苯磺酸左氨氯地平缬沙坦片项目信息
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4000
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%
113.991193551188311192091190441191971191270.17
213.961199551197311198430.14
单位质量响应值RSD%判断
8515.158584.740.58数据可信
加速6月-供试品溶液-2024081921批-苯磺酸左氨氯地平-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%
5min166678-6667849.24048.413.0249.2448.413.01
265798-6579848.59048.59
366864-6686449.37749.38
464609-6460947.71247.71
567316-6731649.71149.71
662027-6202745.80545.81
10min1102012-10201275.33373.752.8575.4273.842.85
2101931-10193175.27375.35
399271-9927173.30973.39
497749-9774972.18572.26
5102717-10271775.85475.94
695569-9556970.57570.65
15min1116148-11614885.77283.402.1285.9883.602.12
2112292-11229282.92583.13
3113947-11394784.14784.35
4110902-11090281.89882.10
5114530-11453084.57784.79
6109776-10977681.06781.26
20min1122229-12222990.26387.801.8390.6188.141.83
2119752-11975288.43488.78
3119352-11935288.13888.48
4117120-11712086.49086.83
5118871-11887187.78388.13
6116021-11602185.67886.01
30min1121706-12170689.87789.972.1690.3890.462.16
2122299-12229990.31490.81
3120697-12069789.13189.62
4122168-12216890.21890.70
5126095-12609593.11893.61
6118001-11800187.14087.61
45min1123705-12370591.35390.592.7392.0091.222.72
2119870-11987088.52189.16
3126452-12645293.38194.02
4122954-12295490.79891.43
5125382-12538292.59193.24
6117658-11765886.88787.50
60min1125080-12508092.36890.932.2893.1791.722.27
2119922-11992288.55989.35
3125079-12507992.36793.16
4121177-12117789.48690.27
5126662-12666293.53694.34
6120903-12090389.28490.05
极限1133784-13378498.79694.092.8399.7595.032.82
2124667-12466792.06393.00
3125392-12539292.59993.55
4127923-12792394.46895.40
5128607-12860794.97395.93
6124083-12408391.63292.54
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.974711322471520447163774716398471486647148330.05
215.974761171476298847620800.03
单位质量响应值RSD%判断
295230.62298189.100.71数据可信
加速6月-供试品溶液-2024081921批-缬沙坦-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%
5min14548993-454899385.46583.402.3385.4783.402.33
24473747-447374784.05284.05
34422713-442271383.09383.09
44423174-442317483.10283.10
54510528-451052884.74384.74
64253708-425370879.91879.92
10min15255528-525552898.74097.101.5798.8897.241.57
25192206-519220697.55097.69
35127516-512751696.33596.47
45162132-516213296.98597.12
55237674-523767498.40498.55
65034088-503408894.57994.71
15min15351963-5351963100.55199.141.54100.8699.441.54
25288628-528862899.36199.66
35264035-526403598.89999.20
45284283-528428399.28099.58
55343575-5343575100.394100.70
65127752-512775296.33996.63
20min15360421-5360421100.71099.491.37101.1899.951.37
25306628-530662899.700100.17
35283235-528323599.26099.72
45304961-530496199.668100.13
55354925-5354925100.607101.08
65161864-516186496.98097.43
30min15355516-5355516100.61899.391.35101.26100.021.35
25301340-530134099.600100.23
35267892-526789298.97299.60
45305191-530519199.673100.30
55350618-5350618100.526101.17
65161712-516171296.97797.59
45min15348681-5348681100.49099.291.35101.30100.091.35
25298318-529831899.544100.34
35274044-527404499.08799.88
45301811-530181199.609100.41
55336268-5336268100.257101.06
65150590-515059096.76897.54
60min15343827-5343827100.39999.161.20101.38100.131.20
25297968-529796899.537100.50
35258384-525838498.79399.75
45291373-529137399.413100.38
55314004-531400499.838100.81
65162911-516291197.00097.94
极限15340865-5340865100.34399.161.44101.49100.281.44
25289657-528965799.381100.51
35265915-526591598.935100.06
45283414-528341499.264100.39
55347472-5347472100.467101.61
65138595-513859596.54397.64
