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%
19.94 9393993784940079364993674938110.17
29.899392994029939790.08
单位质量响应值RSD%判断
9437.739502.430.49数据可信
供试品溶液-24072301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%
5min138777-3877736.48044.5520.2636.4844.5520.26
241910-4191039.42839.43
341947-4194739.46339.46
442458-4245839.94339.94
561499-6149957.85757.86
657522-5752254.11554.12
10min178490-7849073.84180.617.6573.9080.687.66
282184-8218477.31777.38
383585-8358578.63578.70
482137-8213777.27277.34
594050-9405088.48088.58
693651-9365188.10488.19
15min1100045-10004594.12095.191.9594.3095.401.97
298473-9847392.64192.84
3101802-10180295.77395.97
4100143-10014394.21294.41
5103620-10362097.48397.73
6102999-10299996.89997.14
20min1104662-10466298.46397.460.6998.8097.830.68
2102845-10284596.75497.10
3103947-10394797.79198.15
4103491-10349197.36297.71
5103846-10384697.69698.10
6102808-10280896.71997.12
30min1104924-10492498.71097.730.6699.2198.260.64
2103801-10380197.65398.16
3104203-10420398.03198.55
4103817-10381797.66898.18
5103720-10372097.57798.15
6102845-10284596.75497.31
45min1105959-10595999.68397.841.14100.3598.531.12
2103628-10362897.49198.16
3104595-10459598.40099.08
4103683-10368397.54298.22
5103714-10371497.57198.30
6102414-10241496.34897.07
60min1104436-10443698.25197.780.8999.0998.640.87
2103837-10383797.68798.52
3105480-10548099.233100.08
4103712-10371297.57098.41
5103304-10330497.18698.08
6102862-10286296.77097.65
极限1105971-10597199.69597.881.10100.6998.891.07
2103840-10384097.69098.69
3104499-10449998.31099.32
4103921-10392197.76698.77
5103416-10341697.29198.35
6102576-10257696.50197.54
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DA-11412209074对照品来源工作对照品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%
110.241085771108266910808391080617108000410819800.22
210.171082112108369310829020.11
单位质量响应值RSD%判断
105662.11106480.040.55数据可信
供试品溶液-24072301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%
5min1527854-52785444.78852.4216.5844.7952.4216.58
2562446-56244647.72447.72
3553549-55354946.96946.97
4567089-56708948.11848.12
5767215-76721565.09865.10
6728356-72835661.80161.80
10min1940246-94024679.78085.195.9879.8585.285.99
2967111-96711182.05982.14
3986037-98603783.66583.74
4973325-97332582.58782.67
51086165-108616592.16192.27
61071289-107128990.89991.00
15min11144230-114423097.08897.211.4397.3097.441.44
21121376-112137695.14995.37
31146086-114608697.24597.46
41137069-113706996.48096.70
51169127-116912799.20099.46
61156435-115643598.12498.38
20min11178995-1178995100.03899.070.63100.4199.460.62
21159676-115967698.39998.77
31167427-116742799.05699.44
41170104-117010499.28399.66
51169800-116980099.25899.68
61159567-115956798.38998.81
30min11183823-1183823100.44799.260.73100.9899.820.71
21165184-116518498.86699.40
31172514-117251499.488100.03
41170374-117037499.30699.85
51169203-116920399.20799.80
61158150-115815098.26998.85
45min11192803-1192803101.20999.221.10101.9199.941.08
21164933-116493398.84599.55
31168530-116853099.15099.86
41169710-116971099.25099.96
51166605-116660598.98699.74
61153776-115377697.89898.64
60min11180912-1180912100.20099.150.83101.07100.040.80
21165435-116543598.88799.76
31176886-117688699.859100.73
41168553-116855399.152100.03
51166015-116601598.93699.86
61153681-115368197.89098.80
极限11187533-1187533100.76298.980.99101.80100.040.97
21163533-116353398.72699.76
31165216-116521698.86999.91
41165994-116599498.93599.97
51164905-116490598.84299.93
61152247-115224797.76898.84
