非奈利酮恩格列净片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.223071083070823071193067463074533071020.09
211.173072403076853074620.11
单位质量响应值RSD%判断
27370.9427525.690.40数据可信
供试品溶液-25103101-2-2批-恩格列净-pH4.5(内含0.1%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1309752-309752101.56594.1614.46101.5794.1614.46
2309302-309302101.418101.42
3304256-30425699.76399.76
4203228-20322866.63766.64
5302382-30238299.14899.15
6294012-29401296.40496.40
10min1316161-316161103.667103.091.14103.84103.251.15
2314356-314356103.075103.24
3311780-311780102.230102.40
4311513-311513102.142102.25
5311958-311958102.288102.45
6320677-320677105.147105.31
15min1316959-316959103.928103.590.87104.27103.920.87
2315507-315507103.452103.79
3313338-313338102.741103.08
4315979-315979103.607103.89
5313230-313230102.705103.04
6320641-320641105.135105.47
20min1316540-316540103.791103.630.84104.31104.140.83
2315947-315947103.596104.11
3314102-314102102.991103.50
4316574-316574103.802104.26
5312766-312766102.553103.06
6320445-320445105.071105.58
30min1316815-316815103.881103.550.82104.57104.220.82
2315109-315109103.322104.01
3313059-313059102.649103.33
4315813-315813103.552104.18
5313780-313780102.886103.56
6320279-320279105.017105.70
45min1317275-317275104.032103.480.76104.89104.320.76
2314154-314154103.008103.87
3313043-313043102.644103.49
4315820-315820103.555104.35
5313880-313880102.919103.77
6319355-319355104.714105.58
60min1316522-316522103.785103.400.83104.82104.420.83
2314622-314622103.162104.19
3313011-313011102.634103.66
4314473-314473103.113104.09
5313422-313422102.768103.79
6319997-319997104.924105.96
极限1315881-315881103.575103.060.81104.78104.260.81
2313228-313228102.705103.91
3311312-311312102.077103.27
4313272-313272102.719103.86
5313727-313727102.868104.06
6318521-318521104.440105.65
非奈利酮恩格列净片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
121.927800667813197813877816847829057814720.13
222.037829637841137835380.11
单位质量响应值RSD%判断
35651.0935566.860.17数据可信
供试品溶液-25103101-2-2批-非奈利酮-pH4.5(内含0.1%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1488806-48880661.71050.3135.8661.7150.3235.86
2499941-49994163.11663.12
3437329-43732955.21155.21
4120479-12047915.21015.21
5379250-37925047.87947.88
6465466-46546658.76358.76
10min1642021-64202181.05373.4218.7881.1673.5018.80
2628956-62895679.40379.51
3617426-61742677.94878.04
4359517-35951745.38845.41
5624754-62475478.87378.95
6616465-61646577.82777.92
15min1675884-67588485.32880.999.3085.5781.209.34
2662285-66228583.61183.85
3663214-66321483.72883.95
4520626-52062665.72765.83
5670910-67091084.70084.91
6656235-65623582.84783.07
20min1686994-68699486.73184.544.7987.1184.884.84
2679016-67901685.72386.10
3688047-68804786.86387.22
4605064-60506476.38776.60
5684099-68409986.36586.72
6674691-67469185.17785.54
30min1700954-70095488.49387.571.6289.0288.051.69
2693731-69373187.58188.10
3702706-70270688.71489.22
4672750-67275084.93285.27
5700769-70076988.47088.97
6690779-69077987.20887.72
45min1708425-70842589.43688.710.9090.1189.340.93
2697881-69788188.10588.77
3707576-70757689.32989.98
4697442-69744288.05088.53
5709051-70905189.51590.16
6695634-69563487.82188.47
60min1710966-71096689.75789.340.9890.5890.121.01
2702950-70295088.74589.56
3716962-71696290.51491.32
4701323-70132388.54089.17
5712979-71297990.01190.80
6700704-70070488.46189.26
极限1710983-71098389.75989.320.8290.7390.240.85
2701353-70135388.54389.50
3714031-71403190.14491.10
4703138-70313888.76989.54
