非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D250501对照品来源原料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1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113611023620403618533621393618563617980.12
211.033639073637973638520.03
单位质量响应值RSD%判断
32890.7332987.490.21数据可信
供试品溶液-6012601批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118846-1884625.72125.3832.1125.7225.3832.12
213664-1366418.64918.65
330244-3024441.27741.28
416677-1667722.76122.76
517010-1701023.21523.22
615132-1513220.65220.65
10min131517-3151743.01443.3433.3543.1643.4933.34
222877-2287731.22231.33
352468-5246871.60871.84
427729-2772937.84437.97
529987-2998740.92641.06
625974-2597435.44935.56
15min140817-4081755.70754.9530.0356.0955.3330.05
230888-3088842.15642.43
363873-6387387.17387.80
434704-3470447.36447.70
538084-3808451.97752.33
633220-3322045.33845.65
20min146788-4678863.85663.3125.9464.5563.9926.00
236036-3603649.18249.69
369675-6967595.09296.20
439964-3996454.54355.14
545039-4503961.46962.11
640815-4081555.70456.27
30min156218-5621876.72675.5619.4677.7776.5919.60
246925-4692564.04364.83
376081-76081103.835105.47
449012-4901266.89167.79
554752-5475274.72575.71
649176-4917667.11567.99
45min163277-6327786.36087.0514.2087.8388.5114.40
256892-5689277.64678.79
381491-81491111.218113.44
458123-5812379.32680.60
563085-6308586.09887.50
659813-5981381.63282.88
60min168256-6825693.15592.607.1295.1194.547.45
264352-6435287.82789.40
376997-76997105.085107.92
464137-6413787.53489.25
568046-6804692.86994.75
665294-6529489.11390.81
90min170735-7073596.53997.972.7499.01100.433.12
271271-7127197.27099.33
375491-75491103.030106.45
469786-6978695.24497.44
571943-7194398.187100.58
671490-7149097.56999.76
120min174980-74980102.332101.591.16105.34104.601.55
274113-74113101.149103.75
375678-75678103.285107.28
473245-7324599.964102.69
574683-74683101.927104.87
673930-73930100.899103.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限175944-75944103.648104.281.51107.22107.841.32
276493-76493104.397107.56
375262-75262102.717107.28
477694-77694106.036109.32
577824-77824106.214109.72
675232-75232102.676105.97
非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541585436158655715887121588995158993715879270.12
210.561596380159701515966980.03
单位质量响应值RSD%判断
150657.21151202.460.26数据可信
供试品溶液-6012601批-卡格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112734-127343.7175.3933.243.725.3933.29
217351-173515.0655.06
327841-278418.1278.13
422737-227376.6376.64
518612-186125.4335.43
611527-115273.3653.36
10min143752-4375212.77116.2131.4012.7916.2431.40
265964-6596419.25419.28
377758-7775822.69722.74
468653-6865320.03920.08
542606-4260612.43612.47
634551-3455110.08510.10
15min180678-8067823.54923.8220.0023.6423.9420.04
289723-8972326.18926.32
3100013-10001329.19329.36
494411-9441127.55827.71
566059-6605919.28219.38
658798-5879817.16317.24
20min197878-9787828.57028.986.9928.7929.247.14
2100817-10081729.42829.71
3108661-10866131.71732.05
4105004-10500430.65030.95
592483-9248326.99527.20
690955-9095526.54926.72
30min1112464-11246432.82733.183.4333.2133.603.59
2112084-11208432.71633.16
3119724-11972434.94635.46
4117002-11700234.15234.62
5111641-11164132.58732.94
6109194-10919431.87332.19
45min1119848-11984834.98335.602.7635.5536.202.86
2118839-11883934.68835.31
3128350-12835037.46438.17
4122426-12242635.73536.40
5121180-12118035.37135.91
6121081-12108135.34335.84
60min1125047-12504736.50036.911.7337.2637.701.80
2123887-12388736.16236.98
3127704-12770437.27638.19
4129982-12998237.94138.80
5125415-12541536.60837.34
6126659-12665936.97137.66
90min1126684-12668436.97837.681.2937.9438.681.26
2129766-12976637.87838.90
3129160-12916037.70138.82
4129262-12926237.73038.80
5128005-12800537.36438.30
6131597-13159738.41239.31
120min1133806-13380639.05738.461.2240.2239.671.12
2129584-12958437.82439.05
3130825-13082538.18739.52
4132598-13259838.70439.98
5130821-13082138.18639.33
6132927-13292738.80039.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1134644-13464439.30139.320.6640.6840.740.63
2133379-13337938.93240.37
3134137-13413739.15340.69
4135807-13580739.64141.14
5135414-13541439.52640.88
6134897-13489739.37540.70
