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%
114.138081381317807158137080929810290.37
214.148101480724808690.26
单位质量响应值RSD%判断
5734.545719.170.19数据可信
供试品溶液-2024050621批-西格列汀-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%
5min111955-1195514.58116.4217.8014.5816.4217.82
214796-1479618.04718.05
311735-1173514.31314.31
415039-1503918.34318.34
516717-1671720.39020.39
610531-1053112.84512.84
10min137929-3792946.26246.6512.9046.2946.6812.90
241780-4178050.95950.99
335639-3563943.46943.49
438964-3896447.52447.55
544687-4468754.50554.54
630486-3048637.18437.21
15min158286-5828671.09171.4910.6071.1971.5910.60
262232-6223275.90476.02
356339-5633968.71768.81
458630-5863071.51171.62
567415-6741582.22682.35
648769-4876959.48359.57
20min172221-7222188.08886.806.6688.3187.036.67
274474-7447490.83691.08
369843-6984385.18785.40
470274-7027485.71385.94
576992-7699293.90794.17
663190-6319077.07377.26
30min180914-8091498.69196.352.3299.0696.722.34
279317-7931796.74397.14
378824-7882496.14196.49
480174-8017497.78898.16
579119-7911996.50196.92
675598-7559892.20792.52
45min180843-8084398.60497.061.1999.1497.591.21
279349-7934996.78297.34
379356-7935696.79097.30
480199-8019997.81998.35
579661-7966197.16297.74
678039-7803995.18495.65
60min180816-8081698.57196.941.1199.2797.631.13
279346-7934696.77897.49
379259-7925996.67297.35
480007-8000797.58498.28
579279-7927996.69697.44
678174-7817495.34995.97
极限180744-8074498.48397.470.7799.3498.320.78
279529-7952997.00197.88
379961-7996197.52898.36
480480-8048098.16199.02
579629-7962997.12398.03
679128-7912896.51297.29
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%
119.974378114437912643900004391350438734943851880.15
219.944365243436545843653500.01
单位质量响应值RSD%判断
219588.78218924.270.22数据可信
供试品溶液-2024050621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%
5min1880420-88042021.23723.1414.8521.2423.1414.85
21057550-105755025.51025.51
3857032-85703220.67320.67
41053313-105331325.40825.41
51135485-113548527.39027.39
6771811-77181118.61718.62
10min12231845-223184553.83654.5510.4553.8754.5910.45
22438149-243814958.81258.85
32153216-215321651.93951.97
42301115-230111555.50755.55
52561992-256199261.80061.85
61882823-188282345.41745.45
15min13142973-314297375.81476.628.3275.9476.748.33
23332128-333212880.37780.52
33098177-309817774.73374.85
43185573-318557376.84176.98
53546631-354663185.55185.70
62751802-275180266.37866.48
20min13723290-372329089.81289.004.9990.0689.255.00
23830595-383059592.40092.67
33628929-362892987.53687.78
43655979-365597988.18888.45
53913738-391373894.40694.70
63384678-338467881.64481.86
30min14068412-406841298.13796.561.5098.5496.971.52
24016276-401627696.87997.31
33997279-399727996.42196.81
44037681-403768197.39697.81
54006579-400657996.64597.09
63892042-389204293.88394.24
45min14073254-407325498.25497.260.6798.8297.820.68
24024892-402489297.08797.68
34021940-402194097.01697.57
44054367-405436797.79898.37
54016305-401630596.88097.49
64000610-400061096.50197.01
60min14075380-407538098.30597.320.5899.0398.050.58
24028972-402897297.18697.94
34026769-402676997.13297.85
44046612-404661297.61198.35
54018885-401888596.94297.71
64011138-401113896.75597.43
极限14066690-406669098.09597.340.4698.9998.230.46
24021704-402170497.01097.92
34034523-403452397.31998.20
44046881-404688197.61898.52
54019428-401942896.95597.89
64022742-402274297.03597.87
