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%
114.138129781067810398121281244811720.14
213.547699177121770560.12
单位质量响应值RSD%判断
5744.665690.990.67数据可信
中间条件6月-供试品溶液-2024050521批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115579-1557919.03216.7515.2419.0316.7415.24
213412-1341216.38516.38
311030-1103013.47513.47
416318-1631819.93519.93
511712-1171214.30814.31
614203-1420317.35117.35
10min139140-3914047.81546.049.6647.8546.079.66
238249-3824946.72746.75
332434-3243439.62339.65
442756-4275652.23352.27
534681-3468142.36842.39
638876-3887647.49347.52
15min157340-5734070.04969.997.1870.1670.107.18
260012-6001273.31473.42
351423-5142362.82162.91
462769-6276976.68276.80
553888-5388865.83265.93
658325-5832571.25371.36
20min167883-6788382.92984.966.1683.1685.186.16
274212-7421290.66190.89
364861-6486179.23779.43
474923-7492391.53091.78
565533-6553380.05880.26
669837-6983785.31685.54
30min174711-7471191.27193.753.0391.6494.113.03
280876-8087698.80299.18
375980-7598092.82193.15
477946-7794695.22395.62
575046-7504691.68092.02
675877-7587792.69593.06
45min176741-7674193.75196.242.2894.2796.762.27
281308-8130899.33099.87
380619-8061998.48898.97
478388-7838895.76396.32
577670-7767094.88595.38
677923-7792395.19595.72
60min177501-7750194.67997.251.8095.3597.921.78
281315-8131599.338100.05
381071-8107199.04099.68
478831-7883196.30497.02
579545-7954597.17697.82
679352-7935296.94097.62
极限179080-7908096.60897.981.2797.4498.821.26
281403-8140399.446100.32
381470-8147099.528100.34
479543-7954397.17498.05
580190-8019097.96498.77
679552-7955297.18598.03
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%
118.974296727430076142867704297245429549242953990.13
218.544120417412109841207580.02
单位质量响应值RSD%判断
226431.15222263.111.32数据可信
中间条件6月-供试品溶液-2024050521批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11157493-115749327.28924.4812.6027.2924.4812.60
21019861-101986124.04524.04
3883431-88343120.82820.83
41203768-120376828.38028.38
5900880-90088021.23921.24
61064796-106479625.10425.10
10min12451594-245159457.80055.967.8857.8556.007.88
22394830-239483056.46156.50
32116527-211652749.90049.93
42642791-264279162.30762.35
52210113-221011352.10652.14
62425929-242592957.19457.24
15min13325325-332532578.39977.956.1678.5478.086.16
23422957-342295780.70180.83
33039053-303905371.65071.77
43598231-359823184.83384.98
53117853-311785373.50873.63
63333007-333300778.58078.72
20min13783128-378312889.19290.465.0989.4690.725.10
24016806-401680694.70294.97
33615365-361536585.23785.47
44100544-410054496.67696.97
53646451-364645185.97086.21
63858198-385819890.96291.23
30min14060287-406028795.72797.622.1296.1598.042.12
24279412-4279412100.893101.32
34073725-407372596.04396.42
44215432-421543299.38499.84
54116443-411644397.05197.44
64097980-409798096.61597.04
45min14147478-414747897.78299.211.2798.3699.791.28
24280223-4280223100.912101.51
34249546-4249546100.189100.73
44229719-422971999.721100.34
54155528-415552897.97298.52
64186839-418683998.71099.29
60min14177943-417794398.50199.840.9399.24100.580.93
24285336-4285336101.032101.80
34270949-4270949100.693101.40
44238717-423871799.933100.72
54214748-421474899.368100.08
64220961-422096199.515100.26
极限14213661-421366199.343100.080.68100.25100.990.68
24279940-4279940100.905101.84
34274627-4274627100.780101.65
44252294-4252294100.253101.21
54232342-423234299.783100.66
64216551-421655199.411100.32