非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D250501对照品来源原料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1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113647763645843646893652053651153648740.08
211.033645553645253645400.01
单位质量响应值RSD%判断
33170.3633049.860.26数据可信
供试品溶液-6012602批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111920-1192016.18416.628.3616.1816.628.35
211985-1198516.27316.27
312924-1292417.54817.55
412516-1251616.99416.99
513538-1353818.38118.38
610558-1055814.33514.34
10min120976-2097628.48030.235.6228.5730.325.63
222421-2242130.44230.53
322508-2250830.56030.66
422886-2288631.07331.17
524079-2407932.69332.80
620719-2071928.13128.21
15min127488-2748837.32240.174.9237.5740.434.93
229660-2966040.27140.53
330460-3046041.35741.62
430878-3087841.92542.19
530891-3089141.94242.23
628153-2815338.22538.46
20min133850-3385045.96048.553.1546.4249.043.16
236398-3639849.41949.90
336291-3629149.27449.77
436586-3658649.67550.17
536524-3652449.59050.11
634916-3491647.40747.86
30min144200-4420060.01260.890.9360.7261.640.96
244771-4477160.78861.55
345368-4536861.59862.37
445169-4516961.32862.10
544933-4493361.00861.80
644628-4462860.59461.31
45min154892-5489274.52974.482.1275.5775.572.09
254641-5464174.18975.28
353327-5332772.40573.52
456874-5687477.22078.34
554368-5436873.81874.95
655015-5501574.69675.74
60min163491-6349186.20584.512.0287.6686.011.98
262610-6261085.00986.52
360273-6027381.83583.35
463581-6358186.32787.87
561601-6160183.63985.18
661891-6189184.03285.50
90min171262-7126296.75694.841.9298.6996.811.89
271153-7115396.60898.59
367993-6799392.31794.29
470524-7052495.75497.78
569366-6936694.18196.19
668789-6878993.39895.33
120min174929-74929101.73599.732.52104.21102.232.46
276167-76167103.415105.93
371376-7137696.91199.39
473629-7362999.970102.53
571826-7182697.522100.05
672773-7277398.807101.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限178511-78511106.598105.661.19109.64108.711.15
278609-78609106.731109.82
376668-76668104.096107.12
477164-77164104.769107.88
577163-77163104.768107.84
678791-78791106.978109.98
非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541599487160082016009661602002160274216012030.08
210.561599417159908815992520.02
单位质量响应值RSD%判断
151916.79151444.320.23数据可信
供试品溶液-6012602批-卡格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112623-126233.6664.1122.763.674.1122.77
211099-110993.2243.22
316439-164394.7754.77
419337-193375.6165.62
511325-113253.2893.29
614032-140324.0764.08
10min139220-3922011.39115.5421.6911.4115.5621.69
244566-4456612.94412.96
365632-6563219.06319.09
467935-6793519.73119.76
555592-5559216.14716.16
648071-4807113.96213.98
15min166450-6645019.30023.1413.2819.3823.2413.31
271415-7141520.74220.83
390408-9040826.25926.39
489350-8935025.95126.09
587468-8746825.40525.51
672849-7284921.15921.26
20min185889-8588924.94627.367.7825.1427.607.85
287779-8777925.49525.70
3100834-10083429.28729.57
4100076-10007629.06729.35
5101524-10152429.48729.74
689106-8910625.88126.10
30min1104666-10466630.40031.265.2230.7331.645.29
2100234-10023429.11329.46
3112618-11261832.71033.15
4109238-10923831.72832.17
5114941-11494133.38433.80
6103988-10398830.20330.56
45min1115357-11535733.50534.003.1434.0034.563.22
2111308-11130832.32932.84
3118904-11890434.53535.16
4118435-11843534.39935.02
5122105-12210535.46536.06
6116272-11627233.77134.30
60min1123127-12312735.76235.852.2236.4536.602.29
2118446-11844634.40235.09
3124636-12463636.20037.01
4123616-12361635.90436.72
5126678-12667836.79337.59
6124068-12406836.03536.75
90min1127670-12767037.08137.041.4937.9637.991.56
2123823-12382335.96436.84
3128892-12889237.43638.45
4127886-12788637.14438.16
5128109-12810937.20938.21
6128855-12885537.42638.34
120min1129875-12987537.72237.820.9738.8138.970.97
2128744-12874437.39338.47
3130068-13006837.77839.00
4129530-12953037.62238.84
5130583-13058337.92739.13
6132446-13244638.46839.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1133553-13355338.79038.930.6340.0940.300.52
2134802-13480239.15340.44
3133395-13339538.74440.18
4133678-13367838.82640.26
5133416-13341638.75040.17
6135357-13535739.31440.65
