西格列汀磷酸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%
113.898252482336825518249982472824760.11
213.968219982361822800.14
单位质量响应值RSD%判断
5937.805893.980.53数据可信
中间条件24月-供试品溶液-2024050721批-西格列汀-1(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%
5min121507-2150725.39417.7323.1725.3917.7323.16
213623-1362316.08516.09
315406-1540618.19018.19
412901-1290115.23315.23
511588-1158813.68213.68
615056-1505617.77717.78
10min150149-5014959.21346.7414.0959.2646.7714.10
236031-3603142.54342.57
339191-3919146.27446.30
436789-3678943.43843.46
534845-3484541.14341.17
640525-4052547.84947.88
15min172030-7203085.04970.1311.1985.1970.2411.19
254484-5448464.33164.43
357895-5789568.35968.47
456124-5612466.26866.37
554794-5479464.69764.79
661036-6103672.06772.18
20min179087-7908793.38183.126.4493.6683.346.45
266633-6663378.67678.88
367604-6760479.82380.04
469423-6942381.97082.18
568505-6850580.88681.09
671125-7112583.98084.21
30min180718-8071895.30792.431.8595.7592.791.87
277366-7736691.34991.69
376713-7671390.57890.93
478625-7862592.83593.18
578833-7883393.08193.42
677418-7741891.41091.78
45min181707-8170796.47595.990.8497.0796.500.84
281159-8115995.82796.32
380471-8047195.01595.52
481317-8131796.01496.51
582356-8235697.24197.73
680753-8075395.34895.87
60min181565-8156596.30796.090.7897.0696.760.77
281457-8145796.17996.83
380732-8073295.32395.99
481070-8107095.72296.38
582488-8248897.39798.05
680955-8095595.58796.27
极限181631-8163196.38596.330.7097.3097.160.69
281731-8173196.50397.31
381012-8101295.65496.48
481173-8117395.84496.66
582606-8260697.53698.35
681346-8134696.04896.89
西格列汀磷酸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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
118.913894090389588438964543898354389756838964700.05
218.913895380389797738966780.05
单位质量响应值RSD%判断
206053.41206064.410.01数据可信
中间条件24月-供试品溶液-2024050721批-磷酸二甲双胍-1(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%
5min11325005-132500534.04225.3918.6134.0425.4018.60
2914913-91491323.50623.51
31027791-102779126.40626.41
4866160-86616022.25422.25
5804504-80450420.67020.67
6991991-99199125.48625.49
10min12653559-265355968.17656.2311.4768.2356.2711.47
22013249-201324951.72551.76
32188305-218830556.22256.27
42073108-207310853.26353.30
51961366-196136650.39250.43
62241237-224123757.58257.62
15min13527707-352770790.63578.018.6990.8178.148.70
22839483-283948372.95373.08
32977264-297726476.49376.63
42924952-292495275.14975.27
52825739-282573972.60072.72
63121675-312167580.20380.34
20min13784746-378474697.23989.025.0097.5689.285.01
23310164-331016485.04685.29
33351921-335192186.11886.38
43446920-344692088.55988.81
53378477-337847786.80187.04
63516893-351689390.35790.63
30min13832151-383215198.45796.491.3498.9496.901.36
23707762-370776295.26195.65
33702029-370202995.11395.52
43788966-378896697.34797.75
53764581-376458196.72197.10
63737875-373787596.03496.46
45min13853228-385322898.99898.930.4899.6599.500.48
23833032-383303298.47999.03
33829759-382975998.39598.96
43868655-386865599.39499.96
53874222-387422299.537100.08
63843520-384352098.74999.33
60min13849920-384992098.91398.950.4199.7399.690.41
23835558-383555898.54499.26
33834001-383400198.50499.24
43866813-386681399.347100.07
53872265-387226599.487100.20
63849164-384916498.89499.64
极限13846873-384687398.83598.850.3799.8199.750.36
23833813-383381398.49999.38
33831986-383198698.45299.35
43857691-385769199.113100.00
53868786-386878699.398100.27
63844629-384462998.77799.69
