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%
19.899016390144898309024390125901010.18
29.929071790735907260.02
单位质量响应值RSD%判断
9110.319145.770.28数据可信
供试品溶液-F24706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%
5min143442-4344242.40038.3014.3642.4038.3014.36
237495-3749536.59636.60
334855-3485534.01934.02
434075-3407533.25833.26
548566-4856647.40147.40
636986-3698636.09936.10
10min188625-8862586.50076.7411.0586.5776.8111.05
275159-7515973.35773.42
373104-7310471.35171.41
469769-6976968.09668.15
590465-9046588.29588.37
674657-7465772.86772.93
15min1101418-10141898.98695.443.8899.2095.633.90
296980-9698094.65494.84
397258-9725894.92695.10
491943-9194389.73889.91
5102504-102504100.046100.27
696589-9658994.27394.45
20min1102185-10218599.734100.440.66100.11100.790.65
2103450-103450100.969101.31
3103230-103230100.754101.09
4102326-10232699.872100.19
5102429-10242999.973100.37
6103799-103799101.310101.65
30min1102647-102647100.185100.830.67100.73101.350.64
2104030-104030101.535102.04
3103347-103347100.869101.37
4103778-103778101.289101.77
5102306-10230699.853100.41
6103736-103736101.248101.76
45min1102203-10220399.752100.600.68100.47101.290.65
2103396-103396100.916101.59
3103349-103349100.871101.54
4103318-103318100.840101.49
5102257-10225799.805100.53
6103932-103932101.440102.12
60min1102207-10220799.756100.730.74100.64101.580.71
2104389-104389101.886102.73
3103235-103235100.759101.60
4103363-103363100.884101.71
5102580-102580100.120101.01
6103428-103428100.948101.79
极限1102151-10215199.701100.430.54100.75101.450.51
2103163-103163100.689101.71
3103250-103250100.774101.78
4103312-103312100.834101.82
5102241-10224199.789100.85
6103268-103268100.791101.81
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%
110.044821874817954818074815094813244817240.07
210.144845374836744841060.13
单位质量响应值RSD%判断
47980.4847742.210.36数据可信
供试品溶液-F24706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%
5min1281321-28132152.90147.9812.3752.9047.9812.38
2242920-24292045.68045.68
3231125-23112543.46243.46
4226553-22655342.60242.60
5306132-30613257.56657.57
6242864-24286445.66945.67
10min1486203-48620391.42882.089.4491.5282.169.45
2417025-41702578.41978.50
3413951-41395177.84177.91
4392645-39264573.83573.91
5490252-49025292.18992.29
6418747-41874778.74378.82
15min1523533-52353398.44796.342.7398.6996.562.75
2512281-51228196.33296.54
3512816-51281696.43296.63
4488262-48826291.81592.01
5528402-52840299.36399.61
6508593-50859395.63895.85
20min1525304-52530498.78099.470.4499.1999.840.42
2529861-52986199.637100.00
3530480-53048099.754100.12
4528629-52862999.40699.75
5527629-52762999.21899.63
6531881-531881100.017100.38
30min1524391-52439198.60999.410.5099.1899.960.48
2529415-52941599.554100.09
3530164-53016499.694100.22
4530031-53003199.669100.18
5526560-52656099.01799.60
6531376-53137699.922100.46
45min1524533-52453398.63599.290.4299.37100.000.40
2528497-52849799.381100.08
3529662-52966299.600100.30
4528999-52899999.475100.15
5526187-52618798.94699.69
6530281-53028199.716100.42
60min1523237-52323798.39299.240.6599.29100.120.63
2532940-532940100.216101.08
3527890-52789099.267100.13
4529003-52900399.476100.32
5524811-52481198.68899.60
6528684-52868499.416100.28
极限1521768-52176898.11698.740.4199.1899.780.39
2525216-52521698.76499.80
3527028-52702899.105100.13
4526159-52615998.94199.95
