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100546-202105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%
113.614235464219564230984230944229644229320.14
213.634222194221504221840.02
单位质量响应值RSD%判断
31075.0930974.610.23数据可信
供试品溶液-2024071721批-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%
5min1387926-38792687.71884.024.1087.7284.024.10
2378592-37859285.60785.61
3362150-36215081.88981.89
4355641-35564180.41880.42
5388313-38831387.80587.81
6356747-35674780.66880.67
10min1421212-42121295.24595.302.2295.5195.562.21
2422132-42213295.45395.71
3406590-40659091.93892.18
4434329-43432998.21198.45
5417442-41744294.39294.66
6427135-42713596.58496.83
15min1423193-42319395.69395.932.1596.2496.462.14
2425220-42522096.15196.69
3410584-41058492.84193.36
4436988-43698898.81299.35
5419174-41917494.78495.33
6430255-43025597.28997.82
20min1423558-42355895.77595.892.1896.6196.712.17
2425246-42524696.15796.99
3409655-40965592.63193.43
4437019-43701998.81999.65
5419583-41958394.87695.71
6429241-42924197.06097.88
30min1420210-42021095.01895.792.2796.1496.902.26
2424827-42482796.06297.18
3410116-41011692.73693.81
4437466-43746698.920100.05
5418686-41868694.67395.79
6430521-43052197.35098.46
45min1422969-42296995.64295.622.5397.0597.022.51
2424713-42471396.03697.44
3411601-41160193.07194.43
4437057-43705798.827100.25
5409763-40976392.65694.06
6431000-43100097.45898.86
60min1420148-42014895.00495.462.0596.7097.152.04
2423745-42374595.81797.51
3409013-40901392.48694.12
4432724-43272497.84899.57
5417558-41755894.41896.10
6429921-42992197.21498.91
极限1420331-42033195.04595.482.1597.0397.452.14
2421920-42192095.40597.39
3409376-40937692.56894.48
4435227-43522798.414100.43
5417317-41731794.36496.32
6429232-42923297.05899.05
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%
110.068404188412628413958412248407988410190.05
210.078403798400038401910.04
单位质量响应值RSD%判断
83600.3083435.050.14数据可信
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%
5min1427685-42768550.79971.7547.8350.8071.7547.83
2158015-15801518.76918.77
3839436-83943699.70699.71
4854727-854727101.522101.52
5499539-49953959.33459.33
6845055-845055100.373100.37
10min1848169-848169100.743100.861.57100.90101.081.65
2829592-82959298.53798.59
3862840-862840102.486102.78
4865354-865354102.784103.09
5843006-843006100.130100.31
6846204-846204100.510100.81
15min1849853-849853100.943100.831.35101.40101.351.42
2835202-83520299.20399.56
3861533-861533102.331102.94
4863136-863136102.521103.13
5842647-842647100.087100.57
6840950-84095099.886100.49
20min1847982-847982100.721100.571.30101.48101.391.38
2832248-83224898.85299.50
3858617-858617101.984102.90
4859974-859974102.145103.07
5840546-84054699.838100.62
6840771-84077199.865100.77
30min1841386-84138699.938100.111.30101.00101.231.38
2828924-82892498.45799.40
3853930-853930101.428102.65
4857629-857629101.867103.09
5836543-83654399.362100.44
6838647-83864799.612100.81
45min1841721-84172199.97799.721.53101.34101.141.60
2826292-82629298.14599.39
3852685-852685101.280102.80
4855092-855092101.566103.10
5824691-82469197.95599.33
6836579-83657999.367100.87
60min1838516-83851699.59799.511.20101.26101.241.28
2824576-82457697.94199.48
3849069-849069100.850102.68
4849747-849747100.931102.77
5831294-83129498.739100.41
6833677-83367799.022100.82
极限1835519-83551999.24199.221.19101.20101.241.27
2822586-82258697.70599.53
3845881-845881100.472102.60
4847937-847937100.716102.86
5829557-82955798.533100.50
6830436-83043698.637100.73
