苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数2000
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%
114.394534804533284535554530954526654532250.08
214.354516824520654518740.06
单位质量响应值RSD%判断
31495.8331489.480.02数据可信
长期12月-供试品溶液-2024071721批-苯磺酸左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1380859-38085984.14376.2211.0584.1476.2211.05
2343662-34366275.92575.93
3280550-28055061.98261.98
4328756-32875672.63272.63
5352484-35248477.87477.87
6383806-38380684.79484.79
10min1422055-42205593.24493.320.8693.5093.550.87
2419219-41921992.61892.85
3420162-42016292.82693.01
4421877-42187793.20593.42
5421753-42175393.17893.41
6429399-42939994.86795.12
15min1424470-42447093.77894.150.6094.3194.660.61
2423719-42371993.61294.12
3425483-42548394.00294.47
4426830-42683094.29994.80
5425630-42563094.03494.55
6430884-43088495.19595.73
20min1424122-42412293.70194.310.6994.5195.100.70
2423875-42387593.64694.43
3427094-42709494.35895.10
4427620-42762094.47495.25
5426565-42656594.24195.04
6431978-43197895.43796.26
30min1426292-42629294.18094.400.7195.2795.470.71
2423254-42325493.50994.58
3427635-42763594.47795.51
4427425-42742594.43195.49
5426625-42662594.25495.33
6432472-43247295.54696.66
45min1424582-42458293.80394.290.8395.1895.650.82
2421770-42177093.18194.53
3428076-42807694.57595.89
4427561-42756194.46195.81
5426547-42654794.23795.60
6432180-43218095.48196.88
60min1424732-42473293.83694.100.6795.4995.740.67
2421613-42161393.14794.77
3426378-42637894.19995.80
4426507-42650794.22895.86
5426106-42610694.13995.78
6430277-43027795.06196.74
极限1424384-42438493.75994.020.8595.7095.940.86
2420216-42021692.83894.74
3426795-42679594.29296.17
4425351-42535193.97295.89
5425233-42523393.94695.87
6431357-43135795.29997.27
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.108513098506118509178506098495778506050.08
210.208473148476848474990.04
单位质量响应值RSD%判断
84218.3283088.140.96数据可信
长期12月-供试品溶液-2024071721批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145092-450925.34733.5080.805.3533.5080.80
2626387-62638774.28374.28
3283751-28375133.65033.65
476583-765839.0829.08
5192629-19262922.84422.84
6470340-47034055.77855.78
10min1824248-82424897.74898.060.4497.7698.160.46
2826305-82630597.99298.21
3829830-82983098.41098.51
4823316-82331697.63797.66
5832617-83261798.74098.81
6824854-82485497.82097.99
15min1833648-83364898.86298.790.8299.1799.180.77
2827771-82777198.16698.68
3829883-82988398.41698.81
4837322-83732299.29899.62
5843991-843991100.089100.45
6825580-82558097.90698.37
20min1830094-83009498.44198.520.8099.0599.210.75
2825858-82585897.93998.75
3828150-82815098.21098.90
4836363-83636399.18499.80
5840848-84084899.716100.38
6823379-82337997.64598.40
30min1829446-82944698.36498.180.7599.2799.170.69
2822393-82239397.52898.63
3825500-82550097.89698.88
4832530-83253098.73099.65
5836783-83678399.234100.20
6820849-82084997.34598.39
45min1824329-82432997.75797.890.8098.9599.170.75
2819413-81941397.17498.57
3823933-82393397.71098.99
4830035-83003598.43499.65
5836095-83609599.153100.41
6818895-81889597.11398.45
60min1823002-82300297.60097.550.8799.0999.130.81
2817360-81736096.93198.62
3819312-81931297.16298.74
4827626-82762698.14899.66
5833738-83373898.873100.43
6814596-81459696.60398.23
极限1819197-81919797.14997.230.7398.9399.100.68
2814126-81412696.54798.53
3817966-81796697.00398.87
4823214-82321497.62599.43
5830114-83011498.443100.30
6814806-81480696.62898.55
