替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号22AD265对照品来源工作对照品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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.643060430533306033041930569305460.26
215.633056530602305840.09
单位质量响应值RSD%判断
1953.071956.750.14数据可信
供试品溶液-1批-氨氯地平-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%
5min127738-2773891.79690.592.9091.8090.592.91
227610-2761091.37291.37
328184-2818493.27293.27
425979-2597985.97485.97
526940-2694089.15589.15
627788-2778891.96191.96
10min129575-2957597.87595.773.0298.3896.273.01
229179-2917996.56497.07
328070-2807092.89493.41
427795-2779591.98492.46
528950-2895095.80796.30
630069-3006999.510100.02
15min129212-2921296.67495.592.6497.7396.622.63
229445-2944597.44598.49
328388-2838893.94794.98
427790-2779091.96892.96
528607-2860794.67195.70
629857-2985798.80899.87
20min129233-2923396.74395.551.7298.3397.111.73
228922-2892295.71497.30
328648-2864894.80796.36
428244-2824493.47094.97
528568-2856894.54296.10
629614-2961498.00499.62
30min128084-2808492.94190.632.3595.0792.732.34
228145-2814593.14395.26
326680-2668088.29490.38
426796-2679688.67890.70
527034-2703489.46691.54
627573-2757391.25093.41
45min127438-2743890.80390.071.5493.4592.681.54
227024-2702489.43392.07
327067-2706789.57592.15
427001-2700189.35791.87
526812-2681288.73191.31
627961-2796192.53495.20
60min128660-2866094.84791.742.2698.0094.842.25
227541-2754191.14494.28
327621-2762191.40894.48
427043-2704389.49692.50
527199-2719990.01293.08
628270-2827093.55696.73
90min127858-2785892.19391.131.5995.8794.741.58
227190-2719089.98293.62
327305-2730590.36393.94
427470-2747090.90994.41
527148-2714889.84393.41
628258-2825893.51697.21
120min126064-2606486.25685.081.2490.4489.201.22
225195-2519583.38087.52
325844-2584485.52889.61
425602-2560284.72788.74
525578-2557884.64788.72
625971-2597185.94890.17
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126874-2687488.93691.162.7593.6095.752.67
227690-2769091.63796.24
327809-2780992.03196.59
426774-2677488.60593.09
527297-2729790.33694.87
628835-2883595.426100.12
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80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%
111.459038419016509018289033029025419026320.11
211.439066289056039061160.08
单位质量响应值RSD%判断
78832.4979275.240.40数据可信
供试品溶液-1批-替米沙坦-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%
5min148602-486025.5336.0836.755.536.0836.78
256097-560976.3866.39
384395-843959.6089.61
428301-283013.2223.22
539282-392824.4724.47
663549-635497.2357.23
10min1112310-11231012.78613.6923.5412.8213.7323.56
2140963-14096316.04816.08
3152005-15200517.30517.36
473898-738988.4138.43
5107882-10788212.28212.31
6134584-13458415.32215.36
15min1154711-15471117.61320.1925.4317.7220.3025.42
2219941-21994125.04025.16
3210721-21072123.99024.14
4111089-11108912.64712.71
5150198-15019817.10017.19
6217249-21724924.73324.86
20min1195147-19514722.21726.1228.2922.4226.3428.24
2285128-28512832.46132.72
3257692-25769229.33829.62
4138785-13878515.80015.94
5191109-19110921.75721.95
6308821-30882135.15835.42
30min1256905-25690529.24835.2533.0929.5735.6233.00
2392057-39205744.63545.08
3324861-32486136.98537.43
4173603-17360319.76419.99
5255271-25527129.06229.37
6455289-45528951.83352.29
45min1316986-31698636.08845.7735.8036.5746.3435.70
2546211-54621162.18562.88
3394292-39429244.88945.54
4216395-21639524.63624.97
5342679-34267939.01339.48
6595703-59570367.81968.57
60min1364387-36438741.48451.9135.3442.1752.7335.26
2629090-62909071.62072.66
3443792-44379250.52551.43
4240279-24027927.35527.82
5398664-39866445.38746.07
6659677-65967775.10276.23
90min1421704-42170448.01061.8731.8048.9362.9831.73
2704090-70409080.15981.59
3499814-49981456.90258.08
4290537-29053733.07733.70
5603315-60331568.68669.63
6741368-74136884.40385.94
120min1456744-45674451.99966.6828.4353.1868.1328.45
2723695-72369582.39184.27
3612396-61239669.72071.22
4323379-32337936.81637.62
5636909-63690972.51073.83
6761160-76116086.65688.66
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1724112-72411282.43888.487.8483.9190.308.21
2814569-81456992.73695.07
3742633-74263384.54786.43
4709677-70967780.79581.80
5807691-80769191.95393.68
6864532-86453298.425100.91
