二甲双胍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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.059545695112948479511894953950970.25
210.019512095219951700.08
单位质量响应值RSD%判断
9462.399507.490.34数据可信
供试品溶液-301793A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%
5min137695-3769535.40729.0015.3435.4129.0115.34
231721-3172129.79529.80
329562-2956227.76727.77
425276-2527623.74223.74
534479-3447932.38632.39
626543-2654324.93224.93
10min175695-7569571.10060.1812.5771.1660.2312.57
264368-6436860.46060.51
360152-6015256.50056.55
455493-5549352.12452.16
571415-7141567.08067.13
657285-5728553.80753.85
15min195883-9588390.06281.007.9090.2481.157.90
285363-8536380.18180.33
383143-8314378.09678.24
478358-7835873.60173.73
592966-9296687.32287.49
681683-8168376.72476.86
20min1101616-10161695.44791.393.2295.7791.673.24
296471-9647190.61590.90
396969-9696991.08291.35
493279-9327987.61687.87
5100268-10026894.18194.49
695148-9514889.37289.63
30min1101677-10167795.50595.600.9495.9996.030.93
2100006-10000693.93594.37
3101860-10186095.67796.10
4102743-10274396.50696.90
5102412-10241296.19596.66
6101954-10195495.76596.17
45min1101590-10159095.42395.761.0196.0796.360.99
2100154-10015494.07494.67
3102391-10239196.17596.76
4103100-10310096.84197.40
5102546-10254696.32196.95
6101935-10193595.74796.31
60min1101243-10124395.09795.670.9495.9096.420.92
2100275-10027594.18894.94
3102430-10243096.21296.95
4102806-10280696.56597.28
5102516-10251696.29397.08
6101826-10182695.64596.37
极限1101339-10133995.18795.540.9196.1596.450.90
2100082-10008294.00694.91
3102158-10215895.95696.86
4102313-10231396.10296.98
5102653-10265396.42197.37
6101714-10171495.53996.43
二甲双胍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20
标示量(mg)500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%
110.00 8985708991449000198997489002018995360.08
210.029025809032999029400.06
单位质量响应值RSD%判断
89953.6090113.770.13数据可信
供试品溶液-301793A批-二甲双胍-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%
5min1437531-43753143.73736.6512.9843.7436.6512.99
2370240-37024037.01037.01
3357481-35748135.73535.73
4309743-30974330.96330.96
5400627-40062740.04840.05
6324244-32424432.41232.41
10min1760099-76009975.98265.3910.7976.0565.4610.79
2655292-65529265.50565.57
3627290-62729062.70662.77
4575963-57596357.57557.63
5711609-71160971.13471.20
6594829-59482959.46159.51
15min1905129-90512990.47982.596.5390.6882.766.54
2817781-81778181.74881.92
3814954-81495481.46581.63
4760854-76085476.05776.20
5872810-87281087.24887.43
6785626-78562678.53378.69
20min1941788-94178894.14490.562.8394.4990.872.85
2898775-89877589.84490.15
3916545-91654591.62091.92
4872529-87252987.22087.49
5921557-92155792.12192.45
6884449-88444988.41288.70
30min1941366-94136694.10193.521.0294.6193.981.02
2923332-92333292.29992.76
3950362-95036295.00195.45
4934330-93433093.39893.82
5935518-93551893.51794.00
6928627-92862792.82893.26
45min1938527-93852793.81893.571.0294.4894.191.02
2924238-92423892.38993.00
3951749-95174995.13995.75
4936467-93646793.61294.19
5936995-93699593.66594.30
6928525-92852592.81893.40
60min1937100-93710093.67593.461.0794.5094.221.07
2923301-92330192.29693.06
3951669-95166995.13195.90
4934182-93418293.38394.11
5936520-93652093.61794.41
6926627-92662792.62893.37
极限1936015-93601593.56793.251.0494.5494.171.04
2921226-92122692.08893.01
3948973-94897394.86295.79
4931516-93151693.11794.00
5933907-93390793.35694.31
6925327-92532792.49893.39