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数2000
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%
114.394508054508004509504511174510234509390.04
214.354532894530604531740.04
单位质量响应值RSD%判断
31336.9731580.070.55数据可信
长期12月-供试品溶液-2024071921批-苯磺酸左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1393514-39351487.03476.5613.0787.0376.5513.07
2392792-39279286.87586.87
3306614-30661467.81567.81
4354623-35462378.43378.43
5281594-28159462.28162.28
6347661-34766176.89376.89
10min1426314-42631494.28994.491.6394.5594.721.65
2432575-43257595.67495.93
3426326-42632694.29294.49
4425034-42503494.00694.24
5416398-41639892.09692.28
6436721-43672196.59196.82
15min1430465-43046595.20795.141.5795.7595.651.58
2426671-42667194.36894.92
3432203-43220395.59196.08
4429606-42960695.01795.53
5420711-42071193.05093.51
6441190-44119097.57998.10
20min1429690-42969095.03695.351.5595.8796.151.56
2435491-43549196.31997.15
3431761-43176195.49496.27
4426142-42614294.25195.05
5422488-42248893.44394.18
6441135-44113597.56798.38
30min1429568-42956895.00995.281.3996.1296.371.40
2434644-43464496.13197.25
3431850-43185095.51396.57
4427867-42786794.63295.72
5421753-42175393.28094.30
6439174-43917497.13398.24
45min1429394-42939494.97095.201.5396.3796.571.55
2435901-43590196.40997.82
3430538-43053895.22396.57
4427811-42781194.62095.99
5420107-42010792.91694.22
6438901-43890197.07398.47
60min1426419-42641994.31294.991.4896.0096.641.48
2432795-43279595.72297.42
3430656-43065695.24996.88
4426650-42665094.36396.02
5420985-42098593.11094.69
6439361-43936197.17498.86
极限1428239-42823994.71594.851.4096.6896.791.41
2432944-43294495.75597.74
3429286-42928694.94696.86
4425568-42556894.12496.06
5419919-41991992.87494.73
6437246-43724696.70798.69
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.108444468448818452588451948452088449970.05
210.208497918490868494380.06
单位质量响应值RSD%判断
83663.0783278.240.33数据可信
长期12月-供试品溶液-2024071921批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1351647-35164741.79136.9028.6641.7936.9028.66
2221529-22152926.32826.33
3439918-43991852.28252.28
4295835-29583535.15835.16
5350179-35017941.61741.62
6203616-20361624.19924.20
10min1795076-79507694.49196.321.7694.6296.431.76
2814879-81487996.84496.92
3829267-82926798.55498.71
4791925-79192594.11694.22
5815383-81538396.90497.03
6816197-81619797.00197.07
15min1803523-80352395.49597.211.5895.9097.611.58
2820919-82091997.56297.93
3834248-83424899.14699.60
4801532-80153295.25895.65
5821889-82188997.67798.09
6825711-82571198.13198.50
20min1799129-79912994.97296.871.7995.6797.561.79
2821906-82190697.67998.34
3830480-83048098.69899.45
4794729-79472994.44995.12
5821013-82101397.57398.28
6823353-82335397.85198.51
30min1798311-79831194.87596.641.5895.8697.621.58
2818289-81828997.24998.20
3828636-82863698.47999.53
4796723-79672394.68695.64
5817512-81751297.15798.16
6819478-81947897.39198.34
45min1795367-79536794.52596.311.5695.7997.581.55
2818361-81836197.25898.50
3824929-82492998.03999.38
4794692-79469294.44595.69
5812720-81272096.58897.88
6816425-81642597.02898.27
60min1788879-78887993.75495.961.7195.3097.531.71
2813436-81343696.67398.21
3823199-82319997.83399.47
4792004-79200494.12695.65
5812096-81209696.51398.10
6815272-81527296.89198.43
极限1791500-79150094.06695.701.5495.9097.551.54
2812829-81282996.60098.43
3817191-81719197.11999.05
4787780-78778093.62495.43
5811059-81105996.39098.26
6811257-81125796.41498.24