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%
19.94 9339993827939289347393616936490.25
29.899391893775938460.11
单位质量响应值RSD%判断
9421.439488.980.51数据可信
供试品溶液-24072302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%
5min159228-5922855.80842.8918.9255.8142.9018.92
242517-4251740.06240.06
338353-3835336.13836.14
449951-4995147.06747.07
547501-4750144.75844.76
635581-3558133.52633.53
10min191027-9102785.77177.207.9385.8677.277.94
282055-8205577.31777.38
378064-7806473.55673.62
481794-8179477.07177.15
586379-8637981.39181.47
672264-7226468.09168.15
15min1100734-10073494.91791.333.1095.1591.533.11
296520-9652090.94691.14
396696-9669691.11291.30
495463-9546389.95090.16
599705-9970593.94894.16
692415-9241587.07987.25
20min1101381-10138195.52794.121.1995.9294.471.21
299946-9994694.17594.52
3100120-10012094.33994.67
498866-9886693.15793.51
5100793-10079394.97395.34
698207-9820792.53692.85
30min1101630-10163095.76194.840.8696.3195.350.88
2100318-10031894.52595.03
3101232-10123295.38695.88
499767-9976794.00694.52
5101332-10133295.48196.01
699629-9962993.87694.34
45min1102621-10262196.69595.090.9897.4195.761.01
2100916-10091695.08995.75
3100573-10057394.76595.42
4100255-10025594.46695.13
5101334-10133495.48296.17
699811-9981194.04794.67
60min1101391-10139195.53694.980.6396.4195.800.65
2101131-10113195.29196.11
3100641-10064194.82995.64
4100290-10029094.49995.32
5101435-10143595.57896.42
699902-9990294.13394.92
极限1102674-10267496.74596.370.6097.7897.360.62
2102658-10265896.73097.71
3102212-10221296.31097.28
4102425-10242596.51097.49
5102615-10261596.69097.69
6101090-10109095.25396.19
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DA-11412209074对照品来源工作对照品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%
110.241078688107900210787041081673108189210799920.16
210.171080195108001910801070.02
单位质量响应值RSD%判断
105467.97106205.210.50数据可信
供试品溶液-24072302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%
5min1806398-80639868.57455.1215.3068.5755.1215.30
2611657-61165752.01452.01
3564378-56437847.99347.99
4699653-69965359.49759.50
5671127-67112757.07157.07
6535947-53594745.57645.58
10min11107908-110790894.21486.786.1894.3386.876.18
21024630-102463087.13287.22
3982214-98221483.52583.61
41016811-101681186.46786.57
51064381-106438190.51390.61
6926902-92690278.82278.90
15min11177842-1177842100.16197.642.13100.4397.872.14
21147199-114719997.55597.79
31144602-114460297.33497.55
41139123-113912396.86897.11
51170722-117072299.55699.80
61109543-110954394.35394.56
20min11179268-1179268100.28299.450.62100.7299.850.64
21171358-117135899.610100.00
31163796-116379698.96799.35
41168202-116820299.34199.75
51174880-117488099.909100.32
61159633-115963398.61398.98
30min11177349-1177349100.11999.520.46100.72100.080.48
21171108-117110899.588100.15
31169277-116927799.43399.98
41169001-116900199.40999.98
51173621-117362199.802100.38
61161410-116141098.76499.29
45min11187721-1187721101.00199.550.82101.77100.280.84
21169713-116971399.470100.20
31162202-116220298.83199.54
41169017-116901799.411100.15
51173287-117328799.774100.52
61161693-116169398.78899.48
60min11174796-117479699.90299.270.50100.84100.160.52
21169080-116908099.416100.31
31160867-116086798.71899.59
41167903-116790399.316100.22
51171022-117102299.581100.49
61160230-116023098.66399.52
极限11172808-117280899.73399.120.60100.84100.180.62
21167203-116720399.256100.31
31160060-116006098.64999.69
41166265-116626599.177100.24
51172273-117227399.687100.76