二甲双胍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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.059514995308953579530395319952870.09
210.019482594968948960.11
单位质量响应值RSD%判断
9481.299480.120.01数据可信
供试品溶液-301793A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%
5min128194-2819426.49427.996.6926.4927.986.69
228149-2814926.45226.45
332616-3261630.65030.65
431982-3198230.05430.05
529072-2907227.31927.32
628671-2867126.94226.94
10min159119-5911955.55558.586.8255.6058.636.82
258164-5816454.65754.70
368045-6804563.94263.99
467282-6728263.22563.28
560464-6046456.81956.86
660979-6097957.30257.35
15min183014-8301478.00979.994.3078.1580.134.30
280912-8091276.03476.17
391483-9148385.96786.12
486762-8676281.53181.69
584249-8424979.16979.31
684294-8429479.21279.35
20min195994-9599490.20690.742.6090.4791.022.61
292741-9274187.14987.41
399998-9999893.96994.27
496131-9613190.33590.63
598596-9859692.65192.92
695927-9592790.14390.42
30min1100431-10043194.37694.830.9294.7995.260.93
299651-9965193.64394.05
3102189-10218996.02896.49
4101113-10111395.01795.46
5101646-10164695.51895.94
6100465-10046594.40894.83
45min1101073-10107394.97995.110.7895.5595.700.79
299994-9999493.96594.53
3102323-10232396.15496.77
4101313-10131395.20595.80
5101683-10168395.55296.14
6100900-10090094.81795.40
60min1100932-10093294.84795.040.7895.5895.790.79
299999-9999993.97094.69
3102293-10229396.12696.90
4100881-10088194.79995.56
5101692-10169295.56196.31
6101033-10103394.94295.68
极限1100416-10041694.36294.960.8295.2595.860.83
2100188-10018894.14895.02
3102297-10229796.12997.07
4100615-10061594.54995.47
5101732-10173295.59896.50
6101042-10104294.95095.85
二甲双胍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20
标示量(mg)500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%
110.00 9030159024759020119021529015289022360.07
210.029026599038079032330.09
单位质量响应值RSD%判断
90223.6090143.010.07数据可信
供试品溶液-301793A批-二甲双胍-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%
5min1342672-34267234.19835.646.1234.2035.646.12
2339819-33981933.91333.91
3389049-38904938.82638.83
4381004-38100438.02338.02
5346204-34620434.55034.55
6344234-34423434.35334.35
10min1617590-61759061.63364.235.8761.6964.295.87
2608806-60880660.75760.81
3693803-69380369.23969.30
4689167-68916768.77768.84
5622256-62225662.09962.16
6630030-63003062.87562.93
15min1811736-81173681.00982.313.3981.1782.483.40
2794850-79485079.32379.48
3873304-87330487.15387.33
4840607-84060783.89084.07
5811749-81174981.01081.17
6816614-81661481.49581.66
20min1908145-90814590.63090.581.7990.9290.891.80
2881322-88132287.95388.24
3928481-92848192.65992.98
4907886-90788690.60490.92
5919601-91960191.77392.07
6900710-90071089.88890.19
30min1936176-93617693.42793.420.6593.8793.880.66
2928122-92812292.62493.06
3943588-94358894.16794.65
4942023-94202394.01194.48
5935684-93568493.37893.83
6931128-93112892.92493.37
45min1938323-93832393.64293.600.5394.2494.210.55
2931125-93112592.92393.51
3944386-94438694.24794.88
4942739-94273994.08294.71
5936216-93621693.43194.04
6934893-93489393.29993.90
60min1935934-93593493.40393.450.4994.1694.220.50
2930968-93096892.90893.65
3943721-94372194.18094.97
4939404-93940493.74994.53
5934284-93428493.23994.00
6934216-93421693.23293.99
极限1932430-93243093.05393.230.4993.9794.150.50
2928810-92881092.69293.59
3941413-94141393.95094.90
4937460-93746093.55594.49
5931971-93197193.00893.92
6933076-93307693.11894.03
