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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
112.543408113402453402383398613397393401790.13
212.473391393388633390010.06
单位质量响应值RSD%判断
27127.5127185.320.16数据可信
供试品溶液-2025041211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%
5min1315553-31555381.18286.383.7481.1886.383.74
2352547-35254790.69990.70
3342496-34249688.11388.11
4335241-33524186.24786.25
5339142-33914287.25087.25
6329621-32962184.80184.80
10min1361145-36114592.91192.322.0293.0592.462.02
2367752-36775294.61194.76
3357849-35784992.06392.21
4359288-35928892.43392.58
5361257-36125792.94093.09
6345766-34576688.95589.10
15min1368656-36865694.84393.742.0795.1394.042.07
2372503-37250395.83396.14
3361272-36127292.94493.24
4365468-36546894.02394.32
5367373-36737394.51394.81
6350954-35095490.28990.58
20min1372497-37249795.83294.812.1196.2895.272.11
2376457-37645796.85097.32
3367705-36770594.59995.05
4369348-36934895.02195.48
5371351-37135195.53795.99
6353913-35391391.05091.49
30min1377426-37742697.10096.082.0897.7196.692.08
2381251-38125198.08498.71
3371997-37199795.70396.32
4374247-37424796.28296.89
5376833-37683396.94797.56
6359000-35900092.35992.95
45min1380105-38010597.78997.072.1898.5697.842.18
2386059-38605999.321100.11
3377215-37721597.04597.82
4377718-37771897.17597.95
5380839-38083997.97898.76
6361836-36183693.08993.83
极限1384634-38463498.95498.241.8999.8999.171.90
2390828-390828100.548101.51
3381892-38189298.24999.18
4382062-38206298.29299.23
5382917-38291798.51299.45
6368799-36879994.88095.78
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
112.543384033386173383813383993387163385030.05
212.473384023385963384990.05
单位质量响应值RSD%判断
26993.8627145.070.40数据可信
供试品溶液-2025041211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%
5min1346887-34688789.53087.872.2289.5387.872.22
2343720-34372088.71388.71
3328870-32887084.88084.88
4346842-34684289.51989.52
5333379-33337986.04486.04
6343109-34310988.55588.56
10min1361517-36151793.30692.271.5593.4692.421.55
2359799-35979992.86393.01
3354293-35429391.44291.58
4362520-36252093.56593.71
5347848-34784889.77889.92
6359129-35912992.69092.84
15min1368118-36811895.01093.941.5395.3194.241.53
2364587-36458794.09894.40
3360874-36087493.14093.43
4369999-36999995.49595.80
5354601-35460191.52191.81
6365694-36569494.38494.69
20min1372950-37295096.25794.941.5096.7295.391.50
2368670-36867095.15295.61
3364694-36469494.12694.58
4373468-37346896.39196.85
5358769-35876992.59793.04
6368478-36847895.10395.56
30min1377067-37706797.32095.991.5297.9496.611.52
2372820-37282096.22396.84
3368051-36805194.99395.60
4377811-37781197.51298.14
5362883-36288393.65994.26
6372878-37287896.23896.86
45min1382307-38230798.67297.111.4299.4697.881.42
2377604-37760497.45898.24
3372224-37222496.07096.83
4380671-38067198.25099.04
5368081-36808195.00095.76
6376597-37659797.19897.98
极限1386293-38629399.70198.211.72100.6599.151.72
2382242-38224298.65599.60
3374629-37462996.69097.61
4386725-38672599.812100.76
5370531-37053195.63396.55
6382726-38272698.78099.72
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
112.543396243396713395703396243395333396040.02
212.473399463395933397700.08
单位质量响应值RSD%判断
27081.6627246.990.44数据可信
供试品溶液-2025041211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%
5min1321148-32114882.59886.188.8782.6086.188.87
2356666-35666691.73391.73
3373555-37355596.07796.08
4300401-30040177.26277.26
5351763-35176390.47290.47
6306924-30692478.93978.94
10min1364225-36422593.67794.792.8893.8194.932.89
2369998-36999895.16295.31
3382008-38200898.25198.41
4357954-35795492.06492.19
5379673-37967397.65097.80
6357491-35749191.94592.08
15min1365310-36531093.95696.701.8094.2597.001.80
2370222-37022295.21995.53
3382463-38246398.36898.69
4378954-37895497.46597.75
5381280-38128098.06398.38
6377628-37762897.12497.41
20min1366166-36616694.17696.811.7394.6397.281.73
2371449-37144995.53596.01
3382616-38261698.40798.89
4380221-38022197.79198.24
5381815-38181598.20198.68
6376212-37621296.76097.21
30min1367584-36758494.54196.851.5695.1597.471.56
2372047-37204795.68996.32
3383057-38305798.52099.17
4378309-37830997.29997.91
5381670-38167098.16498.80
6376646-37664696.87297.48
45min1368657-36865794.81797.371.6595.5898.151.66
2373277-37327796.00596.79
3384576-38457698.91199.73
4381746-38174698.18398.95
5383042-38304298.51799.32
6380199-38019997.78598.55
极限1372354-37235495.76898.461.7996.6999.401.79
2376803-37680396.91297.86
3389544-389544100.189101.17
4386464-38646499.397100.33
5388269-38826999.861100.83
6383430-38343098.61699.55
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
112.543371833369863374383369193367663370580.08
212.473393123394153393640.03
单位质量响应值RSD%判断
26878.6327214.430.88数据可信
供试品溶液-2025041211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%
5min1345426-34542689.23184.825.3989.2384.825.39
2347094-34709489.66289.66
3328109-32810984.75884.76
4324477-32447783.82083.82
5326805-32680584.42184.42
6298278-29827877.05277.05
10min1375726-37572697.05994.552.3197.2194.692.31
2363930-36393094.01194.16
3369983-36998395.57595.72
4358195-35819592.53092.67
5373388-37338896.45596.60
6354864-35486491.66991.80
15min1376620-37662097.29095.662.9597.6095.962.94
2364501-36450194.15994.47
3371897-37189796.07096.37
4359904-35990492.97193.27
5388161-388161100.271100.57
6360820-36082093.20893.49
20min1376858-37685897.35196.043.4597.8296.503.44
2365080-36508094.30994.77
3371978-37197896.09096.55
4360615-36061593.15593.60
5394638-394638101.944102.41
6361597-36159793.40993.85
30min1376582-37658297.28096.183.9597.9196.803.94
2365336-36533694.37594.99
3372169-37216996.14096.76
4360543-36054393.13793.74
5399195-399195103.121103.76
6360088-36008893.01993.61
45min1378064-37806497.66396.473.7998.4697.253.78
2366538-36653894.68595.46
3372733-37273396.28597.07
4361669-36166993.42794.19
5399298-399298103.148103.96
6362388-36238893.61394.36
极限1383679-38367999.11397.664.22100.0798.604.20
2371318-37131895.92096.86
3375382-37538296.97097.91
4365558-36555894.43295.35
5407358-407358105.230106.21
6365023-36502394.29495.20
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