5523341-52334198.41199.49
6527071-52707199.113100.14
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%
19.899068690643908259065990718907060.08
29.929053490274904040.21
单位质量响应值RSD%判断
9171.499113.310.45数据可信
供试品溶液-F24706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%
5min150154-5015448.87541.4713.7848.8741.4713.78
238832-3883237.84137.84
339632-3963238.62138.62
434442-3444233.56333.56
545855-4585544.68544.69
646408-4640845.22445.22
10min192348-9234889.99280.4910.0490.0780.5610.04
276699-7669974.74374.81
376898-7689874.93675.00
472405-7240570.55870.61
587124-8712484.90284.98
690116-9011687.81787.89
15min199480-9948096.94294.382.5497.1794.582.55
295738-9573893.29693.48
394969-9496992.54792.74
493521-9352191.13591.31
598213-9821395.70895.92
699186-9918696.65696.88
20min199188-9918896.65895.820.4797.0596.180.49
298177-9817795.67396.02
398328-9832895.82096.16
497840-9784095.34495.67
598149-9814995.64596.02
698292-9829295.78596.17
30min198501-9850195.98895.620.2796.5496.140.27
297920-9792095.42295.92
397888-9788895.39195.89
498395-9839595.88596.37
598010-9801095.51096.04
698050-9805095.54996.09
45min197782-9778295.28895.580.3296.0096.260.32
297653-9765395.16295.82
398356-9835695.84796.51
498265-9826595.75896.40
598051-9805195.55096.24
698408-9840895.89896.60
60min198143-9814395.64095.400.2996.5196.240.30
297438-9743894.95395.77
397698-9769895.20696.03
497991-9799195.49196.30
598068-9806895.56696.42
698072-9807295.57096.43
极限197353-9735394.87094.970.2495.9095.970.24
297204-9720494.72495.70
397212-9721294.73295.71
497753-9775395.25996.22
597636-9763695.14596.16
697582-9758295.09396.11
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%
110.044846624847104849534846904849084847850.03
210.144842904845154844020.04
单位质量响应值RSD%判断
48285.3647771.400.76数据可信
供试品溶液-F24706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%
5min1311735-31173558.41750.3112.0558.4250.3112.05
2247765-24776546.43046.43
3250074-25007446.86346.86
4225624-22562442.28142.28
5286551-28655153.69853.70
6289130-28913054.18154.18
10min1485799-48579991.03683.228.3091.1383.318.30
2417773-41777378.28878.37
3414918-41491877.75377.83
4401239-40123975.19075.26
5467181-46718187.54787.64
6477779-47777989.53389.62
15min1501106-50110693.90592.761.3494.1592.991.35
2492782-49278292.34592.55
3488392-48839291.52291.73
4486733-48673391.21191.41
5501249-50124993.93194.17
6499864-49986493.67293.91
20min1500244-50024493.74393.440.4494.1593.820.46
2497354-49735493.20193.56
3495011-49501192.76293.12
4498303-49830393.37993.73
5500767-50076793.84194.23
6500054-50005493.70794.10
30min1499590-49959093.62093.350.4294.1893.880.43
2496748-49674893.08893.60
3494579-49457992.68193.20
4499408-49940893.58694.09
5499887-49988793.67694.22
6498651-49865193.44494.00
45min1497312-49731293.19493.110.4693.9193.800.47
2495576-49557692.86893.54
3493022-49302292.39093.06
4497805-49780593.28693.95
5499291-49929193.56494.27
6498189-49818993.35894.07
60min1498335-49833593.38593.100.3294.2693.950.34
2495512-49551292.85693.68
3494390-49439092.64693.47
4497141-49714193.16293.98
5498208-49820893.36194.22
6497409-49740993.21294.07
极限1496046-49604692.95692.720.4693.9993.720.47
2493864-49386492.54793.53
3490727-49072791.96092.94
4495848-49584892.91993.89
5496876-49687693.11294.13
6495499-49549992.85493.87
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%
