坎地沙坦酯氢氯噻嗪片项目信息
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%
111.904635934636494631934637624636194635630.05
212.024624484622334623400.04
单位质量响应值RSD%判断
38954.8738464.230.90数据可信
供试品溶液-2024052221批-氢氯噻嗪-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%
5min1294040-29404054.53055.318.5654.5355.318.56
2254863-25486347.26447.26
3324096-32409660.10460.10
4318458-31845859.05859.06
5310819-31081957.64157.64
6287204-28720453.26253.26
10min1451299-45129983.69384.864.4883.7884.954.49
2432978-43297880.29680.37
3494936-49493691.78691.89
4459240-45924085.16685.26
5456964-45696484.74484.84
6450138-45013883.47883.57
15min1498927-49892792.52694.042.7592.7694.282.75
2493141-49314191.45391.67
3530646-53064698.40898.66
4510089-51008994.59694.84
5512990-51299095.13495.37
6496748-49674892.12292.35
20min1518605-51860596.17596.851.9096.5697.241.90
2517321-51732195.93796.30
3538174-53817499.804100.22
4520487-52048796.52496.92
5528922-52892298.08998.48
6510061-51006194.59194.97
30min1533976-53397699.02698.771.3999.5799.321.39
2530883-53088398.45298.98
3542512-542512100.609101.19
4527675-52767597.85798.42
5538414-53841499.849100.41
6522161-52216196.83597.37
45min1542582-542582100.62299.871.07101.33100.581.08
2537039-53703999.594100.28
3543485-543485100.789101.54
4534801-53480199.17999.90
5543649-543649100.820101.55
6529533-52953398.20298.90
60min1542172-542172100.54699.900.73101.42100.780.74
2536499-53649999.494100.35
3541655-541655100.450101.37
4536151-53615199.429100.32
5542477-542477100.602101.50
6533212-53321298.88499.75
极限1542681-542681100.64099.830.82101.69100.880.82
2535090-53509099.232100.25
3538295-53829599.827100.91
4536075-53607599.415100.47
5544319-544319100.944102.01
6533336-53333698.90799.94
坎地沙坦酯氢氯噻嗪片项目信息
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%
115.921617501618441615741617071619221617590.09
215.961618411619151618780.04
单位质量响应值RSD%判断
10160.7410142.730.13数据可信
供试品溶液-2024052221批-坎地沙坦酯-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%
5min110550-105505.8345.824.005.835.824.00
210441-104415.7745.77
39840-98405.4415.44
411086-110866.1306.13
510799-107995.9725.97
610402-104025.7525.75
10min113942-139427.7107.237.797.727.247.80
212713-127137.0307.04
311218-112186.2036.21
413212-132127.3067.32
513534-135347.4847.49
613867-138677.6687.68
15min115306-153068.4648.165.908.498.185.90
214937-149378.2608.28
313197-131977.2987.32
415593-155938.6238.65
514347-143477.9347.96
615149-151498.3778.40
20min115570-155708.6108.623.238.658.663.21
215415-154158.5248.56
314894-148948.2368.27
416433-164339.0879.12
515475-154758.5578.59
615738-157388.7038.74
30min116807-168079.2949.114.609.359.164.61
216513-165139.1319.18
315385-153858.5088.55
417661-176619.7669.82
516454-164549.0999.15
616068-160688.8858.94
45min117415-174159.6309.582.879.709.652.85
217750-177509.8159.88
316612-166129.1869.25
416940-169409.3689.44
517299-172999.5669.63
617945-179459.9239.99
60min118471-1847110.2149.814.5810.309.894.58
218461-1846110.20910.29
316463-164639.1049.18
418323-1832310.13210.22
517380-173809.6119.69
617359-173599.5999.68
极限117999-179999.9539.951.8310.0510.051.79
217914-179149.90610.00
317956-179569.92910.02
417642-176429.7569.86
517855-178559.8749.97
618618-1861810.29510.39
坎地沙坦酯氢氯噻嗪片项目信息