5713051-71305190.02090.96
6702422-70242288.67889.63
非奈利酮恩格列净片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.223059253053583057883061713056363057760.10
211.173064983051553058260.32
单位质量响应值RSD%判断
27252.7627379.230.33数据可信
供试品溶液-25111101批-恩格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1287909-28790994.86094.703.2594.8694.703.25
2299346-29934698.62898.63
3287574-28757494.75094.75
4295191-29519197.25997.26
5280833-28083392.52992.53
6273667-27366790.16890.17
10min1296339-29633997.63798.631.2097.8098.791.20
2305675-305675100.714100.88
3296907-29690797.82597.98
4301089-30108999.20399.36
5296858-29685897.80897.96
6299279-29927998.60698.76
15min1297050-29705097.87298.881.0798.1999.201.07
2305883-305883100.782101.11
3298849-29884998.46498.79
4301162-30116299.22799.55
5297785-29778598.11498.43
6299872-29987298.80299.12
20min1296573-29657397.71599.051.1198.2099.541.11
2305294-305294100.588101.09
3303302-30330299.932100.42
4301160-30116099.22699.72
5297636-29763698.06598.55
6299864-29986498.79999.28
30min1297326-29732697.96399.141.0298.6199.801.02
2305499-305499100.656101.32
3298363-29836398.30498.96
4301017-30101799.17999.84
5303219-30321999.904100.55
6299998-29999898.84399.49
45min1296184-29618497.58698.921.1898.4099.741.17
2306333-306333100.930101.77
3298915-29891598.48699.30
4300644-30064499.05699.88
5297969-29796998.17598.99
6301292-30129299.269100.08
60min1295875-29587597.48598.561.0998.4699.551.09
2304859-304859100.445101.45
3298280-29828098.27799.26
4300241-30024198.92399.91
5296441-29644197.67198.65
6299179-29917998.57399.55
极限1294879-29487997.15698.331.0598.2999.481.05
2303661-303661100.050101.22
3298319-29831998.29099.43
4298951-29895198.49899.65
5295645-29564597.40998.55
6299267-29926798.60299.74
非奈利酮恩格列净片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
121.927807187792497789007797057807747798690.11
222.037814347779467796900.32
单位质量响应值RSD%判断
35577.9735392.190.38数据可信
供试品溶液-25111101批-非奈利酮
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1368109-36810946.63544.407.7846.6344.407.77
2383101-38310148.53448.53
3333394-33339442.23742.24
4372839-37283947.23447.23
5320555-32055540.61040.61
6325032-32503241.17841.18
10min1645452-64545281.77180.334.7481.8580.404.74
2660154-66015483.63483.71
3639932-63993281.07281.14
4664452-66445284.17884.26
5600779-60077976.11176.18
6593741-59374175.22075.29
15min1700807-70080788.78488.132.8289.0088.332.82
2711070-71107090.08490.30
3700371-70037188.72988.93
4713407-71340790.38090.60
5687805-68780587.13787.33
6660244-66024483.64583.84
20min1716413-71641390.76191.181.9491.1291.531.94
2729331-72933192.39792.77
3721897-72189791.45691.81
4737074-73707493.37893.75
5717290-71729090.87291.21
6696244-69624488.20688.54
30min1739583-73958393.69693.931.6194.2194.441.61
2749623-74962394.96895.49
3734209-73420993.01593.52
4753508-75350895.46095.99
5749441-74944194.94595.44
6722104-72210491.48291.96
45min1746079-74607994.51995.291.3595.1995.951.36
2758874-75887496.14096.82
3748431-74843194.81795.48
4767814-76781497.27397.96
5752622-75262295.34896.00
6739124-73912493.63894.27
60min1750247-75024795.04795.841.6795.8796.661.68
2761826-76182696.51497.36
3756804-75680495.87896.70
4775209-77520998.21099.06
5757727-75772795.99596.80
6737116-73711693.38494.17
极限1753591-75359195.47196.001.4796.4696.981.48
2764389-76438996.83997.84
3753346-75334695.44096.42
4773730-77373098.02299.03
5760423-76042396.33697.30
6741232-74123293.90594.85