西格列汀磷酸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%
113.898229482234822288209682218822140.09
213.968212982202821660.07
单位质量响应值RSD%判断
5918.935885.820.40数据可信
中间条件24月-供试品溶液-2024050721批-西格列汀-2(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%
5min114050-1405016.62714.908.9716.6314.908.97
212309-1230914.56714.57
313717-1371716.23316.23
411628-1162813.76113.76
512658-1265814.98014.98
611189-1118913.24113.24
10min142607-4260750.42343.4512.5250.4543.4712.51
231887-3188737.73637.76
340169-4016947.53747.56
437244-3724444.07644.10
537532-3753244.41744.44
630831-3083136.48636.51
15min162077-6207773.46465.749.7573.5865.849.75
249524-4952458.60858.70
358061-5806168.71168.82
457560-5756068.11868.21
557758-5775868.35368.45
648310-4831057.17257.25
20min172086-7208685.30979.506.5085.5479.716.51
262383-6238373.82674.01
369959-6995982.79283.01
468873-6887381.50781.72
568561-6856181.13781.35
661209-6120972.43772.61
30min177086-7708691.22691.302.4591.6091.642.46
275898-7589889.82090.13
377557-7755791.78492.14
478959-7895993.44393.79
579177-7917793.70194.05
674216-7421687.83088.13
45min180244-8024494.96395.901.0495.4996.391.00
282364-8236497.47297.93
380402-8040295.15095.66
480392-8039295.13995.64
581348-8134896.27096.77
681472-8147296.41796.86
60min180186-8018694.89595.941.2695.5896.601.22
282741-8274197.91998.54
380374-8037495.11795.79
480259-8025994.98195.64
581138-8113896.02196.69
681728-8172896.72097.33
极限180123-8012394.82096.131.4795.6796.941.43
283159-8315998.41399.20
380691-8069195.49296.32
480155-8015594.85895.68
581173-8117396.06396.89
682059-8205997.11197.88
西格列汀磷酸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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
118.913888730388468538857913888731388833138872540.05
218.913888924389071738898200.04
单位质量响应值RSD%判断
205566.05205701.750.05数据可信
中间条件24月-供试品溶液-2024050721批-磷酸二甲双胍-2(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%
5min1942774-94277424.27222.027.2224.2722.027.21
2845031-84503121.75621.76
3905703-90570323.31823.32
4798175-79817520.54920.55
5859440-85944022.12722.13
6781382-78138220.11720.12
10min12329953-232995359.98553.0910.1060.0353.1310.10
21843036-184303647.45047.49
32216702-221670257.07057.11
42079659-207965953.54253.58
52107074-210707454.24754.28
61796133-179613346.24246.28
15min13152942-315294281.17474.067.9381.3174.187.93
22607647-260764767.13567.25
32992939-299293977.05477.19
42946677-294667775.86375.99
52972022-297202276.51676.64
62587627-258762766.61966.73
20min13530842-353084290.90386.085.1991.1886.335.19
23138521-313852180.80281.03
33461470-346147089.11789.38
43401590-340159087.57587.83
53411778-341177887.83788.09
63117797-311779780.26980.49
30min13713663-371366395.61095.671.7396.0496.061.74
23651663-365166394.01394.38
33749207-374920796.52596.94
43771296-377129697.09397.49
53782222-378222297.37597.78
63627618-362761893.39493.75
45min13816724-381672498.26398.920.6898.8599.470.65
23871976-387197699.685100.20
33833024-383302498.68399.25
43811543-381154398.13098.69
53850774-385077499.14099.70
63869591-386959199.624100.14
60min13811090-381109098.11898.910.8798.8799.630.84
23881906-388190699.941100.63
33823041-382304198.42699.16
43806295-380629597.99498.72
53850976-385097699.14599.87
63877561-387756199.829100.51
极限13805860-380586097.98398.830.9198.9099.710.88
23881601-388160199.933100.78
33819526-381952698.33599.24
43803039-380303997.91198.80
53845301-384530198.99999.89
63876581-387658199.804100.65
西格列汀磷酸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%