二甲双胍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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.059525795353950799503995355952170.16
210.019564895629956380.02
单位质量响应值RSD%判断
9474.339554.250.60数据可信
供试品溶液-301793A批-恩格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126828-2682825.12225.6626.4025.1225.6626.41
230327-3032728.39828.40
340429-4042937.85837.86
423672-2367222.16722.17
522494-2249421.06421.06
620683-2068319.36819.37
10min148911-4891145.80148.1428.2145.8448.1828.21
257300-5730053.65653.70
377862-7786272.91172.97
443680-4368040.90240.94
542037-4203739.36439.40
638646-3864636.18836.22
15min165625-6562561.45262.9222.2961.5763.0422.30
275407-7540770.61270.75
393130-9313087.20887.39
458665-5866554.93455.04
558018-5801854.32954.43
652316-5231648.98949.08
20min178823-7882373.81173.1217.4374.0373.3517.46
287498-8749881.93482.19
399738-9973893.39593.73
469922-6992265.47665.67
569635-6963565.20765.40
662916-6291658.91559.09
30min191321-9132185.51484.2010.2785.8684.5510.32
2100210-10021093.83794.23
3100641-10064194.24194.73
485582-8558280.14080.45
584130-8413078.78079.08
677629-7762972.69272.96
45min197393-9739391.20091.464.0091.6991.944.05
2103402-10340296.82697.37
399997-9999793.63894.28
494043-9404388.06388.50
598398-9839892.14192.57
692764-9276486.86587.26
60min199164-9916492.85894.371.9393.5095.021.93
2102884-10288496.34197.05
3100379-10037993.99694.79
498785-9878592.50393.09
5103441-10344196.86397.45
6100029-10002993.66894.21
极限1103118-10311896.56196.771.4897.3597.571.37
2102845-10284596.30597.17
3100704-10070494.30095.26
4104228-10422897.60098.34
5104122-10412297.50198.25
6105053-10505398.37299.07
二甲双胍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20
标示量(mg)500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%
110.00 8994718997628989278990708988878992230.05
210.029029919032299031100.02
单位质量响应值RSD%判断
89922.3090130.740.17数据可信
供试品溶液-301793A批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340559-34055934.04634.2621.8734.0534.2621.87
2372819-37281937.27137.27
3476566-47656647.64347.64
4301116-30111630.10330.10
5294109-29410929.40229.40
6270943-27094327.08627.09
10min1545389-54538954.52356.2023.0854.5856.2623.08
2614813-61481361.46361.53
3797650-79765079.74279.82
4489538-48953848.93948.99
5480706-48070648.05748.11
6445023-44502344.48944.53
15min1691477-69147769.12769.5918.4269.2869.7518.43
2769683-76968376.94677.11
3914002-91400291.37391.59
4618508-61850861.83361.96
5618090-61809061.79161.92
6565152-56515256.49956.62
20min1797360-79736079.71378.3814.5479.9878.6414.56
2864970-86497086.47286.76
3960932-96093296.06596.43
4710874-71087471.06771.30
5715923-71592371.57171.80
6654055-65405565.38665.60
30min1899029-89902989.87787.878.8090.2788.278.84
2961843-96184396.15696.59
3968093-96809396.78197.31
4835279-83527983.50383.86
5834250-83425083.40183.75
6775172-77517277.49477.82
45min1951899-95189995.16293.713.7295.7194.253.77
2978016-97801697.77398.37
3963624-96362496.33497.02
4903340-90334090.30890.80
5938205-93820593.79394.28
6888945-88894588.86889.32
60min1959310-95931095.90395.791.7396.6196.491.77
2975661-97566197.53798.30
3965170-96517096.48997.34
4937317-93731793.70494.35
5972603-97260397.23297.88
6939062-93906293.87994.48
极限1980877-98087798.05997.310.4898.9298.160.45
2974477-97447797.41998.34
3966922-96692296.66497.67
4970969-97096997.06897.87
5974067-97406797.37898.19
6972732-97273297.24598.00
