阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.042960802970122960152964702954952962140.20
211.202950982959662955320.21
单位质量响应值RSD%判断
26830.9826386.791.19数据可信
供试品溶液-2023101221批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min117299-172995.8345.0337.985.835.0337.97
26749-67492.2762.28
311510-115103.8823.88
412334-123344.1604.16
521342-213427.1977.20
620254-202546.8306.83
10min175449-7544925.44524.0710.5225.4824.1010.55
258723-5872319.80419.82
367563-6756322.78522.81
470361-7036123.72923.75
577660-7766026.19026.23
678424-7842426.44826.49
15min1162279-16227954.72753.393.0054.9053.553.02
2151567-15156751.11551.24
3153688-15368851.83051.98
4160616-16061654.16654.32
5158457-15845753.43853.62
6163229-16322955.04855.23
20min1193131-19313165.13264.182.3165.6164.642.33
2186066-18606662.74963.16
3185554-18555462.57763.01
4196573-19657366.29366.75
5188202-18820263.47063.95
6192400-19240064.88565.38
30min1211125-21112571.20072.093.1072.0472.903.08
2205500-20550069.30370.06
3224461-22446175.69876.48
4209373-20937370.60971.43
5216265-21626572.93473.77
6215819-21581972.78373.63
45min1227856-22785676.84378.133.3478.0879.343.31
2223518-22351875.38076.52
3244192-24419282.35283.56
4225945-22594576.19877.41
5236981-23698179.92081.16
6231477-23147778.06479.32
60min1223923-22392375.51678.312.2077.1879.962.12
2237812-23781280.20081.76
3236723-23672379.83381.49
4233840-23384078.86180.50
5230062-23006277.58779.27
6230870-23087077.85979.55
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.042941712932452926522934372924242931860.24
211.202961692961562961620.01
单位质量响应值RSD%判断
26556.7026443.040.31数据可信
供试品溶液-2023101221批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111344-113443.8415.0920.113.845.0920.11
215113-151135.1175.12
319556-195566.6226.62
417288-172885.8545.85
514247-142474.8244.82
612613-126134.2714.27
10min164188-6418821.73523.795.5421.7623.825.55
271545-7154524.22624.25
375074-7507425.42125.46
471009-7100924.04424.08
572416-7241624.52124.55
667311-6731122.79222.82
15min1145327-14532749.20952.383.4249.3552.543.43
2156466-15646652.98053.14
3157481-15748153.32453.50
4155617-15561752.69352.86
5160650-16065054.39754.56
6152588-15258851.66751.82
20min1176427-17642759.73963.013.2360.1563.463.24
2188003-18800363.65964.12
3184489-18448962.46962.94
4189742-18974264.24864.71
5193993-19399365.68766.15
6183830-18383062.24662.68
30min1188128-18812863.70168.705.1464.4569.505.12
2203665-20366568.96269.77
3215389-21538972.93273.75
4203068-20306868.76069.58
5212701-21270172.02272.85
6194469-19446965.84966.63
45min1217537-21753773.66076.434.6774.7677.614.65
2235868-23586879.86781.06
3237879-23787980.54781.77
4220659-22065974.71775.91
5230372-23037278.00679.24
6211946-21194671.76672.92
60min1227039-22703976.87776.561.7478.3978.171.73
2231514-23151478.39280.03
3225447-22544776.33878.01
4227564-22756477.05578.67
5225577-22557776.38278.05
6219456-21945674.30975.86
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.042909432918022907882912362920982913730.20
211.202924892930622927760.14
单位质量响应值RSD%判断
26392.4826140.710.68数据可信
供试品溶液-2024010621批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122356-223567.6375.2426.297.645.2426.29
212284-122844.1964.20
317736-177366.0596.06
411776-117764.0234.02
514074-140744.8084.81
613745-137454.6964.70
10min175823-7582325.90323.706.5025.9523.736.53
265421-6542122.34922.37
373152-7315224.99025.02
464051-6405121.88121.90
569704-6970423.81223.84
668100-6810023.26423.29
15min1154485-15448552.77551.792.7452.9651.952.76
2152818-15281852.20652.35
3156823-15682353.57453.75
4146862-14686250.17150.31
5152170-15217051.98452.14
6146506-14650650.04950.20
20min1182374-18237462.30362.332.4762.7862.782.47
2182195-18219562.24262.68
3190890-19089065.21265.68
4179334-17933461.26461.69
5181918-18191862.14762.59
6178014-17801460.81361.25
30min1204849-20484969.98170.512.5470.8171.312.53
2208855-20885571.34972.13
3214821-21482173.38774.22
4205607-20560770.24071.00
5205370-20537070.15970.95
6198918-19891867.95468.73
45min1219276-21927674.90976.602.9876.1277.782.96
2229069-22906978.25579.43
3233984-23398479.93481.17
4225171-22517176.92378.08
5222230-22223075.91877.10
6215619-21561973.66074.81
60min1224626-22462676.73776.612.0378.3778.222.03
2229489-22948978.39880.01
3229315-22931578.33980.02
4223619-22361976.39377.97
5218807-21880774.74976.35
6219740-21974075.06876.63
阿齐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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.042925782921932936892929622935562929960.22
211.202903772934202918980.74
单位质量响应值RSD%判断
26539.4926062.321.29数据可信
供试品溶液-2024010621批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min116679-166795.6916.4330.675.696.4230.70
224414-244148.3308.33
320819-208197.1037.10
413924-139244.7514.75
525748-257488.7858.79
611407-114073.8923.89
10min172112-7211224.60424.848.5324.6424.888.56
277546-7754626.45826.50
377504-7750426.44426.48
465756-6575622.43622.46
578895-7889526.91926.97
665013-6501322.18222.20
15min1153069-15306952.22653.094.3752.3953.274.39
2159088-15908854.28054.47
3166184-16618456.70156.89
4146935-14693550.13350.28
5157421-15742153.71153.91
6150972-15097251.51151.66
20min1183836-18383662.72463.164.3463.1863.634.35
2192052-19205265.52766.02
3196631-19663167.09067.59
4174388-17438859.50059.93
5183362-18336262.56263.06
6180485-18048561.58162.01
30min1208899-20889971.27571.224.9372.0872.044.94
2214091-21409173.04773.91
3225194-22519476.83577.71
4195531-19553166.71467.47
5207191-20719170.69371.54
6201476-20147668.74369.52
45min1213579-21357972.87278.135.3174.0779.345.28
2233696-23369679.73681.00
3248375-24837584.74486.05
4233205-23320579.56880.70
5223284-22328476.18377.42
6221751-22175175.66076.82
60min1233876-23387679.79778.143.9281.4179.793.82
2234607-23460780.04781.75
3215433-21543373.50575.28
4222319-22231975.85477.43
5239833-23983381.83083.49
6227973-22797377.78379.36
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