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数2000
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%
114.394481054495044492094492014491494490340.12
214.354508264506084507170.04
单位质量响应值RSD%判断
31204.5931408.850.47数据可信
长期12月-供试品溶液-2024072121批-苯磺酸左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1346813-34681377.07771.5113.8777.0871.5113.87
2275607-27560761.25261.25
3362938-36293880.66180.66
4273693-27369360.82760.83
5373109-37310982.92182.92
6298332-29833266.30266.30
10min1405992-40599290.22990.482.1390.4690.692.14
2405937-40593790.21790.40
3405665-40566590.15790.40
4392833-39283387.30587.49
5416997-41699792.67592.92
6415289-41528992.29592.49
15min1408178-40817890.71591.331.7991.2291.821.80
2409729-40972991.06091.51
3408337-40833790.75091.26
4400575-40057589.02589.47
5418912-41891293.10193.63
6419980-41998093.33893.81
20min1407647-40764790.59791.231.9491.3791.991.94
2409470-40947091.00291.73
3407903-40790390.65491.44
4398870-39887088.64689.36
5419929-41992993.32794.13
6419089-41908993.14093.90
30min1406943-40694390.44191.201.8191.4992.241.81
2408507-40850790.78891.79
3408337-40833790.75091.81
4400283-40028388.96089.94
5419261-41926193.17894.26
6418933-41893393.10594.14
45min1405379-40537990.09390.702.0091.4192.012.00
2407696-40769690.60891.88
3401192-40119289.16290.49
4398792-39879288.62989.87
5418205-41820592.94394.31
6417465-41746592.77994.09
60min1402946-40294689.55290.671.8091.1492.251.80
2406704-40670490.38791.93
3406707-40670790.38891.98
4398404-39840488.54390.05
5416747-41674792.61994.26
6416325-41632592.52694.12
极限1403109-40310989.58890.491.8691.4492.341.87
2405182-40518290.04991.87
3405090-40509090.02991.90
4397262-39726288.28990.06
5416759-41675992.62294.54
6415476-41547692.33794.21
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.108397328419248413698413558407658410290.10
210.208443088439798441440.03
单位质量响应值RSD%判断
83270.2082759.220.44数据可信
长期12月-供试品溶液-2024072121批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1280378-28037833.50527.78106.1433.5027.78106.14
29517-95171.1371.14
355390-553906.6196.62
4661758-66175879.07979.08
563888-638887.6347.63
6324140-32414038.73438.73
10min1794235-79423594.91095.191.3295.0195.281.34
2787407-78740794.09494.10
3798634-79863495.43595.46
4792389-79238994.68994.93
5790364-79036494.44794.47
6816558-81655897.57797.69
15min1802680-80268095.91996.291.2296.3096.661.23
2798537-79853795.42495.71
3813829-81382997.25197.56
4800145-80014595.61696.14
5797873-79787395.34495.65
6821843-82184398.20998.62
20min1799786-79978695.57395.881.2796.2596.541.26
2796897-79689795.22895.80
3810532-81053296.85797.45
4791499-79149994.58395.39
5796665-79666595.20095.79
6818639-81863997.82698.53
30min1796411-79641195.17095.571.2896.1396.511.27
2793359-79335994.80595.66
3808596-80859696.62697.51
4790200-79020094.42795.52
5793914-79391494.87195.75
6816007-81600797.51198.51
45min1794892-79489294.98895.341.2296.2396.581.21
2791411-79141194.57295.71
3805273-80527396.22997.41
4789028-78902894.28795.66
5792690-79269094.72595.89
6813888-81388897.25898.55
60min1788982-78898294.28294.971.3395.8196.491.32
2787665-78766594.12495.55
3804449-80444996.13097.60
4786433-78643393.97795.64
5789302-78930294.32095.77
6811477-81147796.97098.55
极限1788940-78894094.27794.761.3196.0996.561.30
2785344-78534493.84795.56
3802086-80208695.84897.60
4784259-78425993.71795.66
5787662-78766294.12495.85
6809620-80962096.74898.62
