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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
110.973080943079543076283078613074623078000.09
2 11.043080603095063087830.34
单位质量响应值RSD%判断
28058.3427969.470.23数据可信
供试品溶液-25111101批-恩格列净-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%
5min1160943-16094350.82759.9918.5250.8360.0018.51
2179827-17982756.79156.79
3194251-19425161.34661.35
4253927-25392780.19280.19
5156636-15663649.46749.47
6194236-19423661.34161.34
10min1301246-30124695.13695.620.5095.2295.720.49
2305138-30513896.36596.46
3303447-30344795.83195.93
4301154-30115495.10795.24
5303189-30318995.75095.83
6302459-30245995.51995.62
15min1305978-30597896.63096.920.6796.8797.180.65
2309614-30961497.77998.03
3307562-30756297.13197.39
4303600-30360095.87996.17
5307900-30790097.23797.48
6306678-30667896.85197.11
20min1306808-30680896.89297.110.7997.3097.530.78
2310504-31050498.06098.48
3308104-30810497.30297.73
4303293-30329395.78296.23
5308738-30873897.50297.91
6307476-30747697.10397.53
30min1306497-30649796.79497.140.7997.3697.730.77
2310718-31071898.12798.71
3309093-30909397.61498.20
4303663-30366395.89996.51
5307723-30772397.18197.75
6307924-30792497.24597.83
45min1306759-30675996.87797.000.8097.6097.740.78
2309940-30994097.88298.63
3308451-30845197.41198.16
4302717-30271795.60196.37
5307416-30741697.08497.81
6307593-30759397.14097.89
60min1305768-30576896.56496.720.6997.4597.620.67
2308375-30837597.38798.30
3307741-30774197.18798.10
4302436-30243695.51296.44
5306581-30658196.82197.71
6306601-30660196.82797.74
极限1304613-30461396.19996.620.6497.2597.690.63
2308182-30818297.32698.40
3307576-30757697.13598.21
4302886-30288695.65496.74
5306212-30621296.70497.76
6306163-30616396.68997.76
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250201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)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%
1 22.148135708117628121978130508120018125160.10
2 22.168128288150718139500.20
单位质量响应值RSD%判断
36699.0136730.600.07数据可信
供试品溶液-25111101批-非奈利酮-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%
5min172263-722638.85711.1130.268.8611.1130.25
2108000-10800013.23713.24
398943-9894312.12712.13
4123236-12323615.10515.10
546248-462485.6685.67
695311-9531111.68211.68
10min1404312-40431249.55549.677.7349.5749.697.74
2407875-40787549.99250.01
3419572-41957251.42551.45
4441217-44121754.07854.10
5347288-34728842.56642.58
6411441-41144150.42950.45
15min1536432-53643265.74966.212.0565.8566.322.06
2543888-54388866.66266.77
3546187-54618766.94467.05
4555245-55524568.05468.17
5522542-52254264.04664.13
6537074-53707465.82765.93
20min1601423-60142373.71474.331.0273.9274.541.03
2611708-61170874.97575.19
3609850-60985074.74774.96
4614019-61401975.25875.49
5601695-60169573.74873.93
6599780-59978073.51373.73
30min1671128-67112882.25882.650.8782.5982.990.87
2681916-68191683.58083.92
3676993-67699382.97783.32
4675846-67584682.83683.19
5675457-67545782.78883.10
6664692-66469281.46981.80
45min1722982-72298288.61388.490.8389.0888.970.82
2728585-72858589.30089.78
3723117-72311788.63089.11
4719426-71942688.17788.67
5726223-72622389.01189.46
6711658-71165887.22587.70
60min1747355-74735591.60191.310.7992.2291.930.79
2749602-74960291.87692.51
3745688-74568891.39692.02
4742156-74215690.96391.60
5750553-75055391.99392.59
6734660-73466090.04590.66
极限1756197-75619792.68492.610.9293.4593.380.91
2762438-76243893.44994.23
3756266-75626692.69393.47
4752047-75204792.17692.97
5762422-76242293.44794.20
