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%
1 12.683625693623433624123627463632633626670.11
2 12.723626703627923627310.03
单位质量响应值RSD%判断
28601.5028516.590.22数据可信
供试品溶液-2025060411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%
5min1402358-40235898.43092.846.2698.4392.846.26
2373661-37366191.41091.41
3343829-34382984.11284.11
4363597-36359788.94888.95
5405191-40519199.12399.12
6388330-38833094.99895.00
10min1406598-40659899.46799.092.5399.6399.252.53
2402852-40285298.55198.70
3391278-39127895.72095.86
4398525-39852597.49297.64
5410017-410017100.304100.47
6421137-421137103.024103.18
15min1406619-40661999.472100.401.3599.80100.721.36
2406679-40667999.48799.80
3411730-411730100.723101.02
4406819-40681999.52199.83
5409814-409814100.254100.59
6420904-420904102.967103.30
20min1406201-40620199.370100.341.3199.87100.821.31
2406363-40636399.41099.89
3410342-410342100.383100.85
4408067-40806799.827100.30
5409361-409361100.143100.64
6420549-420549102.880103.38
30min1404905-40490599.053100.101.3599.71100.761.35
2405103-40510399.10299.75
3410077-410077100.318100.95
4406583-40658399.464100.11
5408874-408874100.024100.69
6419606-419606102.649103.32
45min1404783-40478399.023100.011.2799.85100.831.27
2404676-40467698.99799.81
3409194-409194100.102100.90
4407631-40763199.720100.53
5407921-40792199.791100.62
6418713-418713102.431103.28
极限1403720-40372098.76399.751.3199.75100.741.31
2403938-40393898.81799.79
3407853-40785399.774100.74
4405839-40583999.282100.26
5407134-40713499.598100.60
6418075-418075102.275103.29
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%
1 12.683627313625833621973625633628023625750.07
2 12.723620643619643620140.02
单位质量响应值RSD%判断
28594.2428460.220.34数据可信
供试品溶液-2025060412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%
5min1408897-408897100.14298.841.90100.1498.841.90
2391251-39125195.82095.82
3399918-39991897.94397.94
4405193-40519399.23499.23
5413304-413304101.221101.22
6402958-40295898.68798.69
10min1412386-412386100.996100.361.49101.16100.521.49
2404975-40497599.18199.34
3403839-40383998.90399.07
4410284-410284100.481100.65
5420349-420349102.946103.11
6406811-40681199.63199.80
15min1412651-412651101.061100.411.58101.40100.741.58
2404050-40405098.95599.28
3403756-40375698.88399.21
4411664-411664100.819101.15
5420762-420762103.047103.39
6407075-40707599.695100.03
20min1412260-412260100.965100.321.45101.47100.821.45
2404366-40436699.03299.52
3404048-40404898.95499.45
4410511-410511100.537101.04
5419708-419708102.789103.30
6406929-40692999.660100.16
30min1411391-411391100.752100.111.49101.42100.781.49
2403793-40379398.89299.55
3402555-40255598.58899.25
4409380-409380100.260100.93
5419157-419157102.654103.34
6406432-40643299.538100.20
45min1410187-410187100.45899.861.43101.30100.701.43
2403108-40310898.72499.54
3401832-40183298.41199.23
4408129-40812999.953100.79
5417821-417821102.327103.18
6405518-40551899.314100.14
极限1409205-409205100.21799.681.49101.22100.681.49
2402192-40219298.49999.48
3400861-40086198.17499.16
4408269-40826999.988100.99
5417412-417412102.227103.25
6404161-40416198.98299.98
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%
1 12.683628223631193631853634823629213631060.08
2 12.723627083629303628190.05
单位质量响应值RSD%判断
28636.1228523.510.28数据可信
供试品溶液-2025060511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%
5min1412181-412181100.76092.375.88100.7692.375.88
2364578-36457889.12389.12
3357300-35730087.34487.34
4361840-36184088.45488.45
5398032-39803297.30197.30
6373326-37332691.26291.26
10min1416809-416809101.89199.741.27102.0699.891.28
2408601-40860199.885100.03
3407554-40755499.62999.77
4402272-40227298.33898.49
5409382-409382100.076100.24
6403426-40342698.62098.77
15min1417604-417604102.086100.141.41102.42100.461.41
2415257-415257101.512101.83
3408023-40802399.744100.06
4404844-40484498.96699.28
5409227-409227100.038100.37
6402955-40295598.50598.82
20min1416250-416250101.755100.151.27102.26100.641.27
2415173-415173101.491101.98
3408277-40827799.806100.28
4405147-40514799.04099.52
5409710-409710100.156100.65
6403496-40349698.63799.12
30min1416906-416906101.915100.041.36102.59100.691.37
2414385-414385101.299101.95
3408008-40800899.740100.38
4403972-40397298.75399.39
5409266-409266100.047100.71
6402897-40289798.49099.14
45min1416628-416628101.84799.961.46102.69100.781.46
2415258-415258101.512102.33
3406950-40695099.481100.29
4403898-40389898.73599.54
5408891-40889199.956100.79
6401926-40192698.25399.06
极限1415895-415895101.66899.771.41102.68100.751.41
2413870-413870101.173102.16
3405755-40575599.189100.17
4402573-40257398.41199.38
5408354-40835499.824100.82
6402284-40228498.34199.31
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