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%
114.138020180350803498032080409803260.10
213.547715077210771800.06
单位质量响应值RSD%判断
5684.785700.150.20数据可信
中间条件6月-供试品溶液-2024050621批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113914-1391417.07316.4511.8117.0716.4411.80
213439-1343916.49116.49
314802-1480218.16318.16
410510-1051012.89612.90
513014-1301415.96915.97
614738-1473818.08418.08
10min139908-3990848.97046.127.0649.0046.157.06
238788-3878847.59547.62
339475-3947548.43848.47
434893-3489342.81642.84
533599-3359941.22841.25
638853-3885347.67547.71
15min158913-5891372.29069.805.3272.4069.905.32
258583-5858371.88571.99
358042-5804271.22171.33
456887-5688769.80469.90
550870-5087062.42162.52
657995-5799571.16471.27
20min169319-6931985.05982.473.6485.2982.693.65
269092-6909284.78085.01
368851-6885184.48584.71
466781-6678181.94582.15
562958-6295877.25477.45
666241-6624181.28281.51
30min177959-7795995.66191.132.7196.0391.492.71
275010-7501092.04292.41
373429-7342990.10290.47
473796-7379690.55390.90
573039-7303989.62489.95
672367-7236788.79989.16
45min178969-7896996.90096.411.4397.4396.921.42
278697-7869796.56697.09
378303-7830396.08396.60
478497-7849796.32196.82
580212-8021298.42598.90
676740-7674094.16594.68
60min178998-7899896.93697.050.9097.6397.720.89
279414-7941497.44698.13
379297-7929797.30397.98
478680-7868096.54697.20
580124-8012498.31798.96
678030-7803095.74896.42
极限178832-7883296.73296.970.8997.5997.800.88
279413-7941397.44598.29
379009-7900996.94997.79
478716-7871696.59097.41
580133-8013398.32899.13
678046-7804695.76896.60
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%
118.974246958424734142492664247059424786942476990.03
218.544127582411466141211220.23
单位质量响应值RSD%判断
223916.66222282.740.52数据可信
中间条件6月-供试品溶液-2024050621批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11040252-104025224.66124.159.8124.6624.159.81
21025063-102506324.30124.30
31112630-111263026.37626.38
4840522-84052219.92619.93
5986684-98668423.39123.39
61106927-110692726.24126.24
10min12466972-246697258.48356.235.6358.5256.275.64
22438274-243827457.80357.84
32471960-247196058.60158.65
42245000-224500053.22153.25
52162495-216249551.26551.30
62446679-244667958.00258.05
15min13390413-339041380.37578.134.4680.5178.264.46
23375198-337519880.01480.15
33336742-333674279.10279.24
43310241-331024178.47478.60
53001876-300187671.16471.29
63360279-336027979.66079.80
20min13830973-383097390.81988.872.9891.0989.132.98
23832949-383294990.86591.14
33828944-382894490.77191.04
43742787-374278788.72888.98
53548535-354853584.12384.37
63707444-370744487.89088.16
30min14173646-417364698.94295.831.9999.3796.241.99
24084722-408472296.83497.26
34023423-402342395.38195.81
44046413-404641395.92696.33
53958412-395841293.84094.22
63967335-396733594.05194.47
45min14201685-420168599.60799.450.66100.20100.020.65
24218818-4218818100.013100.60
34193251-419325199.40799.99
44193661-419366199.41799.98
54218035-421803599.994100.53
64143883-414388398.23798.81
60min14199253-419925399.54999.730.46100.30100.470.46
24226363-4226363100.192100.94
34229042-4229042100.255101.00
44191518-419151899.366100.09
54214213-421421399.904100.61
64181611-418161199.13199.87
极限14190730-419073099.34799.600.43100.27100.510.43
24224278-4224278100.142101.06
34219375-4219375100.026100.94
44188255-418825599.289100.18
54205718-420571899.703100.58
64180466-418046699.104100.01
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%
