西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.908265082547824038283883122827120.34
213.898223982255822470.02
单位质量响应值RSD%判断
5950.505921.310.35数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min110462-1046212.31115.8722.7812.3115.8722.77
213156-1315615.48115.48
315869-1586918.67418.67
418376-1837621.62421.62
512066-1206614.19914.20
610980-1098012.92112.92
10min133494-3349439.41445.5412.6939.4345.5712.71
238992-3899245.88445.91
343743-4374351.47451.51
445370-4537053.38953.43
535793-3579342.11942.14
634827-3482740.98341.00
15min153539-5353963.00267.887.0163.0967.987.03
257025-5702567.10467.21
361810-6181072.73572.85
463466-6346674.68374.81
555677-5567765.51865.61
654577-5457764.22364.31
20min164974-6497476.45880.604.3376.6580.824.35
267190-6719079.06679.28
370528-7052882.99483.23
473226-7322686.16886.42
566671-6667178.45578.66
668389-6838980.47780.67
30min173390-7339086.36189.262.6186.6889.622.63
273748-7374886.78387.13
377435-7743591.12191.50
478379-7837992.23292.63
575881-7588189.29389.63
676299-7629989.78590.12
45min178434-7843492.29793.981.3992.7694.481.41
279272-7927293.28393.77
380769-8076995.04595.57
480671-8067194.92995.48
581088-8108895.42095.90
678972-7897292.93093.41
60min179799-7979993.90394.741.1794.5295.401.17
279581-7958193.64794.29
380936-8093695.24195.93
480965-8096595.27595.98
581973-8197396.46197.10
679813-7981393.92094.56
极限180853-8085395.14495.461.2695.9296.271.25
280072-8007294.22495.03
381356-8135695.73596.58
480947-8094795.25496.12
582996-8299697.66598.47
680483-8048394.70895.50
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.533974742397526040074214006746400125739930850.42
219.553965172395299439590830.22
单位质量响应值RSD%判断
204459.04202510.640.68数据可信
影响因素30天-供试品溶液-2024050521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%
5min1712332-71233218.51522.9719.1518.5122.9719.16
2867358-86735822.54422.54
31024859-102485926.63826.64
41147274-114727429.82029.82
5792840-79284020.60720.61
6757612-75761219.69219.69
10min11905436-190543649.52655.4310.8049.5655.4610.80
22143886-214388655.72455.76
32366206-236620661.50261.55
42450278-245027863.68763.74
51985672-198567251.61151.65
61942943-194294350.50150.53
15min12821051-282105173.32477.686.0473.4477.816.05
22982826-298282677.52977.66
33172366-317236682.45682.60
43241517-324151784.25384.41
52886780-288678075.03375.15
62826366-282636673.46273.58
20min13337521-333752186.74889.443.3486.9889.703.36
23393285-339328588.19888.46
33540451-354045192.02392.31
43623477-362347794.18194.48
53349559-334955987.06187.31
63402396-340239688.43588.67
30min13676442-367644295.55797.551.9195.9497.961.92
23674855-367485595.51695.92
33832459-383245999.613100.05
43832324-383232499.609100.06
53730410-373041096.96097.35
63771781-377178198.03698.42
45min13872110-3872110100.643101.471.21101.18102.041.23
23870302-3870302100.596101.16
33959497-3959497102.915103.52
43934308-3934308102.260102.88
53942563-3942563102.474103.03
63845412-384541299.949100.50
60min13946088-3946088102.566102.341.02103.27103.081.02
23890999-3890999101.134101.87
33971179-3971179103.218103.99
43942213-3942213102.465103.26
53984416-3984416103.562104.29
63889131-3889131101.086101.80
极限13958568-3958568102.890102.581.01103.77103.491.02
23906485-3906485101.537102.44
33983940-3983940103.550104.50
43940550-3940550102.422103.38
53993954-3993954103.810104.71
63896469-3896469101.276102.16