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100546-202105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%
113.614216994216854214274211324212384214360.07
213.634225034223754224390.03
单位质量响应值RSD%判断
30965.1730993.320.07数据可信
供试品溶液-2024071721批-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%
5min1314107-31410771.13077.4415.8471.1377.4415.83
2274755-27475562.21962.22
3391988-39198888.76788.77
4383964-38396486.95086.95
5394001-39400189.22389.22
6293114-29311466.37666.38
10min1418644-41864494.80395.611.8595.0295.851.87
2418892-41889294.85995.05
3430527-43052797.49497.76
4427739-42773996.86397.12
5427576-42757696.82697.09
6409960-40996092.83793.04
15min1422309-42230995.63396.421.9296.1396.941.94
2424045-42404596.02696.50
3435203-43520398.55399.11
4429509-42950997.26397.81
5431433-43143397.69998.26
6412294-41229493.36593.84
20min1421867-42186795.53396.361.8096.3297.171.82
2424066-42406696.03196.79
3435353-43535398.58799.44
4428464-42846497.02797.87
5430066-43006697.39098.24
6413286-41328693.59094.35
30min1419113-41911394.90996.321.7895.9897.421.80
2424745-42474596.18597.23
3435375-43537598.59299.74
4428795-42879597.10298.24
5429406-42940697.24098.38
6414555-41455593.87794.92
45min1419163-41916394.92196.211.6996.2897.591.72
2424734-42473496.18297.52
3434114-43411498.30699.75
4427895-42789596.89898.32
5428884-42888497.12298.56
6414229-41422993.80395.12
60min1415390-41539094.06695.901.9195.7197.581.93
2423481-42348195.89897.52
3433846-43384698.24699.99
4425972-42597296.46298.18
5429445-42944597.24998.98
6412923-41292393.50795.11
极限1415592-41559294.11295.801.7896.0397.771.81
2423232-42323295.84297.75
3431686-43168697.75699.79
4426540-42654096.59198.60
5428731-42873197.08799.11
6412631-41263193.44195.32
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%
110.068386928374668380108378388375908379190.06
210.078405778398358402060.07
单位质量响应值RSD%判断
83292.1583436.540.13数据可信
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%
5min1-0.00034.49113.640.0034.49113.64
2825085-82508598.18298.18
3220128-22012826.19426.19
446802-468025.5695.57
593603-9360311.13811.14
6553474-55347465.86165.86
10min1821624-82162497.77098.810.7997.7798.920.87
2835346-83534699.40399.70
3831470-83147098.94199.02
4822993-82299397.93397.95
5836798-83679899.57599.61
6834194-83419499.26699.46
15min1830221-83022198.79399.200.8199.0999.600.81
2833322-83332299.16299.75
3836735-83673599.56899.94
4825318-82531898.20998.52
5844922-844922100.542100.87
6831439-83143998.93899.43
20min1828873-82887398.63298.870.7699.2299.570.75
2828183-82818398.55099.44
3835412-83541299.411100.08
4822720-82272097.90098.51
5840613-840613100.029100.66
6829561-82956198.71499.51
30min1823467-82346797.98998.520.8298.8799.510.84
2826816-82681698.38899.57
3831361-83136198.92899.90
4818959-81895997.45398.35
5838640-83864099.795100.73
6828350-82835098.57099.66
45min1823239-82323997.96298.210.7799.1499.500.79
2825496-82549698.23199.71
3828732-82873298.61699.88
4815345-81534597.02398.21
5834522-83452299.305100.54
6824651-82465198.13099.51
60min1820609-82060997.64997.910.8899.1299.500.88
2821807-82180797.79299.57
3826187-82618798.31399.88
4811823-81182396.60498.09
5833733-83373399.211100.74
6822610-82261097.88799.57
极限1818451-81845197.39297.570.8299.1699.440.83
2818880-81888097.44399.51
3821549-82154997.76199.62
4810082-81008296.39698.17
5830965-83096598.881100.71
6819518-81951897.51999.49