113.898216581961822028231182197821670.16
213.968227082461823660.17
单位质量响应值RSD%判断
5915.555900.140.19数据可信
中间条件24月-供试品溶液-X022139批-西格列汀-1(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%
5min123789-2378928.12627.0711.1328.1327.0711.14
220622-2062224.38224.38
324516-2451628.98628.99
421945-2194525.94625.95
519876-1987623.50023.50
626614-2661431.46731.47
10min152244-5224461.77058.937.9861.8258.987.98
246492-4649254.96955.01
352404-5240461.95962.01
449179-4917958.14658.19
544142-4414252.19052.23
654586-5458664.53964.59
15min170193-7019382.99180.015.7683.1480.155.76
265212-6521277.10277.23
370706-7070683.59883.75
467791-6779180.15180.29
561118-6111872.26272.39
671011-7101183.95884.12
20min176207-7620790.10288.144.8790.3988.424.88
273345-7334586.71886.98
376670-7667090.64990.94
473819-7381987.27887.55
568394-6839480.86481.11
678860-7886093.23993.54
30min180248-8024894.88092.873.2795.3293.293.28
277831-7783192.02292.43
380439-8043995.10695.55
477229-7722991.31091.73
574382-7438287.94488.33
681151-8115195.94796.40
45min181005-8100595.77595.591.2896.3796.171.30
279656-7965694.18094.74
382487-8248797.52798.13
480187-8018794.80895.38
580250-8025094.88295.41
681495-8149596.35496.97
60min181014-8101495.78595.860.8496.5496.600.86
279933-7993394.50795.22
381816-8181696.73497.50
481253-8125396.06896.80
580785-8078595.51596.20
681654-8165496.54297.32
极限181073-8107395.85596.140.7596.7797.040.76
280267-8026794.90295.78
382032-8203296.98997.91
481609-8160996.48997.38
581307-8130796.13296.98
681614-8161496.49597.43
西格列汀磷酸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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
118.913879449387562838782013881928387936038789130.06
218.913892362389639438943780.08
单位质量响应值RSD%判断
205124.96205942.780.29数据可信
中间条件24月-供试品溶液-X022139批-磷酸二甲双胍-1(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%
5min11426089-142608936.73335.429.3436.7335.429.34
21261905-126190532.50432.50
31458846-145884637.57737.58
41326440-132644034.16634.17
51219732-121973231.41831.42
61558108-155810840.13440.13
10min12738279-273827970.53368.056.3570.5968.116.35
22501123-250112364.42464.48
32754382-275438270.94771.01
42609457-260945767.21467.27
52403719-240371961.91561.97
62844797-284479773.27673.34
15min13486295-348629589.80087.164.3289.9887.334.32
23286236-328623684.64784.81
33480043-348004389.63989.82
43384445-338444587.17687.35
53143064-314306480.95981.11
63522380-352238090.72990.92
20min13712077-371207795.61694.203.5695.9494.523.56
23614972-361497293.11493.42
33736680-373668096.24996.58
43621104-362110493.27293.59
53441605-344160588.64988.94
63816733-381673398.31198.65
30min13859971-385997199.42598.012.3899.9198.492.39
23778607-377860797.32997.79
33868544-386854499.646100.14
43751974-375197496.64397.11
53664498-366449894.39094.83
63907339-3907339100.645101.15
45min13885503-3885503100.083100.020.86100.74100.660.88
23838833-383883398.88199.50
33933159-3933159101.310101.97
43861340-386134099.460100.09
53873968-387396899.786100.38
63906320-3906320100.619101.29
60min13886446-3886446100.107100.240.61100.93101.050.62
23848857-384885799.13999.92
33913298-3913298100.799101.62
43902317-3902317100.516101.31
53889976-3889976100.198100.96
63909309-3909309100.696101.54
极限13880685-388068599.959100.150.56100.95101.120.57
23851417-385141799.205100.15
33913129-3913129100.794101.79
43894849-3894849100.323101.29
53885649-3885649100.086101.02
63902636-3902636100.524101.53
西格列汀磷酸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%