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%
114.138068880710805488073180455806260.15
214.148097480878809260.09
单位质量响应值RSD%判断
5706.025723.200.22数据可信
供试品溶液-2024050721批-西格列汀-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%
5min110393-1039312.70315.3013.6012.7015.3013.61
213850-1385016.92916.93
314748-1474818.02718.03
412175-1217514.88214.88
513073-1307315.97915.98
610852-1085213.26513.26
10min132677-3267739.94242.827.9539.9642.857.96
238074-3807446.53846.57
338349-3834946.87446.90
432875-3287540.18440.21
535938-3593843.92743.95
632293-3229339.47239.49
15min153568-5356865.47766.555.3165.5666.645.32
257654-5765470.47170.58
357655-5765570.47270.58
451094-5109462.45362.54
555192-5519267.46267.56
651511-5151162.96363.05
20min167805-6780582.87983.313.0283.0883.523.03
269240-6924084.63384.86
371344-7134487.20587.43
466430-6643081.19881.39
568538-6853883.77583.99
665593-6559380.17580.37
30min178961-7896196.51595.650.6896.8596.000.68
278422-7842295.85696.22
378641-7864196.12496.49
477694-7769494.96695.30
577639-7763994.89995.25
678160-7816095.53695.86
45min179975-7997597.75496.800.7298.2597.310.72
278887-7888796.42596.95
379627-7962797.32997.86
479422-7942297.07897.57
578461-7846195.90496.41
678812-7881296.33396.82
60min180103-8010397.91197.090.6398.5797.760.62
278985-7898596.54497.23
379741-7974197.46898.16
479678-7967897.39198.04
578798-7879896.31696.99
679305-7930596.93597.58
极限180870-8087098.84897.600.8099.6798.430.79
279613-7961397.31298.16
380080-8008097.88398.74
480079-8007997.88298.70
579335-7933596.97297.80
679126-7912696.71797.52
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%
119.974371911437639743850014377982438340243789390.13
219.944355666436206943588680.11
单位质量响应值RSD%判断
219275.86218599.200.22数据可信
供试品溶液-2024050721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%
5min1788036-78803619.03621.9911.7119.0422.0011.71
21009674-100967424.39124.39
31045710-104571025.26125.26
4885058-88505821.38021.38
5935420-93542022.59722.60
6799074-79907419.30319.30
10min12032728-203272849.10451.626.3149.1451.656.31
22277793-227779355.02455.06
32299828-229982855.55755.60
42031297-203129749.07049.11
52183429-218342952.74552.78
61994892-199489248.19048.22
15min13010013-301001372.71273.284.1272.8373.404.12
23163897-316389776.43076.56
33162934-316293476.40676.54
42891887-289188769.85969.98
53084251-308425174.50674.63
62888514-288851469.77769.89
20min13629719-362971987.68287.252.4387.9287.492.44
23651217-365121788.20288.46
33739196-373919690.32790.59
43537222-353722285.44885.68
53622183-362218387.50087.75
63490436-349043684.31884.55
30min14059754-405975498.07196.900.7698.4597.290.76
24005324-400532496.75697.16
34036721-403672197.51497.93
43991395-399139596.41996.80
53985900-398590096.28796.68
63989243-398924396.36796.74
45min14107385-410738599.22197.810.8699.7798.360.86
24034722-403472297.46698.03
34068435-406843598.28098.86
44049156-404915697.81598.35
54012942-401294296.94097.50
64021839-402183997.15597.68
60min14105206-410520699.16998.020.7299.8898.730.72
24028293-402829397.31198.04
34067802-406780298.26599.00
44069250-406925098.30099.00
54042717-404271797.65998.38
64032345-403234597.40998.10
极限14126221-412622199.67698.010.99100.5598.890.99
24036396-403639697.50798.40
34068608-406860898.28599.19
44068799-406879998.28999.15
54026749-402674997.27398.15
64016660-401666097.03097.88
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