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%
113.614225994214314224404227184214084221190.16
213.634219844217434218640.05
单位质量响应值RSD%判断
31015.3630951.140.15数据可信
供试品溶液-2024072121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%
5min1361427-36142781.83684.068.5381.8484.068.54
2400204-40020490.61690.62
3383238-38323886.77486.77
4409583-40958392.73992.74
5341366-34136677.29377.29
6331599-33159975.08275.08
10min1427409-42740996.77598.071.3397.0298.321.33
2432727-43272797.98098.25
3433188-43318898.08498.34
4436575-43657598.85199.13
5442136-442136100.110100.34
6426814-42681496.64196.87
15min1427053-42705396.69598.391.4597.2398.941.45
2433880-43388098.24198.81
3434817-43481798.45399.01
4439148-43914899.433100.01
5443739-443739100.473101.01
6428693-42869397.06697.58
20min1427879-42787996.88298.441.3597.7199.281.35
2433653-43365398.18999.05
3434955-43495598.48499.33
4438402-43840299.265100.14
5443941-443941100.519101.35
6429743-42974397.30498.11
30min1426587-42658796.58998.111.3897.7199.251.38
2432672-43267297.96799.12
3435116-43511698.52199.67
4436829-43682998.908100.08
5441859-441859100.047101.18
6426835-42683596.64697.74
45min1425045-42504596.24097.971.5297.6599.401.52
2429284-42928497.20098.65
3435301-43530198.562100.00
4436402-43640298.812100.28
5442601-442601100.215101.65
6427464-42746496.78898.18
60min1424427-42442796.10097.631.3097.8099.361.30
2429240-42924097.19098.93
3432606-43260697.95299.69
4434480-43448098.377100.14
5439732-43973299.566101.30
6426687-42668796.61298.29
极限1423496-42349695.88997.331.3597.8799.341.35
2428347-42834796.98899.02
3431403-43140397.68099.71
4431552-43155297.71499.77
5439514-43951499.516101.55
6424755-42475596.17598.14
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%
110.068412398394978414958418998390728406400.16
210.078419208422008420600.03
单位质量响应值RSD%判断
83562.6283620.660.05数据可信
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%
5min1548652-54865265.11038.6759.7065.1138.6759.70
2343045-34304540.71040.71
3207738-20773824.65324.65
4355062-35506242.13642.14
5488186-48818657.93457.93
612633-126331.4991.50
10min1835527-83552799.15498.341.1399.3598.461.16
2844482-844482100.217100.34
3821788-82178897.52397.60
4823849-82384997.76897.89
5824514-82451497.84798.02
6821869-82186997.53397.54
15min1835631-83563199.16698.821.0099.6699.231.00
2847950-847950100.628101.05
3828202-82820298.28598.65
4828680-82868098.34198.76
5824978-82497897.90298.37
6831002-83100298.61798.91
20min1832318-83231898.77398.481.0099.5699.181.01
2845404-845404100.326101.05
3824886-82488697.89198.55
4824946-82494697.89898.61
5823635-82363597.74398.50
6827701-82770198.22598.82
30min1828631-82863198.33598.070.9799.4299.080.98
2841683-84168399.884100.91
3822927-82292797.65998.61
4821069-82106997.43898.45
5820564-82056497.37898.43
6823712-82371297.75298.64
45min1824626-82462697.86097.740.9099.2499.040.91
2838072-83807299.456100.78
3820684-82068497.39298.64
4818984-81898497.19198.49
5818761-81876197.16498.51
6820526-82052697.37498.55
60min1823404-82340497.71597.510.9899.3999.100.99
2836900-83690099.317100.94
3818932-81893297.18498.72
4817265-81726596.98798.58
5814299-81429996.63598.27
6819205-81920597.21798.69
极限1822156-82215697.56797.060.9899.5498.940.99
2831987-83198798.734100.66
3813147-81314796.49898.33
4812408-81240896.41098.29
5811123-81112396.25898.19
6816294-81629496.87198.64
