盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.724702054704034698994706194699084702070.07
215.674709274713124711200.06
单位质量响应值RSD%判断
29911.3930065.090.37数据可信
供试品溶液-2024041121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%
2min1228799-22879948.29145.1715.7948.2945.1715.79
2261379-26137955.16755.17
3163138-16313834.43234.43
4197656-19765641.71841.72
5230219-23021948.59048.59
6202857-20285742.81542.82
5min1323912-32391268.36569.755.9168.3769.755.92
2360118-36011876.00776.01
3306737-30673764.74064.74
4319294-31929467.39167.39
5325754-32575468.75468.75
6347045-34704573.24873.25
10min1324918-32491868.57868.752.6368.5868.752.63
2341419-34141972.06072.06
3327036-32703669.02569.02
4323333-32333368.24368.24
5321515-32151567.85967.86
6316117-31611766.72066.72
15min1332494-33249470.17769.382.6370.1869.382.63
2331779-33177970.02670.03
3334353-33435370.56970.57
4324965-32496568.58868.59
5312883-31288366.03866.04
6335860-33586070.88770.89
20min1318579-31857967.24067.302.1667.2467.302.16
2319448-31944867.42367.42
3330383-33038369.73169.73
4312437-31243765.94365.94
5311327-31132765.70965.71
6321051-32105167.76267.76
30min1304155-30415564.19564.553.2764.2064.553.27
2320285-32028567.60067.60
3314907-31490766.46566.46
4300461-30046163.41663.42
5302115-30211563.76563.76
6293138-29313861.87061.87
45min1283724-28372459.88361.472.4059.8861.472.40
2294202-29420262.09562.09
3300400-30040063.40363.40
4292920-29292061.82461.82
5282106-28210659.54259.54
6294063-29406362.06562.07
极限1280118-28011859.12260.142.0059.1260.142.00
2292646-29264661.76661.77
3288078-28807860.80260.80
4283574-28357459.85259.85
5277338-27733858.53558.54
6287949-28794960.77560.77
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.724714504704184704054708534711164708480.10
215.674703784705784704780.04
单位质量响应值RSD%判断
29952.1630024.120.17数据可信
供试品溶液-2024041121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%
2min1234218-23421849.43444.0011.9849.4344.0011.98
2215242-21524245.42945.43
3192326-19232640.59340.59
4214519-21451945.27745.28
5166736-16673635.19235.19
6227696-22769648.05848.06
5min1314284-31428466.33362.345.6166.3362.345.60
2304893-30489364.35164.35
3291744-29174461.57661.58
4308619-30861965.13865.14
5278198-27819858.71758.72
6274450-27445057.92657.93
10min1302204-30220463.78461.925.9663.7861.925.96
2303443-30344364.04564.05
3279263-27926358.94258.94
4319284-31928467.38867.39
5279847-27984759.06559.06
6276238-27623858.30358.30
15min1271729-27172957.35160.133.8557.3560.133.85
2282620-28262059.65059.65
3300666-30066663.45963.46
4279031-27903158.89358.89
5279849-27984959.06559.07
6295557-29555762.38162.38
20min1268957-26895756.76661.206.4756.7761.206.47
2298612-29861263.02563.03
3308930-30893065.20365.20
4300880-30088063.50463.50
5298664-29866463.03663.04
6263784-26378455.67555.67
30min1246403-24640352.00658.016.1952.0158.016.19
2280149-28014959.12959.13
3295283-29528362.32362.32
4278554-27855458.79258.79
5283750-28375059.88959.89
6264913-26491355.91355.91
45min1258905-25890554.64558.583.6854.6458.583.69
2283774-28377459.89459.89
3288517-28851760.89560.89
4280863-28086359.27959.28
5277601-27760158.59158.59
6275618-27561858.17258.17
极限1269034-26903456.78357.302.9756.7857.302.97
2271541-27154157.31257.31
3285108-28510860.17560.18
4267972-26797256.55956.56
5260922-26092255.07155.07
6274442-27444257.92457.92
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.724720814725194721204718674712744719720.10
215.674727234721464724340.09
