氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014664784659514656944653804655224658050.10
212.064652214651544651880.02
单位质量响应值RSD%判断
38784.7638572.800.39数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪-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%
5min1347094-34709464.41867.918.1364.4267.918.13
2377209-37720970.00770.01
3386851-38685171.79671.80
4315091-31509158.47858.48
5374171-37417169.44369.44
6395098-39509873.32773.33
10min1485939-48593990.18690.723.6990.2990.833.69
2502845-50284593.32493.44
3508991-50899194.46494.58
4457251-45725184.86284.96
5491214-49121491.16591.28
6486505-48650590.29190.41
15min1520517-52051796.60496.132.3096.8696.392.30
2528040-52804098.00098.27
3533177-53317798.95399.23
4501358-50135893.04893.29
5516065-51606595.77796.04
6508619-50861994.39594.67
20min1524180-52418097.28397.211.7297.7097.631.72
2531109-53110998.56999.00
3537508-53750899.757100.20
4514773-51477395.53895.93
5518783-51878396.28296.71
6516353-51635395.83196.26
30min1524555-52455597.35397.731.2897.9398.311.28
2531379-53137998.61999.22
3537569-53756999.768100.38
4524913-52491397.41997.97
5520320-52032096.56797.15
6520688-52068896.63597.23
45min1526017-52601797.62497.951.2398.3798.701.23
2532366-53236698.80399.57
3537814-53781499.814100.59
4527903-52790397.97498.69
5520755-52075596.64897.40
6521809-52180996.84397.59
60min1526070-52607097.63498.091.1498.5499.011.14
2532914-53291498.90499.83
3538016-53801699.851100.79
4528535-52853598.09298.97
5521960-52196096.87197.78
6523804-52380497.21498.13
极限1532487-53248798.82599.450.8899.89100.520.88
2535694-53569499.420100.51
3543740-543740100.914102.02
4538008-53800899.850100.89
5530287-53028798.41799.49
6534780-53478099.251100.32
氢氯噻嗪坎地沙坦酯片项目信息
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%
116.521533871533361532181529941531801532230.11
216.491531951535131533540.15
单位质量响应值RSD%判断
9275.009299.820.19数据可信
加速6月-供试品溶液-2024082721批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014638144631244629014632434639164634000.10
212.064661314659454660380.03
单位质量响应值RSD%判断
38584.5138643.280.11数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪-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%
5min1338283-33828362.88858.727.5862.8958.727.58
2285469-28546953.06953.07
3318635-31863559.23559.23
4291503-29150354.19154.19
5344680-34468064.07764.08
6316559-31655958.84958.85
10min1491441-49144191.36086.614.7691.4686.704.76
2440558-44055881.90181.99
3471755-47175587.70087.80
4438676-43867681.55181.64
5485508-48550890.25790.36
6467264-46726486.86586.96
15min1529969-52996998.52297.461.1898.7897.701.19
2514958-51495895.73295.96
3529876-52987698.50598.75
4519502-51950296.57796.80
5528109-52810998.17798.43
6523051-52305197.23697.48
20min1533722-53372299.22099.380.3199.6499.780.31
2535351-53535199.52399.91
3537493-53749399.921100.33
4534116-53411699.29399.68
5532823-53282399.05399.47
6533999-53399999.27299.68
30min1535101-53510199.476100.010.44100.06100.580.43
2539309-539309100.259100.81
3540240-540240100.432101.01
4540618-540618100.502101.05
5535901-53590199.625100.21
6536743-53674399.782100.35
45min1535842-53584299.61499.930.28100.37100.670.26
2538935-538935100.189100.91
3538024-538024100.020100.76
4539332-539332100.263100.98
5536038-53603899.651100.40
6537119-53711999.852100.59
60min1535070-53507099.47199.940.34100.39100.840.33
2537838-53783899.985100.87
3539860-539860100.361101.27
4539278-539278100.253101.14
5536565-53656599.749100.67
6536918-53691899.814100.72
极限1534829-53482999.42699.810.40100.51100.880.39
2536426-53642699.723100.77
3539361-539361100.268101.35
4539057-539057100.212101.27
5534314-53431499.330100.41
6537358-53735899.896100.97
氢氯噻嗪坎地沙坦酯片项目信息
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%
116.521532851528071525121526801528811528330.19
216.491538751541261540000.12
单位质量响应值RSD%判断
9251.399338.990.67数据可信
加速6月-供试品溶液-2024082721批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014638134636274638974640184639794638670.04
