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%
110.059311493676932369323393313933140.23
210.019442593876941500.42
单位质量响应值RSD%判断
9284.989405.590.92数据可信
供试品溶液-F24707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%
5min148106-4810645.86344.8112.9745.8644.8112.97
242742-4274240.74940.75
349345-4934547.04447.04
456052-5605253.43853.44
538143-3814336.36436.36
647630-4763045.40945.41
10min189544-8954485.36881.899.9585.4481.969.96
279350-7935075.65075.72
389686-8968685.50485.58
497824-9782493.26293.35
573563-7356370.13270.19
685399-8539981.41681.49
15min1111214-111214106.02898.905.11106.2599.115.12
299608-9960894.96395.16
3105823-105823100.888101.11
4105832-105832100.897101.14
596090-9609091.60991.79
6103853-10385399.01099.22
20min1105567-105567100.644101.060.79101.04101.430.79
2106443-106443101.479101.83
3106047-106047101.102101.49
4105940-105940101.000101.41
5104761-10476199.876100.21
6107236-107236102.235102.61
30min1105343-105343100.430101.120.63100.99101.670.62
2107132-107132102.136102.66
3106390-106390101.429101.99
4105855-105855100.918101.50
5105488-105488100.569101.07
6106212-106212101.259101.81
45min1105588-105588100.664100.990.54101.39101.700.54
2106642-106642101.669102.36
3105875-105875100.938101.66
4105684-105684100.755101.50
5105207-105207100.301100.96
6106567-106567101.597102.31
60min1105446-105446100.529100.830.73101.43101.720.73
2106577-106577101.607102.47
3106029-106029101.084101.98
4105360-105360100.447101.36
5104625-10462599.746100.58
6106555-106555101.586102.47
极限1105911-105911100.972100.980.64102.04102.020.65
2106500-106500101.533102.56
3105662-105662100.734101.80
4106398-106398101.436102.52
5104713-10471399.830100.83
6106306-106306101.348102.40
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%
110.055963815969565969815927545931295952400.36
29.985974615979305976960.06
单位质量响应值RSD%判断
59227.8659889.380.79数据可信
供试品溶液-F24707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%
5min1356765-35676553.91352.2710.3553.9152.2610.35
2319448-31944848.27448.27
3358450-35845054.16854.17
4398531-39853160.22560.22
5294376-29437644.48544.49
6347603-34760352.52852.53
10min1577510-57751087.27184.197.7487.3684.287.74
2524476-52447679.25779.34
3576121-57612187.06187.15
4616635-61663593.18493.28
5494729-49472974.76274.84
6553263-55326383.60783.69
15min1648042-64804297.93096.372.3898.1796.602.39
2629144-62914495.07495.29
3647815-64781597.89598.13
4648069-64806997.93498.19
5610666-61066692.28292.48
6642773-64277397.13397.36
20min1647045-64704597.77998.020.5498.1898.410.54
2653956-65395698.82399.19
3647533-64753397.85398.25
4648392-64839297.98398.40
5643951-64395197.31197.66
6650967-65096798.37298.76
30min1645521-64552197.54997.820.5598.1198.370.54
2653235-65323598.71499.25
3646956-64695697.76698.33
4645538-64553897.55198.13
5643327-64332797.21797.73
6649295-64929598.11998.67
45min1645202-64520297.50197.820.5798.2298.530.57
2653574-65357498.76699.47
3646867-64686797.75298.48
4644851-64485197.44798.19
5643766-64376697.28497.96
6649460-64946098.14498.86
60min1643387-64338797.22697.640.7298.1198.510.71
2651648-65164898.47599.34
3645060-64506097.47998.37
4643846-64384697.29698.20
5640782-64078296.83397.67
6651874-65187498.50999.39
极限1644707-64470797.42697.530.6298.4798.570.63
2649480-64948098.14799.18
3642942-64294297.15998.21
4649842-64984298.20299.27
5639396-63939696.62397.62