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100546-202105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%
113.614196464200424192214188324185094192500.15
213.634253144232584242860.35
单位质量响应值RSD%判断
30804.5631128.830.75数据可信
供试品溶液-2024071921批-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%
5min1315142-31514271.39675.4210.6871.4075.4210.68
2312166-31216670.72170.72
3373764-37376484.67684.68
4369412-36941283.69083.69
5343638-34363877.85177.85
6283371-28337164.19864.20
10min1423557-42355795.95796.901.7596.1797.121.73
2428230-42823097.01697.23
3423153-42315395.86696.12
4418459-41845994.80295.05
5435310-43531098.62098.85
6437569-43756999.13299.32
15min1429831-42983197.37897.941.8497.8898.461.82
2433146-43314698.12998.63
3426586-42658696.64397.18
4421773-42177395.55396.09
5440945-44094599.896100.43
6441696-441696100.066100.56
20min1429545-42954597.31497.871.8898.1198.681.86
2432078-43207897.88898.69
3425915-42591596.49197.32
4421616-42161695.51796.34
5441313-44131399.980100.81
6441457-441457100.012100.80
30min1431115-43111597.66997.821.8998.7698.921.87
2428736-42873697.13098.22
3426066-42606696.52597.65
4421735-42173595.54496.65
5441471-441471100.016101.14
6441522-441522100.027101.12
45min1431689-43168997.79997.971.9899.1899.371.95
2432999-43299998.09699.48
3425775-42577596.46097.87
4420572-42057295.28196.68
5442522-442522100.254101.68
6441108-44110899.933101.32
60min1429817-42981797.37597.311.9999.0599.001.96
2428152-42815296.99898.68
3423282-42328295.89597.59
4417805-41780594.65496.34
5438140-43814099.261100.99
6439980-43998099.678101.37
极限1427928-42792896.94797.171.9698.9199.151.94
2428090-42809096.98498.95
3422878-42287895.80397.79
4417530-41753094.59296.56
5438372-43837299.313101.34
6438632-43863299.372101.36
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%
110.068349028358858340938339178347638347120.10
210.078418838417428418120.02
单位质量响应值RSD%判断
82973.3683596.030.53数据可信
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%
5min1800497-80049795.34864.1258.6295.3564.1258.62
265013-650137.7447.74
3622799-62279974.18274.18
4225566-22556626.86726.87
5800584-80058495.35995.36
6715490-71549085.22385.22
10min1827909-82790998.61397.861.4898.9098.051.55
2810970-81097096.59696.62
3814952-81495297.07097.29
4811576-81157696.66896.75
5821713-82171397.87598.16
6842398-842398100.339100.59
15min1827622-82762298.57997.981.1199.1698.471.17
2820154-82015497.69098.00
3815718-81571897.16197.67
4815493-81549397.13497.50
5817930-81793097.42598.00
6838872-83887299.919100.48
20min1824586-82458698.21797.611.1599.1098.391.20
2815785-81578597.16997.78
3811788-81178896.69397.50
4812257-81225796.74997.41
5816129-81612997.21098.08
6836163-83616399.596100.45
30min1821200-82120097.81497.261.1398.9998.341.18
2813262-81326296.86997.77
3807759-80775996.21397.31
4810477-81047796.53797.49
5813969-81396996.95398.12
6832865-83286599.204100.36
45min1818506-81850697.49397.081.1798.9698.441.22
2812297-81229796.75497.94
3806078-80607896.01397.40
4808232-80823296.26997.51
5812707-81270796.80298.26
6832386-83238699.146100.60
60min1818267-81826797.46596.761.3299.2298.411.38
2807640-80764096.19997.68
3803029-80302995.65097.32
4804340-80434095.80697.34
5809336-80933696.40198.15
6831238-83123899.010100.76
极限1812578-81257896.78796.471.1298.8498.411.17
2805383-80538395.93097.70
3802736-80273695.61597.57
4803796-80379695.74197.56
5808063-80806396.24998.28
6826785-82678598.479100.53
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100546-202105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%
