达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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%
112.451008121013601013001014211012721012330.24
212.581015791015881015840.01
单位质量响应值RSD%判断
8131.168075.040.49数据可信
供试品溶液-STGC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%
2min14346-43464.3126.4318.114.316.4318.12
26770-67706.7176.72
37553-75537.4947.49
47447-74477.3897.39
56118-61186.0706.07
66661-66616.6096.61
5min154892-5489254.46570.9111.6954.4770.9111.69
274315-7431573.73773.74
378459-7845977.84977.85
473010-7301072.44272.44
574821-7482174.23974.24
673270-7327072.70072.70
10min1100699-10069999.91697.322.4099.9297.322.40
296951-9695196.19796.20
3100842-100842100.058100.06
498417-9841797.65297.65
595048-9504894.30994.31
696525-9652595.77495.77
15min1104476-104476103.66498.883.11103.6698.883.11
298366-9836697.60197.60
3102013-102013101.220101.22
499511-9951198.73798.74
596068-9606895.32195.32
697523-9752396.76596.76
20min1103977-103977103.16998.563.14103.1798.563.14
298318-9831897.55497.55
3101776-101776100.985100.98
499490-9949098.71698.72
595751-9575195.00695.01
696658-9665895.90695.91
30min1104216-104216103.40698.723.17103.4198.723.18
298258-9825897.49497.49
3101999-101999101.206101.21
499565-9956598.79198.79
595663-9566394.91994.92
697278-9727896.52296.52
极限1103935-103935103.12798.593.08103.1398.593.08
298016-9801697.25497.25
3101794-101794101.002101.00
499623-9962398.84898.85
595953-9595395.20795.21
696853-9685396.10096.10
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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%
112.452012432014622016702011032011352013230.12
212.582021952021442021700.02
单位质量响应值RSD%判断
16170.5216070.750.44数据可信
供试品溶液-WA3063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%
2min135983-3598317.9469.5244.5117.959.5244.54
216238-162388.0998.10
314904-149047.4337.43
418845-188459.3999.40
512860-128606.4146.41
615745-157457.8537.85
5min1178412-17841288.98277.688.1288.9877.688.12
2155243-15524377.42777.43
3139829-13982969.73969.74
4157118-15711878.36278.36
5151371-15137175.49575.50
6152513-15251376.06576.07
10min1195086-19508697.29896.331.7297.3096.331.72
2195425-19542597.46797.47
3195206-19520697.35897.36
4187456-18745693.49393.49
5194934-19493497.22297.22
6190716-19071695.11995.12
15min1196979-19697998.24297.951.7698.2497.941.76
2199125-19912599.31299.31
3199007-19900799.25499.25
4191297-19129795.40895.41
5199008-19900899.25499.25
6192893-19289396.20496.20
20min1197497-19749798.50198.201.4798.5098.201.47
2199479-19947999.48999.49
3199226-19922699.36399.36
4192706-19270696.11196.11
5198543-19854399.02299.02
6193911-19391196.71296.71
30min1197440-19744098.47298.441.2098.4798.441.21
2199361-19936199.43099.43
3198887-19888799.19499.19
4193914-19391496.71496.71
5199527-19952799.51399.51
6195093-19509397.30297.30
极限1197718-19771898.61198.750.9598.6198.750.95
2200037-20003799.76799.77
3199476-19947699.48899.49
4195219-19521997.36497.36
5199010-19901099.25599.26
6196499-19649998.00398.00
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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%
112.452006092008612009442009522006782008090.08
212.582014832026892020860.43
单位质量响应值RSD%判断
16129.2416064.070.29数据可信
供试品溶液-24092901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%
2min177584-7758438.75237.594.4938.7537.594.48
269125-6912534.52734.53
376569-7656938.24538.25
474510-7451037.21737.22
578651-7865139.28539.28
675086-7508637.50437.50
5min1135070-13507067.46562.694.0967.4762.694.09
2121527-12152760.70160.70
3120998-12099860.43760.44
4125045-12504562.45862.46
5126551-12655163.21063.21
6123892-12389261.88261.88
10min1150716-15071675.28070.423.8175.2870.423.81
2137720-13772068.78968.79
3135106-13510667.48367.48
4140581-14058170.21870.22
5142308-14230871.08171.08
6139537-13953769.69769.70
15min1155578-15557877.70973.493.2277.7173.493.22
2145125-14512572.48872.49
3141292-14129270.57370.57
4146561-14656173.20573.20
5148147-14814773.99774.00
6146099-14609972.97472.97
20min1158918-15891879.37774.813.2979.3874.813.29
2149252-14925274.54974.55
3144131-14413171.99171.99
4149996-14999674.92174.92
5148304-14830474.07674.08
6147992-14799273.92073.92
30min1161180-16118080.50776.622.9280.5176.622.93
2152726-15272676.28476.28
3147367-14736773.60873.61
4153262-15326276.55276.55
5154011-15401176.92676.93
6151824-15182475.83475.83
极限1185002-18500292.40692.431.5492.4192.431.54
2189214-18921494.51094.51
3181124-18112490.46990.47
4183951-18395191.88191.88
5187249-18724993.52893.53
6183748-18374891.77991.78
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