113.898207881988822838218981893820860.19
213.968216181987820740.15
单位质量响应值RSD%判断
5909.725879.230.37数据可信
中间条件24月-供试品溶液-X022139批-西格列汀-2(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%
5min117268-1726820.46327.0622.2120.4627.0522.22
221970-2197026.03526.03
321592-2159225.58725.59
419656-1965623.29323.29
531890-3189037.79037.79
624610-2461029.16329.16
10min142462-4246250.31858.8012.7850.3558.8412.78
249663-4966358.85258.90
348562-4856257.54757.59
443376-4337651.40151.44
558512-5851269.33869.40
655135-5513565.33665.38
15min159579-5957970.60278.717.4670.7278.867.47
266886-6688679.26179.40
368150-6815080.75980.90
461545-6154572.93273.06
572487-7248785.89886.08
669889-6988982.82082.98
20min169616-6961682.49687.014.1282.7387.284.13
274520-7452088.30888.58
374304-7430488.05288.32
469807-6980782.72382.97
575351-7535189.29289.61
676929-7692991.16291.46
30min175973-7597390.02991.351.9690.4091.761.97
278959-7895993.56893.99
377136-7713691.40891.83
475235-7523589.15589.54
576449-7644990.59491.06
678754-7875493.32593.77
45min179250-7925093.91394.551.2994.4495.121.29
280964-8096495.94496.52
379275-7927593.94294.51
479839-7983994.61195.14
578403-7840392.90993.53
680982-8098295.96596.57
60min179836-7983694.60795.331.0595.2996.061.05
280936-8093695.91196.65
379922-7992294.70995.44
480763-8076395.70696.40
579505-7950594.21594.99
681735-8173596.85897.62
极限179973-7997394.77095.460.8495.6196.360.84
280828-8082895.78396.68
380192-8019295.02995.92
481160-8116096.17697.03
579774-7977494.53495.47
681427-8142796.49397.42
西格列汀磷酸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1000664-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
118.913875451387106738737003874137387312738734960.05
218.913884345388717538857600.06
单位质量响应值RSD%判断
204838.50205487.040.23数据可信
中间条件24月-供试品溶液-X022139批-磷酸二甲双胍-2(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%
5min11080357-108035727.87835.5519.1527.8835.5519.15
21335536-133553634.46334.46
31306856-130685633.72333.72
41223236-122323631.56531.57
51846303-184630347.64347.64
61474674-147467438.05338.05
10min12319599-231959959.85668.3810.4859.9068.4410.48
22679669-267966969.14869.21
32602140-260214067.14767.20
42380205-238020561.42061.47
53025811-302581178.08078.16
62892026-289202674.62774.69
15min13069768-306976879.21486.525.9879.3686.705.99
23400730-340073087.75487.93
33431146-343114688.53988.71
43148788-314878881.25381.41
53582282-358228292.43992.65
63485825-348582589.95090.14
20min13477857-347785789.74493.793.2990.0294.113.30
23699876-369987695.47495.79
33674432-367443294.81795.13
43493956-349395690.16090.45
53696441-369644195.38595.75
63765203-376520397.15997.50
30min13734626-373462696.37097.531.5796.8098.001.58
23862447-386244799.669100.15
33777850-377785097.48697.96
43714120-371412095.84196.28
53749925-374992596.76597.29
63838177-383817799.04299.54
45min13840680-384068099.10799.731.0999.70100.361.08
23925549-3925549101.297101.94
33842055-384205599.14299.78
43861125-386112599.635100.23
53815083-381508398.44699.13
63903404-3903404100.726101.39
60min13854881-385488199.473100.300.85100.23101.100.85
23928888-3928888101.383102.20
33870676-387067699.881100.68
43901051-3901051100.665101.43
53850063-385006399.349100.20
63915364-3915364101.034101.87
极限13851094-385109499.376100.140.84100.30101.110.84
23921416-3921416101.190102.17
33860474-386047499.618100.59
43903557-3903557100.729101.66
53844384-384438499.203100.22
63903354-3903354100.724101.73
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