缬沙坦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%
114.062530712530702531412530762531392530990.02
214.072540512543452541980.09
单位质量响应值RSD%判断
18001.3518066.670.26数据可信
供试品溶液-241210JK批-氨氯地平-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145671-4567116.41716.653.2016.4216.653.19
248018-4801817.26117.26
345286-4528616.27916.28
10min133086-3308611.89312.796.1111.9212.826.11
236773-3677313.21813.25
336922-3692213.27213.30
15min174512-7451226.78427.292.6926.8327.342.69
278254-7825428.12928.18
374973-7497326.95027.00
20min157813-5781320.78221.603.4120.8721.693.42
260626-6062621.79321.89
361791-6179122.21122.31
30min197049-9704934.88534.880.7235.0135.010.72
297728-9772835.12935.26
396329-9632934.62734.76
45min172425-7242526.03426.903.6426.2227.093.61
274318-7431826.71426.91
377786-7778627.96128.15
60min1113606-11360640.83740.191.4741.0640.431.44
2111442-11144240.05940.30
3110390-11039039.68139.92
90min185563-8556330.75731.442.8331.0531.742.82
286585-8658531.12431.43
390256-9025632.44432.75
120min1135967-13596748.87548.301.0549.2248.651.03
2133377-13337747.94448.30
3133753-13375348.07948.43
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1104371-10437137.51738.352.4237.9538.792.39
2106266-10626638.19938.63
3109460-10946039.34739.78
缬沙坦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100
标示量(mg)160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%
115.964588420459312545954954598392459399945938860.08
216.094630425463746046339420.11
单位质量响应值RSD%判断
287837.47288001.370.05数据可信
供试品溶液-241210JK批-缬沙坦-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1519758-51975810.0639.406.0910.069.406.06
2467512-4675129.0519.05
3469815-4698159.0969.10
10min1212835-2128354.1214.283.484.144.293.40
2221877-2218774.2964.31
3228144-2281444.4174.43
15min11020665-102066519.76118.655.2719.7818.675.25
2924271-92427117.89517.92
3945066-94506618.29718.32
20min1489132-4891329.4709.703.729.539.763.68
2491767-4917679.5219.57
3522643-52264310.11910.17
30min11398319-139831927.07325.894.2027.1525.964.20
21288078-128807824.93825.01
31325144-132514425.65625.73
45min1732896-73289614.19014.372.2314.3114.482.20
2732389-73238914.18014.29
3761292-76129214.73914.85
60min11720039-172003933.30131.794.4933.4431.924.47
21573979-157397930.47430.61
31631158-163115831.58131.72
90min1936641-93664118.13418.341.8418.3318.531.84
2937458-93745818.15018.33
3967187-96718718.72618.92
120min12191371-219137142.42740.893.6542.6541.113.65
22037513-203751339.44839.66
32107254-210725440.79841.02
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11277704-127770424.73725.041.7525.0425.331.72
21282858-128285824.83725.12
31319020-131902025.53725.83
缬沙坦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%
114.062539152545592545432543192544792543630.11
214.072545182549842547510.13
单位质量响应值RSD%判断
18091.2518105.970.06数据可信
供试品溶液-20241026批-氨氯地平-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181791-8179129.29629.571.5329.3029.571.52
281874-8187429.32529.33
384005-8400530.08930.09
10min161076-6107621.87621.920.5621.9221.970.58
261579-6157922.05622.11
360927-6092721.82321.87
15min1144179-14417951.64252.091.5151.7352.181.50
2144161-14416151.63551.72
3147960-14796052.99653.08
20min1112102-11210240.15240.761.3340.3240.931.33
2114984-11498441.18541.36
3114285-11428540.93441.11
30min1183123-18312365.59165.471.1065.8365.711.10
2180648-18064864.70464.94
3184620-18462066.12766.37
45min1143854-14385451.52552.321.4251.8752.671.42
2147955-14795552.99453.34
3146406-14640652.43952.79
60min1207736-20773674.40673.771.6774.8474.211.67
2202007-20200772.35472.79
3208168-20816874.56175.00
90min1168003-16800360.17560.490.5660.7361.050.55
2169865-16986560.84261.40
3168815-16881560.46661.03
120min1231103-23110382.77682.901.1683.4383.561.15
2228989-22898982.01982.68
3234292-23429283.91884.58
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1196377-19637770.33871.291.3271.1372.091.30
2201595-20159572.20773.00
3199130-19913071.32472.13
缬沙坦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100
标示量(mg)160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%
