缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405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250
标示量(mg)40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%
114.131210381208941210301210141207601209470.10
214.081222921222981222950.01
单位质量响应值RSD%判断
8559.598685.721.04数据可信
供试品溶液-25071001批-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%
5min151524-5152453.72853.494.2753.7353.494.27
249370-4937051.48251.48
354320-5432056.64356.64
449637-4963751.76051.76
549436-4943651.55151.55
653481-5348155.76955.77
10min187871-8787191.63092.181.3791.7592.301.37
286924-8692490.64290.76
387755-8775591.50991.63
488146-8814691.91692.03
590009-9000993.85993.97
689715-8971593.55293.68
15min1102304-102304106.680108.601.94107.00108.931.94
2102202-102202106.574106.89
3105956-105956110.488110.82
4102656-102656107.047107.37
5105019-105019109.511109.83
6106754-106754111.320111.65
20min1110453-110453115.177116.882.15115.74117.442.15
2109326-109326114.002114.55
3113801-113801118.669119.24
4110122-110122114.832115.39
5113703-113703118.567119.13
6115116-115116120.040120.62
30min1116073-116073121.038123.382.38121.85124.212.38
2114935-114935119.851120.66
3120874-120874126.044126.88
4116382-116382121.360122.17
5120732-120732125.896126.73
6120937-120937126.110126.96
45min1120154-120154125.293126.822.00126.38127.922.00
2118283-118283123.342124.41
3124164-124164129.475130.59
4120201-120201125.342126.42
5124147-124147129.457130.57
6122771-122771128.022129.15
60min1120879-120879126.049127.682.41127.41129.062.40
2118051-118051123.100124.45
3124563-124563129.891131.30
4121451-121451126.646128.01
5123325-123325128.600130.00
6126360-126360131.765133.18
90min1125294-125294130.653130.972.20132.30132.642.19
2121855-121855127.067128.69
3124702-124702130.036131.73
4125665-125665131.040132.68
5125686-125686131.062132.75
6130390-130390135.967137.67
120min1-0.0000.00-1.931.952.07
2-0.0001.90
3-0.0001.98
4-0.0001.93
5-0.0001.97
6-0.0002.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.931.952.07
2-0.0001.90
3-0.0001.98
4-0.0001.93
5-0.0001.97
6-0.0002.01
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405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250
标示量(mg)40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%
114.131218871220141221711220711222071220700.11
214.081190371191621191000.08
单位质量响应值RSD%判断
8639.078458.811.50数据可信
供试品溶液-25071002批-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%
5min147451-4745149.91048.146.0149.9148.146.01
243307-4330745.55145.55
345975-4597548.35848.36
448193-4819350.69150.69
541577-4157743.73243.73
648087-4808750.57950.58
10min185763-8576390.20888.372.4790.3288.482.47
282506-8250686.78286.88
384566-8456688.94989.06
486867-8686791.36991.48
581482-8148285.70585.80
682899-8289987.19587.31
15min1105008-105008110.450106.843.01110.76107.153.01
2100162-100162105.353105.65
3103863-103863109.246109.55
4103926-103926109.312109.63
598304-98304103.399103.69
698203-98203103.293103.60
20min1115470-115470121.454117.223.07122.01117.763.07
2108749-108749114.385114.91
3113781-113781119.678120.23
4114250-114250120.171120.73
5108674-108674114.306114.82
6107714-107714113.296113.83
30min1124117-124117130.550125.323.56131.38126.123.56
2115933-115933121.941122.72
3121813-121813128.126128.94
4122890-122890129.259130.08
5114878-114878120.832121.60
6115238-115238121.210122.00
45min1128394-128394135.048129.463.76136.17130.543.75
2120400-120400126.640127.69
3126816-126816133.388134.49
4126140-126140132.677133.79
5117085-117085123.153124.19
6119633-119633125.833126.89
60min1126792-126792133.363130.563.38134.78131.923.37
2120793-120793127.053128.39
3127582-127582134.194135.59
4129216-129216135.913137.32
5120551-120551126.799128.11
6119805-119805126.014127.35
90min1130063-130063136.804134.482.69138.52136.142.70
2125288-125288131.781133.40
3130294-130294137.047138.74
4132330-132330139.188140.90
5124808-124808131.276132.87
6124361-124361130.806132.42
120min1-0.0000.00-2.021.963.13
2-0.0001.91
3-0.0002.00
4-0.0002.02
5-0.0001.89
6-0.0001.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-2.021.963.13
2-0.0001.91
3-0.0002.00
4-0.0002.02
5-0.0001.89
6-0.0001.91
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405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250
标示量(mg)40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%