苯磺酸左氨氯地平缬沙坦片项目信息
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4000
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%
113.991174791183271185531181191180191180990.35
213.961191801191831191820.01
单位质量响应值RSD%判断
8441.678537.390.80数据可信
加速6月-供试品溶液-2024082021批-苯磺酸左氨氯地平-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%
5min163416-6341647.16547.135.0147.1647.135.01
269044-6904451.35151.35
360819-6081945.23345.23
463548-6354847.26347.26
563410-6341047.16047.16
659967-5996744.60044.60
10min1100239-10023974.55272.023.0274.6372.103.02
299011-9901173.63873.72
393368-9336869.44169.52
497623-9762372.60672.68
597585-9758572.57872.66
693200-9320069.31669.39
15min1114037-11403784.81483.391.7285.0283.591.72
2113398-11339884.33984.55
3109807-10980781.66881.86
4111833-11183383.17583.37
5113790-11379084.63084.83
6109888-10988881.72881.92
20min1123536-12353691.87987.752.6592.2288.082.64
2115303-11530385.75586.10
3116999-11699987.01787.34
4118641-11864188.23888.58
5118420-11842088.07488.41
6114984-11498485.51885.84
30min1124753-12475392.78491.081.8393.2891.571.83
2124094-12409492.29492.79
3120144-12014489.35689.83
4124596-12459692.66793.15
5121011-12101190.00190.49
6120196-12019689.39489.86
45min1123171-12317191.60791.751.1092.2692.381.10
2124196-12419692.36993.02
3121608-12160890.44591.07
4124412-12441292.53093.17
5124834-12483492.84493.48
6121929-12192990.68391.30
60min1125057-12505793.01091.692.3993.8192.472.38
2126140-12614093.81594.61
3118778-11877888.34089.11
4122408-12240891.04091.83
5125936-12593693.66494.46
6121339-12133990.24591.01
极限1125537-12553793.36794.011.5794.3394.951.56
2127811-12781195.05896.01
3124397-12439792.51993.44
4127692-12769294.97095.92
5128827-12882795.81496.76
6124111-12411192.30693.23
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.974694361470442147161214701250470207747036460.17
215.974747467475015247488100.04
单位质量响应值RSD%判断
294530.12297358.170.68数据可信
加速6月-供试品溶液-2024082021批-缬沙坦-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%
5min14331745-433174581.59480.602.0781.5980.602.07
24386597-438659782.62782.63
34147361-414736178.12178.12
44284279-428427980.70080.70
54319594-431959481.36581.37
64204197-420419779.19279.19
10min15161929-516192997.23296.131.3297.3796.261.32
25124770-512477096.53296.67
35003547-500354794.24894.38
45111044-511104496.27396.41
55174333-517433397.46597.60
65044129-504412995.01395.14
15min15291350-529135099.67098.691.2499.9798.991.24
25247360-524736098.84199.14
35154983-515498397.10197.39
45251737-525173798.92399.22
55318996-5318996100.190100.49
65172810-517281097.43797.73
20min15306726-530672699.95998.951.27100.4299.411.27
25260941-526094199.09799.56
35166030-516603097.30997.76
45266101-526610199.19499.65
55333909-5333909100.471100.94
65184540-518454097.65898.11
30min15306073-530607399.94798.821.41100.5899.441.41
25261920-526192099.11599.74
35150158-515015897.01097.62
45266968-526696899.21099.84
55329130-5329130100.381101.01
65163355-516335597.25997.87
45min15282441-528244199.50298.701.17100.3099.491.17
25255594-525559498.99699.79
35155715-515571597.11597.89
45254896-525489698.98399.77
55313432-5313432100.086100.89
65178181-517818197.53898.32
60min15280227-528022799.46098.511.25100.4299.461.25
25237753-523775398.66099.62
35150044-515004497.00897.94
45249973-524997398.89099.85
55306666-530666699.958100.92
65153534-515353497.07498.01
极限15265075-526507599.17598.461.16100.3099.571.16
25232865-523286598.56899.69
35140791-514079196.83497.93
45246340-524634098.82299.94
55304257-530425799.913101.05
65171883-517188397.41998.52
苯磺酸左氨氯地平缬沙坦片项目信息