212.064626804626584626690.01
单位质量响应值RSD%判断
38623.4038363.930.48数据可信
中间条件6月-供试品溶液-2024082721批-氢氯噻嗪-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%
5min1290127-29012754.10454.0511.9954.1054.0511.99
2283430-28343052.85552.86
3280240-28024052.26052.26
4260779-26077948.63148.63
5267155-26715549.82049.82
6357213-35721366.61566.61
10min1444690-44469082.92883.817.6483.0283.907.64
2458750-45875085.55085.64
3428290-42829079.87079.96
4420894-42089478.49078.57
5430135-43013580.21480.30
6513804-51380495.81795.93
15min1519933-51993396.96096.722.7497.1996.962.75
2530458-53045898.92299.15
3505506-50550694.26994.49
4514690-51469095.98296.19
5502457-50245793.70193.92
6539005-539005100.516100.79
20min1541542-541542100.989100.720.46101.38101.110.46
2543557-543557101.365101.76
3541068-541068100.901101.28
4536954-536954100.134100.51
5537984-537984100.326100.70
6539458-539458100.601101.04
30min1547494-547494102.099101.550.59102.66102.110.57
2545612-545612101.748102.31
3546297-546297101.876102.42
4541802-541802101.038101.58
5546646-546646101.941102.48
6539528-539528100.614101.22
45min1547205-547205102.045101.470.65102.77102.200.63
2545162-545162101.664102.40
3545589-545589101.744102.46
4541246-541246100.934101.64
5547129-547129102.031102.74
6538512-538512100.424101.20
60min1545712-545712101.767101.290.63102.67102.190.61
2544026-544026101.453102.36
3544765-544765101.590102.48
4540864-540864100.863101.74
5546118-546118101.843102.72
6537383-537383100.214101.15
极限1545000-545000101.634101.310.41102.70102.380.42
2542305-542305101.132102.20
3543145-543145101.288102.34
4539422-539422100.594101.64
5544621-544621101.564102.61
6545161-545161101.664102.77
氢氯噻嗪坎地沙坦酯片项目信息
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%
116.521536061535771535201537641537101536350.07
216.491533881533641533760.02
单位质量响应值RSD%判断
9299.949301.150.01数据可信
中间条件6月-供试品溶液-2024082721批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.014619824616774609454609394611764613440.11
212.064561074570164565620.15
单位质量响应值RSD%判断
38413.3237857.551.04数据可信
中间条件6月-供试品溶液-2024082721批-氢氯噻嗪-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%
5min1463651-46365187.28065.8017.3587.2865.8017.35
2327873-32787361.72061.72
3337505-33750563.53363.53
4328432-32843261.82561.83
5355457-35545766.91366.91
6284257-28425753.51053.51
10min1524810-52481098.79390.445.5198.9490.555.53
2476853-47685389.76589.87
3461473-46147386.87086.98
4492527-49252792.71592.82
5478228-47822890.02490.14
6448657-44865784.45784.55
15min1532322-532322100.20797.482.59100.5297.742.60
2521145-52114598.10398.36
3496521-49652193.46793.72
4529689-52968999.71199.97
5518352-51835297.57797.84
6509036-50903695.82396.05
20min1531953-531953100.13799.521.63100.6199.941.63
2531203-53120399.996100.41
3511239-51123996.23896.64
4533775-533775100.480100.90
5531564-531564100.064100.49
6532286-532286100.200100.59
30min1530835-53083599.927100.251.31100.57100.841.30
2534649-534649100.645101.23
3520071-52007197.90098.47
4534009-534009100.524101.12
5534746-534746100.663101.25
6540974-540974101.835102.39
45min1529460-52946099.668100.411.02100.48101.171.01
2534156-534156100.552101.30
3525484-52548498.91999.65
4534629-534629100.641101.40
5535428-535428100.791101.55
6541372-541372101.910102.64
60min1527762-52776299.348100.341.01100.32101.260.98
2533528-533528100.434101.35
3527641-52764199.325100.22
4532872-532872100.310101.24
5534084-534084100.538101.47
6542213-542213102.069102.96
极限1530418-53041899.848101.310.98100.99102.400.95
2536248-536248100.946102.03
3545777-545777102.739103.80
4540173-540173101.685102.78
5535683-535683100.839101.93
6540693-540693101.782102.85
氢氯噻嗪坎地沙坦酯片项目信息
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%
116.521530021531031529701528101532341530240.11
216.491514051517741515900.18
单位质量响应值RSD%判断
9262.959192.840.54数据可信
中间条件6月-供试品溶液-2024082721批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
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