非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D250501对照品来源原料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1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113668153672853674163669043673573671550.08
211.033683523684933684220.03
单位质量响应值RSD%判断
33377.7333401.810.06数据可信
供试品溶液-6012603批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111574-1157415.58316.4720.5415.5816.4720.53
214556-1455619.59819.60
314228-1422819.15619.16
48450-845011.37711.38
510366-1036613.95613.96
614215-1421519.13919.14
10min127088-2708836.47033.6724.6636.5633.7624.64
223822-2382232.07332.18
331677-3167742.64942.76
417539-1753923.61423.68
518468-1846824.86524.94
631437-3143742.32642.43
15min138999-3899952.50746.5924.7652.8046.8724.74
232757-3275744.10344.39
345094-4509460.71361.06
424356-2435632.79232.99
525302-2530234.06634.28
641135-4113555.38355.72
20min148108-4810864.77155.8723.0765.3556.4123.07
239208-3920852.78853.32
352984-5298471.33672.02
430006-3000640.39940.78
531094-3109441.86442.27
647583-4758364.06464.71
30min160773-6077381.82368.8619.7682.7669.7019.79
248252-4825264.96565.79
361514-6151482.82183.90
439000-3900052.50853.11
540229-4022954.16354.80
657084-5708476.85677.86
45min169284-6928493.28282.1614.5594.6883.3814.65
258798-5879879.16480.35
368857-6885792.70794.24
451545-5154569.39970.29
549878-4987867.15468.09
667761-6776191.23192.66
60min173832-7383299.40590.509.18101.3292.189.36
265736-6573688.50590.13
372826-7282698.051100.10
459019-5901979.46180.74
561349-6134982.59883.91
670540-7054094.97396.91
90min175128-75128101.15099.444.60103.62101.634.85
273407-7340798.833100.95
376471-76471102.958105.56
469151-6915193.10394.82
570903-7090395.46297.23
678097-78097105.148107.61
120min173472-7347298.921101.922.01101.95104.662.12
276630-76630103.172105.84
377516-77516104.365107.53
474524-74524100.337102.57
575432-75432101.559103.86
676640-76640103.186106.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限175594-75594101.778104.381.56105.35107.691.34
278975-78975106.330109.57
377320-77320104.101107.85
477584-77584104.457107.25
578626-78626105.860108.72
677067-77067103.761107.38
非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541610842161243716114251611997161253416118470.05
210.561616259161656516164120.02
单位质量响应值RSD%判断
152926.66153069.320.07数据可信
供试品溶液-6012603批-卡格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124889-248897.1674.9657.967.174.9657.96
232514-325149.3629.36
39309-93092.6802.68
418891-188915.4405.44
58764-87642.5242.52
68948-89482.5772.58
10min167775-6777519.51514.9625.4819.5614.9925.51
257749-5774916.62916.68
346734-4673413.45713.47
463582-6358218.30818.34
533588-335889.6719.69
642338-4233812.19112.21
15min186157-8615724.80822.1316.8924.9622.2516.93
285004-8500424.47624.62
381371-8137123.43023.52
485396-8539624.58924.72
553473-5347315.39715.47
669823-6982320.10520.19
20min197165-9716527.97825.8513.4028.2626.0813.46
297280-9728028.01128.29
397152-9715227.97428.19
495965-9596527.63327.90
568031-6803119.58919.74
682964-8296423.88924.08
30min1108506-10850631.24430.395.4331.6930.775.58
2109799-10979931.61632.05
3109662-10966231.57731.95
4107811-10781131.04431.47
595377-9537727.46327.73
6102106-10210629.40129.73
45min1116997-11699733.68935.8514.8434.3036.3914.58
2119924-11992434.53235.14
3118437-11843734.10334.65
4118492-11849234.11934.71
5111442-11144232.08932.50
6161721-16172146.56747.06
60min1117801-11780133.92035.302.0534.7236.041.99
2123854-12385435.66336.47
3122457-12245735.26136.00
4124530-12453035.85836.64
5122584-12258435.29735.89
6124315-12431535.79636.54
90min1126055-12605536.29737.582.2137.2938.522.13
2130499-13049937.57738.58
3129891-12989137.40138.34
4130832-13083237.67238.66
5130685-13068537.63038.42
6135094-13509438.90039.85
120min1125931-12593136.26137.982.2337.4539.132.11
2132786-13278638.23539.45
3132669-13266938.20139.35
4132999-13299938.29639.49
5133613-13361338.47339.47
6133335-13333538.39339.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1134926-13492638.85139.330.7340.2540.690.63
2137082-13708239.47240.89
3136260-13626039.23540.59
4136236-13623639.22840.63
5137618-13761839.62640.84
6137351-13735139.55040.93
