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%
113.998124581215812548121081190812230.04
214.038016780523803450.32
单位质量响应值RSD%判断
5805.795726.660.98数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-bzgw(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111625-1162514.08315.4316.7514.0815.4316.76
212236-1223614.82314.82
312070-1207014.62214.62
411416-1141613.83013.83
517044-1704420.64820.65
612023-1202314.56514.56
10min132729-3272939.64942.699.8739.6742.719.88
236138-3613843.77843.80
331770-3177038.48738.51
435463-3546342.96142.98
541506-4150650.28150.32
633828-3382840.98041.00
15min150144-5014460.74665.027.2860.8465.127.29
256031-5603167.87767.98
348710-4871059.00959.10
456489-5648968.43268.53
558516-5851670.88871.01
652152-5215263.17863.27
20min162122-6212275.25677.956.0175.4578.166.01
266639-6663980.72880.94
358578-5857870.96371.15
467907-6790782.26482.47
568269-6826982.70382.94
662572-6257275.80176.00
30min171397-7139786.49286.394.7686.8186.724.77
272618-7261887.97188.32
366054-6605480.01980.32
473919-7391989.54789.89
575151-7515191.04091.41
668740-6874083.27383.60
45min176140-7614092.23891.343.1692.7091.823.17
276339-7633992.47992.97
371361-7136186.44886.89
476591-7659192.78493.28
578029-7802994.52695.05
673916-7391689.54490.01
60min177178-7717893.49592.641.7594.1193.271.77
276536-7653692.71893.36
374149-7414989.82690.41
476732-7673292.95593.60
578145-7814594.66795.35
676077-7607792.16292.77
极限177493-7749393.87793.061.4994.6593.851.52
276551-7655192.73693.54
374937-7493790.78191.51
476872-7687293.12593.93
578385-7838594.95895.80
676697-7669792.91393.68
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%
119.264231015422989742273354227749422675342285500.05
219.314179695418102441803600.03
单位质量响应值RSD%判断
219550.88216486.791.00数据可信
影响因素30天-供试品溶液-2024050521批-二甲双胍-bzgw(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1897772-89777221.78023.2113.1421.7823.2113.14
2921541-92154122.35622.36
3910165-91016522.08022.08
4878844-87884421.32121.32
51211007-121100729.37929.38
6920209-92020922.32422.32
10min12080549-208054950.47453.207.2750.5153.247.28
22222221-222222153.91153.95
32024573-202457349.11649.15
42211829-221182953.65853.69
52479269-247926960.14660.20
62139604-213960451.90651.94
15min12927205-292720571.01374.605.3871.1374.735.38
23162900-316290076.73176.86
32859752-285975269.37769.50
43218175-321817578.07278.20
53266950-326695079.25579.40
63016416-301641673.17873.30
20min13459734-345973483.93285.834.3784.1786.094.37
23611471-361147187.61387.87
33301054-330105480.08380.32
43705273-370527389.88990.14
53677532-367753289.21689.50
63473785-347378584.27384.52
30min13847551-384755193.34192.993.3593.7293.383.35
23854429-385442993.50893.91
33635537-363553788.19788.57
43956207-395620795.97796.38
53966970-396697096.23896.67
63737216-373721690.66491.05
45min14038269-403826997.96796.862.1498.5097.402.15
24011018-401101897.30697.86
33851109-385110993.42793.94
44051515-405151598.28998.85
54073411-407341198.82099.41
63929404-392940495.32695.86
60min14071377-407137798.77197.751.2299.4798.461.23
24002831-400283197.10897.83
33952602-395260295.88996.56
44057274-405727498.42899.16
54079478-407947898.96799.72
64011264-401126497.31298.01
极限14074707-407470798.85197.901.0499.7198.771.06
24001295-400129597.07097.95
33975049-397504996.43497.26
44055035-405503598.37499.27
54079629-407962998.97199.89
64026696-402669697.68798.54