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%
113.614200124199734195384196804192734196950.08
213.634196094197904197000.04
单位质量响应值RSD%判断
30837.2530792.370.11数据可信
供试品溶液-2024072121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%
5min1384992-38499287.64886.804.3987.6586.804.39
2390163-39016388.82588.82
3378929-37892986.26786.27
4403489-40348991.85991.86
5353205-35320580.41180.41
6376880-37688085.80185.80
10min1429625-42962597.80997.111.0698.0797.361.05
2423238-42323896.35596.62
3432336-43233698.42698.68
4424844-42484496.72097.00
5428891-42889197.64297.88
6420278-42027895.68195.94
15min1430620-43062098.03598.180.8798.5998.730.87
2425566-42556696.88597.44
3435935-43593599.24599.80
4433651-43365198.72599.29
5432927-43292798.56199.09
6428722-42872297.60398.15
20min1428711-42871197.60198.141.1098.4598.981.09
2423361-42336196.38397.23
3434553-43455398.93199.78
4432781-43278198.52799.39
5436656-43665699.410100.24
6430357-43035797.97698.81
30min1429289-42928997.73298.280.9198.8899.430.90
2425318-42531896.82897.96
3434137-43413798.83699.98
4433402-43340298.66999.83
5436294-43629499.327100.46
6431844-43184498.31499.45
45min1427544-42754497.33597.840.9198.7799.280.90
2424430-42443096.62698.05
3432344-43234498.42899.87
4430001-43000197.89599.35
5435633-43563399.177100.60
6428659-42865997.58999.02
60min1423665-42366596.45297.371.1298.1899.101.11
2420814-42081495.80397.52
3431908-43190898.329100.07
4431079-43107998.14099.89
5432082-43208298.368100.09
6426712-42671297.14698.86
极限1424141-42414196.56097.000.8298.5899.020.82
2420999-42099995.84597.85
3430597-43059798.030100.07
4424943-42494396.74398.78
5429173-42917397.70699.72
6426451-42645197.08699.10
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%
110.068402558398088386848403928400188398310.09
210.078385828372388379100.12
单位质量响应值RSD%判断
83482.2183208.540.24数据可信
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%
5min1768782-76878291.50360.1230.3391.5060.1230.33
2517391-51739161.58161.58
3364192-36419243.34743.35
4561197-56119766.79566.80
5353064-35306442.02342.02
6466021-46602155.46755.47
10min1819854-81985497.58297.731.0097.8697.911.01
2814798-81479896.98097.16
3823509-82350998.01798.15
4836267-83626799.53599.74
5814726-81472696.97197.10
6817352-81735297.28497.45
15min1820289-82028997.63398.150.7998.2098.620.78
2818089-81808997.37297.85
3829163-82916398.69099.11
4833401-83340199.19499.69
5818434-81843497.41397.83
6828172-82817298.57299.03
20min1818248-81824897.39097.750.8598.2598.520.85
2812626-81262696.72197.49
3824366-82436698.11998.84
4833192-83319299.16999.97
5820095-82009597.61098.32
6819150-81915097.49898.25
30min1815167-81516797.02497.750.7398.1898.820.72
2816276-81627697.15698.21
3823623-82362398.03099.04
4831095-83109598.920100.01
5818321-81832197.39998.40
6823360-82336097.99999.05
45min1812283-81228396.68097.280.7598.1298.630.75
2813048-81304896.77298.12
3820173-82017397.62098.93
4828416-82841698.60199.99
5815964-81596497.11998.41
6814014-81401496.88698.23
60min1807909-80790996.16096.860.9297.8998.500.91
2807014-80701496.05397.69
3819025-81902597.48399.08
4826076-82607698.322100.01
5809267-80926796.32197.91
6813452-81345296.82098.45
极限1806143-80614395.95096.410.7097.9798.350.69
2805845-80584595.91497.84
3815051-81505197.01098.90
4817799-81779997.33799.32
5803920-80392095.68597.56
6811378-81137896.57398.49
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