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4000
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%
113.991188181187471185541188621186261187210.11
213.961192941192371192660.04
单位质量响应值RSD%判断
8486.138543.410.48数据可信
加速6月-供试品溶液-2024082121批-苯磺酸左氨氯地平-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%
5min168649-6864950.90548.534.6050.9048.524.60
266349-6634949.19949.20
366468-6646849.28749.29
466117-6611749.02749.03
559728-5972844.28944.29
665331-6533148.44448.44
10min1100093-10009374.22172.482.2774.3172.562.27
2100564-10056474.57074.65
398195-9819572.81472.90
496366-9636671.45771.54
595674-9567470.94471.02
695594-9559470.88570.97
15min1113308-11330884.02082.701.7984.2382.901.79
2113009-11300983.79884.00
3113258-11325883.98384.19
4109828-10982881.44081.64
5111146-11114682.41782.61
6108613-10861380.53980.74
20min1118506-11850687.87586.412.4688.2286.742.46
2119592-11959288.68089.03
3117129-11712986.85387.20
4111726-11172682.84783.18
5117480-11748087.11487.44
6114723-11472385.06985.40
30min1120916-12091689.66289.701.2490.1690.181.24
2122529-12252990.85891.35
3121268-12126889.92390.41
4119339-11933988.49288.97
5122590-12259090.90391.38
6119140-11914088.34588.82
45min1117796-11779687.34889.792.1987.9990.432.18
2121319-12131989.96090.61
3124459-12445992.28992.93
4118248-11824887.68388.31
5123237-12323791.38392.01
6121500-12150090.09590.72
60min1122953-12295391.17291.551.5091.9692.341.50
2124189-12418992.08992.88
3125447-12544793.02193.81
4121229-12122989.89490.66
5125420-12542093.00193.78
6121571-12157190.14790.92
极限1125984-12598493.42092.852.2694.3693.792.24
2125289-12528992.90493.85
3126636-12663693.90394.85
4126016-12601693.44394.36
5127689-12768994.68495.62
6119699-11969988.75989.68
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.974746387472986647339204731764472703947337950.16
215.974759228475748047583540.03
单位质量响应值RSD%判断
296417.97297955.790.37数据可信
加速6月-供试品溶液-2024082121批-缬沙坦-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%
5min14598955-459895586.26484.381.4286.2684.381.42
24549014-454901485.32785.33
34477148-447714883.97983.98
44458838-445883883.63683.64
54478519-447851984.00584.00
64427100-442710083.04083.04
10min15214837-521483797.81696.941.0097.9697.081.00
25218266-521826697.88098.02
35170530-517053096.98597.12
45123009-512300996.09496.23
55190538-519053897.36097.50
65090891-509089195.49195.63
15min15296179-529617999.34298.640.9799.6598.940.96
25284875-528487599.13099.44
35267263-526726398.79999.10
45186695-518669597.28897.59
55310366-531036699.60899.91
65206474-520647497.65997.96
20min15304913-530491399.50699.060.9999.9899.520.99
25321987-532198799.826100.30
35292168-529216899.26799.73
45208066-520806697.68998.15
55333115-5333115100.035100.50
65225051-522505198.00898.47
30min15303753-530375399.48499.101.07100.1299.731.07
25322360-532236099.833100.47
35298575-529857599.387100.02
45216158-521615897.84198.47
55347032-5347032100.296100.93
65212112-521211297.76598.39
45min15298724-529872499.39098.911.21100.1999.701.20
25322432-532243299.834100.64
35300627-530062799.425100.22
45192653-519265397.40098.19
55330624-533062499.988100.79
65192644-519264497.40098.19
60min15286767-528676799.16598.921.04100.1399.881.03
25309955-530995599.600100.57
35270055-527005598.85299.81
45208616-520861697.69998.65
55349371-5349371100.340101.31
65216350-521635097.84498.79
极限15300246-530024699.41898.911.01100.55100.041.01
25299188-529918899.398100.53
35278162-527816299.004100.13
45218629-521862997.88799.00
55341319-5341319100.189101.32
65202913-520291397.59298.70
苯磺酸左氨氯地平缬沙坦片项目信息
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4000
