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%
114.038234782245822918221082170822530.09
214.068169281561816260.12
单位质量响应值RSD%判断
5862.655805.550.70数据可信
供试品溶液-2024031621批-西格列汀-0.025mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111378-1137813.62315.4720.0113.6215.4819.99
212242-1224214.65714.66
39977-997711.94511.95
411906-1190614.25514.26
516930-1693020.27020.27
615111-1511118.09218.09
10min133506-3350640.11744.1612.0340.1444.1812.04
235853-3585342.92742.95
332241-3224138.60238.62
435119-3511942.04842.07
543505-4350552.08952.12
641049-4104949.14849.18
15min153873-5387364.50268.356.4764.5968.456.48
255978-5597867.02367.12
352847-5284763.27463.36
456917-5691768.14768.24
561110-6111073.16773.29
661816-6181674.01274.12
20min169054-6905482.67985.233.1682.8885.443.17
270114-7011483.94884.16
369131-6913182.77182.96
471106-7110685.13585.34
573120-7312087.54787.79
674581-7458189.29689.53
30min182009-8200998.19099.061.0698.5299.421.07
282895-8289599.25099.60
382588-8258898.88399.21
482791-8279199.12699.48
581841-8184197.98898.38
684306-84306100.940101.32
45min183773-83773100.302100.670.80100.80101.190.81
284719-84719101.434101.95
383542-83542100.025100.52
483270-8327099.699100.21
584247-84247100.869101.42
684936-84936101.694102.25
60min183551-83551100.036100.560.65100.70101.250.67
284449-84449101.111101.79
383689-83689100.201100.86
483332-8333299.774100.45
584218-84218100.834101.55
684700-84700101.412102.13
极限183504-8350499.980100.650.93100.81101.500.95
284942-84942101.701102.55
383251-8325199.677100.50
483368-8336899.817100.66
584913-84913101.667102.55
684387-84387101.037101.93
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10
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%
19.593840508384105038512883842378384350838437460.12
29.623859970385236538561680.14
单位质量响应值RSD%判断
400807.72400849.060.01数据可信
供试品溶液-2024031621批-二甲双胍-0.025mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1743832-74383219.62921.8416.2619.6321.8416.26
2785352-78535220.72520.73
3676460-67646017.85117.85
4780855-78085520.60620.61
51035916-103591627.33727.34
6942429-94242924.87024.87
10min11820790-182079048.05051.869.3148.0851.899.31
21918959-191895950.64050.67
31769086-176908646.68546.71
41903590-190359050.23550.27
52218225-221822558.53858.58
62159407-215940756.98657.03
15min12686578-268657870.89774.195.0471.0174.325.04
22760657-276065772.85272.97
32654387-265438770.04870.16
42806464-280646474.06174.18
52975020-297502078.50978.65
62985788-298578878.79378.93
20min13277784-327778486.49988.262.3086.7388.512.31
23295164-329516486.95887.20
33273575-327357586.38886.61
43347930-334793088.35088.59
53422308-342230890.31390.59
63451096-345109691.07391.34
30min13737923-373792398.64299.060.6299.0299.450.61
23738760-373876098.66499.05
33772262-377226299.54899.92
43763282-376328299.31199.70
53725748-372574898.32098.74
63784479-378447999.870100.29
45min13777617-377761799.68999.940.22100.23100.500.23
23791678-3791678100.060100.61
33778434-377843499.711100.25
43784266-378426699.865100.42
53795985-3795985100.174100.76
63794177-3794177100.126100.71
60min13772267-377226799.54899.750.28100.25100.470.30
23780145-378014599.756100.47
33767618-376761899.425100.13
43774873-377487399.617100.34
53795606-3795606100.164100.92
63787914-378791499.961100.71
极限13758002-375800299.17299.640.42100.04100.540.43
23774318-377431899.602100.48
33766739-376673999.402100.27
43771934-377193499.539100.43
53803367-3803367100.369101.29
63781166-378116699.783100.70
