沙库巴曲缬沙坦钠氨氯地平片项目信息
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100374-202106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2000
标示量(mg)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%
115.471018741016801017471018081016101017440.11
215.461030031030511030270.04
单位质量响应值RSD%判断
6576.866664.100.94数据可信
供试品溶液-8196156批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196949-9694994.93394.282.3194.9394.282.31
296794-9679494.78194.78
397537-9753795.50995.51
495053-9505393.07693.08
592503-9250390.57990.58
698840-9884096.78496.78
10min197790-9779095.75696.321.6995.9196.481.69
298511-9851196.46296.62
399879-9987997.80297.96
497946-9794695.90996.06
595729-9572993.73893.89
6100358-10035898.27198.43
15min197030-9703095.01295.801.9195.3396.121.91
297427-9742795.40195.72
399711-9971197.63797.96
497092-9709295.07395.39
595386-9538693.40293.71
6100382-10038298.29498.62
20min196937-9693794.92195.401.8695.4095.881.86
296911-9691194.89695.37
399292-9929297.22797.71
496373-9637394.36994.84
595170-9517093.19193.65
699896-9989697.81898.31
30min195779-9577993.78795.031.7794.4295.661.77
296675-9667594.66495.30
399077-9907797.01697.66
496542-9654294.53495.16
595044-9504493.06793.69
699167-9916797.10597.76
45min195789-9578993.79793.951.4894.5994.741.47
296234-9623494.23395.03
398440-9844096.39397.20
495901-9590193.90794.69
595012-9501293.03693.81
694270-9427092.30993.12
60min195055-9505593.07894.261.6594.0395.211.65
295913-9591393.91894.87
398286-9828696.24297.21
495450-9545093.46594.41
594687-9468792.71893.65
698188-9818896.14697.11
极限194002-9400292.04793.391.3693.1594.501.37
294954-9495492.97994.09
397035-9703595.01796.15
494673-9467392.70493.80
594637-9463792.66993.75
696967-9696794.95096.08
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.571550272154900615528911552936155403615518280.14
2 22.611584079158224815831640.09
单位质量响应值RSD%判断
68756.2370020.521.29数据可信
供试品溶液-8196156批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.15244.950.000.14244.95
229880-298800.8710.87
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0001.84111.850.001.84111.80
2172553-1725535.0295.03
3-0.0000.00
4113722-1137223.3143.31
578440-784402.2862.29
615015-150150.4380.44
15min116266-162660.4743.0486.770.473.0486.78
2213883-2138836.2336.24
341814-418141.2191.22
4193425-1934255.6375.64
5143672-1436724.1874.19
616327-163270.4760.48
20min123147-231470.6754.1376.680.684.1476.72
2248028-2480287.2287.25
374060-740602.1582.16
4264320-2643207.7037.72
5202492-2024925.9015.91
639184-391841.1421.14
30min140196-401961.1715.7566.951.175.7667.01
2284299-2842998.2858.32
3114489-1144893.3373.34
4362731-36273110.57110.60
5292406-2924068.5228.54
689361-893612.6042.61
45min174126-741262.1607.9056.892.167.9356.98
2327176-3271769.5359.58
3178527-1785275.2035.21
4477830-47783013.92513.97
5397412-39741211.58211.62
6172114-1721145.0165.02
60min1118249-1182493.4469.3250.583.459.3650.67
2361904-36190410.54710.61
3218059-2180596.3556.37
4534557-53455715.57815.65
5466941-46694113.60813.66
6218673-2186736.3736.39
极限1597117-59711717.40219.368.5117.4119.418.66
2671060-67106019.55719.64
3650266-65026618.95118.98
4732032-73203221.33321.43
5724883-72488321.12521.20
6610008-61000817.77717.80
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.571062173106098310631671062757106370610625570.10
2 22.611079309107830110788050.07
单位质量响应值RSD%判断
47078.2947713.620.95数据可信
供试品溶液-8196156批-缬沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.14244.950.000.14244.95
221572-215720.8700.87
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0001.87121.610.001.87121.64
2134460-1344605.4245.43
3-0.0000.00
485872-858723.4643.46
557949-579492.3382.34
6-0.0000.00
15min110520-105200.4243.1389.080.423.1389.15
2161506-1615066.5156.53
330049-300491.2121.21
4145085-1450855.8525.86