114.131207391205331207101205911207421206630.08
214.081226161223481224820.16
单位质量响应值RSD%判断
8539.498699.011.31数据可信
供试品溶液-25071001批-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%
5min123870-2387024.90224.474.5224.9024.464.52
223248-2324824.25324.25
322356-2235623.32223.32
422988-2298823.98223.98
522889-2288923.87823.88
625365-2536526.46126.46
10min139829-3982941.55038.954.4041.6139.004.39
237082-3708238.68538.74
335571-3557137.10837.16
436275-3627537.84337.90
538795-3879540.47240.52
636449-3644938.02438.08
15min151525-5152553.75249.875.0953.9050.015.08
249322-4932251.45451.59
345131-4513147.08247.22
445601-4560147.57247.71
548408-4840850.50050.64
646811-4681148.83448.98
20min161495-6149564.15362.723.7764.4262.973.76
263785-6378566.54266.80
359089-5908961.64361.88
457194-5719459.66659.91
559515-5951562.08762.34
659631-5963162.20862.46
30min180783-8078384.27484.622.7384.6885.012.73
285096-8509688.77489.18
381327-8132784.84285.22
478318-7831881.70382.08
580355-8035583.82884.22
680813-8081384.30684.70
45min1103071-103071107.526107.511.97108.12108.091.97
2106531-106531111.135111.73
3103482-103482107.954108.52
4100352-100352104.689105.25
5102788-102788107.230107.81
6102127-102127106.541107.12
60min1115765-115765120.768121.451.65121.60122.261.66
2120068-120068125.257126.10
3116263-116263121.288122.09
4114558-114558119.509120.30
5115322-115322120.306121.12
6116524-116524121.560122.37
90min1126477-126477131.943133.891.60133.05134.981.58
2128890-128890134.461135.59
3127773-127773133.295134.37
4132171-132171137.883138.94
5127804-127804133.328134.41
6126965-126965132.452133.54
120min1129298-129298134.886136.010.78136.28137.390.78
2131624-131624137.313138.74
3131396-131396137.075138.44
4129556-129556135.155136.52
5130713-130713136.362137.74
6129657-129657135.261136.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1129948-129948135.564136.810.75137.26138.500.75
2132202-132202137.916139.64
3131551-131551137.237138.91
4129904-129904135.518137.18
5131503-131503137.187138.87
6131759-131759137.454139.13
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405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250
标示量(mg)40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%
114.131201521203601203211204131204081203310.09
214.081204931208631206780.22
单位质量响应值RSD%判断
8515.998570.880.46数据可信
供试品溶液-25071002批-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%
5min113063-1306313.74713.4913.6013.7513.4913.60
211323-1132311.91611.92
311225-1122511.81311.81
413153-1315313.84213.84
515954-1595416.79016.79
612179-1217912.81712.82
10min125936-2593627.29527.197.9327.3327.227.94
223836-2383625.08525.11
324061-2406125.32225.35
426889-2688928.29828.33
529297-2929730.83230.87
624985-2498526.29426.32
15min134243-3424336.03737.8913.9136.1337.9813.89
231533-3153333.18533.27
331470-3147033.11933.20
435665-3566537.53437.63
538372-3837240.38340.49
644721-4472147.06447.15
20min142890-4289045.13745.919.6045.3146.089.60
239029-3902941.07441.23
339500-3950041.57041.73
446239-4623948.66248.84
550105-5010552.73052.93
643958-4395846.26146.45
30min161695-6169564.92866.368.7565.2066.648.74
256928-5692859.91160.16
358203-5820361.25361.50
466341-6634169.81770.10
571894-7189475.66175.97
663288-6328866.60466.90
45min186623-8662391.16290.405.6891.5890.835.69
279650-7965083.82384.20
382008-8200886.30586.69
488676-8867693.32293.76
593360-9336098.25298.73
685103-8510389.56290.00
60min1103798-103798109.237107.633.85109.86108.253.88
297464-97464102.571103.14
398798-98798103.975104.55
4103724-103724109.159109.81
5108368-108368114.046114.75
6101456-101456106.772107.41
90min1119695-119695125.967125.752.10126.83126.612.13
2116501-116501122.605123.40
3117075-117075123.209124.02
4119654-119654125.924126.81
5123419-123419129.886130.84
6120573-120573126.891127.77
120min1125975-125975132.576133.011.70133.72134.151.72
2124738-124738131.274132.34
3123296-123296129.756130.84
4127322-127322133.993135.16
5127937-127937134.641135.88
6129058-129058135.820136.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1128255-128255134.975135.402.16136.41136.842.16
2127801-127801134.497135.86
3124525-124525131.050132.42
4129882-129882136.687138.16
5128502-128502135.235136.78
6132993-132993139.962141.42
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