磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811747131750291751741750661752341750430.12
212.851751661748571750120.13
单位质量响应值RSD%判断
13664.5613619.610.24数据可信
中间条件36月-供试品溶液-2022030401批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1167894-16789486.16282.335.4386.1682.325.42
2148952-14895276.44176.44
3150273-15027377.11977.12
4166903-16690385.65385.65
5167113-16711385.76185.76
6161384-16138482.82182.82
10min1178196-17819691.44989.031.9891.5989.161.99
2169436-16943686.95387.08
3170024-17002487.25587.38
4175274-17527489.94990.09
5175468-17546890.04990.19
6172469-17246988.51088.65
15min1182204-18220493.50591.772.9993.8092.062.98
2174459-17445989.53189.80
3174989-17498989.80390.08
4177829-17782991.26091.55
5188017-18801796.48996.78
6175434-17543490.03190.32
20min1184189-18418994.52492.171.5094.9892.611.51
2176536-17653690.59791.02
3177982-17798291.33991.76
4180175-18017592.46492.91
5180534-18053492.64893.10
6178236-17823691.46991.90
30min1186073-18607395.49194.121.5496.1094.721.54
2180060-18006092.40592.98
3181035-18103592.90693.48
4183022-18302293.92594.52
5182939-18293993.88394.49
6187332-18733296.13796.73
45min1187244-18724496.09295.001.4296.8695.741.42
2182585-18258593.70194.43
3183350-18335094.09494.82
4189071-18907197.03097.78
5185378-18537895.13495.90
6183012-18301293.92094.67
极限1189495-18949597.24795.121.2298.1896.031.23
2184329-18432994.59695.48
3182723-18272393.77294.66
4184870-18487094.87495.79
5185624-18562495.26196.18
6185049-18504994.96695.87
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811748301751701749841751271748431749910.09
212.851756981755531756260.06
单位质量响应值RSD%判断
13660.5013667.390.04数据可信
中间条件36月-供试品溶液-2022030501批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1157773-15777380.83881.992.0680.8481.992.06
2164997-16499784.53984.54
3156683-15668380.27980.28
4157941-15794180.92480.92
5159781-15978181.86781.87
6162993-16299383.51383.51
10min1176485-17648590.42589.650.9990.5689.780.99
2173790-17379089.04589.19
3177380-17738090.88491.02
4172705-17270588.48988.62
5174645-17464589.48389.62
6174805-17480589.56589.70
15min1180297-18029792.37991.460.9292.6691.740.92
2177311-17731190.84991.14
3180358-18035892.41092.70
4176478-17647890.42290.70
5178987-17898791.70791.99
6177565-17756590.97991.27
20min1179997-17999792.22592.400.6592.6692.840.65
2179767-17976792.10792.55
3182288-18228893.39993.84
4178840-17884091.63292.07
5180819-18081992.64693.08
6180350-18035092.40692.85
30min1186334-18633495.47294.380.9896.0694.970.97
2182621-18262193.56994.16
3186463-18646395.53896.13
4182408-18240893.46094.05
5184043-18404394.29894.89
6183347-18334793.94194.54
45min1189118-18911896.89895.421.0097.6596.170.99
2184459-18445994.51195.26
3187633-18763396.13796.89
4184890-18489094.73295.47
5186403-18640395.50796.26
6184864-18486494.71995.47
极限1190822-19082297.77197.301.9198.6898.211.89
2185858-18585895.22896.14
3190337-19033797.52398.44
4191098-19109897.91398.81
5195428-195428100.131101.04
6185928-18592895.26496.17
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811752601752231755651754491754471753890.09
212.851750451753771752110.14
单位质量响应值RSD%判断
13691.5713635.100.30数据可信
中间条件36月-供试品溶液-2022030601批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1165877-16587784.99477.796.3784.9977.796.37
2159906-15990681.93581.93
3144738-14473874.16374.16
4143981-14398173.77573.77
5142440-14244072.98572.99
6153965-15396578.89178.89
10min1175074-17507489.70787.481.9089.8587.611.90
2171734-17173487.99588.13
3170850-17085087.54287.67
4169665-16966586.93587.06
5165244-16524484.67084.79
6171777-17177788.01788.15
15min1179238-17923891.84089.961.5892.1390.231.58
2175640-17564089.99790.28
3176839-17683990.61190.88
4174813-17481389.57389.84
5170849-17084987.54287.80
6175977-17597790.17090.45
20min1181705-18170593.10591.341.4593.5591.771.46
2178587-17858791.50791.94
3179601-17960192.02692.45
4176968-17696890.67791.09
5174059-17405989.18789.60
6178662-17866291.54591.97
30min1184983-18498394.78492.961.4695.3893.541.46
2180525-18052592.50093.09
3183229-18322993.88594.46
4180867-18086792.67593.24
5177241-17724190.81791.37
6181740-18174093.12293.70
45min1187283-18728395.96394.900.7296.7295.630.72
2183836-18383694.19694.94
3185524-18552495.06195.79
4183980-18398094.27094.99
5186024-18602495.31896.03
6184597-18459794.58695.32
极限1188216-18821696.44195.411.1597.3696.301.15
2184492-18449294.53395.43
3187310-18731095.97696.87
4188237-18823796.45197.33
5182992-18299293.76494.63
6185967-18596795.28896.18
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.811758201755401754111758761754781756250.12
212.851756091757711756900.07
单位质量响应值RSD%判断
13709.9913672.370.20数据可信
中间条件36月-供试品溶液-U028516批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1134053-13405368.54869.5317.4468.5569.5317.44
2116543-11654359.59459.59
3107379-10737954.90854.91
4171450-17145087.67187.67
5154332-15433278.91878.92
6132125-13212567.56267.56
10min1158591-15859181.09681.507.5681.2181.627.57
2147799-14779975.57775.68
3143806-14380673.53573.63
4173575-17357588.75888.90
5171351-17135187.62087.75
6161210-16121082.43582.55
15min1168477-16847786.15186.743.8486.4086.993.86
2162758-16275883.22683.45
3162359-16235983.02283.24
4177687-17768790.86091.15
5176298-17629890.15090.43
6170175-17017587.01987.27
20min1178061-17806191.05289.602.3991.4490.002.42
2169650-16965086.75187.11
3170646-17064687.26087.61
4179507-17950791.79192.24
5178199-17819991.12291.55
6175292-17529289.63690.03
30min1178508-17850891.28091.950.9591.8292.500.98
2179756-17975691.91892.43
3178164-17816491.10491.60
4182727-18272793.43894.04
5180771-18077192.43793.02
6178988-17898891.52692.07
45min1182329-18232993.23494.461.7793.9395.161.78
2183816-18381693.99494.66
3183027-18302793.59194.24
4191218-19121897.77998.53
5183669-18366993.91994.65
6184321-18432194.25394.95
极限1186102-18610295.16396.461.2296.0297.311.20
2190163-19016397.24098.06
3188823-18882396.55597.36
4186560-18656095.39896.31
5192172-19217298.26799.16
6187958-18795896.11296.97
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