非奈利酮恩格列净片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.223077613077853083273081283076763079350.10
211.173063743068113065920.11
单位质量响应值RSD%判断
27445.1927447.810.01数据可信
供试品溶液-25111102批-恩格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184285-8428527.63869.8237.5227.6469.8237.52
2272481-27248189.34989.35
3263549-26354986.42186.42
4228973-22897375.08375.08
5281126-28112692.18492.18
6147061-14706148.22348.22
10min1225750-22575074.02691.7811.1974.0791.9011.22
2306076-306076100.366100.51
3298227-29822797.79297.94
4295422-29542296.87297.00
5295498-29549896.89797.05
6258428-25842884.74184.82
15min1284721-28472193.36396.912.6493.5397.182.70
2307097-307097100.700101.02
3299146-29914698.09398.40
4297031-29703197.40097.69
5295943-29594397.04397.36
6289349-28934994.88195.10
20min1294037-29403796.41898.161.5596.7498.591.57
2306816-306816100.608101.09
3299008-29900898.04898.52
4298073-29807397.74198.19
5295803-29580396.99797.47
6302325-30232599.13699.52
30min1295246-29524696.81498.371.7397.3098.971.74
2307307-307307100.769101.42
3299177-29917798.10398.74
4297270-29727097.47898.09
5295536-29553696.90997.55
6305466-305466100.166100.71
45min1296593-29659397.25698.421.5797.9099.181.57
2306983-306983100.663101.48
3298946-29894698.02898.83
4296896-29689697.35598.13
5296351-29635197.17797.98
6305125-305125100.054100.77
60min1296003-29600397.06398.281.7097.8799.201.71
2307132-307132100.712101.70
3297812-29781297.65698.62
4297077-29707797.41598.35
5295114-29511496.77197.73
6305105-305105100.047100.93
极限1295210-29521096.80398.211.8097.7799.301.79
2305636-305636100.221101.38
3297424-29742497.52998.65
4295234-29523496.81097.91
5296507-29650797.22898.35
6307002-307002100.669101.71
非奈利酮恩格列净片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
121.927841167844887857027858757853077850980.10
222.037808247816897812560.08
单位质量响应值RSD%判断
35816.5135463.280.71数据可信
供试品溶液-25111102批-非奈利酮
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1209926-20992626.48034.8719.2626.4834.8719.25
2219830-21983027.72927.73
3323713-32371340.83340.83
4341397-34139743.06443.06
5285199-28519935.97535.97
6278669-27866935.15135.15
10min1628669-62866979.30075.137.4379.3475.187.42
2518637-51863765.42165.47
3569210-56921071.80071.87
4609019-60901976.82276.89
5635504-63550480.16280.22
6612397-61239777.24877.31
15min1687731-68773186.75084.513.2486.9384.703.25
2630080-63008079.47879.63
3664089-66408983.76883.96
4676121-67612185.28685.49
5689108-68910886.92487.12
6672760-67276084.86285.05
20min1710446-71044689.61688.291.4689.9488.621.47
2684341-68434186.32386.61
3699087-69908788.18388.51
4706197-70619789.08089.42
5707699-70769989.26989.61
6692042-69204287.29487.62
30min1726262-72626291.61191.311.0192.0891.781.02
2720076-72007690.83091.26
3727603-72760391.78092.25
4727021-72702191.70692.20
5731422-73142292.26192.75
6710989-71098989.68490.16
45min1741339-74133993.51293.231.1694.1493.851.16
2737426-73742693.01993.60
3739494-73949493.28093.91
4747305-74730594.26594.91
5745435-74543594.02994.67
6723408-72340891.25191.87
60min1749157-74915794.49993.761.0495.2894.541.04
2740055-74005593.35094.09
3741263-74126393.50394.29
4750180-75018094.62895.43
5748747-74874794.44795.24
6730323-73032392.12392.90
极限1746898-74689894.21494.020.8795.1594.960.87
2743036-74303693.72694.62
3746788-74678894.20095.14
4748461-74846194.41195.37
5753117-75311794.99895.95
6734060-73406092.59493.52
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