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%
1113633573632703637693638943638223636220.08
211.033678533678853678690.01
单位质量响应值RSD%判断
33056.5533351.680.63数据可信
供试品溶液-6012201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%
5min116684-1668422.58921.6314.0622.5921.6414.07
214003-1400318.95918.96
314593-1459319.75819.76
415070-1507020.40420.40
515343-1534320.77320.77
620183-2018327.32627.33
10min129449-2944939.87238.1113.3740.0038.2313.37
223587-2358731.93532.04
325415-2541534.41034.52
427841-2784137.69537.81
528074-2807438.01038.13
634526-3452646.74646.90
15min136887-3688749.94248.6510.9050.2948.9810.92
231864-3186443.14143.42
332642-3264244.19544.50
435895-3589548.59948.92
535449-3544947.99548.32
642870-4287058.04358.45
20min142674-4267457.77756.8411.0258.4057.4511.03
237398-3739850.63451.16
337834-3783451.22451.77
440846-4084655.30255.90
543055-4305558.29358.89
650098-5009867.82968.56
30min151717-5171770.02168.109.2570.9769.029.28
246297-4629762.68363.49
344916-4491660.81361.64
449165-4916566.56667.47
551795-5179570.12771.04
657894-5789478.38479.49
45min159130-5913080.05880.946.8481.3982.246.90
256001-5600175.82176.97
355997-5599775.81676.98
458817-5881779.63480.90
562009-6200983.95685.26
666751-6675190.37691.92
60min163361-6336185.78687.945.2187.5789.695.28
263124-6312485.46587.04
362498-6249884.61886.21
462872-6287285.12486.84
566753-6675390.37992.15
671098-7109896.26198.31
90min168898-6889893.28395.823.5995.5498.053.69
269604-6960494.23996.29
368825-6882593.18495.24
469949-6994994.70696.89
571918-7191897.37299.65
675420-75420102.113104.70
120min171187-7118796.38298.943.3099.16101.713.39
271885-7188597.32799.90
372060-7206097.564100.14
471655-7165597.01699.73
574157-74157100.403103.22
677525-77525104.963108.11
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173139-7313999.025102.102.23102.33105.422.32
274883-74883101.386104.50
374386-74386100.713103.83
476330-76330103.345106.60
575730-75730102.533105.91
677984-77984105.585109.32
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%
110.541599976159994116002031600666160027016002110.02
210.561615490161770816165990.10
单位质量响应值RSD%判断
151822.68153087.030.59数据可信
供试品溶液-6012201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%
5min112763-127633.6885.9144.163.695.9144.17
215125-151254.3714.37
333573-335739.7029.70
427677-276777.9988.00
522635-226356.5416.54
610916-109163.1543.15
10min134990-3499010.11116.0633.3810.1316.0933.40
245315-4531513.09513.12
379762-7976223.04923.10
462023-6202317.92317.97
572476-7247620.94420.98
638875-3887511.23411.25
15min158423-5842316.88323.6620.7116.9623.7820.76
291595-9159526.46926.57
398224-9822428.38428.57
484648-8464824.46124.61
595038-9503827.46427.62
663331-6333118.30118.38
20min184741-8474124.48827.839.5524.6628.089.69
299991-9999128.89529.14
3106269-10626930.70931.05
495169-9516927.50227.78
5105158-10515830.38830.69
686489-8648924.99325.17
30min1105832-10583230.58331.683.5830.8932.083.68
2113709-11370932.85933.26
3109204-10920431.55732.07
4107175-10717530.97131.40
5115140-11514033.27333.75
6106622-10662230.81131.13
45min1114401-11440133.05934.782.7633.5435.362.90
2121136-12113635.00535.59
3121990-12199035.25235.94
4119679-11967934.58435.19
5124338-12433835.93136.59
6120559-12055934.83935.33
60min1119612-11961234.56535.702.1735.2336.472.23
2125210-12521036.18336.96
3124204-12420435.89236.77
4120740-12074034.89135.69
5125967-12596736.40137.26
6125402-12540236.23836.92
90min1124855-12485536.08036.961.3336.9337.941.47
2128364-12836437.09438.08
3129848-12984837.52338.60
4127406-12740636.81737.81
5128380-12838037.09938.16
6128606-12860637.16438.05
120min1126671-12667136.60537.461.6737.6638.651.71
2129918-12991837.54338.73
3130728-13072837.77739.07
4127451-12745136.83038.03
5130835-13083537.80839.08
6132283-13228338.22739.32
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1128948-12894837.26338.341.4338.5239.731.58
2133262-13326238.50939.91
3134038-13403838.73440.23
4132798-13279838.37539.78
5133952-13395238.70940.19
6133042-13304238.44639.75
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%
1113682413683263685283682373684593683580.04
211.033719153720773719960.04
单位质量响应值RSD%判断
33487.0933725.840.51数据可信
供试品溶液-6012202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%