115.964641275465030446519174650596465304146494270.11
216.094655487466233546589110.11
单位质量响应值RSD%判断
291317.48289553.200.43数据可信
供试品溶液-20241026批-缬沙坦-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12862726-286272654.94554.801.2654.9554.801.27
22815778-281577854.04454.04
32886338-288633855.39855.40
10min11998264-199826438.35338.120.6438.4438.210.63
21986786-198678638.13338.22
31973129-197312937.87137.96
15min13853645-385364573.96473.751.2774.1273.901.27
23788998-378899872.72472.88
33884560-388456074.55874.71
20min12961346-296134656.83856.960.5457.1257.240.53
22985836-298583657.30857.58
32955828-295582856.73257.01
30min14337388-433738883.24983.001.0683.6283.371.06
24273778-427377882.02882.40
34362458-436245883.73084.10
45min13499033-349903367.15867.460.6367.6767.970.62
23539855-353985567.94268.45
33505133-350513367.27567.79
60min14602134-460213488.33088.320.9788.9588.940.97
24556754-455675487.45988.08
34645424-464542489.16189.79
90min13891678-389167874.69474.670.8475.4775.440.83
23921883-392188375.27476.04
33857076-385707674.03074.80
120min14848970-484897093.06893.390.7893.9694.280.77
24839466-483946692.88693.78
34908644-490864494.21395.11
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14369242-436924283.86083.691.0584.9184.741.04
24400823-440082384.46785.51
34310790-431079082.73883.79
缬沙坦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%
114.062546822554662555412554742553852553100.14
214.072562312569812566060.21
单位质量响应值RSD%判断
18158.6118237.810.31数据可信
供试品溶液批-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%
5min147357-4735716.86916.840.3316.8716.840.33
247104-4710416.77916.78
347377-4737716.87716.88
10min134218-3421812.18912.935.6312.2212.965.60
238300-3830013.64313.67
336400-3640012.96612.99
15min188679-8867931.58932.482.4631.6432.532.45
292988-9298833.12433.17
391908-9190832.73932.79
20min174365-7436526.49026.751.7726.5926.851.78
276615-7661527.29227.40
374277-7427726.45926.56
30min1121623-12162343.32444.242.5543.4744.392.55
2127723-12772345.49745.65
3123245-12324543.90244.05
45min1103649-10364936.92237.064.4037.1437.294.39
2108809-10880938.76038.99
399688-9968835.51135.73
60min1143118-14311850.98152.833.2051.2653.113.19
2152385-15238554.28254.57
3149442-14944253.23453.51
90min1130180-13018046.37345.504.4946.7445.874.46
2131824-13182446.95847.34
3121193-12119343.17143.54
120min1172802-17280261.55564.253.6462.0064.703.63
2183698-18369865.43765.90
3184590-18459065.75466.20
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1159417-15941756.78756.462.9857.3357.022.96
2162702-16270257.95758.53
3153409-15340954.64755.20
缬沙坦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100
标示量(mg)160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%
115.964651689465926846663484672007467719546653010.22
216.094701948471321347075800.17
单位质量响应值RSD%判断
292312.09292578.000.07数据可信
供试品溶液批-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%
5min11538488-153848829.32629.651.0029.3329.650.99
21568830-156883029.90429.90
31559033-155903329.71729.72
10min11009800-100980019.24819.682.5519.3019.732.54
21061342-106134220.23120.28
31026363-102636319.56419.61
15min12437763-243776346.46747.341.8946.5547.431.89
22531520-253152048.25448.34
32481813-248181347.30747.39
20min11715604-171560432.70232.812.1732.8632.972.16
21761193-176119333.57133.73
31687252-168725232.16132.32
30min12995771-299577157.10358.352.0757.3258.572.07
23122262-312226259.51459.73
33065904-306590458.44058.65
45min12227919-222791942.46742.482.1942.7842.802.19
22277731-227773143.41643.74
32180194-218019441.55741.87
60min13371669-337166964.26865.882.2364.6566.262.23
23522583-352258367.14567.54
33474001-347400166.21966.60
90min12617888-261788849.90050.300.8050.3950.800.81
22660050-266005050.70451.21
32638845-263884550.30050.79
120min13861380-386138073.60375.572.2874.1776.152.27
24027043-402704376.76177.35
34005753-400575376.35576.93
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13193464-319346460.87260.332.4561.5661.042.42
23224364-322436461.46062.18
33077629-307762958.66459.37
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