19.899099890911910779093491059909960.09
29.929095391260911060.24
单位质量响应值RSD%判断
9200.819184.070.13数据可信
供试品溶液-F24706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%
5min152707-5270751.08242.0919.8251.0842.0919.82
237189-3718936.04336.04
348139-4813946.65546.66
429703-2970328.78728.79
549310-4931047.79047.79
643546-4354642.20442.20
10min195581-9558192.63581.9212.6992.7281.9912.70
275156-7515672.84072.90
391541-9154188.71988.80
469183-6918367.05167.10
593231-9323190.35790.44
682454-8245479.91379.98
15min1101657-10165798.52496.873.5798.7697.083.59
297851-9785194.83595.02
3103630-103630100.436100.66
494202-9420291.29891.46
5102987-10298799.813100.04
699391-9939196.32896.53
20min1101577-10157798.44698.781.2398.8599.141.25
2100368-10036897.27497.61
3103762-103762100.564100.96
4101717-10171798.58298.89
5102986-10298699.812100.21
6101098-10109897.98298.35
30min1100478-10047897.38198.671.1397.9599.211.13
2101210-10121098.09098.59
3103336-103336100.151100.71
4101903-10190398.76299.24
5102969-10296999.795100.36
6100971-10097197.85998.39
45min1100557-10055797.45898.400.9398.1999.100.91
2101897-10189798.75699.42
3102755-10275599.588100.32
4102281-10228199.12899.77
5101269-10126998.14898.88
6100444-10044497.34898.04
60min1100865-10086597.75698.150.8698.6599.010.86
2100636-10063697.53498.36
3102735-10273599.568100.46
4101586-10158698.45599.26
5101489-10148998.36199.25
6100337-10033797.24498.10
极限199775-9977596.70098.351.1197.7699.381.09
2101499-10149998.37199.36
3102647-10264799.483100.54
4102734-10273499.567100.54
5101404-10140498.27899.34
6100804-10080497.69798.71
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%
110.044839794837174840784839014840784839510.04
210.144832264828714830480.06
单位质量响应值RSD%判断
48202.2947637.870.84数据可信
供试品溶液-F24706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%
5min1328814-32881461.75852.3816.3161.7652.3816.31
2247146-24714646.41946.42
3304615-30461557.21357.21
4206358-20635838.75838.76
5309229-30922958.07958.08
6277243-27724352.07252.07
10min1504293-50429394.71686.699.7594.8286.789.75
2421757-42175779.21479.29
3494076-49407692.79792.89
4398440-39844074.83574.90
5500684-50068494.03894.13
6450082-45008284.53484.62
15min1519663-51966397.60397.401.8497.8697.631.86
2514742-51474296.67896.89
3528913-52891399.34099.59
4502574-50257494.39394.58
5527102-52710299.00099.25
6518600-51860097.40397.63
20min1519476-51947697.56898.440.7897.9998.830.78
2518916-51891697.46297.83
3528838-52883899.32699.74
4526779-52677998.93999.29
5526267-52626798.84399.26
6524334-52433498.48098.87
30min1518741-51874197.43098.190.8998.0298.750.88
2519270-51927097.52998.06
3527586-52758699.09199.67
4528034-52803499.17599.69
5525158-52515898.63599.22
6518048-51804897.29997.85
45min1517686-51768697.23198.170.8597.9898.890.83
2524773-52477398.56299.26
3526048-52604898.80299.55
4527261-52726199.03099.71
5523471-52347198.31899.07
6516773-51677397.06097.78
60min1516060-51606096.92697.720.8297.8498.610.81
2516722-51672297.05097.91
3524996-52499698.60499.52
4524985-52498598.60299.44
5522083-52208398.05798.97
6516933-51693397.09097.97
极限1514556-51455696.64497.350.9197.7298.400.90
2514839-51483996.69797.72
3523300-52330098.28699.36
4523623-52362398.34699.35
5520441-52044197.74998.82
6513219-51321996.39297.43
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