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%
113.991196911195101197601192121195811195510.18
213.961192041192181192110.01
单位质量响应值RSD%判断
8545.468539.470.05数据可信
加速6月-供试品溶液-2024081921批-苯磺酸左氨氯地平-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%
5min164777-6477747.87746.463.2347.8846.463.24
263245-6324546.74546.74
361316-6131645.31945.32
465239-6523948.21948.22
559912-5991244.28144.28
662650-6265046.30546.31
10min1102187-10218775.52772.933.3375.6173.013.33
2100108-10010873.99174.07
3100298-10029874.13174.21
4100333-10033374.15774.24
594123-9412369.56769.64
695010-9501070.22370.30
15min1116738-11673886.28284.302.5186.4984.502.51
2115553-11555385.40685.61
3116751-11675186.29286.49
4111443-11144382.36882.57
5109907-10990781.23381.42
6113987-11398784.24984.44
20min1123334-12333491.15788.502.5491.5188.842.54
2121648-12164889.91190.25
3118802-11880287.80788.15
4121549-12154989.83890.18
5114949-11494984.96085.28
6118168-11816887.33987.67
30min1125388-12538892.67590.732.9093.1891.212.89
2124597-12459792.09192.58
3125120-12512092.47792.97
4123715-12371591.43991.93
5116061-11606185.78286.25
6121619-12161989.88990.37
45min1125656-12565692.87391.042.2193.5391.682.21
2125225-12522592.55593.20
3123476-12347691.26291.91
4123657-12365791.39692.04
5118078-11807887.27287.88
6122927-12292790.85691.49
60min1127470-12747094.21491.452.4595.0292.242.44
2122146-12214690.27991.08
3126881-12688193.77994.57
4124364-12436491.91892.71
5120057-12005788.73589.49
6121436-12143689.75490.54
极限1128863-12886395.24494.121.8696.2195.071.85
2131118-13111896.91097.86
3125313-12531392.62093.57
4125543-12554392.79093.74
5125387-12538792.67493.58
6127866-12786694.50795.44
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.974629621463340646335654632120462665846310740.07
215.974637773463361246356920.07
单位质量响应值RSD%判断
289985.85290275.020.08数据可信
加速6月-供试品溶液-2024081921批-缬沙坦-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%
5min14425614-442561485.03182.773.2585.0382.773.24
24414289-441428984.81384.81
34310426-431042682.81882.82
44402725-440272584.59184.59
54070975-407097578.21778.22
64223505-422350581.14881.15
10min15140685-514068598.77096.302.7598.9196.442.75
25084143-508414397.68397.82
35029460-502946096.63396.77
45100934-510093498.00698.15
54764709-476470991.54691.68
64952335-495233595.15195.29
15min15247134-5247134100.81598.502.58101.1298.802.58
25194904-519490499.811100.12
35133946-513394698.64098.94
45216083-5216083100.218100.52
54885843-488584393.87394.16
65082235-508223597.64797.94
20min15260500-5260500101.07298.882.47101.5599.342.47
25211854-5211854100.137100.61
35153480-515348099.01699.48
45235960-5235960100.600101.07
54916410-491641094.46194.90
65099936-509993697.98798.44
30min15253794-5253794100.94398.862.29101.5999.492.29
25206660-5206660100.037100.67
35146520-514652098.88299.51
45227453-5227453100.437101.08
54933235-493323594.78495.38
65104472-510447298.07498.69
45min15246917-5246917100.81198.832.13101.6299.622.14
25198008-519800899.871100.68
35138390-513839098.72699.52
45223400-5223400100.359101.17
54946895-494689595.04695.80
65108262-510826298.14798.93
60min15246881-5246881100.81098.792.10101.7999.752.11
25197448-519744899.860100.83
35136687-513668798.69399.65
45218637-5218637100.267101.24
54951040-495104095.12696.04
65099588-509958897.98098.93
极限15244985-5244985100.77499.371.24101.92100.501.25
25218040-5218040100.256101.39
35135881-513588198.67799.80
45217443-5217443100.245101.39
55081579-508157997.63498.71
65135033-513503398.66199.77
苯磺酸左氨氯地平缬沙坦片项目信息
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4000