61155052-115505298.22399.25
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%
19.94 9413494376943539446294285943220.14
29.899389094009939500.09
单位质量响应值RSD%判断
9489.139499.490.08数据可信
供试品溶液-24072303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%
5min133147-3314731.10429.836.3431.1029.846.34
228977-2897727.19127.19
334747-3474732.60532.61
432038-3203830.06330.06
530603-3060328.71728.72
631253-3125329.32729.33
10min163694-6369459.76861.132.3459.8261.182.34
262936-6293659.05759.10
365178-6517861.16161.21
466189-6618962.10962.16
566710-6671062.59862.65
666166-6616662.08862.14
15min180856-8085675.87275.961.0876.0276.111.08
279790-7979074.87275.02
380355-8035575.40275.56
480933-8093375.94476.10
582312-8231277.23877.39
681438-8143876.41876.57
20min185572-8557280.29879.540.9580.5879.820.95
284672-8467279.45379.72
384717-8471779.49579.78
483491-8349178.34578.62
585679-8567980.39880.68
684487-8448779.27979.56
30min185843-8584380.55280.681.1780.9681.101.17
285583-8558380.30880.71
386962-8696281.60282.02
484246-8424679.05379.46
586659-8665981.31781.73
686612-8661281.27381.69
45min187132-8713281.76180.971.3282.3181.521.31
285811-8581180.52281.06
387782-8778282.37182.92
484633-8463379.41679.96
586670-8667081.32881.88
685706-8570680.42380.97
60min186560-8656081.22580.631.1181.9181.311.11
285536-8553680.26480.93
386517-8651781.18481.87
484544-8454479.33380.01
587087-8708781.71982.41
685326-8532680.06780.75
极限188556-8855683.09882.440.6883.9283.260.68
287266-8726681.88782.69
388121-8812182.68983.51
487075-8707581.70882.51
588344-8834482.89983.72
687795-8779582.38383.20
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DA-11412209074对照品来源工作对照品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%
110.241083700108443910841251084074108519710843070.06
210.171081231108182010815260.04
单位质量响应值RSD%判断
105889.36106344.740.31数据可信
供试品溶液-24072303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%
5min1589369-58936949.98648.744.9249.9948.744.92
2532614-53261445.17245.17
3616443-61644352.28252.28
4579748-57974849.17049.17
5560299-56029947.52047.52
6569721-56972148.31948.32
10min1967005-96700582.01483.342.1982.1083.422.19
2950208-95020880.58980.66
3976624-97662482.83082.92
41001092-100109284.90584.99
51001407-100140784.93285.01
6999530-99953084.77384.85
15min11139590-113959096.65196.560.9796.8796.780.97
21119817-111981794.97495.18
31133284-113328496.11796.34
41144215-114421597.04497.27
51151796-115179697.68797.91
61142656-114265696.91197.13
20min11181552-1181552100.21098.890.75100.5999.270.75
21159603-115960398.34998.72
31161039-116103998.47198.86
41158660-115866098.26998.65
51169926-116992699.22499.61
61165117-116511798.81699.20
30min11172971-117297199.48299.120.69100.0399.660.69
21158193-115819398.22998.76
31172051-117205199.40499.95
41158766-115876698.27898.83
51173594-117359499.535100.08
61176371-117637199.771100.32
45min11182793-1182793100.31699.040.87101.0399.750.87
21157227-115722798.14798.84
31174928-117492899.648100.36
41158291-115829198.23798.95
51170459-117045999.26999.98
61163112-116311298.64699.36
60min11169160-116916099.15998.630.37100.0499.500.37
21161138-116113898.47999.34
31162201-116220198.56999.45
41157938-115793898.20899.08
51166746-116674698.95599.83
61160255-116025598.40499.28
极限11166764-116676498.95698.320.51100.0099.360.51
21151462-115146297.65898.68
31159956-115995698.37999.42
41154053-115405397.87898.92
51164391-116439198.75599.80
61158657-115865798.26899.31
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