二甲双胍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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.059559595803958099584395655957410.12
210.019621096216962130.01
单位质量响应值RSD%判断
9526.479611.690.63数据可信
供试品溶液-301793A批-恩格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128403-2840326.44523.9213.1626.4423.9213.16
222323-2232320.78420.78
322391-2239120.84720.85
425459-2545923.70423.70
524748-2474823.04223.04
630852-3085228.72528.72
10min153762-5376250.05545.7712.5950.1045.8112.59
242709-4270939.76439.80
345784-4578442.62742.66
448126-4812644.80844.85
545349-4534942.22242.26
659242-5924255.15755.21
15min174453-7445369.31962.4912.5469.4562.6112.53
258166-5816654.15554.26
363738-6373859.34359.45
465635-6563561.10961.22
560747-6074756.55856.67
679986-7998674.47174.61
20min189003-8900382.86674.4011.3683.1174.6211.36
270004-7000465.17765.37
376558-7655871.27971.48
478645-7864573.22273.44
572555-7255567.55267.76
692703-9270386.31186.57
30min197077-9707790.38386.266.7490.7686.616.76
285254-8525479.37679.68
391523-9152385.21285.54
490612-9061284.36484.70
588793-8879382.67182.99
6102659-10265995.58195.99
45min1101240-10124094.25992.002.7594.7992.492.79
294732-9473288.20088.63
398849-9884992.03392.50
497757-9775791.01791.50
597946-9794691.19291.65
6102340-10234095.28495.85
60min1102497-10249795.43093.931.5396.1294.571.57
298529-9852991.73592.31
3100309-10030993.39394.01
4100214-10021493.30493.93
5101208-10120894.23094.83
6102552-10255295.48196.21
极限1103017-10301795.91495.730.7096.7696.520.67
2103895-10389596.73197.46
3102419-10241995.35796.13
4101923-10192394.89595.68
5103269-10326996.14896.91
6102364-10236495.30696.19
二甲双胍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20
标示量(mg)500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%
110.00 9031389025829030479029889029329029370.03
210.029075719081709078700.05
单位质量响应值RSD%判断
90293.7090605.790.25数据可信
供试品溶液-301793A批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1358589-35858935.68132.7311.0135.6832.7411.01
2290999-29099928.95528.96
3294185-29418529.27229.27
4327638-32763832.60132.60
5319406-31940631.78231.78
6383056-38305638.11538.12
10min1592286-59228658.93454.5410.2158.9954.5910.21
2484155-48415548.17548.22
3522886-52288652.02952.08
4541789-54178953.91053.96
5511996-51199650.94551.00
6635363-63536363.22163.28
15min1766203-76620376.24069.8210.1876.4069.9710.19
2618467-61846761.53961.67
3682829-68282967.94468.08
4693155-69315568.97169.12
5644343-64434364.11464.25
6805163-80516380.11680.29
20min1882078-88207887.76980.229.2388.0580.489.23
2716051-71605171.24971.48
3790602-79060278.66778.92
4803452-80345279.94680.21
5741796-74179673.81174.06
6903086-90308689.86090.16
30min1944201-94420193.95190.175.5294.3890.575.54
2835891-83589183.17483.52
3909697-90969790.51890.90
4900007-90000789.55389.95
5871636-87163686.73087.10
6975917-97591797.10797.56
45min1976556-97655697.17094.712.7097.7695.252.73
2907839-90783990.33390.82
3962838-96283895.80596.34
4953754-95375494.90195.44
5937526-93752693.28793.80
6972258-97225896.74397.36
60min1985544-98554498.06596.331.6798.8197.041.70
2938745-93874593.40894.05
3973034-97303496.82097.51
4974500-97450096.96697.67
5962360-96236095.75896.43
6974602-97460296.97697.75
极限1985399-98539998.05097.280.6498.9698.150.65
2971702-97170296.68797.48
3983398-98339897.85198.70
4980666-98066697.57998.44
5972279-97227996.74597.57
6972759-97275996.79397.73
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