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数2000
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%
114.394515924528604514084513874512354516960.15
214.354502304504384503340.04
单位质量响应值RSD%判断
31389.5831382.160.02数据可信
中间条件12月-供试品溶液-2024071721批-苯磺酸左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1283528-28352862.85366.799.7662.8566.799.76
2305924-30592467.81867.82
3282214-28221462.56162.56
4266328-26632859.04059.04
5343188-34318876.07876.08
6326522-32652272.38472.38
10min1425763-42576394.38490.912.6794.5791.112.67
2406891-40689190.20090.40
3402714-40271489.27489.46
4395409-39540987.65587.83
5418403-41840392.75292.98
6411358-41135891.19091.41
15min1432510-43251095.87991.632.9096.3592.102.89
2412414-41241491.42491.90
3407804-40780490.40290.86
4399702-39970288.60689.05
5421802-42180293.50594.01
6405781-40578189.95490.44
20min1433991-43399196.20892.202.6796.9792.952.67
2413206-41320691.60092.35
3408384-40838490.53191.26
4402107-40210789.13989.85
5421807-42180793.50794.29
6415913-41591392.20092.96
30min1434238-43423896.26292.162.7197.3193.182.71
2413609-41360991.68992.71
3410317-41031790.95991.96
4403028-40302889.34490.32
5423364-42336493.85294.92
6409739-40973990.83191.87
45min1434585-43458596.33992.412.6497.6893.712.64
2414152-41415291.81093.11
3409385-40938590.75392.02
4403079-40307989.35590.60
5422824-42282493.73295.08
6417004-41700492.44293.75
60min1432757-43275795.93492.102.5397.5693.682.53
2412250-41225091.38892.96
3407924-40792490.42991.97
4403068-40306889.35390.86
5420769-42076993.27694.91
6415922-41592292.20293.79
极限1432880-43288095.96192.082.6897.8793.932.68
2412241-41224191.38693.23
3405841-40584189.96791.78
4402596-40259689.24891.03
5422022-42202293.55495.46
6416545-41654592.34094.20
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.108468608473838450758454538461958461930.12
210.208451688450328451000.02
单位质量响应值RSD%判断
83781.4982852.940.79数据可信
中间条件12月-供试品溶液-2024071721批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.00026.5496.840.0026.5496.85
2502439-50243959.82459.82
3450588-45058853.65053.65
4-0.0000.00
5163310-16331019.44519.44
6220885-22088526.30026.30
10min1819873-81987397.62097.831.4797.6297.911.52
2841374-841374100.180100.36
3817134-81713497.29397.45
4805292-80529295.88395.88
5827354-82735498.51098.57
6818784-81878497.49097.57
15min1834701-83470199.38598.811.2099.6899.181.22
2843835-843835100.473100.95
3822082-82208297.88398.34
4822250-82225097.90398.19
5836798-83679899.63599.99
6819573-81957397.58497.96
20min1833116-83311699.19698.651.0899.7999.321.10
2841007-841007100.136100.92
3817922-81792297.38798.13
4820362-82036297.67898.26
5833926-83392699.29399.95
6824700-82470098.19498.86
30min1830129-83012998.84198.351.0599.7399.311.07
2838593-83859399.849100.93
3815726-81572697.12698.16
4817874-81787497.38298.26
5830326-83032698.86499.81
6823364-82336498.03598.99
45min1827975-82797598.58498.061.0899.7799.321.10
2835899-83589999.528100.91
3812654-81265496.76098.09
4815051-81505197.04598.21
5828677-82867798.66899.92
6821109-82110997.76799.02
60min1824419-82441998.16197.691.1199.6499.251.13
2834058-83405899.309100.99
3809217-80921796.35197.97
4812856-81285696.78498.24
5824861-82486198.21499.76
6817538-81753897.34298.89
极限1822790-82279097.96797.451.2199.7499.301.22
2831988-83198899.062101.04
3805211-80521195.87497.78
4810733-81073396.53198.28
5824851-82485198.212100.05
6815175-81517597.06098.90
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数2000
