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2000
标示量(mg)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%
110.149423494356940989423794341942530.11
210.149317193376932740.16
单位质量响应值RSD%判断
9295.179198.620.74数据可信
长期6月-供试品溶液-2024120421批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138634-3863437.60346.3920.5137.6046.3920.51
244273-4427343.09243.09
335548-3554834.60034.60
450898-5089849.54049.54
557644-5764456.10656.11
658958-5895857.38557.39
10min173849-7384971.87983.9010.6971.9483.9810.70
280842-8084278.68678.76
381165-8116579.00079.06
488286-8828685.93186.01
596034-9603493.47293.57
697008-9700894.42094.52
15min192723-9272390.25094.424.0990.4394.644.12
295147-9514792.60992.81
392817-9281790.34190.53
498978-9897896.33896.56
5101539-10153998.83199.08
6100856-10085698.16698.42
20min196037-9603793.47596.342.0493.8196.722.06
297459-9745994.85995.22
398775-9877596.14096.48
499427-9942796.77597.16
5101353-10135398.65099.06
6100838-10083898.14898.56
30min196503-9650393.92996.791.9694.4297.321.99
297911-9791195.29995.81
399356-9935696.70697.21
4100229-10022997.55698.10
5101607-10160798.89799.48
6101047-10104798.35298.93
45min196994-9699494.40797.271.7795.0597.971.79
298955-9895596.31696.99
3101056-10105698.36099.02
499712-9971297.05297.76
5101302-10130298.60099.34
6101621-10162198.91099.65
60min196886-9688694.30296.641.5395.1097.501.55
298389-9838995.76596.60
399374-9937496.72397.55
499436-9943696.78497.66
5101022-10102298.32799.23
6100625-10062597.94198.85
极限196993-9699394.40696.791.4995.3797.811.51
298577-9857795.94896.94
3100196-10019697.52398.51
499364-9936496.71497.75
5101007-10100798.31399.38
6100516-10051697.83598.91
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.025172645187615188045197395207655190670.26
210.055124275128435126350.06
单位质量响应值RSD%判断
51803.0951008.461.10数据可信
长期6月-供试品溶液-2024120421批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1248292-24829243.47351.7717.3243.4751.7617.32
2279052-27905248.85948.86
3231769-23176940.58040.58
4312067-31206754.63954.64
5348406-34840661.00261.00
6354364-35436462.04562.04
10min1430857-43085775.43885.879.0375.5185.969.04
2466202-46620281.62681.71
3466070-46607081.60381.67
4498752-49875287.32687.42
5537315-53731594.07794.18
6543430-54343095.14895.25
15min1520631-52063191.15694.573.3891.3594.803.40
2531716-53171693.09793.31
3520605-52060591.15291.36
4548822-54882296.09296.33
5561337-56133798.28398.54
6557558-55755897.62297.88
20min1535849-53584993.82195.881.5294.1796.271.55
2542200-54220094.93395.31
3545511-54551195.51295.87
4548445-54844596.02696.42
5556939-55693997.51397.94
6556775-55677597.48597.91
30min1536386-53638693.91596.111.4994.4296.661.52
2542870-54287095.05095.58
3547710-54771095.89796.41
4553601-55360196.92997.49
5556637-55663797.46098.05
6556396-55639697.41898.01
45min1536677-53667793.96696.131.3794.6396.841.39
2548757-54875796.08196.77
3548343-54834396.00896.68
4546869-54686995.75096.47
5555527-55552797.26698.01
6558014-55801497.70298.45
60min1534181-53418193.52995.631.4294.3596.501.44
2542355-54235594.96095.81
3545214-54521495.46096.30
4546294-54629495.65096.53
5554844-55484497.14798.06
6554089-55408997.01497.93
极限1534291-53429193.54895.421.3694.5296.441.39
2539936-53993694.53695.54
3544531-54453195.34196.33
4544702-54470295.37196.41
5553038-55303896.83097.90
6553254-55325496.86897.94