6744004-74400491.19091.96
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
110.973114513125583131833119483135033125290.28
2 11.043084873087233086050.06
单位质量响应值RSD%判断
28489.4327953.351.35数据可信
供试品溶液-25111102批-恩格列净-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%
5min1217825-21782568.29164.5013.3468.2964.5013.34
2199800-19980062.64062.64
3245305-24530576.90776.91
4218593-21859368.53268.53
5168275-16827552.75752.76
6184541-18454157.85657.86
10min1302572-30257294.86195.211.4594.9795.311.45
2303245-30324595.07295.18
3304870-30487095.58195.71
4310245-31024597.26697.38
5296668-29666893.01093.10
6304440-30444095.44695.54
15min1312342-31234297.92496.671.3798.2096.941.38
2306808-30680896.18996.45
3307397-30739796.37396.66
4312924-31292498.10698.38
5301442-30144294.50694.75
6309171-30917196.92997.18
20min1306579-30657996.11796.501.1096.5596.931.11
2308296-30829696.65597.08
3307773-30777396.49196.94
4312796-31279698.06698.51
5302442-30244294.82095.22
6308958-30895896.86397.28
30min1306895-30689596.21696.490.9896.8197.080.99
2308509-30850996.72297.31
3306816-30681696.19196.80
4312641-31264198.01798.62
5303451-30345195.13695.69
6308314-30831496.66197.24
45min1305425-30542595.75596.161.0696.5196.911.07
2307965-30796596.55197.30
3306188-30618895.99496.76
4311382-31138297.62398.39
5301587-30158794.55295.27
6307820-30782096.50697.25
60min1304611-30461195.50095.981.0296.4296.891.03
2306971-30697196.24097.15
3305339-30533995.72896.66
4311063-31106397.52398.45
5301704-30170494.58895.46
6307098-30709896.27997.18
极限1303989-30398995.30595.801.0796.3896.871.07
2307076-30707696.27397.34
3304796-30479695.55896.65
4310296-31029697.28298.37
5300668-30066894.26495.30
6306545-30654596.10697.17
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250201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)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%
1 22.148215228248178263098231348262298244020.26
2 22.168130888142688136780.11
单位质量响应值RSD%判断
37235.8636718.320.99数据可信
供试品溶液-25111102批-非奈利酮-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%
5min1118715-11871514.44811.2924.9814.4511.2924.96
2100243-10024312.20012.20
365206-652067.9367.94
4112256-11225613.66213.66
564389-643897.8367.84
695746-9574611.65311.65
10min1418807-41880750.97049.395.2950.9949.415.30
2419095-41909551.00551.03
3375031-37503145.64245.66
4426701-42670151.93151.95
5382819-38281946.59046.60
6412523-41252350.20550.22
15min1590776-59077671.89965.825.1172.0165.925.11
2540241-54024165.74965.85
3514041-51404162.56062.65
4544076-54407666.21666.32
5516654-51665462.87862.97
6539043-53904365.60365.71
20min1608639-60863974.07372.641.8874.3072.861.89
2603327-60332773.42773.64
3582683-58268370.91471.11
4602801-60280173.36373.58
5582902-58290270.94171.14
6601044-60104473.14973.36
30min1676387-67638782.31880.781.4282.6781.111.43
2671621-67162181.73882.08
3653671-65367179.55479.87
4663127-66312780.70481.05
5652858-65285879.45579.77
6664598-66459880.88481.22
45min1722189-72218987.89386.201.3288.3886.671.32
2713306-71330686.81187.28
3702135-70213585.45285.90
4702376-70237685.48185.96
5697207-69720784.85285.30
6712484-71248486.71187.18
60min1749018-74901891.15889.161.4291.7989.771.42
2736311-73631189.61190.23
3727450-72745088.53389.12
4722557-72255787.93788.56
5722561-72256187.93888.53
6737485-73748589.75490.37
极限1759404-75940492.42290.591.2693.2191.341.27
2748584-74858491.10591.87
3739257-73925789.97090.70
4735375-73537589.49790.26
5735609-73560989.52690.26
6747668-74766890.99391.76