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%
114.394480054494054492524489104493964489940.14
214.354503714497204500460.11
单位质量响应值RSD%判断
31201.8131362.090.37数据可信
中间条件12月-供试品溶液-2024071921批-苯磺酸左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1389039-38903986.53076.9810.7286.5376.9810.72
2333518-33351874.18174.18
3369783-36978382.24782.25
4347641-34764177.32277.32
5355632-35563279.09979.10
6281137-28113762.53062.53
10min1429928-42992895.62493.841.2495.8894.081.25
2419969-41996993.40993.63
3424594-42459494.43894.68
4414212-41421292.12992.36
5422042-42204293.87094.11
6420817-42081793.59893.79
15min1432784-43278496.25994.761.0096.8195.271.00
2424397-42439794.39494.90
3426818-42681894.93295.46
4419694-41969493.34893.86
5426164-42616494.78795.31
6426279-42627994.81295.28
20min1431600-43160095.99694.750.8896.8395.550.89
2424940-42494094.51595.30
3426917-42691794.95495.77
4420027-42002793.42294.21
5425521-42552194.64495.45
6426986-42698694.97095.72
30min1430043-43004395.65094.620.8696.7795.700.86
2425868-42586894.72195.79
3425907-42590794.73095.83
4418988-41898893.19194.26
5424838-42483894.49295.58
6426846-42684694.93995.98
45min1431774-43177496.03594.670.8897.4496.030.89
2424727-42472794.46795.82
3424998-42499894.52895.91
4420132-42013293.44594.79
5426233-42623394.80296.17
6425957-42595794.74196.06
60min1430997-43099795.86294.321.0197.5695.961.02
2422556-42255693.98495.62
3423308-42330894.15295.82
4417914-41791492.95294.58
5425524-42552494.64596.30
6423992-42399294.30495.91
极限1430121-43012195.66794.230.9997.6596.161.00
2423354-42335494.16296.08
3423154-42315494.11796.07
4417024-41702492.75494.66
5424609-42460994.44196.38
6423734-42373494.24696.14
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.108408598408158416068403098403188407810.07
210.208419518415898417700.04
单位质量响应值RSD%判断
83245.6482526.470.62数据可信
中间条件12月-供试品溶液-2024071921批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1495445-49544559.29725.9898.5359.3025.9898.53
299797-9979711.94411.94
361625-616257.3767.38
4476738-47673857.05857.06
5156887-15688718.77718.78
611708-117081.4011.40
10min1807307-80730796.62296.311.0596.8096.391.03
2805132-80513296.36296.40
3818124-81812497.91797.94
4792924-79292494.90195.07
5805654-80565496.42496.48
6799214-79921495.65495.66
15min1811689-81168997.14797.351.3697.6197.721.31
2815136-81513697.55997.88
3829860-82986099.32199.64
4795419-79541995.19995.66
5815814-81581497.64097.99
6812482-81248297.24297.53
20min1807548-80754896.65197.011.3797.4197.671.31
2813029-81302997.30797.92
3827307-82730799.01699.63
4792967-79296794.90695.65
5812383-81238397.23097.87
6810279-81027996.97897.56
30min1805387-80538796.39296.821.3797.4497.771.31
2812805-81280597.28098.19
3824748-82474898.71099.62
4790996-79099694.67095.70
5811760-81176097.15598.09
6807848-80784896.68797.56
45min1804762-80476296.31896.561.3097.6697.801.24
2808575-80857596.77497.98
3822597-82259798.45299.66
4790039-79003994.55695.87
5809024-80902496.82898.05
6805654-80565496.42497.59
60min1802503-80250396.04796.141.3097.6797.671.25
2804529-80452996.29097.78
3818920-81892098.01299.51
4786359-78635994.11595.71
5805801-80580196.44297.95
6801709-80170995.95297.41
极限1800435-80043595.80095.941.3197.7297.761.26
2804033-80403396.23098.01
3816690-81669097.74599.54
4784179-78417993.85495.73
5804266-80426696.25898.06
6799830-79983095.72797.47
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数2000
