坎地沙坦酯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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.217564575838763017614676228760320.37
216.337600076314761570.30
单位质量响应值RSD%判断
4690.444663.630.41数据可信
坎地沙坦酯--供试品溶液-6041401批-pH1.2(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13536-35364.2443.5650.014.243.5650.01
23962-39624.7564.76
33079-30793.6963.70
4-0.0000.00
53764-37644.5184.52
63466-34664.1604.16
10min16843-68438.2147.877.878.227.877.91
26867-68678.2428.25
36217-62177.4627.47
45651-56516.7836.78
56963-69638.3588.37
66778-67788.1368.14
15min18914-891410.69910.523.7910.7210.543.80
29133-913310.96210.98
38416-841610.10210.12
48302-83029.9659.98
58998-899810.80010.82
68810-881010.57510.60
20min110604-1060412.72812.462.2012.7712.502.24
210562-1056212.67712.72
310087-1008712.10712.14
410103-1010312.12712.15
510456-1045612.55012.59
610468-1046812.56512.60
30min112795-1279515.35814.983.3315.4215.043.35
212486-1248614.98715.05
312253-1225314.70714.76
411772-1177214.13014.18
512763-1276315.31915.38
612837-1283715.40815.47
45min114756-1475617.71117.881.4217.8017.961.43
215234-1523418.28518.37
314705-1470517.65017.73
414715-1471517.66217.73
514938-1493817.93018.02
615026-1502618.03618.12
60min116146-1614619.38019.691.3219.4919.801.33
216694-1669420.03820.15
316299-1629919.56419.67
416285-1628519.54719.65
516360-1636019.63719.75
616641-1664119.97420.09
极限117819-1781921.38821.511.0721.5421.661.08
218226-1822621.87622.03
317677-1767721.21821.36
417948-1794821.54321.68
517832-1783221.40421.55
618029-1802921.64021.79
坎地沙坦酯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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.217789777619778047782378006778300.19
216.337910679171791380.06
单位质量响应值RSD%判断
4801.364846.170.66数据可信
坎地沙坦酯--供试品溶液-6041501批-pH1.2(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14145-41454.8244.6111.014.824.6110.96
24141-41414.8194.82
34582-45825.3335.33
43813-38134.4384.44
53803-38034.4264.43
63289-32893.8283.83
10min17376-73768.5848.543.258.598.543.26
27491-74918.7188.73
37676-76768.9338.94
47316-73168.5148.52
57025-70258.1768.18
67123-71238.2908.30
15min19592-959211.16311.013.0011.1911.033.01
29593-959311.16411.19
39822-982211.43111.45
49471-947111.02211.04
59007-900710.48210.50
69286-928610.80710.83
20min111139-1113912.96412.952.3613.0012.992.39
211218-1121813.05513.10
311465-1146513.34313.39
411297-1129713.14713.19
510737-1073712.49612.53
610927-1092712.71712.75
30min113624-1362415.85615.842.4415.9215.912.44
213840-1384016.10716.17
313975-1397516.26416.33
413688-1368815.93015.99
513017-1301715.14915.21
613542-1354215.76015.82
45min116272-1627218.93718.711.6219.0318.801.63
216143-1614318.78718.88
316306-1630618.97719.07
416224-1622418.88118.97
515780-1578018.36518.45
615711-1571118.28418.37
60min117853-1785320.77720.591.8620.9020.721.86
217800-1780020.71620.84
317938-1793820.87621.00
417958-1795820.89921.02
517113-1711319.91620.03
617512-1751220.38020.50
极限119152-1915222.28922.131.1122.4422.281.12
218898-1889821.99322.15
319231-1923122.38122.54
419043-1904322.16222.32
518649-1864921.70421.85
619108-1910822.23822.39
坎地沙坦酯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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.217874178873787587872578758787710.08
216.337891079233790720.29
单位质量响应值RSD%判断
4859.414842.130.26数据可信
坎地沙坦酯--供试品溶液-6041502批-pH1.2(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14028-40284.6623.4150.154.663.4250.14
23489-34894.0384.04
33625-36254.1954.20
43040-30403.5183.52
53520-35204.0744.07
6-0.0000.00
10min17164-71648.2917.965.918.307.965.92
27024-70248.1298.14
37245-72458.3858.39
46369-63697.3717.38
57099-70998.2168.22
66352-63527.3517.35
15min19323-932310.78910.584.2510.8110.604.25
29534-953411.03411.05
39287-928710.74810.77
48589-85899.9409.96
59386-938610.86210.88
68718-871810.08910.10
20min111104-1110412.85112.333.3512.8912.373.35
210830-1083012.53312.57
310768-1076812.46212.50
410329-1032911.95411.99
510762-1076212.45512.49
610134-1013411.72811.76
30min113136-1313615.20215.081.8315.2615.141.83
213170-1317015.24215.30
312914-1291414.94515.00
412629-1262914.61514.67
513306-1330615.39915.46
613036-1303615.08615.14
45min115612-1561218.06817.941.6318.1518.021.64
215752-1575218.23018.31
315594-1559418.04718.13
415335-1533517.74717.83
515632-1563218.09118.18
615069-1506917.43917.51
60min117226-1722619.93619.831.2320.0519.941.23
217320-1732020.04420.16
317043-1704319.72419.84
416955-1695519.62219.73
517398-1739820.13520.25
616878-1687819.53319.64
极限118272-1827221.14621.391.0921.3021.531.09
218781-1878121.73521.88
318465-1846521.36921.52
418353-1835321.24021.38
518665-1866521.60121.75
618352-1835221.23921.37
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