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%
111.904622334620764619394619254620134620370.03
212.024601124597574599340.06
单位质量响应值RSD%判断
38826.6438264.061.04数据可信
供试品溶液-2024052221批-氢氯噻嗪-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%
5min1322778-32277860.11559.274.9360.1159.274.93
2314036-31403658.48758.49
3338782-33878263.09663.10
4291385-29138554.26854.27
5317645-31764559.15959.16
6324913-32491360.51360.51
10min1471472-47147287.80887.012.3087.9187.112.30
2470253-47025387.58187.68
3462355-46235586.11086.22
4448352-44835283.50283.59
5471207-47120787.75987.86
6479602-47960289.32289.42
15min1510792-51079295.13195.292.3595.3895.542.35
2516919-51691996.27296.52
3511304-51130495.22795.48
4489117-48911791.09491.32
5518509-51850996.56896.81
6523297-52329797.46097.71
20min1526416-52641698.04197.571.7998.4597.981.79
2528112-52811298.35798.76
3526014-52601497.96698.37
4505430-50543094.13394.51
5525646-52564697.89898.30
6531810-53181099.04699.46
30min1536198-53619899.86399.420.90100.4399.990.91
2534774-53477499.598100.17
3538152-538152100.227100.80
4525337-52533797.84098.38
5531308-53130898.95299.52
6537138-537138100.038100.62
45min1541230-541230100.800100.340.45101.53101.070.45
2538102-538102100.217100.95
3541289-541289100.811101.55
4537742-537742100.150100.85
5534998-53499899.639100.37
6539177-539177100.418101.16
60min1540097-540097100.589100.280.63101.49101.180.63
2536099-53609999.844100.75
3540766-540766100.714101.62
4538388-538388100.271101.14
5533102-53310299.286100.19
6542242-542242100.989101.90
极限1538738-538738100.33699.890.57101.41100.960.57
2535045-53504599.648100.72
3538480-538480100.288101.36
4535081-53508199.655100.69
5531552-53155298.998100.06
6539319-539319100.444101.52
坎地沙坦酯氢氯噻嗪片项目信息
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%
115.921617141619141618981617181619251618340.07
215.961614061614021614040.01
单位质量响应值RSD%判断
10165.4510113.030.37数据可信
供试品溶液-2024052221批-坎地沙坦酯-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%
5min110978-109786.0785.763.046.085.763.03
210162-101625.6265.63
310504-105045.8165.82
410406-104065.7615.76
510124-101245.6055.61
610255-102555.6785.68
10min113346-133467.3897.443.007.407.442.99
212917-129177.1527.16
313669-136697.5687.58
414078-140787.7957.80
513375-133757.4057.41
613192-131927.3047.31
15min115250-152508.4438.123.428.478.143.44
214556-145568.0598.08
314497-144978.0278.05
414508-145088.0338.06
513929-139297.7127.73
615220-152208.4278.45
20min115891-158918.7988.611.708.838.641.69
215383-153838.5178.55
315496-154968.5808.62
415292-152928.4678.50
515371-153718.5108.54
615872-158728.7888.82
30min116217-162178.9798.902.999.038.952.98
216505-165059.1389.19
316126-161268.9288.98
415259-152598.4488.50
515789-157898.7428.79
616519-165199.1469.20
45min116905-169059.3609.311.959.439.371.93
216575-165759.1779.24
317321-173219.5909.65
416880-168809.3469.41
516827-168279.3179.38
616358-163589.0579.12
60min117915-179159.9199.822.9810.009.902.99
217329-173299.5959.67
318325-1832510.14610.23
417691-176919.7959.87
518243-1824310.10110.18
616966-169669.3949.47
极限118363-1836310.1679.923.3010.2710.023.28
218079-1807910.01010.11
318034-180349.98510.08
416767-167679.2839.38
518337-1833710.15310.25
617962-179629.94510.04
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