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%
112.782084182085672086642094632086832087590.20
212.902105232098962102100.22
单位质量响应值RSD%判断
16334.8216295.350.18数据可信
供试品溶液-2025080321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159673-15967378.68674.473.5378.6974.473.53
2149768-14976873.80573.81
3148474-14847473.16773.17
4143880-14388070.90470.90
5151089-15108974.45674.46
6153834-15383475.80975.81
10min1176978-17697887.21484.402.4087.3384.512.40
2168177-16817782.87782.99
3169059-16905983.31283.42
4169291-16929183.42683.53
5168045-16804582.81282.92
6176026-17602686.74586.86
15min1182891-18289190.12887.571.7790.3887.811.77
2175307-17530786.39186.63
3175333-17533386.40386.64
4177576-17757687.50987.74
5175201-17520186.33886.57
6179858-17985888.63388.88
20min1185838-18583891.58089.381.4191.9689.751.41
2180455-18045588.92889.29
3179373-17937388.39488.76
4181210-18121089.30089.66
5178878-17887888.15088.52
6182516-18251689.94390.32
30min1189375-18937593.32391.191.2793.8491.701.27
2183429-18342990.39390.89
3183460-18346090.40890.91
4184382-18438290.86391.36
5183596-18359690.47590.97
6186074-18607491.69792.21
45min1191405-19140594.32492.411.1394.9993.061.14
2186958-18695892.13292.77
3185454-18545491.39192.02
4187362-18736292.33192.96
5185998-18599891.65992.29
6188001-18800192.64693.30
极限1201948-20194899.51998.621.26100.3299.401.25
2197375-19737597.26698.04
3199613-19961398.36999.14
4203584-203584100.325101.10
5197345-19734597.25198.02
6200905-20090599.00599.79
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%
112.782091652117652109692096302100582103170.50
212.902103742097652100700.21
单位质量响应值RSD%判断
16456.7316284.500.75数据可信
供试品溶液-2025080321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154113-15411375.69175.842.9775.6975.842.97
2157696-15769677.45077.45
3149322-14932273.33873.34
4160803-16080378.97678.98
5149293-14929373.32373.32
6155225-15522576.23776.24
10min1173532-17353285.22885.392.2885.3485.502.28
2176759-17675986.81386.93
3169552-16955283.27383.38
4178901-17890187.86587.98
5169036-16903683.02083.13
6175422-17542286.15686.27
15min1182000-18200089.38789.011.8989.6389.251.90
2183291-18329190.02190.27
3177091-17709186.97687.21
4184577-18457790.65390.90
5176787-17678786.82787.06
6183603-18360390.17490.42
20min1186193-18619391.44690.501.7491.8290.881.75
2185611-18561191.16191.54
3181164-18116488.97689.34
4186958-18695891.82292.21
5179327-17932788.07488.44
6186407-18640791.55191.93
30min1188545-18854592.60292.171.8193.1192.681.81
2189397-18939793.02093.54
3183300-18330090.02690.52
4189726-18972693.18293.71
5183658-18365890.20190.70
6191425-19142594.01694.53
45min1192228-19222894.41093.212.2395.0693.862.23
2191319-19131993.96494.62
3185061-18506190.89091.52
4193358-19335894.96595.63
5183777-18377790.26090.89
6192949-19294994.76495.42
极限1200736-20073698.58997.631.2999.3898.421.28
2196817-19681796.66497.46
3198230-19823097.35898.13
4196831-19683196.67197.48
5197046-19704696.77797.54
6202995-20299599.698100.50
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%
112.782093002087812092312087892098482091900.22
212.902087022084202085610.10
单位质量响应值RSD%判断
16368.5416167.520.88数据可信
供试品溶液-2025080421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152196-15219675.22176.672.3275.2276.672.32
2155294-15529476.75276.75
3158181-15818178.17978.18
4150244-15024474.25774.26
5154934-15493476.57576.57
6159882-15988279.02079.02
10min1168681-16868183.36986.402.5783.4886.512.57
2177798-17779887.87587.99
3179650-17965088.79088.91
4169839-16983983.94184.05
5177100-17710087.53087.64
6175772-17577286.87386.99
15min1175025-17502586.50489.912.6986.7490.162.68
2186014-18601491.93592.18
3188297-18829793.06493.31
4178701-17870188.32188.56
5183095-18309590.49390.74
6180415-18041589.16889.42
20min1179892-17989288.91091.802.4189.2892.182.41
2188442-18844293.13693.52
3192423-19242395.10395.49
4183787-18378790.83591.20
5187026-18702692.43692.82
6182817-18281790.35590.74
30min1182614-18261490.25593.242.1490.7693.762.14
2191715-19171594.75395.28
3193884-19388495.82596.36
4186953-18695392.40092.91
5189995-18999593.90394.42
6186788-18678892.31892.84
45min1185147-18514791.50794.392.4192.1495.042.41
2194044-19404495.90496.57
3196865-19686597.29897.97
4187421-18742192.63193.28
5193886-19388695.82696.49
6188471-18847193.15093.81
极限1196665-19666597.20099.741.7797.97100.541.77
2203527-203527100.591101.40
3206357-206357101.990102.81
4200195-20019598.94499.73
5204352-204352100.999101.80
6199698-19969898.69999.50