单位质量响应值RSD%判断
30023.6630148.950.30数据可信
供试品溶液-2024041121批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1336280-33628070.74475.8710.9770.7475.8710.96
2306527-30652764.48564.49
3335147-33514770.50670.51
4399827-39982784.11384.11
5391018-39101882.26082.26
6395012-39501283.10083.10
5min1538976-538976113.386110.863.96113.39110.863.96
2487601-487601102.578102.58
3519232-519232109.233109.23
4539117-539117113.416113.42
5540572-540572113.722113.72
6536167-536167112.795112.80
10min1548527-548527115.395114.510.66115.40114.510.66
2543127-543127114.259114.26
3539218-539218113.437113.44
4544179-544179114.481114.48
5548308-548308115.349115.35
6542511-542511114.130114.13
15min1549511-549511115.602114.890.80115.60114.880.81
2545661-545661114.792114.79
3538435-538435113.272113.27
4545812-545812114.824114.82
5551061-551061115.928115.93
6546189-546189114.904114.90
20min1549312-549312115.561114.980.63115.56114.980.63
2545763-545763114.814114.81
3541535-541535113.924113.92
4546380-546380114.944114.94
5551277-551277115.974115.97
6545000-545000114.653114.65
30min1563086-563086118.458115.501.42118.46115.511.42
2544844-544844114.621114.62
3541547-541547113.927113.93
4546672-546672115.005115.01
5552625-552625116.258116.26
6545493-545493114.757114.76
45min1551504-551504116.022115.030.76116.02115.030.75
2547299-547299115.137115.14
3541401-541401113.896113.90
4543626-543626114.364114.36
5551346-551346115.988115.99
6545437-545437114.745114.75
极限1550380-550380115.785114.850.85115.79114.850.85
2546436-546436114.956114.96
3542278-542278114.081114.08
4542671-542671114.163114.16
5552381-552381116.206116.21
6541510-541510113.919113.92
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.724705844710154709724707964706754708080.04
215.674703484697754700620.09
单位质量响应值RSD%判断
29949.6229997.570.12数据可信
供试品溶液-2024041121批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1374124-37412479.00179.888.8479.0079.888.84
2328798-32879869.43069.43
3371021-37102178.34678.35
4415437-41543787.72587.73
5363734-36373476.80776.81
6416639-41663987.97987.98
5min1528720-528720111.646109.143.80111.65109.143.80
2481894-481894101.758101.76
3517397-517397109.255109.26
4525844-525844111.039111.04
5509636-509636107.617107.62
6537590-537590113.519113.52
10min1540325-540325114.097113.870.87114.10113.870.87
2532344-532344112.412112.41
3541619-541619114.370114.37
4536570-536570113.304113.30
5538570-538570113.726113.73
6546084-546084115.313115.31
15min1542207-542207114.494114.490.59114.49114.490.59
2538949-538949113.806113.81
3542591-542591114.575114.58
4538910-538910113.798113.80
5542905-542905114.642114.64
6547529-547529115.618115.62
20min1541111-541111114.263114.470.61114.26114.470.61
2536569-536569113.304113.30
3544506-544506114.980114.98
4541669-541669114.381114.38
5542589-542589114.575114.57
6546148-546148115.327115.33
30min1542023-542023114.455114.510.69114.46114.510.69
2539122-539122113.843113.84
3543659-543659114.801114.80
4537518-537518113.504113.50
5543447-543447114.756114.76
6547977-547977115.713115.71
45min1548379-548379115.798115.120.68115.80115.120.68
2540981-540981114.235114.24
3544639-544639115.008115.01
4542352-542352114.525114.52
5543887-543887114.849114.85
6550729-550729116.294116.29
极限1545455-545455115.180114.650.62115.18114.650.62
2540947-540947114.228114.23
3544674-544674115.015115.02
4539416-539416113.905113.90
5539798-539798113.986113.99
6547357-547357115.582115.58
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