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
110.973105593106633099293117903118743109630.28
2 11.043089013073793081400.35
单位质量响应值RSD%判断
28346.6727911.231.10数据可信
供试品溶液-25111101批-恩格列净-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137423-13742343.22442.6414.3443.2242.6414.34
2119541-11954137.60037.60
3107003-10700333.65633.66
4158443-15844349.83649.84
5152283-15228347.89847.90
6138613-13861343.59943.60
10min1308812-30881297.13294.323.3297.2094.393.32
2302665-30266595.19995.26
3281000-28100088.38488.44
4305405-30540596.06096.14
5297690-29769093.63493.71
6303625-30362595.50195.57
15min1312074-31207498.15896.371.4598.3996.601.46
2307519-30751996.72596.95
3300303-30030394.45694.66
4309729-30972997.42197.66
5302347-30234795.09995.33
6306414-30641496.37896.61
20min1316247-31624799.47196.711.7499.8797.101.74
2307918-30791896.85197.23
3303309-30330995.40195.76
4310118-31011897.54397.95
5301249-30124994.75395.15
6305972-30597296.23996.63
30min1311298-31129897.91496.581.1598.4897.131.15
2307326-30732696.66597.21
3306184-30618496.30596.83
4309341-30934197.29897.87
5300889-30088994.64095.19
6307230-30723096.63497.19
45min1311919-31191998.10996.751.1598.8497.471.14
2307589-30758996.74797.45
3308801-30880197.12997.81
4309108-30910897.22597.96
5301352-30135294.78695.50
6306905-30690596.53297.25
60min1311397-31139797.94596.761.0798.8497.631.07
2307325-30732596.66497.53
3308899-30889997.15998.00
4309026-30902697.19998.09
5301633-30163394.87495.74
6307452-30745296.70497.58
极限1311881-31188198.09797.260.6899.1598.300.67
2307249-30724996.64097.67
3311393-31139397.94498.95
4307949-30794996.86197.91
5307183-30718396.62097.65
6309746-30974697.42698.46
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250201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)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%
1 22.148191758191068166998207658219978195480.25
2 22.168135348115788125560.18
单位质量响应值RSD%判断
37016.6236667.690.67数据可信
供试品溶液-25111101批-非奈利酮-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116614-11661414.2449.5038.5114.249.5038.50
240729-407294.9754.97
3110954-11095413.55313.55
464478-644787.8767.88
573636-736368.9948.99
660238-602387.3587.36
10min1659697-65969780.57972.8814.0480.6072.8914.05
2458277-45827755.97655.98
3649412-64941279.32379.35
4546287-54628766.72666.74
5588479-58847971.88071.90
6677630-67763082.76982.78
15min1763198-76319893.22190.831.4493.3890.961.45
2739558-73955890.33490.44
3742451-74245190.68790.84
4734579-73457989.72589.85
5734795-73479589.75289.89
6746922-74692291.23391.38
20min1777316-77731694.94692.971.5195.2693.251.51
2771536-77153694.24094.49
3761378-76137892.99993.30
4753008-75300891.97692.25
5747057-74705791.25091.53
6756360-75636092.38692.69
30min1783668-78366895.72194.221.7996.1994.661.79
2785058-78505895.89196.30
3777026-77702694.91095.37
4765651-76565193.52193.95
5748170-74817091.38691.82
6768735-76873593.89794.35
45min1792928-79292896.85395.431.6197.4896.031.61
2794794-79479497.08097.65
3787710-78771096.21596.83
4775388-77538894.71095.29
5762645-76264593.15493.74
6774263-77426394.57395.19
60min1794219-79421997.01096.091.5997.8096.851.58
2801421-80142197.89098.62
3790706-79070696.58197.36
4785834-78583495.98696.73
5764998-76499893.44194.19
6783092-78309295.65196.42
极限1812031-81203199.186100.100.66100.14101.020.64
2824583-824583100.719101.61
3826256-826256100.923101.86
4818905-818905100.026100.93
5819817-819817100.137101.04
6815324-81532499.588100.52