5107758-1077584.3474.35
610058-100580.4060.41
20min115193-151930.6134.2278.580.614.2378.68
2185200-1852007.4717.49
352874-528742.1332.13
4197323-1973237.9607.98
5150544-1505446.0736.08
627247-272471.0991.10
30min125427-254271.0265.7569.151.035.7669.17
2208261-2082618.4018.43
380232-802323.2363.24
4265421-26542110.70710.74
5213432-2134328.6098.63
662054-620542.5032.51
45min146642-466421.8817.7359.511.887.7659.57
2234400-2344009.4559.50
3123370-1233704.9774.99
4344159-34415913.88313.93
5284764-28476411.48711.52
6116818-1168184.7124.72
60min171687-716872.8928.9054.372.908.9454.43
2255396-25539610.30210.37
3145793-1457935.8815.90
4378889-37888915.28415.35
5329559-32955913.29413.35
6142792-1427925.7605.77
极限1429741-42974117.33519.418.8717.3519.479.02
2488620-48862019.71019.79
3471885-47188519.03519.06
4530937-53093721.41721.51
5527040-52704021.26021.34
6439514-43951417.72917.75
沙库巴曲缬沙坦钠氨氯地平片项目信息
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100374-202106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2000
标示量(mg)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%
115.471026001023701023521023811020851023580.18
215.461012441014771013600.17
单位质量响应值RSD%判断
6616.556556.270.65数据可信
供试品溶液-8196156批-氨氯地平-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%
5min177502-7750276.28183.436.2776.2883.436.27
293651-9365192.17692.18
384531-8453183.19983.20
484685-8468583.35183.35
586157-8615784.80084.80
682061-8206180.76880.77
10min184684-8468483.35090.935.4483.4891.075.43
2100025-10002598.44998.60
393499-9349992.02692.16
490514-9051489.08889.23
594048-9404892.56692.71
691557-9155790.11590.25
15min187591-8759186.21192.194.6886.4892.484.69
2100603-10060399.01899.34
394294-9429492.80893.10
491552-9155290.11090.40
595678-9567894.17194.47
692262-9226290.80891.09
20min189557-8955788.14692.544.5788.5692.994.57
2100735-10073599.14899.63
394214-9421492.73093.18
490667-9066789.23989.68
597267-9726795.73596.19
691695-9169590.25090.69
30min190242-9024288.82092.904.1389.3893.494.14
2100828-10082899.24099.89
393577-9357792.10392.70
491934-9193490.48691.07
597110-9711095.58096.19
692603-9260391.14491.73
45min191103-9110389.66893.103.5090.3793.863.52
299856-9985698.28399.10
393962-9396292.48293.24
492686-9268691.22691.96
597280-9728095.74796.52
692679-9267991.21991.96
60min191272-9127289.83493.353.8290.6994.263.83
2100810-10081099.222100.20
394228-9422892.74493.65
492622-9262291.16392.05
597509-9750995.97396.90
692650-9265091.19092.08
极限197754-9775496.21496.471.9697.2297.531.98
2100076-10007698.49999.64
396261-9626194.74495.81
496118-9611894.60495.64
5100621-10062199.036100.13
697229-9722995.69796.74
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.571569905156758615709921569637156725115690740.11
2 22.611550998155456715527820.17
单位质量响应值RSD%判断
69520.3468676.780.87数据可信
供试品溶液-8196156批-沙库巴曲-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%
5min1335714-3357149.82412.6727.059.8212.6727.06
2560875-56087516.41316.41
3311372-3113729.1129.11
4588185-58818517.21217.21
5370534-37053410.84310.84
6431760-43176012.63512.63
10min1696350-69635020.37827.5518.1020.3927.5718.10
2995915-99591529.14429.17
3819246-81924623.97423.99
41190326-119032634.83334.86
5933701-93370127.32427.34
61012898-101289829.64129.66
15min1986702-98670228.87536.6813.8628.9236.7513.87
21335434-133543439.08039.16
31099227-109922732.16732.22
41450989-145098942.46142.55
51325645-132564538.79338.86
61323099-132309938.71938.79
20min11203372-120337235.21543.1712.3335.3143.3012.34
21572871-157287146.02846.17
31286888-128688837.65937.77
41637946-163794647.93248.09
51576328-157632846.12946.26
61573732-157373246.05346.19
30min11463808-146380842.83648.648.6042.9948.848.62
21739904-173990450.91651.13
31494923-149492343.74743.92
41739060-173906050.89151.13
51781983-178198352.14752.35