114.138072680404806528040580612805600.19
213.547701176798769040.20
单位质量响应值RSD%判断
5701.345679.760.27数据可信
中间条件6月-供试品溶液-2024050721批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115021-1502118.43816.7711.1218.4416.7711.11
215494-1549419.01919.02
314258-1425817.50117.50
411933-1193314.64814.65
511972-1197214.69514.70
613306-1330616.33316.33
10min139533-3953348.52645.8010.4148.5645.8210.41
243763-4376353.71853.75
336457-3645744.75044.78
432480-3248039.86939.89
536159-3615944.38444.41
635468-3546843.53643.56
15min159373-5937372.87968.046.4772.9968.156.48
259413-5941372.92873.05
355062-5506267.58867.69
450099-5009961.49661.59
555297-5529767.87667.97
653359-5335965.49765.60
20min171198-7119887.39481.345.3887.6381.565.38
268107-6810783.60083.84
367254-6725482.55382.77
461456-6145675.43675.63
566707-6670781.88282.09
662889-6288977.19577.40
30min177806-7780695.50592.083.3095.8892.433.30
274849-7484991.87692.26
377173-7717394.72895.08
472450-7245088.93189.25
576026-7602693.32093.67
671790-7179088.12188.46
45min179162-7916297.17098.021.0597.7198.531.04
280143-8014398.37498.91
380315-8031598.58599.10
481168-8116899.632100.10
579368-7936897.42397.93
678979-7897996.94597.43
60min178820-7882096.75098.441.6597.4599.111.62
280419-8041998.71399.41
379517-7951797.60698.28
482617-82617101.411102.04
579560-7956097.65898.32
680264-8026498.52299.17
极限178802-7880296.72898.091.5897.5998.921.56
280386-8038698.67299.54
379404-7940497.46798.31
482195-82195100.893101.70
578903-7890396.85297.68
679757-7975797.90098.71
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%
118.974244581424445842435784242966424345642438080.02
218.544111649412143841165440.17
单位质量响应值RSD%判断
223711.54222035.810.54数据可信
中间条件6月-供试品溶液-2024050721批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11123194-112319426.65424.828.8226.6524.828.80
21164476-116447627.63427.63
31073050-107305025.46425.46
4935333-93533322.19622.20
5950152-95015222.54822.55
61028547-102854724.40824.41
10min12452121-245212158.19055.737.9358.2355.767.93
22647163-264716362.81862.86
32310878-231087854.83854.88
42096855-209685549.75949.80
52323462-232346255.13755.17
62259110-225911053.61053.65
15min13387399-338739980.38576.454.8580.5376.594.85
23381320-338132080.24080.39
33207876-320787676.12476.26
42973784-297378470.56970.69
53241191-324119176.91577.04
63139144-313914474.49374.62
20min13912682-391268292.85087.864.2593.1388.124.26
23756013-375601389.13289.42
33749695-374969588.98289.24
43474026-347402682.44082.68
53758044-375804489.18089.44
63564050-356405084.57784.83
30min14167893-416789398.90696.542.4899.3496.942.49
24039310-403931095.85596.29
34163313-416331398.79799.21
43963625-396362594.05994.43
54132317-413231798.06298.47
63941606-394160693.53693.93
45min14219614-4219614100.133100.540.61100.73101.100.59
24225017-4225017100.262100.85
34239804-4239804100.613101.19
44282687-4282687101.630102.16
54242126-4242126100.668101.24
64210013-421001399.906100.46
60min14199640-419964099.659100.861.00100.42101.600.97
24232217-4232217100.433101.19
34230115-4230115100.383101.12
44315781-4315781102.416103.12
54238792-4238792100.589101.33
64285215-4285215101.690102.41
极限14212851-421285199.973100.520.84100.90101.420.81
24225433-4225433100.272101.20
34224870-4224870100.258101.17
44307224-4307224102.212103.08
54223541-4223541100.227101.13
64220334-4220334100.151101.04
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