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号22AD265对照品来源工作对照品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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.643072230658307183061430616306660.18
215.633077230674307230.23
单位质量响应值RSD%判断
1960.741965.640.18数据可信
供试品溶液-1批-氨氯地平-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%
5min126321-2632186.73991.443.0786.7491.443.07
228219-2821992.99392.99
328479-2847993.85093.85
427308-2730889.99189.99
527627-2762791.04391.04
628533-2853394.02894.03
10min128314-2831493.30794.541.8793.7995.051.87
229194-2919496.20696.72
329303-2930396.56697.09
427938-2793892.06792.57
528484-2848493.86794.37
628903-2890395.24895.77
15min128323-2832393.33695.001.2894.3496.031.28
228998-2899895.56196.61
329408-2940896.91297.97
428637-2863794.37195.38
528875-2887595.15596.18
628719-2871994.64195.69
20min127693-2769391.26093.801.8692.7895.361.85
228946-2894695.38996.97
328573-2857394.16095.76
428118-2811892.66194.20
528337-2833793.38294.94
629109-2910995.92697.50
30min128652-2865294.42094.221.0896.4596.301.08
228362-2836293.46595.58
329128-2912895.98998.11
428410-2841093.62395.67
528296-2829693.24795.32
628702-2870294.58596.70
45min127375-2737590.21290.621.4592.7693.221.44
227761-2776191.48494.12
327897-2789791.93294.58
427133-2713389.41591.99
526966-2696688.86491.46
627856-2785691.79794.43
60min126833-2683388.42690.852.2391.4893.962.20
227795-2779591.59694.74
328618-2861894.30897.47
427378-2737890.22293.29
527174-2717489.55092.64
627616-2761691.00694.15
90min127023-2702389.05290.571.9192.5994.181.89
227903-2790391.95295.60
328241-2824193.06696.75
427066-2706689.19492.76
527030-2703089.07592.66
627632-2763291.05994.71
120min125955-2595585.53387.981.7489.5792.101.73
226958-2695888.83893.00
327364-2736490.17694.38
426621-2662187.72791.79
526683-2668387.93292.01
626601-2660187.66191.82
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126969-2696988.87489.412.7493.3994.022.66
227255-2725589.81794.47
327465-2746590.50995.21
426082-2608285.95190.50
526732-2673288.09392.66
628290-2829093.22797.87
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80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%
111.459003109046639044099037069044049034980.21
211.439078149061659069900.13
单位质量响应值RSD%判断
78908.1279351.710.40数据可信
供试品溶液-1批-替米沙坦-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%
5min186046-860469.78710.568.429.7910.568.42
293722-9372210.66010.66
3105487-10548711.99812.00
493065-9306510.58510.59
595308-9530810.84010.84
683238-832389.4679.47
10min1174737-17473719.87420.924.4519.9320.984.46
2180313-18031320.50820.57
3193702-19370222.03122.10
4192823-19282321.93121.99
5185662-18566221.11721.18
6176225-17622520.04320.10
15min1243392-24339227.68330.146.3727.8530.326.36
2263683-26368329.99130.16
3275915-27591531.38231.57
4282043-28204332.07932.26
5278860-27886031.71731.89
6246241-24624128.00728.17
20min1303533-30353334.52337.785.4434.8438.125.44
2340906-34090638.77439.11
3332532-33253237.82138.18
4345801-34580139.33139.69
5351381-35138139.96540.32
6318756-31875636.25536.57
30min1423143-42314348.12751.925.7148.6452.485.69
2496091-49609156.42456.98
3468024-46802453.23253.81
4449780-44978051.15751.73
5466500-46650053.05953.63
6435559-43555949.54050.06
45min1548415-54841562.37667.123.8263.1567.963.83
2612555-61255569.67170.54
3602520-60252068.52969.40
4591104-59110467.23168.09
5600741-60074168.32769.20
6585512-58551266.59567.39
60min1617188-61718870.19875.874.0771.3277.084.06
2664973-66497375.63376.89
3698340-69834079.42880.68
4678895-67889577.21678.45
5674921-67492176.76478.01
6668100-66810075.98877.15
90min1677282-67728277.03382.804.4678.5584.444.41
2709082-70908280.65082.33
3761623-76162386.62588.32
4727264-72726482.71784.38
5730227-73022783.05484.73
6762405-76240586.71488.30
120min1703059-70305979.96485.294.5981.9187.394.53
2720578-72057881.95784.08
3771949-77194987.80089.97
4758298-75829886.24788.37
5747680-74768085.04087.18
6797925-79792590.75492.82
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1732624-73262483.32788.154.5385.7190.724.47
2753794-75379485.73588.31
3792418-79241890.12892.79
4766835-76683587.21889.82
5769981-76998187.57690.19
6834324-83432494.89497.47
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