达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.392018862015752014562014802012232015240.12
212.312015462012632014040.10
单位质量响应值RSD%判断
16265.0516361.010.42数据可信
供试品溶液-2025041711批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119104-11910458.70264.997.2058.7064.997.21
2120728-12072859.50259.50
3137089-13708967.56667.57
4134439-13443966.26066.26
5139791-13979168.89868.90
6140036-14003669.01869.02
10min1139811-13981168.90876.226.6069.0076.326.60
2144992-14499271.46171.55
3161111-16111179.40579.51
4155703-15570376.74076.84
5159931-15993178.82478.93
6166313-16631381.96982.07
15min1148151-14815173.01881.126.4273.2181.336.42
2157518-15751877.63577.83
3170556-17055684.06184.28
4164549-16454981.10081.31
5168600-16860083.09783.32
6178197-17819787.82688.05
20min1153835-15383575.81984.125.9776.1284.465.97
2167345-16734582.47882.79
3175756-17575686.62386.97
4169403-16940383.49283.83
5173310-17331085.41885.76
6184449-18444990.90891.27
30min1159940-15994078.82888.246.4279.2488.706.42
2181233-18123389.32389.76
3182002-18200289.70290.18
4175708-17570886.60087.06
5179851-17985188.64289.12
6195482-19548296.34696.84
45min1166220-16622081.92390.985.9082.4691.585.89
2190191-19019193.73894.31
3187163-18716392.24592.86
4180487-18048788.95589.55
5184803-18480391.08291.69
6198726-19872697.94498.58
极限1196406-19640696.80199.061.8397.4699.791.84
2204117-204117100.601101.31
3205647-205647101.356102.10
4197374-19737497.27898.00
5200281-20028198.71199.45
6202106-20210699.610100.40
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.392026492029632028972029132031052029050.09
212.312013332016342014840.11
单位质量响应值RSD%判断
16376.5116367.510.04数据可信
供试品溶液-2025041711批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1138997-13899768.25963.049.9568.2663.049.96
2121286-12128659.56159.56
3108607-10860753.33553.33
4136695-13669567.12867.13
5141315-14131569.39769.40
6123348-12334860.57460.57
10min1164085-16408580.57974.708.3580.6874.798.35
2146326-14632671.85871.95
3132108-13210864.87664.96
4159091-15909178.12778.23
5164381-16438180.72580.83
6146647-14664772.01672.11
15min1177064-17706486.95379.748.4687.1879.958.46
2156175-15617576.69576.89
3141065-14106569.27469.45
4167903-16790382.45482.67
5175433-17543386.15286.38
6156674-15667476.94077.14
20min1183384-18338490.05782.828.0190.4183.158.01
2166251-16625181.64381.96
3147091-14709172.23472.51
4172534-17253484.72885.07
5181179-18117988.97489.33
6161495-16149579.30779.62
30min1190546-19054693.57486.657.5794.0687.107.58
2177892-17789287.36087.79
3154375-15437575.81176.20
4179271-17927188.03788.51
5188006-18800692.32692.81
6168572-16857282.78383.22
45min1196586-19658696.54089.497.2497.1790.077.24
2184643-18464390.67591.24
3160879-16087979.00579.51
4182699-18269989.72090.32
5194115-19411595.32695.95
6174493-17449385.69086.25
极限1207364-207364101.83398.092.92102.6198.802.95
2196144-19614496.32397.02
3195421-19542195.96896.59
4196062-19606296.28397.02
5207133-207133101.719102.49
6196283-19628396.39197.08
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.392023952026362023822027072025852025410.08
212.312025632023812024720.07
单位质量响应值RSD%判断
16347.1316447.770.44数据可信
供试品溶液-2025041711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%
5min1126285-12628561.92163.336.0361.9263.336.03
2116217-11621756.98456.98
3134258-13425865.83065.83
4131914-13191464.68164.68
5138700-13870068.00868.01
6127560-12756062.54662.55
10min1153087-15308775.06277.274.1175.1677.374.11
2149043-14904373.07973.16
3164012-16401280.41980.52
4157802-15780277.37477.47
5166007-16600781.39781.50
6155632-15563276.31076.40
15min1162621-16262179.73782.214.0679.9482.424.06
2158568-15856877.75077.94
3173932-17393285.28385.50
4167735-16773582.24582.46
5176720-17672086.65086.87
6166460-16646081.61981.83
20min1167628-16762882.19285.074.1782.5285.404.17
2163185-16318580.01480.33
3178930-17893087.73488.08
4177988-17798887.27287.61
5181695-18169589.09089.44
6171512-17151284.09784.43
30min1173558-17355885.10087.814.2285.5588.274.22
2167864-16786482.30882.74
3185211-18521190.81491.29
4183724-18372490.08490.55
5187152-18715291.76592.25
6176985-17698586.78087.24
45min1178747-17874787.64489.834.1288.2290.424.12
2171777-17177784.22784.78
3189762-18976293.04593.66
4187088-18708891.73492.34
5191418-19141893.85794.48
6180461-18046188.48489.07
极限1199430-19943097.78598.641.5298.4999.361.53
2196633-19663396.41497.10
3205394-205394100.710101.46
4200644-20064498.38199.12
5201694-20169498.89699.66
6203209-20320999.638100.36
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.392020102022202019482020872016832019900.10
212.312023062018022020540.18
单位质量响应值RSD%判断
16302.6616413.810.49数据可信
供试品溶液-2025041711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%
5min1126962-12696262.40264.124.1262.4064.124.12
2133009-13300965.37465.37
3130006-13000663.89863.90
4131322-13132264.54564.54
5122854-12285460.38360.38
6138638-13863868.14168.14
10min1154475-15447575.92577.412.1076.0277.502.10
2157804-15780477.56177.66
3156568-15656876.95377.05
4160380-16038078.82778.92
5153649-15364975.51975.61
6162093-16209379.66979.77
15min1162806-16280680.01982.261.9980.2382.471.99
2167102-16710282.13182.35
3167193-16719382.17682.39
4170630-17063083.86584.08
5164877-16487781.03781.24
6171544-17154484.31484.54
20min1167014-16701482.08884.711.9782.4285.051.96
2171018-17101884.05684.39
3172848-17284884.95585.29
4175432-17543286.22586.57
5171439-17143984.26284.59
6176386-17638686.69487.04
30min1172179-17217984.62687.151.8985.0887.611.88
2175671-17567186.34386.81
3176422-17642286.71287.17
4180658-18065888.79489.26
5177838-17783887.40887.86
6181089-18108989.00589.48
45min1176577-17657786.78888.691.6487.3789.281.64
2179187-17918788.07188.66
3178623-17862387.79388.39
4184388-18438890.62791.23
5180610-18061088.77089.35
6183259-18325990.07290.68
极限1200380-20038098.48798.321.0699.1999.051.04
2197724-19772497.18297.91
3198490-19849097.55898.28
4201145-20114598.86399.60
5203510-203510100.025100.74
6199054-19905497.83598.58
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