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%
114.137902278902790227894878914789620.08
214.147935079323793360.03
单位质量响应值RSD%判断
5588.255610.750.29数据可信
供试品溶液-2024050521批-西格列汀-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%
5min17859-78599.80412.1016.509.8012.1016.52
210330-1033012.88612.89
37730-77309.6439.64
49999-999912.47312.47
510500-1050013.09813.10
611800-1180014.72014.72
10min127374-2737434.14738.0310.3534.1638.0510.36
231629-3162939.45539.48
326368-2636832.89332.91
430501-3050138.04838.07
532209-3220940.17940.20
634827-3482743.44543.47
15min145688-4568856.99361.988.1057.0762.068.11
251542-5154264.29664.38
344381-4438155.36355.43
449593-4959361.86461.95
551854-5185464.68564.77
655040-5504068.65968.76
20min159490-5949074.21078.745.7374.3878.925.74
264551-6455180.52480.72
358719-5871973.24873.41
462368-6236877.80077.99
565509-6550981.71981.92
668068-6806884.91185.12
30min171867-7186789.65091.512.3889.9491.832.39
272497-7249790.43690.76
371118-7111888.71589.00
475016-7501693.57893.89
574621-7462193.08593.42
675032-7503293.59893.95
45min174749-7474993.24594.061.6093.6994.531.61
274412-7441292.82593.30
373991-7399192.29992.73
477100-7710096.17896.65
575926-7592694.71395.20
676236-7623695.10095.61
60min175364-7536494.01294.531.4294.6195.161.44
274718-7471893.20693.84
374540-7454092.98493.57
477177-7717796.27496.91
576254-7625495.12295.77
676644-7664495.60996.28
极限177936-7793697.22196.260.7697.9797.040.76
276262-7626295.13295.92
376759-7675995.75296.49
477452-7745296.61797.41
577178-7717896.27597.08
677408-7740896.56297.39
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%
119.054278251427970642906224285408428546042838890.12
218.924278275428080342795390.05
单位质量响应值RSD%判断
224876.06226191.280.42数据可信
供试品溶液-2024050521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%
5min1672506-67250615.77118.6413.5615.7718.6413.57
2836750-83675019.62219.62
3661584-66158415.51415.51
4810865-81086519.01519.02
5851274-85127419.96319.96
6936703-93670321.96621.97
10min11903770-190377044.64448.558.3044.6748.588.30
22134690-213469050.05950.09
31845747-184574743.28443.31
42059333-205933348.29248.32
52176627-217662751.04351.08
62301883-230188353.98054.02
15min12888767-288876767.74371.926.2167.8472.046.22
23141876-314187673.67873.79
32821989-282198966.17766.27
43038352-303835271.25171.36
53180203-318020374.57774.70
63331354-333135478.12278.25
20min13544394-354439483.11886.454.0483.3386.684.05
23728923-372892387.44587.68
33514223-351422382.41082.62
43639306-363930685.34385.57
53790972-379097288.90089.14
63900281-390028191.46391.72
30min14049962-404996294.97396.021.3195.3396.401.32
24050407-405040794.98495.37
34037889-403788994.69095.04
44140268-414026897.09197.46
54141735-414173597.12697.52
64147882-414788297.27097.68
45min14157314-415731497.49197.830.7498.0098.360.75
24131299-413129996.88197.42
34147524-414752497.26197.76
44209949-420994998.72599.26
54189124-418912498.23798.79
64195096-419509698.37798.95
60min14189121-418912198.23798.210.5398.9198.900.54
24150201-415020197.32498.03
34176332-417633297.93798.60
44206532-420653298.64599.34
54195418-419541898.38499.10
64209291-420929198.71099.45
极限14252470-425247099.72298.680.64100.5699.540.63
24171165-417116597.81698.68
34210788-421078898.74599.57
44195966-419596698.39799.26
54200419-420041998.50299.38
64216222-421622298.87299.77
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%
