.753.99101.9199.083.99
292587-9258799.859100.19
388329-8832995.26795.58
492352-9235299.60699.93
595797-95797103.322103.66
686108-8610892.87293.18
20min192766-92766100.05398.213.81100.5698.703.81
291691-9169198.89399.39
388379-8837995.32195.80
492239-9223999.48499.98
595530-95530103.034103.55
685752-8575292.48892.95
30min192873-92873100.16898.083.66100.8498.743.66
291193-9119398.35699.02
387771-8777194.66595.30
491320-9132098.49399.15
595770-95770103.292103.98
686713-8671393.52494.14
45min192274-9227499.52297.703.53100.3698.523.54
291171-9117198.33299.16
387119-8711993.96294.75
491490-9149098.67699.50
594906-94906102.361103.22
686541-8654193.33994.11
极限192504-9250499.77097.463.70100.7798.443.70
290145-9014597.22698.21
387485-8748594.35795.30
491063-9106398.21699.20
595090-95090102.559103.59
685894-8589492.64193.57
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)0
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%
113.851041021040451044621040101043931042020.21
213.971038911035871037390.21
单位质量响应值RSD%判断
7523.617425.840.93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%
5min1109188-10918894.69894.642.1394.7094.642.13
2110642-11064295.95995.96
3111144-11114496.39596.39
4110754-11075496.05696.06
5107939-10793993.61593.61
6105072-10507291.12891.13
10min1110335-11033595.69396.391.6795.8596.551.67
2111664-11166496.84697.01
3111150-11115096.40096.56
4114518-11451899.32199.48
5109778-10977895.21095.37
6109408-10940894.88995.04
15min1112113-11211397.23596.922.3197.5597.242.31
2112151-11215197.26897.59
3111280-11128096.51396.83
4116113-116113100.704101.03
5110613-11061395.93496.25
6108244-10824493.87994.19
20min1111237-11123796.47596.902.2296.9597.382.22
2111623-11162396.81097.29
3112332-11233297.42597.91
4115923-115923100.539101.03
5110932-11093296.21196.69
6108283-10828393.91394.38
30min1111232-11123296.47196.511.6697.1197.151.66
2110945-11094596.22296.87
3110664-11066495.97896.62
4114840-11484099.600100.26
5110469-11046995.80996.44
6109484-10948494.95595.58
45min1110039-11003995.43696.122.1296.2496.922.12
2110452-11045295.79496.60
3110032-11003295.43096.23
4115518-115518100.188101.02
5109961-10996195.36996.16
6108975-10897594.51395.29
极限1109863-10986395.28482.0042.7096.2482.9642.22
2109884-10988495.30296.27
3110414-11041495.76196.73
4114692-11469299.472100.47
5110173-11017395.55296.51
612232-1223210.60911.55
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