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%
113.991197661196221195971197551195721196620.08
213.961192231193931193080.11
单位质量响应值RSD%判断
8553.408546.420.06数据可信
加速6月-供试品溶液-2024082021批-苯磺酸左氨氯地平-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%
5min163342-6334246.77646.204.8546.7846.204.85
264602-6460247.70647.71
363403-6340346.82146.82
458905-5890543.49943.50
558879-5887943.48043.48
666232-6623248.91048.91
10min198216-9821672.52972.501.9372.6172.581.93
298277-9827772.57472.65
399305-9930573.33373.41
494769-9476969.98370.06
598088-9808872.43472.51
6100402-10040274.14374.22
15min1114495-11449584.55084.671.8784.7584.861.87
2114836-11483684.80285.00
3116921-11692186.34286.54
4111345-11134582.22482.41
5113391-11339183.73583.93
6116918-11691886.34086.54
20min1121361-12136189.62189.191.0889.9689.531.08
2120470-12047088.96389.30
3122487-12248790.45290.80
4119341-11934188.12988.46
5119331-11933188.12288.45
6121712-12171289.88090.23
30min1125704-12570492.82892.132.3393.3292.622.32
2120202-12020288.76589.25
3123230-12323091.00191.50
4126632-12663293.51393.99
5124227-12422791.73792.22
6128558-12855894.93595.43
45min1125657-12565792.79393.521.7393.4494.161.72
2125627-12562792.77193.41
3130668-13066896.49497.14
4124997-12499792.30692.93
5125258-12525892.49993.13
6127633-12763394.25294.91
60min1126982-12698293.77293.752.0194.5794.552.00
2124531-12453191.96292.75
3131119-13111996.82797.63
4125753-12575392.86493.65
5124735-12473592.11292.90
6128598-12859894.96595.78
极限1130416-13041696.30895.061.1297.2696.021.12
2126582-12658293.47694.42
3130225-13022596.16697.14
4127982-12798294.51095.45
5128486-12848694.88295.82
6128700-12870095.04096.01
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.974640879463861446431394641608464238246413240.04
215.974640428464213246412800.03
单位质量响应值RSD%判断
290627.68290624.920.01数据可信
加速6月-供试品溶液-2024082021批-缬沙坦-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%
5min14227470-422747081.08580.592.4481.0980.592.45
24270100-427010081.90381.90
34228056-422805681.09681.10
44023042-402304277.16477.16
54150616-415061679.61179.61
64311145-431114582.69082.69
10min15049365-504936596.85096.501.2096.9896.641.20
25028394-502839496.44796.58
35062631-506263197.10497.24
44946488-494648894.87695.01
54983987-498398795.59695.73
65116484-511648498.13798.27
15min15191933-519193399.58499.281.0799.8899.581.07
25148837-514883798.75899.05
35209511-520951199.921100.22
45115418-511541898.11798.40
55130066-513006698.39898.69
65260852-5260852100.906101.21
20min15201444-520144499.76799.571.02100.23100.031.02
25155013-515501398.87699.34
35223962-5223962100.199100.66
45143994-514399498.66599.11
55147142-514714298.72599.18
65276418-5276418101.205101.67
30min15204371-520437199.82399.581.05100.45100.211.05
25153171-515317198.84199.47
35227477-5227477100.266100.90
45144619-514461998.67799.29
55144894-514489498.68299.30
65277254-5277254101.221101.86
45min15190121-519012199.54999.360.98100.34100.150.98
25146200-514620098.70799.50
35217349-5217349100.072100.87
45135704-513570498.50699.28
55135280-513528098.49899.28
65257741-5257741100.846101.65
60min15179501-517950199.34699.201.00100.31100.161.00
25139227-513922798.57399.53
35203398-520339899.804100.77
45126271-512627198.32599.27
55126513-512651398.32999.28
65255819-5255819100.810101.78
极限15178827-517882799.33399.130.94100.46100.250.94
25130731-513073198.41099.53
35200680-520068099.752100.88
45125714-512571498.31499.42
55128509-512850998.36899.48
65244410-5244410100.591101.73
苯磺酸左氨氯地平缬沙坦片项目信息
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4000