非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D250501对照品来源原料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1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113707663702283705243700713698893702960.10
211.033650663646413648540.09
单位质量响应值RSD%判断
33663.2733078.331.24数据可信
供试品溶液批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19602-960212.93611.976.0112.9411.976.03
28128-812810.95010.95
38463-846311.40211.40
49254-925412.46712.47
58841-884111.91111.91
69034-903412.17112.17
10min130746-3074641.42231.6716.3941.4931.7416.37
220494-2049427.61027.67
321070-2107028.38628.45
423555-2355531.73431.80
524203-2420332.60732.67
620994-2099428.28428.35
15min140097-4009754.02042.4214.6654.3242.6614.65
227319-2731936.80537.02
328941-2894138.99039.21
431316-3131642.19042.44
532479-3247943.75744.00
628765-2876538.75338.98
20min146914-4691463.20449.9613.9063.8150.4413.91
232953-3295344.39644.81
334190-3419046.06246.50
436274-3627448.87049.35
538101-3810151.33151.82
634080-3408045.91446.35
30min156703-5670376.39362.1412.0677.3562.9012.09
241639-4163956.09856.76
342900-4290057.79758.49
444599-4459960.08660.84
547587-4758764.11164.89
643331-4333158.37759.07
45min167228-6722890.57275.2610.6391.9576.3610.66
251350-5135069.18170.16
352455-5245570.66971.68
453860-5386072.56273.65
557347-5734777.26078.39
652921-5292171.29772.32
60min170596-7059695.11083.916.9896.9985.437.07
260381-6038181.34882.71
358995-5899579.48080.89
461610-6161083.00384.49
562964-6296484.82886.39
659146-5914679.68481.10
90min173839-7383999.47993.533.46101.8995.513.61
268655-6865592.49594.31
367687-6768791.19193.04
467965-6796591.56593.51
570487-7048794.96397.00
667890-6789091.46493.32
120min172351-7235197.47498.211.01100.44100.720.91
273168-7316898.575100.90
374042-7404299.752102.11
471992-7199296.99099.45
573234-7323498.664101.22
672601-7260197.811100.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限171137-7113795.83999.912.8599.34102.962.60
273138-7313898.534101.41
374414-74414100.253103.16
474913-74913100.926103.92
573822-7382299.456102.56
677515-77515104.431107.34
非奈利酮卡格列净片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541625977162416016246311622097162279416239320.10
210.561600091159899315995420.05
单位质量响应值RSD%判断
154073.24151471.781.21数据可信
供试品溶液批-卡格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140289-4028911.61910.5815.0611.6210.5815.07
236538-3653810.53710.54
337832-3783210.91010.91
441421-4142111.94511.95
537977-3797710.95210.95
626008-260087.5007.50
10min171518-7151820.62520.082.4820.6920.142.51
269800-6980020.13020.19
369163-6916319.94620.01
470042-7004220.19920.27
570756-7075620.40520.47
666534-6653419.18819.23
15min185045-8504524.52624.300.7324.7124.460.74
283338-8333824.03424.20
383781-8378124.16224.33
484608-8460824.40024.58
584221-8422124.28924.46
684468-8446824.36024.51
20min192172-9217226.58226.310.7026.9026.620.70
291127-9112726.28026.58
391657-9165726.43326.74
490727-9072726.16526.48
590413-9041326.07426.38
691326-9132626.33826.62
30min1101344-10134429.22729.220.6129.6929.680.57
2100630-10063029.02129.47
3101131-10113129.16529.62
4100995-10099529.12629.59
5101435-10143529.25329.71
6102434-10243429.54129.97
45min1110478-11047831.86131.651.1632.4932.271.14
2107592-10759231.02931.64
3109279-10927931.51532.13
4109643-10964331.62032.24
5111249-11124932.08332.70
6110322-11032231.81632.41
60min1112915-11291532.56432.771.6133.3733.561.57
2110831-11083131.96332.75
3114193-11419332.93233.72
4116339-11633933.55134.35
5113216-11321632.65033.45
6114302-11430232.96433.73
90min1115930-11593033.43334.381.6834.4235.361.62
2117918-11791834.00634.97
3120931-12093134.87535.85
4120065-12006534.62635.61
5119328-11932834.41335.39
6121187-12118734.94935.90
120min1117743-11774333.95635.342.4035.1336.502.31
2122322-12232235.27736.43
3126578-12657836.50437.67
4122752-12275235.40136.58
5121613-12161335.07236.24
6124158-12415835.80636.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1119686-11968634.51636.653.5435.8738.013.41
2125143-12514336.09037.44
3128714-12871437.12038.49
4129671-12967137.39638.77
5126596-12659636.50937.87
6132792-13279238.29639.64
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