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%
113.998105281012810028106081069810390.04
214.038092780640807840.26
单位质量响应值RSD%判断
5792.645757.950.43数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-bzgs(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113736-1373616.61314.8218.0516.6114.8218.04
210335-1033512.50012.50
310683-1068312.92112.92
411153-1115313.48913.49
516050-1605019.41219.41
611568-1156813.99113.99
10min139070-3907047.25444.9811.5147.2845.0011.51
234275-3427541.45541.48
336920-3692044.65444.68
436455-3645544.09144.11
544395-4439553.69553.73
632001-3200138.70438.73
15min158983-5898371.33968.967.1171.4569.067.12
254785-5478566.26166.35
357351-5735169.36569.46
457668-5766869.74869.84
562688-6268875.82075.94
650645-5064561.25461.34
20min171934-7193487.00283.294.5087.2383.514.50
268830-6883083.24883.45
369450-6945083.99884.21
470844-7084485.68485.90
569108-6910883.58583.83
663025-6302576.22776.42
30min178658-7865895.13592.662.7495.5193.012.74
276259-7625992.23392.57
377421-7742193.63993.99
478897-7889795.42495.78
574502-7450290.10890.50
673911-7391189.39489.71
45min179218-7921895.81296.741.3696.3497.251.34
280632-8063297.52398.02
381476-8147698.54399.05
479921-7992196.66397.18
578393-7839394.81495.35
680268-8026897.08297.55
60min179299-7929995.91096.731.3796.6097.401.35
280541-8054197.41298.07
381565-8156598.65199.32
479746-7974696.45197.13
578405-7840594.82995.52
680324-8032497.15097.78
极限179162-7916295.74596.621.3696.5997.451.33
280897-8089797.84398.66
381169-8116998.17299.01
479542-7954296.20497.04
578332-7833294.74195.59
680200-8020097.00097.79
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%
119.264217850421523342148234217718421789242167030.04
219.314193997419467841943380.02
单位质量响应值RSD%判断
218935.77217210.670.56数据可信
影响因素30天-供试品溶液-2024050521批-二甲双胍-bzgs(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1980788-98078823.78721.6715.1323.7921.6715.13
2789672-78967219.15219.15
3803214-80321419.48019.48
4808527-80852719.60919.61
51129450-112945027.39227.39
6849613-84961320.60620.61
10min12356127-235612757.14354.259.7557.1854.289.76
22108688-210868851.14251.17
32208558-220855853.56453.60
42171754-217175452.67152.70
52601322-260132263.09063.14
61973698-197369847.86847.90
15min13285646-328564679.68676.955.9479.8277.075.95
23089403-308940374.92775.04
33177754-317775477.07077.19
43160979-316097976.66376.78
53441464-344146483.46583.62
62880520-288052069.86169.98
20min13833028-383302892.96289.153.7393.2389.413.74
23692757-369275789.56089.80
33690125-369012589.49689.75
43730823-373082390.48390.73
53689330-368933089.47789.77
63419937-341993782.94383.17
30min14082850-408285099.02196.662.0899.4497.062.08
23993748-399374896.86097.25
34010128-401012897.25797.66
44049107-404910798.20398.60
53912274-391227494.88495.32
63864054-386405493.71494.08
45min14090328-409032899.20299.581.0399.79100.141.01
24152499-4152499100.710101.26
34158665-4158665100.860101.42
44079170-407917098.93299.49
54051301-405130198.25698.85
64102757-410275799.504100.03
60min14087342-408734299.13099.481.0099.88100.210.98
24144782-4144782100.523101.24
34153727-4153727100.740101.47
44076047-407604798.85699.58
54047658-404765898.16798.93
64102128-410212899.488100.18
极限14082437-408243799.01199.331.0999.93100.221.07
24152474-4152474100.710101.60
34142242-4142242100.461101.36
44060103-406010398.46999.36
54040528-404052897.99498.92
64095143-409514399.319100.18
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%