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
110.973081373069963073873079663073393075650.16
2 11.043082373095853089110.31
单位质量响应值RSD%判断
28036.9227981.070.15数据可信
供试品溶液-25111102批-恩格列净-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122651-12265138.74137.2934.1238.7437.2834.12
2107239-10723933.87333.87
3166980-16698052.74352.74
482927-8292726.19426.19
5160672-16067250.75050.75
667789-6778921.41221.41
10min1302452-30245295.53395.192.5495.6095.262.53
2289947-28994791.58491.64
3302466-30246695.53895.63
4312100-31210098.58198.62
5295993-29599393.49393.58
6305297-30529796.43296.47
15min1308300-30830097.38196.291.5797.6096.501.56
2301786-30178695.32395.53
3305053-30505396.35596.60
4311069-31106998.25598.46
5297538-29753893.98194.22
6305266-30526696.42296.62
20min1307196-30719697.03296.231.3397.4296.611.32
2301844-30184495.34195.71
3305233-30523396.41296.82
4309376-30937697.72098.09
5298135-29813594.17094.57
6306073-30607396.67797.03
30min1308216-30821697.35496.621.6597.9097.161.64
2301849-30184995.34395.87
3306083-30608396.68097.25
4312808-31280898.80599.34
5298543-29854394.29994.85
6307769-30776997.21397.73
45min1306562-30656296.83296.181.3397.5496.891.32
2302223-30222395.46196.15
3306940-30694096.95197.68
4309872-30987297.87798.58
5298682-29868294.34395.05
6302802-30280295.64496.32
60min1306162-30616296.70597.001.0397.5897.861.03
2301601-30160195.26596.11
3307005-30700596.97297.86
4310456-31045698.06298.92
5309726-30972697.83198.70
6307631-30763197.16998.01
极限1308267-30826797.37097.511.5298.4098.531.50
2303239-30323995.78296.79
3309186-30918697.66098.71
4312288-31228898.64099.67
5303896-30389695.99097.02
6315294-31529499.590100.59
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250201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)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%
1 22.148125268095828103988118448094838107670.17
2 22.168126908156508141700.26
单位质量响应值RSD%判断
36620.0136740.520.24数据可信
供试品溶液-25111102批-非奈利酮-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165311-653118.01212.5345.488.0112.5345.48
260893-608937.4707.47
3172730-17273021.19121.19
477239-772399.4769.48
589997-8999711.04111.04
6146614-14661417.98717.99
10min1499670-49967061.30176.8312.7161.3176.8512.72
2580593-58059371.22871.24
3709874-70987487.08987.12
4626552-62655276.86776.88
5633879-63387977.76677.78
6706968-70696886.73286.76
15min1729710-72971089.52289.591.5489.6489.741.55
2725557-72555789.01389.14
3745019-74501991.40091.58
4741766-74176691.00191.15
5715462-71546287.77487.92
6724290-72429088.85789.03
20min1755289-75528992.66091.311.4592.9391.611.44
2746874-74687491.62891.91
3751299-75129992.17192.50
4750533-75053392.07792.37
5731703-73170389.76790.06
6729975-72997589.55589.88
30min1764343-76434393.77192.311.4694.1992.761.44
2753341-75334192.42192.85
3756780-75678092.84393.33
4761443-76144393.41593.86
5740789-74078990.88291.33
6737691-73769190.50190.97
45min1764444-76444493.78492.181.7594.3692.781.73
2757373-75737392.91693.50
3756716-75671692.83693.48
4757460-75746092.92793.53
5743532-74353291.21891.81
6728510-72851089.37590.00
60min1764247-76424793.75992.951.2094.4993.711.18
2756462-75646292.80493.55
3757529-75752992.93593.73
4761171-76117193.38294.14
5765907-76590793.96394.71
6740812-74081290.88491.66
极限1799090-79909098.03498.340.3098.9299.260.30
2802932-80293298.50599.40
3798882-79888298.00998.96
4805043-80504398.76499.68
5801096-80109698.28099.18
6802648-80264898.47199.39
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