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%
113.991197801199721198871199971199691199210.08
213.961190621191981191300.09
单位质量响应值RSD%判断
8571.918533.670.32数据可信
加速6月-供试品溶液-2024082121批-苯磺酸左氨氯地平-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%
5min163843-6384347.13048.511.4647.1348.521.46
265970-6597048.70048.70
366465-6646549.06649.07
465700-6570048.50148.50
566309-6630948.95148.95
666018-6601848.73648.74
10min197041-9704171.63772.321.1771.7272.401.17
297758-9775872.16772.25
398300-9830072.56772.65
497806-9780672.20272.28
5100027-10002773.84273.92
696838-9683871.48871.57
15min1110494-11049481.56981.661.7181.7781.861.71
2110093-11009381.27381.47
3112937-11293783.37283.57
4109634-10963480.93481.14
5112632-11263283.14783.35
6107953-10795379.69379.89
20min1115367-11536785.16686.231.3485.5086.561.34
2119503-11950388.21988.56
3117581-11758186.80087.14
4115489-11548985.25685.59
5116121-11612185.72386.07
6116760-11676086.19486.53
30min1119549-11954988.25389.351.0988.7389.841.08
2122139-12213990.16590.65
3122967-12296790.77791.26
4120173-12017388.71489.19
5120221-12022188.74989.24
6121193-12119389.46789.94
45min1112957-11295783.38789.633.5384.0190.263.51
2124079-12407991.59792.23
3123574-12357491.22591.86
4122002-12200290.06490.69
5124190-12419091.67992.31
6121692-12169289.83590.46
60min1121005-12100589.32889.471.5490.0990.261.53
2123281-12328191.00891.80
3121999-12199990.06290.85
4121472-12147289.67390.45
5121710-12171089.84990.64
6117755-11775586.92987.70
极限1125682-12568292.78193.082.2493.6994.002.22
2127724-12772494.28895.23
3127161-12716193.87394.81
4121673-12167389.82190.75
5129778-12977895.80596.74
6124465-12446591.88292.80
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.974692126469560746944004699892469751946959090.07
215.974661265466430946627870.05
单位质量响应值RSD%判断
294045.65291971.630.51数据可信
加速6月-供试品溶液-2024082121批-缬沙坦-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%
5min14365319-436531983.05083.870.9483.0583.870.94
24400321-440032183.71583.72
34433801-443380184.35284.35
44370356-437035683.14583.15
54475201-447520185.14085.14
64406039-440603983.82483.82
10min14982468-498246894.79195.691.1694.9395.831.16
25048292-504829296.04396.18
35082538-508253896.69596.84
44970328-497032894.56094.70
55108687-510868797.19297.33
64986768-498676894.87395.01
15min15085090-508509096.74397.391.1697.0497.681.16
25142249-514224997.83198.13
35164068-516406898.24698.55
45059625-505962596.25996.55
55201767-520176798.96399.27
65060171-506017196.26996.57
20min15095167-509516796.93597.581.2197.3998.041.21
25152678-515267898.02998.49
35175365-517536598.46198.93
45070791-507079196.47196.93
55216503-521650399.24399.71
65064056-506405696.34396.80
30min15096722-509672296.96497.511.1897.5898.131.18
25147685-514768597.93498.56
35173844-517384498.43299.06
45067509-506750996.40997.03
55207313-520731399.06899.70
65058676-505867696.24196.86
45min15100336-510033697.03397.491.2197.8198.281.21
25151733-515173398.01198.80
35167584-516758498.31299.11
45060965-506096596.28497.06
55209162-520916299.10499.90
65057033-505703396.20996.99
60min15093660-509366096.90697.391.2397.8598.341.23
25146849-514684997.91898.87
35161583-516158398.19899.16
45055986-505598696.18997.13
55207305-520730599.068100.03
65050778-505077896.09097.03
极限15150570-515057097.98998.121.4899.0999.231.47
25199954-519995498.928100.04
35226824-522682499.440100.56
45063826-506382696.33997.44
55233958-523395899.575100.70
65069603-506960396.44897.55
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-03-13 17:10:12 完成)
生成报告数据部分(等待生成报告)
Current page cost:2.141 s