恩格列净二甲双胍片项目信息
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800
标示量(mg)12.5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%
19.792284072287642293722280082298982288900.33
29.832303722293562298640.32
单位质量响应值RSD%判断
23379.9823383.930.02数据可信
供试品溶液-3214147批-恩格列净-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min159621-5962122.94935.7921.5022.9535.7921.50
2104209-10420940.11140.11
385146-8514632.77432.77
4102949-10294939.62639.63
588915-8891534.22434.22
6117074-11707445.06345.06
15min1146466-14646656.37766.918.9056.4166.978.91
2179788-17978869.20369.27
3171096-17109665.85765.91
4183244-18324470.53370.60
5171063-17106365.84465.90
6191340-19134073.64973.72
20min1206554-20655479.50583.384.1379.6483.554.15
2218947-21894784.27584.46
3210747-21074781.11981.28
4220040-22004084.69684.88
5211836-21183681.53881.71
6231590-23159089.14289.34
30min1245489-24548994.49293.342.1894.7693.652.18
2240135-24013592.43192.75
3234819-23481990.38590.68
4239551-23955192.20692.53
5245619-24561994.54294.84
6249346-24934695.97696.32
45min1253206-25320697.46295.222.2997.8895.682.27
2245188-24518894.37694.85
3239498-23949892.18692.64
4243155-24315593.59394.07
5250095-25009596.26596.72
6253135-25313597.43597.94
60min1251237-25123796.70495.331.9797.2995.961.96
2244015-24401593.92494.56
3242022-24202293.15793.76
4244015-24401593.92494.56
5251130-25113096.66397.28
6253590-25359097.61098.28
120min1251152-25115296.67195.301.9997.4296.081.98
2244116-24411693.96394.75
3242063-24206393.17393.93
4243352-24335293.66994.46
5252438-25243897.16697.95
6252456-25245697.17398.00
240min1251344-25134496.74595.412.1297.6596.352.12
2242590-24259093.37694.32
3242134-24213493.20094.11
4245089-24508994.33895.28
5251602-25160296.84597.79
6254426-25442697.93298.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1248883-24888395.79895.192.1696.8796.302.15
2243816-24381693.84894.95
3240666-24066692.63593.71
4243961-24396193.90495.01
5253876-25387697.72098.83
6252635-25263597.24298.40
480min1248548-24854895.66994.951.9696.9096.201.96
2243091-24309193.56994.83
3240166-24016692.44393.67
4244551-24455194.13195.39
5251577-25157796.83598.10
6252073-25207397.02698.34
600min1253024-25302497.39295.992.3098.7897.412.29
2245334-24533494.43295.85
3241339-24133992.89494.27
4246758-24675894.98096.40
5255783-25578398.45499.88
6254022-25402297.77699.26
720min1250691-25069196.49495.502.1898.0497.082.17
2243380-24338093.68095.25
3241358-24135892.90294.43
4245884-24588494.64496.22
5255156-25515698.21399.81
6252203-25220397.07698.72
840min1248279-24827995.56694.762.5097.2896.502.49
2240475-24047592.56294.29
3238763-23876391.90393.59
4243858-24385893.86495.60
5253567-25356797.60199.36
6252223-25222397.08498.89
960min1248228-24822895.54694.252.3997.4296.152.37
2240793-24079392.68494.57
3237246-23724691.31993.16
4241406-24140692.92094.81
5251876-25187696.95098.87
6249640-24964096.08998.06
极限1246527-24652794.89193.982.5496.9296.032.52
2238514-23851491.80793.84
3238239-23823991.70193.69
4239490-23949092.18394.23
5251783-25178396.91499.00
6250376-25037696.37398.50
恩格列净二甲双胍片项目信息
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100664-202106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10
标示量(mg)1000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%
19.829135009177609208269171799241239186780.44
29.869258529266309262410.06
单位质量响应值RSD%判断
93551.7393939.250.30数据可信
供试品溶液-3214147批-二甲双胍-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min15284-52840.5070.7948.540.510.8048.19
26829-68290.6560.66
36668-66680.6400.64
411985-119851.1511.15
54432-44320.4250.43
614483-144831.3901.39
15min134135-341353.2774.1022.283.284.1022.25
240017-400173.8423.84
339555-395553.7973.80
452261-522615.0175.02
533717-337173.2373.24
656463-564635.4215.42
20min175656-756567.2638.2413.407.278.2413.43
282979-829797.9667.97
382349-823497.9067.91
497759-977599.3859.40
574132-741327.1177.12
6101882-1018829.7819.79
30min1154282-15428214.81215.185.7914.8315.205.80
2153945-15394514.77914.80
3155478-15547814.92714.95
4168062-16806216.13516.16
5146658-14665814.08014.10
6170338-17033816.35316.38
45min1233919-23391922.45722.492.9822.5022.542.99