西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.908250182652828958258882543826360.19
213.898216481938820510.20
单位质量响应值RSD%判断
5945.045907.200.46数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-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%
5min121886-2188625.79721.0513.8425.8021.0513.84
218484-1848421.78721.79
317320-1732020.41520.42
418789-1878922.14722.15
515508-1550818.27918.28
615168-1516817.87817.88
10min147777-4777756.31548.1911.0456.3648.2211.05
243619-4361951.41451.45
340527-4052747.76947.80
440790-4079048.07948.12
537755-3775544.50244.53
634814-3481441.03541.06
15min165481-6548177.18269.087.9977.3269.207.99
261907-6190772.97073.09
358866-5886669.38569.50
457809-5780968.13968.26
555241-5524165.11265.22
652345-5234561.69961.80
20min176003-7600389.58483.075.0789.8583.305.08
272900-7290085.92786.17
370062-7006282.58282.81
469488-6948881.90582.14
568736-6873681.01981.23
665671-6567177.40677.61
30min178938-7893893.04491.071.8693.4691.441.88
277470-7747091.31491.70
376730-7673090.44190.81
478609-7860992.65693.02
576836-7683690.56690.91
674993-7499388.39488.72
45min179933-7993394.21793.511.1394.7994.031.15
279844-7984494.11294.65
378963-7896393.07393.59
480492-8049294.87695.40
578597-7859792.64293.14
678176-7817692.14692.62
60min179963-7996394.25294.310.8094.9894.990.81
280525-8052594.91495.61
379686-7968693.92694.60
480455-8045594.83295.51
580526-8052694.91695.57
678923-7892393.02693.66
极限181651-8165196.24294.841.1997.1395.671.20
280156-8015694.48095.33
379728-7972893.97594.80
480507-8050794.89395.73
581465-8146596.02296.83
679245-7924593.40694.19
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.533974020398225339822543985011397778339802640.11
219.553943337393499939391680.15
单位质量响应值RSD%判断
203802.56201491.970.81数据可信
影响因素30天-供试品溶液-X022139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%
5min11281925-128192533.45828.0812.0233.4628.0812.03
21113412-111341229.06029.06
31049348-104934827.38727.39
41127053-112705329.41629.42
5953799-95379924.89424.89
6929277-92927724.25424.25
10min12534611-253461166.15258.029.2766.2158.079.27
22348675-234867561.29961.35
32211310-221131057.71457.76
42226749-222674958.11758.17
52068050-206805053.97554.02
61949060-194906050.87050.91
15min13307621-330762186.32778.746.6986.4978.886.69
23162842-316284282.54982.70
33027500-302750079.01679.16
42988254-298825477.99278.14
52874411-287441175.02175.15
62741009-274100971.53971.66
20min13734684-373468497.47391.804.1297.7892.074.14
23620061-362006194.48294.77
33504756-350475691.47291.75
43493244-349324491.17291.45
53430590-343059089.53789.79
63320305-332030586.65886.90
30min13873556-3873556101.09899.161.74101.5799.581.75
23815776-381577699.590100.04
33774110-377411098.50298.93
43862582-3862582100.812101.24
53771845-377184598.44398.85
63697223-369722396.49696.88
45min13896269-3896269101.691101.420.90102.33102.010.92
23904136-3904136101.896102.51
33894672-3894672101.649102.24
43929932-3929932102.569103.17
53857002-3857002100.666101.24
63832898-3832898100.037100.59
60min13903727-3903727101.885101.880.70102.70102.650.71
23909023-3909023102.024102.81
33889954-3889954101.526102.29
43930046-3930046102.572103.34
53930332-3930332102.580103.32
63858292-3858292100.700101.42
极限13967998-3967998103.563102.291.05104.54103.231.06
23916695-3916695102.224103.18
33887012-3887012101.449102.38
43932029-3932029102.624103.56
53953862-3953862103.194104.10