6646015-64601597.62398.67
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%
110.059419393670940089396693780939230.22
210.019370593618936620.07
单位质量响应值RSD%判断
9345.579356.840.09数据可信
供试品溶液-F24707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%
5min143177-4317741.13638.768.9041.1438.768.90
237926-3792636.13336.13
343749-4374941.68141.68
434605-3460532.96932.97
542420-4242040.41440.41
642208-4220840.21240.21
10min178373-7837374.66875.637.8574.7475.707.85
273954-7395470.45870.52
387185-8718583.06383.13
470779-7077967.43367.49
581989-8198978.11378.18
684047-8404780.07380.14
15min198360-9836093.71093.633.3893.9093.823.39
295698-9569891.17491.35
3101349-10134996.55796.77
493462-9346289.04389.21
598605-9860593.94394.14
6102213-10221397.38197.58
20min1100105-10010595.37296.551.0795.7296.901.08
2100719-10071995.95796.29
3102077-10207797.25197.62
4100355-10035595.61095.93
5102237-10223797.40397.76
6102584-10258497.73498.10
30min199245-9924594.55396.611.3195.0697.121.31
2100496-10049695.74596.23
3101722-10172296.91397.44
4102960-10296098.09298.57
5101810-10181096.99797.51
6102182-10218297.35197.88
45min199602-9960294.89396.771.0895.5697.441.06
2102740-10274097.88398.53
3101599-10159996.79697.49
4102368-10236897.52898.17
5101386-10138696.59397.27
6101754-10175496.94397.63
60min1100095-10009595.36396.710.8096.1997.540.78
2102359-10235997.52098.33
3101673-10167396.86697.72
4102124-10212497.29698.10
5101200-10120096.41597.25
6101581-10158196.77897.63
极限198812-9881294.14095.681.3195.1296.681.29
299938-9993895.21396.19
399214-9921494.52395.54
4101815-10181597.00197.96
5100969-10096996.19597.20
6101851-10185197.03698.05
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%
110.055958435967305962595958015957125960690.08
29.985941735935665938700.08
单位质量响应值RSD%判断
59310.3559506.010.24数据可信
供试品溶液-F24707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%
5min1350672-35067253.12550.287.6153.1250.287.61
2312656-31265647.36647.37
3351928-35192853.31553.32
4289425-28942543.84643.85
5343046-34304651.97051.97
6343489-34348952.03752.04
10min1549946-54994683.31483.735.7383.4083.815.73
2527936-52793679.98080.06
3587452-58745288.99689.08
4504787-50478776.47376.55
5567434-56743485.96386.05
6578442-57844287.63187.72
15min1640761-64076197.07296.742.1797.3096.962.18
2629849-62984995.41995.63
3646937-64693798.00898.24
4615545-61554593.25293.45
5643961-64396197.55797.79
6654163-65416399.10299.34
20min1646894-64689498.00198.220.4098.3998.600.38
2651955-65195598.76899.14
3647209-64720998.04998.45
4651157-65115798.64799.00
5645685-64568597.81898.21
6647181-64718198.04498.44
30min1643211-64321197.44397.950.5598.0098.500.53
2651218-65121898.65699.19
3645322-64532297.76398.33
4650924-65092498.61299.13
5644055-64405597.57198.13
6644714-64471497.67198.23
45min1641993-64199397.25997.770.5497.9798.480.53
2650378-65037898.52999.23
3643930-64393097.55298.28
4648968-64896898.31599.00
5642530-64253097.34098.06
6644444-64444497.63098.35
60min1639742-63974296.91897.470.5697.7998.340.54
2648392-64839298.22899.09
3642216-64221697.29298.18
4647265-64726598.05798.91
5641097-64109797.12398.00
6641493-64149397.18398.07
极限1638724-63872496.76397.360.5397.8098.400.52
2648102-64810298.18499.21
3642382-64238297.31798.37
4644793-64479397.68398.69
5640036-64003696.96298.00
6642086-64208697.27398.32