113.998115481138810828108681096811110.05
214.038084080867808540.03
单位质量响应值RSD%判断
5797.785762.940.43数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-bzgz(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117714-1771421.40615.6119.2121.4115.6119.22
210825-1082513.08113.08
313221-1322115.97615.98
411824-1182414.28814.29
512307-1230714.87214.87
611606-1160614.02514.02
10min144518-4451853.79643.1113.6453.8343.1413.64
230251-3025136.55636.58
336042-3604243.55443.58
433029-3302939.91339.94
533903-3390340.96940.99
636312-3631243.88043.90
15min165414-6541479.04765.5910.8079.1765.6810.80
248702-4870258.85258.94
355299-5529966.82466.92
451259-5125961.94262.03
552549-5254963.50163.59
652424-5242463.35063.45
20min172028-7202887.04079.464.9987.3079.675.01
264554-6455478.00878.19
366628-6662880.51480.72
464328-6432877.73577.93
563254-6325476.43776.64
663760-6376077.04977.25
30min179536-7953696.11391.322.9896.5191.662.99
275655-7565591.42391.73
375933-7593391.75992.10
475363-7536391.07091.39
572997-7299788.21188.54
673938-7393889.34889.68
45min181364-8136498.32296.311.6798.8896.801.69
279302-7930295.83096.29
379569-7956996.15296.65
480277-8027797.00897.48
577414-7741493.54894.02
680261-8026196.98997.47
60min181237-8123798.16896.611.9698.8997.261.97
279265-7926595.78596.41
379577-7957796.16296.82
481495-8149598.48099.12
577322-7732293.43794.07
680791-8079197.62998.27
极限181021-8102197.90796.541.7198.8097.351.72
279292-7929295.81896.60
379558-7955896.13996.96
480904-8090497.76698.57
577581-7758193.75094.54
680972-8097297.84898.65
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%
119.264221077422166542234634222721422437142226590.04
219.314201778420374742027620.04
单位质量响应值RSD%判断
219245.02217646.920.52数据可信
影响因素30天-供试品溶液-2024050521批-二甲双胍-bzgz(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11189553-118955328.80121.9416.4628.8021.9416.47
2771722-77172218.68518.68
3933596-93359622.60422.60
4831144-83114420.12320.12
5879720-87972021.29921.30
6830453-83045320.10620.11
10min12600345-260034562.95851.7411.6363.0151.7811.63
21876219-187621945.42645.46
32186385-218638552.93652.97
42018172-201817248.86348.90
52082530-208253050.42150.46
62057858-205785849.82449.86
15min13527027-352702785.39473.588.5485.5573.708.55
22779227-277922767.28967.40
33089562-308956274.80374.93
42904226-290422670.31670.43
52972822-297282271.97672.10
62961229-296122971.69671.81
20min13783147-378314791.59585.753.5991.8985.993.61
23482432-348243284.31584.53
33583540-358354086.76387.01
43483423-348342384.33984.57
53452497-345249783.59083.83
63464904-346490483.89084.13
30min14079358-407935898.76795.501.9299.2295.891.94
23942112-394211295.44495.80
33961324-396132495.90996.30
43935241-393524195.27895.65
53866832-386683293.62294.00
63881598-388159893.97994.35
45min14134738-4134738100.10899.121.01100.7299.671.02
24067222-406722298.47398.99
34091371-409137199.05899.61
44120117-412011799.754100.29
54026632-402663297.49198.03
64123526-412352699.837100.37
60min14125655-412565599.88899.271.32100.6799.981.32
24066784-406678498.46399.15
34086526-408652698.94199.66
44163501-4163501100.804101.50
54016673-401667397.24997.95
64140446-4140446100.246100.95
极限14119353-411935399.73699.071.11100.6899.941.11
24059603-405960398.28999.14
34081248-408124898.81399.70
44132221-4132221100.047100.91
54022510-402251097.39198.25
64135294-4135294100.121100.99
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%