2232319-23231922.30422.35
3230859-23085922.16422.21
4238435-23843522.89122.94
5224953-22495321.59721.64
6245353-24535323.55523.61
60min1290139-29013927.85527.792.4127.9427.882.43
2284217-28421727.28627.37
3285227-28522727.38327.47
4294929-29492928.31528.41
5282129-28212927.08627.16
6300102-30010228.81128.91
120min1445856-44585642.80442.791.2842.9342.921.29
2440501-44050142.29042.42
3443042-44304242.53442.66
4448784-44878443.08643.22
5440568-44056842.29742.42
6455273-45527343.70843.85
240min1646756-64675662.09262.511.3362.2962.711.35
2641150-64115061.55461.75
3653342-65334262.72462.92
4656695-65669563.04663.26
5644244-64424461.85162.04
6664252-66425263.77263.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1791342-79134275.97376.791.3676.2777.101.37
2791873-79187376.02476.32
3805806-80580677.36177.66
4808788-80878877.64877.96
5787724-78772475.62575.92
6813731-81373178.12278.44
480min1894980-89498085.92386.061.1186.3586.491.12
2893660-89366085.79686.22
3895769-89576985.99886.43
4901444-90144486.54386.99
5881109-88110984.59185.01
6911275-91127587.48787.94
600min1971354-97135493.25594.090.8393.8394.670.84
2969976-96997693.12393.69
3981248-98124894.20594.78
4988483-98848394.89995.49
5980489-98048994.13294.70
6988991-98899194.94895.55
720min11012089-101208997.16697.330.6597.8998.060.65
21001913-100191396.18996.91
31015240-101524097.46898.20
41014695-101469597.41698.16
51018625-101862597.79398.51
61020155-102015597.94098.70
840min11027947-102794798.68898.771.0699.5899.671.06
21009352-100935296.90397.79
31033093-103309399.182100.08
41031794-103179499.05799.97
51028696-102869698.76099.64
61042186-1042186100.055100.97
960min11035013-103501399.36699.010.67100.42100.080.67
21019314-101931497.85998.91
31029996-102999698.88599.95
41029515-102951598.83999.91
51035153-103515399.380100.43
61039030-103903099.752100.84
极限11026819-102681998.58099.191.1999.80100.411.19
21012829-101282997.23798.45
31035674-103567499.430100.66
41039875-103987599.833101.07
51034851-103485199.351100.56
61048827-1048827100.693101.94
恩格列净二甲双胍片项目信息
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800
标示量(mg)12.5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%
19.792288922294432300042295842289062293660.21
29.832311082309652310360.05
单位质量响应值RSD%判断
23428.6023503.150.23数据可信
供试品溶液-3214147批-恩格列净-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min180907-8090731.03134.4210.6731.0334.4210.68
284954-8495432.58332.58
397645-9764537.45037.45
4104706-10470640.15940.16
581369-8136931.20831.21
688841-8884134.07434.07
15min1172113-17211366.01267.097.3166.0667.157.31
2174869-17486967.06967.12
3173225-17322566.43866.50
4199293-19929376.43676.50
5162173-16217362.19962.25
6167924-16792464.40564.46
20min1219464-21946484.17282.675.8084.3382.845.80
2215951-21595182.82582.99
3208863-20886380.10780.28
4238205-23820591.36091.55
5204752-20475278.53078.69
6206071-20607179.03679.20
30min1249110-24911095.54392.594.3495.8492.904.34
2240756-24075692.33992.64
3232971-23297189.35389.66
4258474-25847499.13499.48
5232350-23235089.11589.40
6234868-23486890.08090.38
45min1254339-25433997.54894.263.5398.0194.723.54
2246167-24616794.41494.87
3236544-23654490.72391.18
4257887-25788798.90999.42
5239895-23989592.00992.44
6239803-23980391.97392.42
60min1252117-25211796.69694.573.5997.3295.193.60
2247340-24734094.86495.48
3237943-23794391.26091.87
4261044-261044100.120100.80
5241409-24140992.58993.18
6239567-23956791.88392.48
120min1256256-25625698.28495.133.1699.0795.903.17
2245902-24590294.31295.09
3238504-23850491.47592.23
4258591-25859199.179100.02
5246284-24628494.45995.20
6242619-24261993.05393.81
240min1255805-25580598.11195.033.1999.0695.963.20
2246375-24637594.49495.42
3239416-23941691.82592.74
4258788-25878899.255100.26
5245432-24543294.13295.03
6240805-24080592.35893.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1254301-25430197.53495.103.0098.6596.193.00
2247509-24750994.92996.02
3237544-23754491.10792.17
4257588-25758898.79499.97
5248520-24852095.31796.37
6242209-24220992.89693.96
480min1255809-25580998.11294.933.0099.3996.183.00
2246005-24600594.35295.60
3237036-23703690.91292.13