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2000
标示量(mg)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%
110.149528295257953099534895408953210.07
210.149438794414944000.03
单位质量响应值RSD%判断
9400.499309.660.69数据可信
长期6月-供试品溶液-2024120421批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161091-6109158.77446.3617.2158.7746.3617.21
246677-4667744.90644.91
347857-4785746.04246.04
453853-5385351.81051.81
540974-4097439.42039.42
638671-3867137.20437.20
10min197324-9732493.63283.4910.1693.7383.5610.17
284615-8461581.40581.48
390591-9059187.15587.23
494405-9440590.82490.91
578214-7821475.24775.31
675522-7552272.65772.72
15min199804-9980496.01895.602.5296.2795.812.53
2100963-10096397.13397.34
3100202-10020296.40196.62
4102315-10231598.43498.67
597491-9749193.79393.98
695431-9543191.81191.99
20min199931-9993196.14096.601.8496.5596.981.85
2101883-10188398.01898.39
3100644-10064496.82697.21
4102825-10282598.92599.33
599605-9960595.82796.17
697580-9758093.87894.21
30min199444-9944495.67296.701.6296.2597.241.63
2102022-10202298.15298.69
3100883-10088397.05697.60
4102352-10235298.46999.04
5100397-10039796.58997.10
698009-9800994.29194.78
45min199913-9991396.12396.731.7396.8697.431.75
2101627-10162797.77298.47
3100872-10087297.04697.75
4103033-10303399.12599.86
599860-9986096.07296.74
697941-9794194.22694.88
60min199850-9985096.06296.361.7896.9697.221.80
2101577-10157797.72498.59
3100331-10033196.52597.39
4102479-10247998.59299.49
599303-9930395.53696.36
697401-9740193.70694.51
极限199529-9952995.75496.761.4896.8197.781.49
2101760-10176097.90098.93
3100719-10071996.89897.93
4102532-10253298.64399.70
5100531-10053196.71897.71
698403-9840394.67095.63
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.025180015179275174825170165178865176620.08
210.055169805167045168420.04
单位质量响应值RSD%判断
51662.8751427.060.33数据可信
长期6月-供试品溶液-2024120421批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1366816-36681664.04851.9214.8764.0551.9214.87
2288303-28830350.33950.34
3294641-29464151.44651.45
4327727-32772757.22357.22
5258894-25889445.20445.20
6247808-24780843.26943.27
10min1541834-54183494.60785.998.3394.7186.088.34
2480822-48082283.95484.04
3510950-51095089.21589.30
4527974-52797492.18792.28
5451301-45130178.80078.88
6442075-44207577.18977.26
15min1550945-55094596.19896.001.7496.4696.221.76
2554755-55475596.86397.09
3552788-55278896.52096.75
4562707-56270798.25298.50
5541135-54113594.48594.69
6536430-53643093.66493.86
20min1549557-54955795.95696.361.1796.3896.751.18
2555369-55536996.97197.36
3552013-55201396.38596.78
4561958-56195898.12198.53
5549243-54924395.90196.27
6542943-54294394.80195.16
30min1548007-54800795.68596.371.1996.2796.931.20
2555252-55525296.95097.50
3550542-55054296.12896.68
4561208-56120897.99098.57
5554469-55446996.81397.34
6542265-54226594.68395.20
45min1547485-54748595.59496.211.2796.3496.921.29
2553653-55365396.67197.38
3552720-55272096.50897.22
4562443-56244398.20698.95
5547461-54746195.59096.28
6542146-54214694.66295.33
60min1545990-54599095.33395.831.2396.2496.701.24
2552671-55267196.50097.37
3548790-54879095.82296.70
4559299-55929997.65798.56
5546777-54677795.47096.32
6539401-53940194.18395.01
极限1545318-54531895.21695.801.0996.2896.831.10
2551750-55175096.33997.37
3547737-54773795.63896.67
4557748-55774897.38698.45
5549271-54927195.90696.91
6540104-54010494.30595.29