63858846-3858846100.714101.60
西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.908287782427824458248182437825330.24
213.898289982727828130.15
单位质量响应值RSD%判断
5937.635962.060.30数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min112318-1231814.46115.3421.5114.4615.3421.51
212110-1211014.21714.22
318072-1807221.21621.22
412086-1208614.18914.19
514048-1404816.49216.49
69750-975011.44611.45
10min137213-3721343.68844.7212.2143.7144.7412.21
235409-3540941.57041.59
345566-4556653.49453.53
436433-3643342.77242.80
541370-4137048.56848.60
632554-3255438.21838.24
15min157694-5769467.73267.995.7667.8368.095.77
256211-5621165.99166.08
363087-6308774.06374.19
458180-5818068.30368.40
559294-5929469.61069.72
653034-5303462.26162.34
20min169854-6985482.00881.642.9482.2281.852.95
267825-6782579.62679.83
371477-7147783.91384.16
472094-7209484.63884.85
569166-6916681.20081.42
666822-6682278.44878.63
30min176836-7683690.20590.620.6790.5590.970.68
276555-7655589.87590.21
377304-7730490.75491.14
477005-7700590.40390.75
578023-7802391.59891.96
677426-7742690.89791.21
45min179848-7984893.74194.401.2394.2494.901.22
279978-7997893.89394.38
379310-7931093.10993.65
480470-8047094.47194.97
582164-8216496.46096.97
680672-8067294.70895.18
60min180790-8079094.84795.281.0095.5095.940.97
281894-8189496.14396.78
379830-7983093.72094.41
481067-8106795.17295.83
582020-8202096.29196.96
681351-8135195.50596.13
极限182459-8245996.80696.091.1097.6296.901.08
282408-8240896.74697.55
380214-8021494.17095.02
481585-8158595.78096.60
582608-8260896.98197.81
681812-8181296.04696.83
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.533951154395165739738053965745395181539588350.27
219.553976505397734439769240.02
单位质量响应值RSD%判断
202705.33203423.220.25数据可信
影响因素30天-供试品溶液-2024050521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%
5min1805577-80557720.98122.0317.0220.9822.0317.01
2797720-79772020.77720.78
31093263-109326328.47428.47
4798320-79832020.79220.79
5912159-91215923.75723.76
6667745-66774517.39217.39
10min12001012-200101252.11752.979.7252.1553.009.73
21943528-194352850.61950.65
32347421-234742161.13961.19
41935951-193595150.42250.46
52179226-217922656.75856.80
61795027-179502746.75246.78
15min12844676-284467674.09074.294.5174.2174.424.52
22805799-280579973.07773.20
33052304-305230479.49879.65
42839674-283967473.96074.08
52910779-291077975.81275.95
62660957-266095769.30569.41
20min13289718-328971885.68185.761.9685.9386.011.97
23249968-324996884.64684.89
33371103-337110387.80188.08
43348160-334816087.20387.45
53301760-330176085.99586.26
63194932-319493283.21283.43
30min13563859-356385992.82193.370.7193.2193.760.72
23592860-359286093.57793.96
33589528-358952893.49093.92
43556363-355636392.62693.01
53627214-362721494.47194.88
63578785-357878593.21093.57
45min13667743-366774395.52796.361.1996.0796.911.19
23703978-370397896.47197.01
33674148-367414895.69496.28
43670515-367051595.59996.14
53783909-378390998.55299.11
63698905-369890596.33996.85
60min13686372-368637296.01292.662.6196.7193.362.57
23508287-350828791.37492.07
33413100-341310088.89589.64
43553591-355359192.55493.25
53608793-360879393.99294.72
63574777-357477793.10693.78
极限13594651-359465193.62393.091.1094.4993.951.09
23611855-361185594.07194.92
33505183-350518391.29392.18
43554551-355455192.57993.43
53601123-360112393.79294.67
63576619-357661993.15493.99
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