4255307-25530797.92099.26
5248965-24896595.48796.70
6241923-24192392.78694.00
600min1259153-25915399.39596.492.70100.8397.902.70
2249914-24991495.85197.25
3241591-24159192.65994.03
4259322-25932299.459100.96
5250926-25092696.23997.61
6248555-24855595.33096.70
720min1260229-26022999.80795.883.45101.4197.453.44
2249881-24988195.83997.40
3237883-23788391.23792.76
4259422-25942299.498101.17
5247257-24725794.83296.37
6245273-24527394.07195.60
840min1256942-25694298.54795.192.98100.3296.922.99
2248546-24854695.32697.05
3237897-23789791.24292.92
4256287-25628798.295100.13
5245437-24543794.13495.83
6244032-24403293.59595.28
960min1254002-25400297.41994.342.6199.3596.232.62
2246744-24674494.63596.52
3237137-23713790.95192.78
4252275-25227596.75798.75
5244184-24418493.65495.50
6241511-24151192.62894.47
极限1253195-25319597.11093.992.5099.2196.042.51
2245135-24513594.01896.06
3235765-23576590.42592.40
4250119-25011995.93098.09
5243818-24381893.51395.52
6242309-24230992.93494.93
恩格列净二甲双胍片项目信息
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100664-202106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10
标示量(mg)1000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%
19.829273649272469263759231219254339259080.19
29.869317999329889323940.10
单位质量响应值RSD%判断
94287.9894563.290.21数据可信
供试品溶液-3214147批-二甲双胍-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13457-34570.3290.4935.850.330.4936.42
24978-49780.4740.47
38133-81330.7750.78
46646-66460.6330.63
53607-36070.3440.34
64244-42440.4050.40
15min128389-283892.7063.4316.262.713.4316.29
236002-360023.4313.43
344223-442234.2154.22
441091-410913.9173.92
531799-317993.0313.03
634531-345313.2913.29
20min167761-677616.4597.439.316.467.439.35
279650-796507.5927.60
387121-871218.3048.31
484332-843328.0388.05
572672-726726.9276.93
675988-759887.2437.25
30min1144280-14428013.75214.374.3613.7714.394.36
2152733-15273314.55714.58
3157066-15706614.97014.99
4159475-15947515.20015.22
5145099-14509913.83013.85
6146100-14610013.92513.94
45min1221285-22128521.09121.522.2921.1321.562.30
2227725-22772521.70521.75
3230763-23076321.99522.04
4232264-23226422.13822.18
5220497-22049721.01621.06
6221937-22193721.15421.19
60min1275309-27530926.24126.922.3026.3127.002.31
2285697-28569727.23127.31
3288011-28801127.45127.54
4290696-29069627.70727.79
5276713-27671326.37426.45
6278353-27835326.53126.61
120min1435594-43559441.51841.780.8641.6441.900.87
2436990-43699041.65141.78
3438326-43832641.77841.91
4445749-44574942.48642.62
5436526-43652641.60741.73
6436565-43656541.61041.73
240min1640627-64062761.06061.331.0561.2561.521.05
2641282-64128261.12361.32
3646756-64675661.64461.84
4654123-65412362.34762.55
5643710-64371061.35461.54
6634091-63409160.43760.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1774014-77401473.77475.161.4774.0675.461.47
2789623-78962375.26275.56
3792423-79242375.52875.83
4804910-80491076.71977.02
5793915-79391575.67175.96
6776698-77669874.03074.32
480min1877210-87721083.61084.901.4084.0285.321.40
2892466-89246685.06485.49
3887475-88747584.58885.02
4899848-89984885.76786.20
5909269-90926986.66587.08
6878330-87833083.71784.13
600min1961427-96142791.63792.820.9292.1993.380.92
2979252-97925293.33693.90
3975349-97534992.96493.53
4974871-97487192.91893.49
5985939-98593993.97394.53
6965909-96590992.06492.62
720min11005113-100511395.80196.380.8396.5097.090.83
21013723-101372396.62197.34
31004812-100481295.77296.50
41020178-102017897.23797.97
51021120-102112097.32698.04
61002003-100200395.50496.21
840min11016703-101670396.90597.400.8297.7798.280.82
21025589-102558997.75298.63
31027924-102792497.97598.86
41028927-102892798.07098.96
51024923-102492397.68998.57
61007346-100734696.01396.88
960min11025127-102512797.70897.690.6098.7398.720.60
21029103-102910398.08799.13
31028465-102846598.02699.07
41026660-102666097.85498.91
51027249-102724997.91098.95
61012819-101281996.53597.56
极限11023693-102369397.57298.080.7298.7699.280.72
21037594-103759498.897100.10
31033446-103344698.50199.71
41022222-102222297.43198.65
51035885-103588598.73499.94
61021449-102144997.35898.55
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