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2000
标示量(mg)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%
110.149473294894949119475894860948310.09
210.149368393807937450.10
单位质量响应值RSD%判断
9352.179245.070.82数据可信
长期6月-供试品溶液-2024120521批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148803-4880347.23746.3020.2047.2446.3020.20
240277-4027738.98538.98
361859-6185959.87459.87
455463-5546353.68453.68
544755-4475543.31943.32
635832-3583234.68234.68
10min186312-8631283.54382.1412.2383.6282.2212.23
275015-7501572.60872.67
397354-9735494.23194.33
495689-9568992.61992.71
582600-8260079.95080.02
672200-7220069.88469.94
15min197882-9788294.74294.383.4794.9694.593.50
293846-9384690.83591.02
3101136-10113697.89198.15
499791-9979196.58996.83
599483-9948396.29196.50
692886-9288689.90690.08
20min198844-9884495.67396.181.8396.0596.551.86
299279-9927996.09496.43
3101635-10163598.37498.79
4100373-10037397.15397.56
599812-9981296.61096.98
696233-9623393.14693.47
30min198676-9867695.51096.181.8296.0596.711.84
2100192-10019296.97897.48
3101162-10116297.91698.50
4100158-10015896.94597.51
599943-9994396.73797.26
696068-9606892.98693.47
45min198614-9861495.45096.471.9796.1497.161.98
2101322-10132298.07198.73
3101338-10133898.08798.83
4100308-10030897.09097.82
5100203-10020396.98897.68
696239-9623993.15193.79
60min198262-9826295.11096.041.7295.9696.891.74
2100254-10025497.03897.86
3100961-10096197.72298.63
499747-9974796.54797.44
599825-9982596.62297.47
696263-9626393.17593.96
极限198451-9845195.29296.321.7396.3097.331.75
2100727-10072797.49598.48
3101306-10130698.05699.13
4100087-10008796.87697.93
599899-9989996.69497.70
696614-9661493.51494.46
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.025204545195715202905206055198955201630.09
210.055129465131135130300.03
单位质量响应值RSD%判断
51912.4851047.761.19数据可信
长期6月-供试品溶液-2024120521批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1302956-30295652.96852.0816.3352.9752.0816.33
2257828-25782845.07845.08
3369971-36997164.68564.68
4333643-33364358.33358.33
5284238-28423849.69549.70
6238468-23846841.69341.69
10min1496556-49655686.81685.309.3486.9085.389.35
2440178-44017876.95977.03
3544383-54438395.17895.29
4533193-53319393.22293.32
5476360-47636083.28583.37
6436506-43650676.31776.39
15min1546674-54667495.57995.311.9695.8195.541.98
2533413-53341393.26093.46
3556938-55693897.37397.64
4547830-54783095.78196.03
5554675-55467596.97897.20
6531398-53139892.90893.10
20min1548747-54874795.94196.501.1296.3396.881.13
2557490-55749097.47097.83
3558138-55813897.58398.01
4548860-54886095.96196.37
5555684-55568497.15497.54
6542628-54262894.87295.22
30min1547493-54749395.72296.631.4896.2797.181.47
2564538-56453898.70299.22
3556303-55630397.26297.85
4547627-54762795.74696.32
5557716-55771697.50998.05
6542595-54259594.86695.38
45min1546728-54672895.58896.251.2896.3096.961.27
2560529-56052998.00198.69
3555037-55503797.04197.79
4545748-54574895.41796.15
5553340-55334096.74497.45
6541621-54162194.69595.36
60min1544920-54492095.27296.701.8896.1497.581.86
2570655-57065599.772100.62
3559653-55965397.84898.76
4544768-54476895.24696.14
5552513-55251396.60097.47
6546170-54617095.49196.32
极限1544022-54402295.11595.781.1996.1596.811.19
2556018-55601897.21398.23
3553188-55318896.71897.80
4543234-54323494.97796.03
5550989-55098996.33397.36
6539473-53947394.32095.30
