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420158-202301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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.252099572103902110582100652102402103420.21
216.292107532110542109040.11
单位质量响应值RSD%判断
12944.1212946.840.02数据可信
供试品溶液-2024042221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%
5min118938-189389.78313.8440.349.7813.8440.32
221058-2105810.87810.88
312595-125956.5066.51
440546-4054620.94420.94
533710-3371017.41317.41
633921-3392117.52217.52
10min184061-8406143.42249.898.0743.4849.978.09
2103923-10392353.68253.74
392815-9281547.94447.98
4103701-10370153.56853.68
5101109-10110952.22952.33
693877-9387748.49348.59
15min1125343-12534364.74765.971.3065.0466.331.32
2126204-12620465.19265.55
3129508-12950866.89867.20
4128131-12813166.18766.60
5129285-12928566.78367.17
6127836-12783666.03566.40
20min1132375-13237568.37968.532.2969.0369.252.29
2131306-13130667.82768.55
3132288-13228868.33569.01
4135598-13559870.04470.83
5136375-13637570.44671.20
6128040-12804066.14066.87
30min1136489-13648970.50570.581.3571.5471.681.36
2134612-13461269.53570.63
3136499-13649970.51071.56
4136883-13688370.70871.88
5139954-13995472.29473.44
6135342-13534269.91271.01
45min1135281-13528169.88166.412.9771.3167.902.87
2127421-12742165.82067.30
3127739-12773965.98567.43
4124667-12466764.39865.96
5130348-13034867.33268.88
6125882-12588265.02566.51
极限1134906-13490669.68763.215.8771.5065.075.71
2117423-11742360.65662.51
3115116-11511659.46461.28
4122819-12281963.44365.36
5125343-12534364.74766.67
6118575-11857561.25163.10
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420158-202301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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.252098182103172112242099872100242102740.27
216.292116042122642119340.23
单位质量响应值RSD%判断
12939.9413010.070.39数据可信
供试品溶液-2024042221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%
5min145099-4509923.24319.2424.8623.2419.2424.84
220985-2098510.81510.82
336475-3647518.79918.80
443504-4350422.42122.42
544379-4437922.87222.87
633541-3354117.28717.29
10min1108464-10846455.90153.265.3456.0353.365.35
298619-9861950.82750.89
396626-9662649.80049.90
499936-9993651.50651.63
5108345-10834555.84055.97
6107990-10799055.65755.75
15min1134626-13462669.38467.993.0269.8268.403.02
2130545-13054567.28167.62
3129010-12901066.49066.87
4126110-12611064.99565.41
5135767-13576769.97370.41
6135506-13550669.83870.24
20min1134814-13481469.48169.932.6470.3170.722.65
2132354-13235468.21468.93
3135441-13544169.80570.56
4136141-13614170.16570.94
5142361-14236173.37174.20
6133023-13302368.55869.35
30min1145889-14588975.18971.863.0376.4073.033.03
2136021-13602170.10371.20
3140627-14062772.47773.62
4136435-13643570.31771.48
5142319-14231973.34974.58
6135308-13530869.73670.91
45min1131535-13153567.79167.801.5769.4269.371.53
2132434-13243468.25569.74
3128026-12802665.98367.52
4131980-13198068.02169.57
5131093-13109367.56469.20
6134288-13428869.21070.77
极限1126113-12611364.99765.561.8267.0067.501.79
2128067-12806766.00467.87
3125062-12506264.45566.36
4128971-12897166.47068.40
5130386-13038667.19969.22
6124578-12457864.20666.15
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420158-202301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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.252112292106662112982108552107252109550.14
216.292116682106392111540.35
单位质量响应值RSD%判断
12981.8512962.190.11数据可信
供试品溶液-2024042321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%
5min145533-4553323.47220.2216.9423.4720.2216.94
235892-3589218.50218.50
339930-3993020.58420.58
438058-3805819.61919.62
547066-4706624.26324.26
628909-2890914.90314.90
10min196894-9689449.94949.595.9750.0849.715.98
288961-8896145.86045.96
3102102-10210252.63452.75
494561-9456148.74648.86
5103334-10333453.26953.40
691381-9138147.10747.19
15min1128927-12892766.46266.212.1366.8766.602.16
2129026-12902666.51366.87
3130221-13022167.12967.54
4127689-12768965.82466.20
5131301-13130167.68668.12
6123473-12347363.65164.00
20min1138497-13849771.39670.091.6572.1770.841.67
2132497-13249768.30269.03
3135667-13566769.93770.72
4136794-13679470.51871.26
5137849-13784971.06171.87
6134467-13446769.31870.02
30min1135776-13577669.99371.321.1571.1772.461.12
2138109-13810971.19572.30
3140428-14042872.39173.56
4139430-13943071.87673.01
5137802-13780271.03772.24
6138517-13851771.40672.49
45min1131524-13152467.80170.652.4169.3672.202.34
2137443-13744370.85272.35
3136942-13694270.59472.16
4141498-14149872.94374.48
5136121-13612170.17171.77
6138827-13882771.56673.05
极限1122480-12248063.13968.224.4665.0870.164.32
2129527-12952766.77168.67
3132419-13241968.26270.22
4136941-13694170.59372.54
5133626-13362668.88470.87
6139088-13908871.70073.58
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420158-202301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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.252107512109112110542108382107222108550.07
216.292116562120022118290.12
单位质量响应值RSD%判断
12975.6913003.620.16数据可信
供试品溶液-2024042321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%
5min121776-2177611.21016.9729.5211.2116.9729.51
222916-2291611.79711.80
338446-3844619.79219.79
429102-2910214.98214.98
544952-4495223.14123.14
640620-4062020.91120.91
10min193528-9352848.14848.805.4448.2148.905.47
289845-8984546.25246.32
393812-9381248.29548.40
489791-8979146.22546.31
599226-9922651.08251.21
6102613-10261352.82552.94
15min1116611-11661160.03265.624.6960.3665.994.71
2127452-12745265.61365.94
3128164-12816465.97966.36
4127007-12700765.38465.72
5134059-13405969.01469.43
6131525-13152567.70968.12
20min1137104-13710470.58170.151.8671.2470.881.89
2133572-13357268.76369.45
3135142-13514269.57170.32
4134041-13404169.00569.71
5140332-14033272.24373.04
6137416-13741670.74271.53
30min1140343-14034372.24971.743.0373.3072.863.05
2134632-13463269.30970.38
3139284-13928471.70472.84
4134228-13422869.10170.19
5143689-14368973.97175.17
6143908-14390874.08475.26
45min1140888-14088872.52972.601.6373.9974.121.65
2141068-14106872.62274.08
3138557-13855771.32972.86
4138876-13887671.49472.96
5144870-14487074.57976.19
6141838-14183873.01974.61
极限1135529-13552969.77170.463.5471.6372.383.51
2127767-12776765.77567.63
3138636-13863671.37073.30
4138701-13870171.40473.27
5139280-13928071.70273.72
6141350-14135072.76774.76
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