113.998106581024810828108681101810720.04
214.038092880588807580.30
单位质量响应值RSD%判断
5795.005756.090.48数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-lpgw(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110540-1054012.74716.8117.8012.7516.8117.80
214488-1448817.52217.52
312510-1251015.13015.13
418007-1800721.77821.78
513643-1364316.50016.50
614222-1422217.20017.20
10min131418-3141837.99846.2012.9038.0246.2312.90
239697-3969748.01148.04
336549-3654944.20344.23
446528-4652856.27256.31
537570-3757045.43845.47
637453-3745345.29745.33
15min149271-4927159.59069.638.8159.6769.738.82
259655-5965572.14872.26
357626-5762669.69469.79
464851-6485178.43378.56
556141-5614167.89868.00
657891-5789170.01570.12
20min160279-6027972.90381.456.4173.0981.686.42
268469-6846982.80883.04
368381-6838182.70282.92
473298-7329888.64988.91
565262-6526278.93079.15
668402-6840282.72782.95
30min171818-7181886.85990.462.7987.1690.812.81
276282-7628292.25792.62
374868-7486890.54790.90
477731-7773194.01094.42
573398-7339888.76989.12
674663-7466390.29990.66
45min176439-7643992.44794.541.5292.9095.051.54
279870-7987096.59797.12
377835-7783594.13694.64
478625-7862595.09195.66
577501-7750193.73294.23
678734-7873495.22395.73
60min177213-7721393.38394.690.9093.9995.350.92
278788-7878895.28895.97
378056-7805694.40395.06
478441-7844194.86995.59
578023-7802394.36395.02
679232-7923295.82596.49
极限177742-7774294.02395.291.4194.7896.111.43
278741-7874195.23196.07
378183-7818394.55795.37
480739-8073997.64898.53
578018-7801894.35795.17
679292-7929295.89896.73
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%
119.264224137422290642250744226062422440042245160.03
219.314202977420560042042880.05
单位质量响应值RSD%判断
219341.43217725.950.53数据可信
影响因素30天-供试品溶液-2024050521批-二甲双胍-lpgw(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1805740-80574019.50024.3914.3919.5024.3914.39
21052942-105294225.48325.48
3937466-93746622.68822.69
41244679-124467930.12330.12
5979386-97938623.70323.70
61027374-102737424.86424.86
10min12001874-200187448.44956.3610.0848.4856.4010.08
22396395-239639557.99758.04
32259340-225934054.68054.72
42724332-272433265.93465.98
52311302-231130255.93855.98
62279756-227975655.17455.22
15min12893284-289328470.02378.386.6970.1478.516.70
23316527-331652780.26680.40
33241319-324131978.44678.57
43563186-356318686.23586.40
53178480-317848076.92577.06
63238183-323818378.37078.50
20min13398726-339872682.25588.594.6282.4988.864.64
23690504-369050489.31789.59
33704251-370425189.64989.91
43914015-391401594.72695.03
53576574-357657486.55986.82
63678626-367862689.02989.29
30min13894623-389462394.25796.021.7594.6296.441.77
23998994-399899496.78397.20
33963050-396305095.91396.32
44087423-408742398.92399.38
53915152-391515294.75395.16
63946839-394683995.52095.93
45min14062468-406246898.31999.040.6798.8499.610.69
24127859-412785999.901100.48
34075070-407507098.62499.19
44120211-412021199.716100.34
54071298-407129898.53399.10
64097129-409712999.15899.73
60min14079393-407939398.72899.030.4399.4299.770.44
24087977-408797798.93699.69
34074153-407415398.60299.33
44110708-411070899.486100.28
54083112-408311298.81899.55
64115712-411571299.607100.34
极限14087846-408784698.93399.441.3899.79100.341.39
24081635-408163598.78399.70
34073124-407312498.57799.47
44221239-4221239102.161103.12
54080811-408081198.76399.65
64106957-410695799.396100.30
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