61754146-175414651.33351.54
45min11622256-162225647.47350.263.6747.7050.543.72
21746859-174685951.12051.42
31655905-165590548.45848.70
41744947-174494751.06451.39
51780438-178043852.10252.39
61755205-175520551.36451.66
60min11654291-165429148.41150.682.9748.7251.043.01
21749228-174922851.18951.58
31685974-168597449.33849.66
41750120-175012051.21551.62
51792370-179237052.45152.83
61758837-175883751.47051.85
极限11766330-176633051.68952.061.9952.0852.511.94
21749532-174953251.19851.67
31846635-184663554.03954.45
41762429-176242951.57552.07
51786728-178672852.28652.75
61761866-176186651.55952.03
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.571073384107190910727931072058107040710721100.11
2 22.611058578106138110599800.19
单位质量响应值RSD%判断
47501.5546881.030.93数据可信
供试品溶液-8196156批-缬沙坦-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%
5min1219268-2192688.88311.6427.958.8811.6427.95
2374547-37454715.17415.17
3205333-2053338.3198.32
4394339-39433915.97615.98
5244697-2446979.9139.91
6285984-28598411.58611.59
10min1462243-46224318.72725.5418.5018.7425.5618.50
2668317-66831727.07627.10
3547100-54710022.16522.18
4800049-80004932.41332.44
5624388-62438825.29625.31
6679848-67984827.54327.56
15min1656781-65678126.60834.1114.2926.6534.1714.30
2899361-89936136.43636.51
3735192-73519229.78529.84
4978086-97808639.62539.71
5890820-89082036.09036.15
6891029-89102936.09836.16
20min1804694-80469432.60140.1812.7132.6940.3012.73
21059032-105903242.90543.04
3859810-85981034.83434.93
41104843-110484344.76144.91
51062752-106275243.05643.17
61060032-106003242.94543.07
30min1978205-97820539.63045.339.2739.7745.529.29
21173396-117339647.53847.74
3993708-99370840.25840.42
41176362-117636247.65847.88
51204571-120457148.80148.99
61186996-118699648.08948.29
45min11083937-108393743.91446.804.4444.1247.064.48
21176720-117672047.67347.95
31097162-109716244.45044.68
41180597-118059747.83048.13
51204371-120437148.79349.06
61188897-118889748.16648.44
60min11098237-109823744.49347.024.0544.7847.364.09
21180275-118027547.81748.18
31105577-110557744.79045.09
41180329-118032947.81948.20
51210367-121036749.03649.39
61189518-118951848.19148.55
极限11191139-119113948.25748.801.7848.6149.221.74
21186783-118678348.08048.52
31244652-124465250.42550.80
41196616-119661648.47948.94
51212450-121245049.12049.56
61196333-119633348.46748.91
沙库巴曲缬沙坦钠氨氯地平片项目信息
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100374-202106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2000
标示量(mg)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%
115.471039931041601041371038791037791039900.16
215.461043481042021042750.10
单位质量响应值RSD%判断
6722.046744.830.24数据可信
供试品溶液-8196156批-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%
5min152307-5230750.35844.3811.6850.3644.3911.68
246758-4675845.01645.02
340187-4018738.69038.69
449855-4985547.99748.00
538968-3896837.51637.52
648540-4854046.73146.73
10min170223-7022367.60660.259.2067.6960.329.20
264032-6403261.64661.72
361192-6119258.91258.98
463622-6362261.25161.33
552568-5256850.60950.67
663849-6384961.47061.55
15min170973-7097368.32863.558.2068.5263.728.20
266742-6674264.25564.43
365102-6510262.67662.84
470568-7056867.93868.12
556053-5605353.96454.11
666631-6663164.14864.33
20min172017-7201769.33365.987.1569.6466.267.15
267970-6797065.43765.72
369341-6934166.75767.02
472844-7284470.13070.42
559232-5923257.02557.26
669829-6982967.22767.51
30min174570-7457071.79169.486.8072.2269.886.80
271983-7198369.30169.69
372582-7258269.87770.26
477052-7705274.18174.59
562847-6284760.50560.84
674005-7400571.24771.65
45min176321-7632173.47772.255.3574.0272.765.36
275012-7501272.21772.73
376652-7665273.79674.29
478747-7874775.81376.35
567247-6724764.74165.17
676304-7630473.46173.98
60min177902-7790274.99973.604.8075.6774.234.81
276126-7612673.28973.92