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%
114.038212882281822508218582261822210.08
214.068176981856818120.08
单位质量响应值RSD%判断
5860.375818.780.51数据可信
供试品溶液-2024031621批-西格列汀
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115196-1519618.17715.5122.0718.1815.5122.07
212285-1228514.69514.69
310205-1020512.20712.21
411804-1180414.12014.12
517589-1758921.03921.04
610700-1070012.79912.80
10min137838-3783845.26142.5812.4445.2942.6112.45
235213-3521342.12142.15
330203-3020336.12836.15
435484-3548442.44542.47
542763-4276351.15251.19
632087-3208738.38138.40
15min157623-5762368.92767.127.1469.0367.227.15
257101-5710168.30268.40
350986-5098660.98861.07
457852-5785269.20169.29
561411-6141173.45873.58
651696-5169661.83761.92
20min170987-7098784.91283.874.8385.1384.084.84
271103-7110385.05185.26
364709-6470977.40377.58
472114-7211486.26086.47
574137-7413788.68088.92
667644-6764480.91481.10
30min180349-8034996.11198.901.6796.4799.251.67
283957-83957100.427100.78
382801-8280199.04499.36
483699-83699100.118100.47
583460-8346099.832100.22
681826-8182697.87898.20
45min183568-8356899.961101.051.19100.48101.561.18
285902-85902102.753103.27
385111-85111101.807102.28
484711-84711101.329101.85
584393-84393100.948101.51
683183-8318399.50199.99
60min184598-84598101.193101.211.23101.88101.901.22
286017-86017102.891103.58
385091-85091101.783102.43
484903-84903101.558102.25
584146-84146100.653101.38
682927-8292799.19599.85
极限184753-84753101.379101.091.25102.24101.931.25
285719-85719102.534103.39
385212-85212101.928102.74
484734-84734101.356102.21
583885-83885100.340101.23
682743-8274398.97499.79
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10
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%
19.593855344384960338587063849645385401538534630.11
29.623856176386436738602720.16
单位质量响应值RSD%判断
401820.96401275.680.10数据可信
供试品溶液-2024031621批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1946616-94661624.93621.7418.1824.9421.7418.19
2791180-79118020.84120.84
3674004-67400417.75517.75
4771545-77154520.32420.32
51063291-106329128.00928.01
6706182-70618218.60218.60
10min12018137-201813753.16250.5110.0153.2050.5510.02
21877905-187790549.46849.50
31672269-167226944.05144.08
41919376-191937650.56150.59
52227398-222739858.67458.72
61790362-179036247.16247.19
15min12811667-281166774.06572.706.2774.2072.826.28
22765055-276505572.83872.95
32516575-251657566.29266.40
42841559-284155974.85374.97
53006979-300697979.21079.35
62618167-261816768.96869.08
20min13335392-333539287.86186.823.8888.1287.063.89
23295871-329587186.82087.06
33089089-308908981.37381.59
43374235-337423588.88589.13
53456237-345623791.04591.32
63223330-322333084.90985.13
30min13675796-367579696.82898.511.0297.2398.901.02
23737606-373760698.45798.84
33729760-372976098.25098.60
43777381-377738199.50499.90
53779123-377912399.55099.98
63738672-373867298.48598.85
45min13767212-376721299.23799.630.2799.80100.180.27
23787990-378799099.784100.33
33790930-379093099.861100.37
43787910-378791099.782100.34
53787132-378713299.761100.36
63771769-377176999.35799.89
60min13793947-379394799.94199.620.35100.67100.340.35
23785956-378595699.730100.44
33788392-378839299.794100.47
43788269-378826999.791100.51
53776009-377600999.468100.23
63758038-375803898.99599.69
极限13782662-378266299.64499.500.39100.54100.380.39
23781404-378140499.610100.49
33789725-378972599.830100.68
43783676-378367699.670100.56
53777161-377716199.499100.42
63748940-374894098.75599.62