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%
110.059368093919936439379593937937950.15
210.019420894037941220.13
单位质量响应值RSD%判断
9332.849402.800.53数据可信
供试品溶液-F24707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%
5min144995-4499542.79240.9914.7342.7940.9914.73
248892-4889246.49946.50
345223-4522343.00943.01
448841-4884146.45046.45
537071-3707135.25635.26
633587-3358731.94331.94
10min188933-8893384.57980.3511.5484.6580.4211.55
291289-9128986.82086.90
387795-8779583.49783.57
494170-9417089.56089.64
574626-7462670.97371.03
670103-7010366.67166.72
15min1103661-10366198.58695.834.7698.8096.044.78
2103723-10372398.64598.87
3104153-10415399.05499.27
4103686-10368698.61098.84
596015-9601591.31591.49
693346-9334688.77688.94
20min1103964-10396498.87599.140.6499.2599.500.66
2104200-10420099.09999.49
3105546-105546100.379100.76
4104196-10419699.09599.49
5103745-10374598.66699.00
6103808-10380898.72699.04
30min1103894-10389498.80898.920.4099.3599.440.41
2103802-10380298.72099.27
3104766-10476699.637100.18
4104010-10401098.91899.47
5104003-10400398.91299.41
6103568-10356898.49898.97
45min1103939-10393998.85199.010.3599.5699.710.35
2103955-10395598.86699.58
3104834-10483499.702100.41
4104007-10400798.91599.64
5103926-10392698.83899.50
6103996-10399698.90599.55
60min1103669-10366998.59498.780.4099.4699.640.41
2103709-10370998.63299.51
3104648-10464899.525100.40
4103788-10378898.70799.59
5103909-10390998.82299.65
6103477-10347798.41199.22
极限1103594-10359498.52398.690.4799.5699.720.48
2103938-10393898.85099.90
3104681-10468199.556100.60
4103377-10337798.31699.37
5103612-10361298.54099.53
6103434-10343498.37099.34
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%
110.055954035955505948655946335952665951430.07
29.985953235961765957500.11
单位质量响应值RSD%判断
59218.2159694.390.57数据可信
供试品溶液-F24707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%
5min1336515-33651550.94048.2712.3050.9448.2712.30
2357664-35766454.14154.14
3327061-32706149.50949.51
4350563-35056353.06653.07
5279915-27991542.37242.37
6261584-26158439.59739.60
10min1549064-54906483.11479.589.4383.2079.669.43
2560645-56064584.86784.96
3542972-54297282.19282.27
4573948-57394886.88186.97
5473501-47350171.67671.75
6453981-45398168.72168.79
15min1605725-60572591.69189.833.3591.9190.053.36
2606931-60693191.87492.11
3606655-60665591.83292.05
4605140-60514091.60391.84
5572719-57271986.69586.88
6563588-56358885.31385.49
20min1603878-60387891.41191.670.5491.7992.030.55
2605942-60594291.72492.11
3611091-61109192.50392.88
4604599-60459991.52191.91
5601402-60140291.03791.37
6606477-60647791.80592.13
30min1604200-60420091.46091.430.3391.9991.950.35
2606422-60642291.79792.33
3605961-60596191.72792.25
4603640-60364091.37591.91
5601390-60139091.03591.52
6602515-60251591.20591.68
45min1603519-60351991.35791.420.3392.0492.090.34
2605115-60511591.59992.29
3606933-60693391.87492.55
4603502-60350291.35592.05
5601103-60110390.99191.63
6603338-60333891.33091.96
60min1602099-60209991.14291.260.3791.9892.080.38
2603847-60384791.40792.25
3606491-60649191.80792.64
4602564-60256491.21392.06
5599920-59992090.81291.60
6602385-60238591.18591.97
极限1600712-60071290.93290.960.3291.9291.930.33
2602737-60273791.23992.23
3603252-60325291.31792.30
4600334-60033490.87591.87
5598200-59820090.55291.49
6599944-59994490.81691.75
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