378175-7817575.26275.88
479958-7995876.97977.64
569435-6943566.84867.39
677107-7710774.23474.87
极限193483-9348390.00091.511.8590.7992.261.81
293224-9322489.75090.50
396440-9644092.84693.59
495945-9594592.37093.16
597382-9738293.75394.41
693837-9383790.34091.10
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.571620614162338116212881615176161341916187760.27
2 22.611630633162683216287320.17
单位质量响应值RSD%判断
71722.4672035.910.31数据可信
供试品溶液-8196156批-沙库巴曲-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%
5min1529943-52994314.9089.5137.1014.919.5137.09
2404719-40471911.38511.39
3153195-1531954.3094.31
4339385-3393859.5479.55
5288477-2884778.1158.12
6312174-3121748.7828.78
10min1945894-94589426.60921.0225.7026.6321.0425.71
2863867-86386724.30124.32
3438214-43821412.32712.33
4833864-83386423.45723.47
5591566-59156616.64116.65
6810515-81051522.80022.81
15min11269059-126905935.70030.8517.9635.7730.9017.98
21169549-116954932.90032.96
3853712-85371224.01624.04
41225221-122522134.46634.52
5837874-83787423.57023.61
61224142-122414234.43634.49
20min11518194-151819442.70838.0215.7042.8438.1215.72
21407360-140736039.59039.70
31146836-114683632.26132.33
41500463-150046342.20942.32
51027055-102705528.89228.97
61509123-150912342.45342.56
30min11723925-172392548.49545.5911.6048.7045.7511.62
21714151-171415148.22048.40
31456043-145604340.96041.08
41751613-175161349.27449.46
51315659-131565937.01037.14
61761483-176148349.55249.73
45min11726854-172685448.57847.286.6648.8647.526.71
21734777-173477748.80149.06
31597493-159749344.93945.13
41759366-175936649.49249.76
51491630-149163041.96142.15
61773636-177363649.89450.16
60min11721655-172165548.43147.555.5048.7947.875.55
21740606-174060648.96449.31
31619966-161996645.57145.84
41755645-175564549.38849.73
51534493-153449343.16643.43
61768796-176879649.75750.10
极限11724583-172458348.51449.291.1448.9649.691.16
21768183-176818349.74050.16
31752910-175291049.31149.65
41760320-176032049.51949.95
51732270-173227048.73049.06
61774286-177428649.91250.34
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.571095685109800610971131093144109265910953210.22
2 22.611101052109890210999770.14
单位质量响应值RSD%判断
48529.9548650.020.18数据可信
供试品溶液-8196156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%
5min1359939-35993914.1628.9438.0214.168.9438.02
2273364-27336410.75610.76
3100919-1009193.9713.97
4227369-2273698.9468.95
5191710-1917107.5437.54
6209357-2093578.2378.24
10min1641867-64186725.25519.8526.2225.2819.8626.23
2584118-58411822.98223.00
3292637-29263711.51411.52
4563358-56335822.16622.18
5395363-39536315.55615.57
6549071-54907121.60321.62
15min1861115-86111533.88129.2018.2933.9529.2518.30
2791579-79157931.14531.20
3576687-57668722.69022.72
4831365-83136532.71032.76
5562048-56204822.11422.15
6829999-82999932.65732.71
20min11032242-103224240.61436.0116.0840.7436.1016.09
2951822-95182237.45037.56
3773674-77367430.44130.50
41017877-101787740.04940.16
5690364-69036427.16327.24
61024684-102468440.31740.42
30min11172622-117262246.13743.2111.9646.3343.3711.97
21161592-116159245.70345.87
3982794-98279438.66838.78
41189251-118925146.79246.96
5885864-88586434.85534.98
61197638-119763847.12247.29
45min11175204-117520446.23944.797.0946.5145.027.13
21174515-117451546.21246.46
31078776-107877642.44542.62
41193992-119399246.97847.23
51001863-100186339.41939.60
61205730-120573047.44047.69
60min11171085-117108546.07744.986.0546.4245.286.10
21177487-117748746.32946.65
31091967-109196742.96443.21
41190730-119073046.85047.18
51026478-102647840.38740.63
61201652-120165247.27947.61
极限11176042-117604246.27247.011.1646.6947.391.18
21206470-120647047.46947.87
31195555-119555547.04047.36
41200162-120016247.22147.63
51180957-118095746.46546.78
61210220-121022047.61748.02
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