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%
114.038187481869819388185181983819030.07
214.068196782079820230.10
单位质量响应值RSD%判断
5837.705833.780.05数据可信
供试品溶液-2024031621批-西格列汀
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111021-1102113.19115.9914.6213.1915.9914.62
214632-1463217.51417.51
312329-1232914.75714.76
415014-1501417.97117.97
515590-1559018.66018.66
611570-1157013.84913.85
10min134098-3409840.81346.1710.0740.8446.2010.07
244052-4405252.72752.76
335304-3530442.25742.28
441325-4132549.46349.49
540183-4018348.09748.13
636468-3646843.65043.67
15min154419-5441965.13671.067.2365.2371.167.24
266677-6667779.80879.93
357134-5713468.38668.48
461002-6100273.01673.13
560058-6005871.88672.00
656907-5690768.11468.21
20min167624-6762480.94285.555.0381.1485.765.04
278252-7825293.66393.91
370330-7033084.18184.39
471404-7140485.46685.70
571310-7131085.35485.58
669899-6989983.66583.87
30min180166-8016695.95498.351.8496.2998.721.84
282766-8276699.06699.47
384614-84614101.278101.63
481653-8165397.73398.11
582458-8245898.69799.07
681356-8135697.37897.73
45min183545-8354599.998100.661.09100.49101.191.08
283157-8315799.534100.10
385528-85528102.372102.89
483508-8350899.954100.49
584838-84838101.546102.08
684025-84025100.573101.08
60min183730-83730100.220100.520.96100.88101.220.95
283311-8331199.718100.46
385324-85324102.127102.82
483192-8319299.576100.28
584501-84501101.142101.85
683850-83850100.363101.04
极限183571-83571100.029100.631.03100.86101.491.01
282730-8273099.02399.93
385217-85217101.999102.86
484112-84112100.677101.55
584667-84667101.341102.22
684127-84127100.695101.54
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10
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%
19.593844420384455938438893847118384109838442170.06
29.623875169387060538728870.09
单位质量响应值RSD%判断
400856.83402587.010.31数据可信
供试品溶液-2024031621批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1739600-73960019.47422.7512.2819.4722.7512.29
2942742-94274224.82324.82
3803730-80373021.16321.16
4949340-94934024.99725.00
5982753-98275325.87725.88
6766162-76616220.17420.17
10min11852833-185283348.78754.038.5948.8254.078.59
22305326-230532660.70160.74
31904061-190406150.13650.17
42174390-217439057.25457.30
52120796-212079655.84255.89
61953796-195379651.44551.48
15min12709896-270989671.35476.375.9971.4776.506.00
23209570-320957084.51184.65
32817390-281739074.18474.30
42940811-294081177.43477.57
52924223-292422376.99777.13
62801050-280105073.75473.87
20min13211802-321180284.57088.264.0284.8088.514.03
23606894-360689494.97395.26
33320646-332064687.43687.68
43331266-333126687.71587.98
53357208-335720888.39888.66
63283661-328366186.46286.70
30min13655632-365563296.25697.721.4996.6398.121.49
23743319-374331998.56599.01
33804704-3804704100.181100.57
43678262-367826296.85297.26
53708947-370894797.66098.07
63676429-367642996.80497.19
45min13758744-375874498.97199.300.9199.5199.860.90
23749726-374972698.73499.34
33834443-3834443100.964101.52
43737812-373781298.42098.99
53780778-378077899.551100.13
63765700-376570099.15499.70
60min13765165-376516599.14099.150.9099.8499.880.88
23746046-374604698.63799.41
33826639-3826639100.759101.48
43729136-372913698.19198.93
53773185-377318599.351100.09
63753546-375354698.83499.55
极限13757036-375703698.92699.140.7199.79100.040.70
23730925-373092598.23999.17
33812662-3812662100.391101.28
43761062-376106299.03299.93
53768463-376846399.227100.13
63761744-376174499.05099.93
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