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2000
标示量(mg)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%
110.149521794819950279484395139950090.19
210.149547495255953640.17
单位质量响应值RSD%判断
9369.729404.730.27数据可信
长期6月-供试品溶液-2024120521批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151689-5168949.55745.3318.0849.5645.3318.08
258360-5836055.95355.95
347858-4785845.88445.88
435578-3557834.11134.11
538916-3891637.31137.31
651265-5126549.15049.15
10min190333-9033386.60780.8111.0886.6980.8811.09
295435-9543591.49991.59
385574-8557482.04482.12
472891-7289169.88469.94
573048-7304870.03570.10
688415-8841584.76884.85
15min198741-9874194.66892.923.2694.9093.133.28
298405-9840594.34694.59
3100461-10046196.31796.53
494634-9463490.73190.90
591795-9179588.00988.19
697483-9748393.46293.69
20min199242-9924295.14994.771.2795.5395.141.27
298802-9880294.72795.13
3100916-10091696.75397.13
499007-9900794.92395.25
597545-9754593.52293.85
697582-9758293.55793.94
30min198731-9873194.65994.781.1095.2095.301.10
298469-9846994.40794.97
3100929-10092996.76697.30
498948-9894894.86795.35
597979-9797993.93894.42
698097-9809794.05194.59
45min198843-9884394.76694.581.1295.4795.261.12
298124-9812494.07794.79
3100568-10056896.42097.12
499017-9901794.93395.57
597889-9788993.85194.49
697484-9748493.46394.15
60min198138-9813894.09094.271.2694.9595.111.25
298039-9803993.99594.87
3100605-10060596.45597.31
498566-9856694.50095.30
597552-9755293.52894.32
697062-9706293.05893.91
极限198572-9857294.50694.641.0795.5295.641.06
298027-9802793.98495.02
3100719-10071996.56597.58
498916-9891694.83695.79
598102-9810294.05695.01
697959-9795993.91894.92
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.025153345158595156645155545151125155050.06
210.055283295270995277140.17
单位质量响应值RSD%判断
51447.6052508.861.45数据可信
长期6月-供试品溶液-2024120521批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1311445-31144553.93250.8715.6353.9350.8615.63
2355385-35538561.54161.54
3297398-29739851.50051.50
4231008-23100840.00340.00
5249938-24993843.28143.28
6317251-31725154.93854.94
10min1507420-50742087.86983.699.2587.9683.779.26
2540361-54036193.57393.68
3486997-48699784.33284.42
4430048-43004874.47074.54
5430060-43006074.47274.54
6504708-50470887.39987.49
15min1542730-54273093.98393.802.0894.2294.032.09
2549065-54906595.08095.34
3555168-55516896.13796.36
4536591-53659192.92093.11
5522612-52261290.49990.70
6543950-54395094.19494.43
20min1541845-54184593.83095.201.0094.2295.580.98
2550678-55067895.36095.78
3556602-55660296.38596.77
4554237-55423795.97696.32
5549612-54961295.17595.52
6545519-54551994.46694.86
30min1541216-54121693.72194.990.9994.2795.530.98
2548220-54822094.93495.51
3555233-55523396.14896.70
4553501-55350195.84896.35
5549373-54937395.13495.64
6543775-54377594.16494.72
45min1540061-54006193.52194.770.9694.2395.460.95
2547566-54756694.82195.55
3553375-55337595.82796.53
4552302-55230295.64196.31
5547649-54764994.83595.50
6542519-54251993.94794.66
60min1538491-53849193.24994.591.0994.1195.451.07
2547095-54709594.73995.63
3553477-55347795.84496.71
4551186-55118695.44796.27
5547105-54710594.74195.56
6540124-54012493.53294.40
极限1538395-53839593.23294.380.8994.2595.390.88
2545098-54509894.39395.44
3551213-55121395.45296.48
4549587-54958795.17196.15
5544489-54448994.28895.27
6541276-54127693.73194.75
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