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%
112.782093812101322099092091952094862096210.19
212.902091522084672088100.24
单位质量响应值RSD%判断
16402.2716186.820.94数据可信
供试品溶液-2025080421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154635-15463576.30379.702.5876.3079.702.58
2163792-16379280.82180.82
3164162-16416281.00481.00
4166157-16615781.98881.99
5161092-16109279.48979.49
6159253-15925378.58278.58
10min1175793-17579386.74389.643.4086.8689.763.40
2189886-18988693.69793.82
3178610-17861088.13388.25
4189052-18905293.28593.41
5177533-17753387.60287.72
6179051-17905188.35188.47
15min1181256-18125689.43992.453.7489.6892.703.74
2196446-19644696.93497.20
3184496-18449691.03791.29
4196083-19608396.75597.02
5183717-18371790.65390.90
6182135-18213589.87290.12
20min1186680-18668092.11594.583.7992.4994.973.78
2202411-20241199.877100.28
3188069-18806992.80093.19
4199429-19942998.40698.81
5187282-18728292.41292.80
6186153-18615391.85592.24
30min1189266-18926693.39195.713.3093.9196.243.30
2201833-20183399.592100.15
3190354-19035493.92894.46
4202571-20257199.956100.51
5190200-19020093.85294.38
6189544-18954493.52894.05
45min1191695-19169594.59096.613.0595.2597.293.05
2202250-20225099.798100.50
3192013-19201394.74795.42
4204603-204603100.959101.66
5192254-19225494.86595.53
6191903-19190394.69295.36
极限1204600-204600100.957100.441.46101.76101.261.47
2206191-206191101.743102.60
3199783-19978398.58199.39
4206345-206345101.819102.68
5204437-204437100.877101.69
6199941-19994198.65999.46
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%
112.782097812109252111442087002094392099980.49
212.902100702107072103880.22
单位质量响应值RSD%判断
16431.7716309.150.53数据可信
供试品溶液-批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154716-15471675.98774.971.9075.9974.981.91
2148459-14845972.91372.91
3156692-15669276.95776.96
4150683-15068374.00674.01
5152694-15269474.99374.99
6152685-15268574.98974.99
10min1171467-17146784.21483.141.8584.3383.251.86
2164989-16498981.03281.14
3172465-17246584.70484.82
4171987-17198784.46984.58
5168160-16816082.58982.70
6166619-16661981.83381.94
15min1178017-17801787.43086.551.4687.6786.791.46
2173481-17348185.20385.43
3180232-18023288.51888.76
4176388-17638886.63086.87
5175365-17536586.12886.36
6173884-17388485.40185.64
20min1181073-18107388.93188.431.6289.3088.801.62
2177730-17773087.29087.65
3184742-18474290.73391.11
4181322-18132289.05489.42
5178526-17852687.68088.05
6176927-17692786.89587.26
30min1186534-18653491.61390.441.8092.1290.941.80
2180181-18018188.49388.98
3188598-18859892.62793.14
4184930-18493090.82691.33
5180575-18057588.68789.18
6184020-18402090.37990.87
45min1189929-18992993.28191.741.8693.9292.371.86
2184787-18478790.75591.38
3190631-19063193.62694.28
4188175-18817592.41993.06
5181487-18148789.13589.76
6185694-18569491.20191.83
极限1202728-20272899.56798.321.25100.3599.101.25
2199362-19936297.91498.67
3201061-20106198.74899.54
4201570-20157098.99899.77
5195610-19561096.07196.83
6200855-20085598.64799.41
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%
112.782113062116582122012114592114222116090.17
212.902158242148262153250.33
单位质量响应值RSD%判断
16557.8216691.860.58数据可信
供试品溶液-2025080521批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154411-15441174.67672.832.6374.6872.842.63
2145828-14582870.52670.53
3146742-14674270.96870.97
4155547-15554775.22675.23
5149715-14971572.40572.41
6151334-15133473.18873.19
10min1172915-17291583.62581.622.0683.7481.732.06
2164696-16469679.65179.76
3165647-16564780.11080.22
4172425-17242583.38883.50
5167264-16726480.89281.00
6169705-16970582.07382.18
15min1179893-17989387.00085.171.9487.2485.401.95
2177009-17700985.60585.83
3170542-17054282.47882.70
4179232-17923286.68086.92
5175064-17506484.66584.89
6174955-17495584.61284.84
20min1186873-18687390.37686.652.5890.7487.012.57
2176240-17624085.23385.59
3173486-17348683.90284.25
4180962-18096287.51787.89
5179835-17983586.97287.33
6177637-17763785.90986.27
30min1185871-18587189.89188.331.9090.3988.821.89
2181899-18189987.97088.45
3177071-17707185.63586.11
4186059-18605989.98290.48
5184217-18421789.09189.58
6180783-18078387.43187.92
45min1187971-18797190.90789.931.4391.5590.561.43
2184969-18496989.45590.07
3184389-18438989.17489.78
4187718-18771890.78491.42
5188793-18879391.30491.93
6181892-18189287.96788.59
极限1201113-20111397.26396.101.7198.0496.861.70
2197655-19765595.59096.34
3198087-19808795.79996.54
4198199-19819995.85396.62
5203565-20356598.44899.21
6193594-19359493.62694.38
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