奥美沙坦酯口崩片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819669296645966659664396690966670.03
28.789733797250972940.07
单位质量响应值RSD%判断
10972.4211081.320.70数据可信
供试品溶液-2024041311批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min199845-99845101.66498.565.12101.6698.565.12
296025-9602597.77597.77
391251-9125192.91492.91
495223-9522396.95896.96
5105051-105051106.965106.96
693412-9341295.11495.11
10min199053-99053100.85898.653.21101.4299.203.21
298984-98984100.787101.33
392190-9219093.87094.39
497905-9790599.689100.23
599410-99410101.221101.82
693785-9378595.49496.02
15min1100867-100867102.70599.012.97103.83100.102.98
297907-9790799.691100.79
393762-9376295.47096.51
496958-9695898.72599.82
599750-99750101.567102.72
694160-9416095.87696.93
20min199242-99242101.05096.893.32102.7598.543.31
293162-9316294.85996.52
391992-9199293.66895.24
497013-9701398.781100.42
597520-9752099.297101.02
691996-9199693.67295.26
30min198150-9815099.93897.513.55102.2099.693.54
294328-9432896.04798.23
390737-9073792.39094.48
498279-98279100.070102.26
599466-99466101.278103.55
693616-9361695.32297.43
45min1100006-100006101.82897.253.62104.6499.983.61
294648-9464896.37299.09
391743-9174393.41596.02
495968-9596897.716100.46
598834-98834100.635103.47
691882-9188293.55696.20
60min197769-9776999.55095.434.02102.9398.704.00
291104-9110492.76496.02
389496-8949691.12794.25
496833-9683398.597101.89
596742-9674298.505101.90
690393-9039392.04095.20
极限194691-9469196.41694.202.95100.3598.002.96
290626-9062692.27796.05
389325-8932590.95294.58
494752-9475296.478100.31
595454-9545497.193101.13
690263-9026391.90895.58
奥美沙坦酯口崩片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819692897258969329693296926969950.16
28.789636096542964510.14
单位质量响应值RSD%判断
11009.6510985.310.16数据可信
供试品溶液-2024041311批-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%
5min170276-7027671.74671.101.8071.7571.101.81
269952-6995271.41571.42
370804-7080472.28572.29
470648-7064872.12672.13
567778-6777869.19669.20
668410-6841069.84169.84
10min183039-8303984.77683.422.1685.1783.822.16
280943-8094382.63683.03
382130-8213083.84884.25
484185-8418585.94686.35
579292-7929280.95181.33
680703-8070382.39182.78
15min186297-8629788.10286.113.3988.9786.973.37
285047-8504786.82687.68
387103-8710388.92589.79
485835-8583587.63088.51
582069-8206983.78684.62
679715-7971581.38282.23
20min187598-8759889.43087.523.2490.7988.863.23
285842-8584287.63888.98
389086-8908690.94992.31
486785-8678588.60089.97
583546-8354685.29486.59
681510-8151083.21584.51
30min189167-8916791.03288.553.1892.8990.373.16
284531-8453186.29988.12
390014-9001491.89793.76
488412-8841290.26192.12
584307-8430786.07087.84
683977-8397785.73487.49
45min187536-8753689.36787.752.1091.7390.062.11
285916-8591687.71390.02
388001-8800189.84292.22
486506-8650688.31590.67
584356-8435686.12088.37
683371-8337185.11587.35
60min186242-8624288.04686.572.5290.9089.372.52
283785-8378585.53888.33
387141-8714188.96491.84
486644-8664488.45691.31
582646-8264684.37587.10
682311-8231184.03386.74
极限187769-8776989.60586.323.9892.9589.603.92
283162-8316284.90288.17
388957-8895790.81894.19
485103-8510386.88390.22
582036-8203683.75286.95
680299-8029981.97985.15
奥美沙坦酯口崩片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819715497049969729700197128970610.09
28.789760497492975480.09
单位质量响应值RSD%判断
11017.1411110.250.60数据可信
供试品溶液-2024041311批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min117273-1727317.52918.544.7817.5318.544.79
217905-1790518.17018.17
318481-1848118.75518.75
417475-1747517.73417.73
519509-1950919.79819.80
618956-1895619.23719.24
10min125055-2505525.42625.923.1925.5226.033.19
224683-2468325.04925.15
325268-2526825.64325.75
425321-2532125.69625.79
526957-2695727.35727.47
625990-2599026.37526.48
15min130374-3037430.82429.606.6531.0629.856.61
225344-2534425.72025.96
329825-2982530.26730.51
429078-2907829.50929.75
530464-3046430.91631.18
629919-2991930.36330.62
20min133783-3378334.28432.058.9734.6932.468.87
231754-3175432.22532.61
332186-3218632.66333.08
426023-2602326.40926.81
533402-3340233.89734.33
632365-3236532.84533.27
30min137325-3732537.87835.693.7738.4836.283.75
233359-3335933.85434.42
334662-3466235.17635.77
434616-3461635.12935.68
535610-3561036.13836.76
635440-3544035.96536.57
45min142634-4263443.26638.616.3344.0839.406.26
236075-3607536.61037.36
336177-3617736.71337.50
437294-3729437.84738.59
538004-3800438.56739.39
638106-3810638.67139.48
60min143486-4348644.13139.266.5245.1840.266.44
236968-3696837.51638.47
336868-3686837.41538.41
437118-3711837.66838.63
538881-3888139.45740.49
638804-3880439.37940.40
极限144306-4430644.96340.086.1546.2641.306.07
237593-3759338.15039.31
338243-3824338.81040.01
438946-3894639.52340.69
539242-3924239.82441.08
638638-3863839.21140.45
奥美沙坦酯口崩片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
18.819723497176970449712696911970980.13
28.789580996021959150.16
单位质量响应值RSD%判断
11021.3410924.260.63数据可信
供试品溶液-2024041311批-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%
5min14546-45464.6524.963.664.654.963.66
25043-50435.1605.16
34939-49395.0545.05
44808-48084.9204.92
54766-47664.8774.88
64953-49535.0685.07
10min17972-79728.1578.372.508.188.402.50
28346-83468.5408.57
38258-82588.4508.48
48388-83888.5838.61
58222-82228.4138.44
67887-78878.0708.10
15min19935-993510.16610.612.8410.2410.682.83
210760-1076011.01011.09
310420-1042010.66210.74
410233-1023310.47110.55
510603-1060310.84910.92
610250-1025010.48810.56
20min111343-1134311.60711.972.0811.7312.102.10
211985-1198512.26312.40
311637-1163711.90712.04
411714-1171411.98612.12
511960-1196012.23812.37
611573-1157311.84211.97
30min113773-1377314.09313.991.7614.2914.191.75
213511-1351113.82514.03
313430-1343013.74213.94
413886-1388614.20914.41
513979-1397914.30414.51
613442-1344213.75413.95
45min114997-1499715.34515.701.8715.6215.981.85
215182-1518215.53515.82
315508-1550815.86816.15
415497-1549715.85716.14
515756-1575616.12216.40
615136-1513615.48815.76
60min115682-1568216.04616.622.4316.4016.982.41
216028-1602816.40016.77
316534-1653416.91817.28
416398-1639816.77917.15
516760-1676017.14917.52
616050-1605016.42316.78
极限116691-1669117.07917.341.6917.5217.801.67
216715-1671517.10317.56
316842-1684217.23317.69
417465-1746517.87118.33
517036-1703617.43217.90
616928-1692817.32117.77
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