盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992101172114862112922110452110382109960.25
216.002075252078192076720.11
单位质量响应值RSD%判断
13195.5012979.501.17数据可信
供试品溶液-2024042421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%
5min128241-2824114.46023.8925.9714.4623.8925.97
261704-6170431.59331.59
342642-4264221.83321.83
440593-4059320.78420.78
549916-4991625.55825.56
656911-5691129.13929.14
10min1160765-16076582.31488.163.7882.3988.303.79
2171647-17164787.88588.06
3180306-18030692.31992.44
4175354-17535489.78389.90
5171092-17109287.60187.74
6173968-17396889.07489.24
15min1190296-19029697.43497.942.2297.9798.562.21
2191749-19174998.17898.84
3186850-18685095.66996.30
4194759-19475999.719100.33
5186758-18675895.62296.25
6197290-197290101.015101.67
20min1193016-19301698.82798.261.8899.9199.431.87
2189186-18918696.86698.07
3189599-18959997.07798.24
4195398-195398100.046101.21
5187758-18775896.13497.29
6196554-196554100.638101.86
30min1194351-19435199.51099.451.86101.14101.171.84
2191074-19107497.83299.58
3192154-19215498.385100.09
4193260-19326098.951100.68
5193385-19338599.015100.71
6201209-201209103.021104.80
45min1200417-200417102.616100.041.65104.80102.311.60
2192876-19287698.755101.05
3194671-19467199.674101.93
4193855-19385599.256101.53
5192366-19236698.494100.74
6198187-198187101.474103.82
极限1197356-197356101.04998.612.00103.80101.431.94
2188075-18807596.29799.14
3189239-18923996.89399.70
4195576-195576100.137102.96
5190338-19033897.455100.25
6194970-19497099.827102.74
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992116172119642121752124822123632121200.17
216.002096462096422096440.01
单位质量响应值RSD%判断
13265.7913102.750.88数据可信
供试品溶液-2024042421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%
5min127150-2715013.79920.7758.7113.8020.7758.72
259748-5974830.36630.37
315137-151377.6937.69
455831-5583128.37528.38
516914-169148.5968.60
670430-7043035.79535.80
10min1165608-16560884.16883.335.2984.2583.455.35
2170264-17026486.53586.70
3159751-15975181.19281.23
4170286-17028686.54686.70
5148338-14833875.39175.44
6169531-16953186.16286.36
15min1185075-18507594.06294.302.6494.6194.882.70
2189560-18956096.34296.99
3182915-18291592.96493.46
4191500-19150097.32897.97
5177788-17778890.35990.83
6186377-18637794.72495.40
20min1185993-18599394.52996.321.7895.6097.421.80
2191548-19154897.35298.54
3191628-19162897.39398.40
4194164-19416498.68299.86
5186511-18651194.79295.76
6187286-18728695.18696.39
30min1190880-19088097.01396.691.3498.6098.331.34
2187237-18723795.16196.89
3190080-19008096.60698.16
4194757-19475798.983100.71
5188889-18888996.00197.50
6189655-18965596.39098.12
45min1187582-18758295.33696.021.3997.4798.201.39
2188999-18899996.05798.31
3186824-18682494.95197.04
4193654-19365498.422100.70
5189776-18977696.45298.48
6186759-18675994.91897.19
极限1188586-18858695.84796.050.7998.5198.760.85
2189989-18998996.56099.35
3187870-18787095.48398.10
4191548-19154897.352100.18
5188065-18806595.58298.15
6187847-18784795.47198.27
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992112492113782111232110802109242111510.09
216.002123842122222123030.06
单位质量响应值RSD%判断
13205.1913268.940.35数据可信
供试品溶液-2024042421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%
5min142912-4291221.72223.9734.2321.7223.9734.22
227115-2711513.72513.73
372546-7254636.72236.72
459787-5978730.26430.26
543135-4313521.83521.83
638598-3859819.53819.54
10min1185926-18592694.11589.206.3794.2489.336.39
2160853-16085381.42381.50
3188796-18879695.56895.77
4165913-16591383.98484.15
5181726-18172691.98992.11
6174056-17405688.10688.21
15min1193378-19337897.88795.881.3098.5396.511.31
2186613-18661394.46394.99
3187512-18751294.91895.65
4189302-18930295.82496.46
5190976-19097696.67197.30
6188755-18875595.54796.14
20min1190390-19039096.37596.171.4297.5697.321.41
2187127-18712794.72395.78
3187361-18736194.84196.10
4188792-18879295.56696.73
5193513-19351397.95599.12
6192679-19267997.53398.66
30min1192363-19236397.37396.540.6599.1098.240.67
2190956-19095696.66198.24
3191874-19187497.12698.91
4190171-19017196.26497.96
5189678-18967896.01497.73
6189283-18928395.81497.48
45min1189036-18903695.68995.930.9697.9598.160.90
2191167-19116796.76898.88
3186984-18698494.65096.98
4189978-18997896.16698.40
5191765-19176597.07199.32
6188183-18818395.25797.46
极限1193319-19331997.85796.151.88100.6598.921.83
2191904-19190497.14199.80
3188511-18851195.42398.28
4190721-19072196.54299.31
5191797-19179797.08799.87
6183451-18345192.86295.59
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992018712020882014822016102018742017850.12
216.002013372014262013820.04
单位质量响应值RSD%判断
12619.4512586.380.19数据可信
供试品溶液-2024042421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%
5min150825-5082527.02232.7290.0427.0232.7290.05
215280-152808.1248.12
3171371-17137191.11291.11
436192-3619219.24219.24
550472-5047226.83426.83
645131-4513123.99523.99
10min1195628-195628104.008103.963.52104.16104.143.56
2182591-18259197.07797.12
3196896-196896104.682105.19
4202527-202527107.676107.78
5199768-199768106.209106.36
6195818-195818104.109104.24
15min1203852-203852108.381105.022.46109.11105.782.42
2192262-192262102.219102.80
3193568-193568102.913104.00
4202695-202695107.766108.47
5197922-197922105.228105.97
6194856-194856103.598104.31
20min1203620-203620108.257105.502.77109.59106.842.72
2193775-193775103.023104.18
3194291-194291103.297104.96
4205907-205907109.473110.78
5199761-199761106.206107.53
6193224-193224102.730104.02
30min1203744-203744108.323104.913.24110.25106.843.18
2193428-193428102.839104.56
3192522-192522102.357104.59
4206268-206268109.665111.58
5197363-197363104.931106.84
6190640-190640101.356103.21
45min1200954-200954106.840103.902.69109.37106.412.62
2192138-192138102.153104.45
3189773-189773100.895103.70
4201354-201354107.053109.57
5197770-197770105.147107.64
6190537-190537101.302103.72
极限1197412-197412104.957103.081.78108.08106.171.67
2193495-193495102.874105.74
3188349-188349100.138103.50
4197531-197531105.020108.14
5194155-194155103.225106.31
6192343-192343102.262105.25
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