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%
114.394454634453924452574454454458394454790.05
214.354516004521744518870.09
单位质量响应值RSD%判断
30957.5431490.381.21数据可信
中间条件12月-供试品溶液-2024072121批-苯磺酸左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1290248-29024864.68168.2912.8964.6868.2912.89
2280884-28088462.59462.59
3250738-25073855.87655.88
4331300-33130073.82973.83
5358922-35892279.98579.98
6326491-32649172.75772.76
10min1406878-40687890.67191.772.2890.8791.982.30
2411273-41127391.65191.84
3395794-39579488.20188.37
4420541-42054193.71693.94
5418724-41872493.31193.55
6417629-41762993.06793.29
15min1410760-41076091.53792.642.1692.0093.122.18
2414282-41428292.32192.78
3400943-40094389.34989.78
4422488-42248894.15094.65
5420905-42090593.79794.32
6424811-42481194.66895.17
20min1411834-41183491.77692.662.1292.5293.422.14
2414443-41444392.35793.10
3400693-40069389.29389.99
4422894-42289494.24195.03
5422245-42224594.09694.90
6422710-42271094.20094.98
30min1410715-41071591.52692.612.1392.5493.652.15
2414505-41450592.37193.39
3400766-40076689.30990.28
4422685-42268594.19495.26
5421614-42161493.95595.04
6423256-42325694.32195.39
45min1409752-40975291.31291.444.5192.6092.764.49
2412384-41238491.89893.19
3374296-37429683.41184.65
4420853-42085393.78695.14
5421326-42132693.89195.26
6423424-42342494.35995.71
60min1409839-40983991.33192.342.0992.9093.932.12
2412929-41292992.02093.59
3399957-39995789.12990.62
4419674-41967493.52395.15
5421263-42126393.87795.52
6422587-42258794.17295.80
极限1407778-40777890.87292.132.2092.7193.992.23
2411664-41166491.73893.58
3398973-39897388.91090.66
4419591-41959193.50495.42
5419172-41917293.41195.34
6423333-42333394.33896.25
苯磺酸左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.108331968348058353518337518334038341010.12
210.208446268456598451420.09
单位质量响应值RSD%判断
82584.2682857.060.24数据可信
中间条件12月-供试品溶液-2024072121批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110652-106521.27718.20145.181.2818.20145.16
2274566-27456632.92732.93
3-0.0000.00
427934-279343.3503.35
547578-475785.7065.71
6549931-54993165.94965.95
10min1794372-79437295.26395.292.3595.2795.342.35
2778268-77826893.33193.43
3770777-77077792.43392.43
4802318-80231896.21696.23
5823402-82340298.74498.76
6798446-79844695.75195.95
15min1805035-80503596.54196.602.3496.8396.942.33
2784379-78437994.06494.44
3787963-78796394.49494.77
4814876-81487697.72298.02
5835996-835996100.254100.57
6804900-80490096.52597.01
20min1804705-80470596.50296.392.4297.0897.022.41
2781188-78118893.68294.34
3785173-78517394.16094.72
4814518-81451897.67998.27
5834079-834079100.024100.64
6803068-80306896.30697.08
30min1802045-80204596.18396.112.4197.0597.032.39
2781453-78145393.71394.66
3781501-78150193.71994.56
4812098-81209897.38898.27
5832142-83214299.792100.71
6799525-79952595.88196.94
45min1800150-80015095.95695.812.3497.1197.022.33
2778111-77811193.31394.54
3779873-77987393.52494.65
4808427-80842796.94898.13
5828173-82817399.316100.53
6798688-79868895.78097.13
60min1797898-79789895.68695.592.3797.1397.082.35
2776058-77605893.06694.57
3778966-77896693.41594.82
4806707-80670796.74298.21
5827302-82730299.212100.72
6795676-79567695.41997.06
极限1794183-79418395.24095.192.4596.9796.972.43
2771872-77187292.56494.35
3774250-77425092.85094.53
4804671-80467196.49898.26
5823843-82384398.797100.61
6793763-79376395.19097.11
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