113.614218844217164207044218744217684215890.12
213.634215104216744215920.03
单位质量响应值RSD%判断
30976.4130931.180.11数据可信
供试品溶液-2024071921批-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%
5min1371400-37140084.17469.6212.5484.1769.6212.54
2315364-31536471.47471.47
3310441-31044170.35870.36
4304071-30407168.91468.91
5253963-25396357.55857.56
6287884-28788465.24665.25
10min1424918-42491896.30397.341.9896.5697.551.98
2425805-42580596.50496.72
3443578-443578100.532100.74
4427928-42792896.98597.19
5419713-41971395.12395.30
6434930-43493098.57298.77
15min1429609-42960997.36698.241.8197.9198.741.80
2429283-42928397.29297.80
3446523-446523101.199101.71
4430482-43048297.56498.06
5425691-42569196.47896.94
6439258-43925899.553100.04
20min1429947-42994797.44398.551.8498.2899.351.84
2430676-43067697.60898.40
3448559-448559101.661102.48
4432204-43220497.95498.74
5427464-42746496.88097.63
6440159-44015999.757100.55
30min1429030-42903097.23598.442.0098.3699.531.99
2429504-42950497.34298.43
3449290-449290101.827102.95
4430127-43012797.48398.57
5427678-42767896.92897.97
6440503-44050399.835100.92
45min1425372-42537296.40698.542.1597.8299.922.14
2431133-43113397.71199.09
3449715-449715101.923103.35
4432364-43236497.99099.37
5427736-42773696.94298.27
6442298-442298100.242101.63
60min1414732-41473293.99497.302.4395.7098.982.41
2426124-42612496.57698.25
3445553-445553100.980102.71
4426708-42670896.70998.38
5426773-42677396.72398.34
6435928-43592898.798100.49
极限1406625-40662592.15797.073.0694.1599.053.02
2428849-42884997.19499.16
3444765-444765100.801102.84
4426740-42674096.71698.68
5424581-42458196.22798.14
6438243-43824399.323101.31
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%
110.068410128410518411118411318398818408370.07
210.078408938380818394870.24
单位质量响应值RSD%判断
83582.2183365.140.19数据可信
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%
5min158118-581186.90730.0899.976.9130.0899.97
285349-8534910.14310.14
3246388-24638829.28129.28
432455-324553.8573.86
5672868-67286879.96479.96
6423561-42356150.33650.34
10min1822175-82217597.70797.981.1997.7398.071.12
2825665-82566598.12298.15
3830314-83031498.67598.76
4833911-83391199.10299.11
5806319-80631995.82396.06
6828617-82861798.47398.62
15min1834006-83400699.11398.391.3599.4398.781.27
2830822-83082298.73599.06
3831637-83163798.83299.22
4838582-83858299.65799.97
5806845-80684595.88696.41
6825818-82581898.14098.59
20min1832188-83218898.89798.311.3499.5198.991.25
2829850-82985098.61999.24
3829291-82929198.55399.23
4839437-83943799.759100.37
5806632-80663295.86096.68
6826061-82606198.16998.91
30min1827369-82736998.32597.751.2799.2398.721.18
2824776-82477698.01698.93
3825714-82571498.12899.10
4832686-83268698.95699.86
5802568-80256895.37796.48
6822142-82214297.70398.74
45min1826834-82683498.26197.651.3999.4698.921.30
2823833-82383397.90499.12
3824455-82445597.97899.25
4834096-83409699.124100.33
5800429-80042995.12396.51
6820487-82048797.50798.84
60min1822148-82214897.70497.121.2499.2098.681.15
2819193-81919397.35398.86
3820669-82066997.52899.09
4828515-82851598.46199.96
5799078-79907894.96296.64
6813631-81363196.69298.31
极限1816436-81643697.02596.791.3598.8298.641.26
2820424-82042497.49999.30
3815838-81583896.95498.81
4825373-82537398.08799.88
5793519-79351994.30296.26
6815198-81519896.87898.79
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原始图谱下载图谱(谢超君 于 2024-08-09 14:39:41 完成)
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