114.137885678807788447888978788788370.06
214.147947379508794900.04
单位质量响应值RSD%判断
5579.415621.640.54数据可信
供试品溶液-2024050521批-西格列汀-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%
5min18656-865610.79612.1211.5610.8012.1211.56
29077-907711.32111.32
39549-954911.91011.91
49095-909511.34411.34
511753-1175314.65914.66
610177-1017712.69312.69
10min130342-3034237.84340.096.5337.8640.116.53
230404-3040437.92137.94
332263-3226340.23940.26
431124-3112438.81938.84
535914-3591444.79344.82
632807-3280740.91840.94
15min149447-4944761.67264.212.7061.7564.292.71
250135-5013562.53062.61
352250-5225065.16865.25
451619-5161964.38164.46
552646-5264665.66165.76
652791-5279165.84265.93
20min163848-6384879.63380.941.0879.8281.131.08
264249-6424980.13380.32
365375-6537581.53781.73
465606-6560681.82582.02
565310-6531081.45681.66
664978-6497881.04281.24
30min176452-7645295.35393.802.0695.6794.132.05
274105-7410592.42692.75
376828-7682895.82296.15
476184-7618495.01995.35
574785-7478593.27493.62
672882-7288290.90091.23
45min177167-7716796.24595.121.8996.7295.601.88
275679-7567994.38994.86
377865-7786597.11597.61
476853-7685395.85396.34
576249-7624995.10095.60
673769-7376992.00792.49
60min177382-7738296.51395.581.8197.1596.231.80
276230-7623095.07695.71
378058-7805897.35698.01
476987-7698796.02096.67
577077-7707796.13296.79
674085-7408592.40193.04
极限177458-7745896.60896.361.2597.4097.161.24
277223-7722396.31597.10
377901-7790197.16097.98
477029-7702996.07396.88
578361-7836197.73498.55
675564-7556494.24595.04
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%
119.054275987427769342850854281108427758442794910.09
218.924285057428686342859600.03
单位质量响应值RSD%判断
224645.20226530.660.60数据可信
供试品溶液-2024050521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%
5min1723287-72328716.95718.659.5316.9618.659.53
2774274-77427418.15318.15
3764890-76489017.93317.93
4751482-75148217.61917.62
5934574-93457421.91121.91
6824234-82423419.32419.32
10min12075326-207532648.65650.554.7148.6850.584.71
22083111-208311148.83948.87
32139224-213922450.15450.18
42106384-210638449.38449.41
52345255-234525554.98555.02
62187665-218766551.29051.32
15min13041011-304101171.29773.782.0771.4173.902.07
23114137-311413773.01173.12
33189042-318904274.76774.88
43133652-313365273.46973.58
53182260-318226074.60874.74
63221367-322136775.52575.64
20min13726678-372667887.37288.120.4787.6088.360.48
23756140-375614088.06388.30
33760454-376045488.16488.40
43776758-377675888.54688.78
53759749-375974988.14788.40
63772288-377228888.44188.68
30min14235733-423573399.30797.771.4799.6898.161.46
24148840-414884097.27097.65
34230525-423052599.18599.57
44186649-418664998.15698.54
54147121-414712197.22997.63
64073129-407312995.49595.89
45min14244684-424468499.51798.591.13100.0699.141.12
24201425-420142598.50399.04
34251917-425191799.686100.24
44203856-420385698.56099.10
54209406-420940698.69099.25
64119328-411932896.57897.13
60min14238408-423840899.37098.740.94100.0799.450.94
24222493-422249398.99699.70
34238392-423839299.369100.09
44202804-420280498.53599.24
54231679-423167999.21299.94
64135672-413567296.96197.67
极限14233324-423332499.25098.860.89100.1299.740.89
24233248-423324899.249100.12
34235929-423592999.311100.19
44195024-419502498.35299.23
54251566-425156699.678100.57
64150427-415042797.30798.18
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