5min127313-2731336.53725.2738.4536.5425.2738.46
223032-2303230.81030.81
325787-2578734.49534.50
413167-1316717.61417.61
511258-1125815.06015.06
612798-1279817.12017.12
10min143263-4326357.87342.7933.4158.0842.9333.42
241942-4194256.10656.28
339502-3950252.84253.03
425219-2521933.73633.83
520440-2044027.34327.43
621547-2154728.82428.92
15min151453-5145368.82954.0827.4369.3554.4627.48
251547-5154768.95569.44
348279-4827964.58365.07
432696-3269643.73844.02
529146-2914638.98939.22
629446-2944639.39039.65
20min157191-5719176.50562.2324.6677.4162.9124.73
258269-5826977.94778.81
355150-5515073.77474.62
438773-3877351.86752.40
535019-3501946.84547.30
634735-3473546.46546.94
30min163611-6361185.09372.5817.7186.4273.6117.87
264572-6457286.37887.68
360337-6033780.71381.97
447905-4790564.08364.90
545649-4564961.06561.78
643473-4347358.15458.89
45min169997-6999793.63583.0913.4995.4484.5113.70
272002-7200296.31898.10
366546-6654689.01990.72
456630-5663075.75476.93
554512-5451272.92173.97
652975-5297570.86571.92
60min170873-7087394.80787.809.2397.1389.699.51
272995-7299597.64699.96
368726-6872691.93594.13
462738-6273883.92585.52
560156-6015680.47181.93
658313-5831378.00679.45
90min172619-7261997.14394.224.9299.9996.605.27
275353-75353100.800103.66
372189-7218996.56899.28
467878-6787890.80192.86
568169-6816991.19093.09
666415-6641588.84490.73
120min174340-7434099.44597.423.29102.84100.323.67
276127-76127101.836105.25
374066-7406699.079102.32
471768-7176896.00498.57
570746-7074694.63797.05
669932-6993293.54895.92
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172210-7221096.59699.281.37100.54102.721.23
274509-7450999.671103.65
375042-75042100.384104.18
474458-7445899.603102.70
574294-7429499.384102.32
674768-74768100.018102.91
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%
110.541617810161995016192391619153162056816193440.07
210.561634995163501716350060.01
单位质量响应值RSD%判断
153637.95154830.110.55数据可信
供试品溶液-6012202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%
5min130166-301668.6176.9929.578.626.9929.60
236434-3643410.40710.41
318153-181535.1855.19
420560-205605.8735.87
521964-219646.2746.27
619516-195165.5755.57
10min179281-7928122.64616.9130.2722.6916.9530.26
281392-8139223.24923.31
354702-5470215.62515.65
444239-4423912.63612.67
557911-5791116.54216.58
637666-3766610.75910.79
15min198257-9825728.06624.7714.5028.2424.9114.55
299805-9980528.50828.70
386284-8628424.64624.76
467300-6730019.22419.33
591321-9132126.08526.21
677389-7738922.10622.20
20min1107438-10743830.68928.888.6031.0229.158.69
2109185-10918531.18831.53
3101282-10128228.93029.18
486300-8630024.65124.86
5106352-10635230.37930.65
696100-9610027.45027.66
30min1115646-11564633.03332.135.6833.5332.565.78
2116883-11688333.38733.91
3112104-11210432.02232.43
4101321-10132128.94129.29
5119046-11904634.00434.44
6109873-10987331.38431.75
45min1125499-12549935.84834.744.3136.5335.354.43
2125457-12545735.83636.54
3121227-12122734.62735.22
4111882-11188231.95832.47
5124971-12497135.69736.33
6120587-12058734.44534.99
60min1126331-12633136.08535.412.7936.9736.222.94
2126761-12676136.20837.11
3125036-12503635.71536.50
4117444-11744433.54734.23
5125267-12526735.78136.61
6123025-12302535.14135.87
90min1129407-12940736.96436.672.4938.0537.672.62
2129819-12981937.08238.19
3129885-12988537.10138.08
4122253-12225334.92135.79
5131154-13115437.46338.49
6127719-12771936.48237.41
120min1133201-13320138.04837.501.8539.3438.701.99
2132760-13276037.92239.23
3133678-13367838.18439.37
4127295-12729536.36137.43
5130543-13054337.28938.52
6130163-13016337.18038.31
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1132649-13264937.89037.951.1139.3939.361.21
2132969-13296937.98139.50
3135103-13510338.59139.99
4130997-13099737.41838.69
5133838-13383838.23039.67
6131695-13169537.61838.95
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%
1113659403659793654963654253654743656630.08
211.033704393712033708210.15
单位质量响应值RSD%判断
33242.0933619.310.80数据可信
供试品溶液-6012301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%
5min120315-2031527.31923.4520.9627.3223.4620.96
215707-1570721.12221.12
312455-1245516.74916.75
422566-2256630.34630.35
515470-1547020.80420.80
618135-1813524.38724.39
10min137009-3700949.76841.3917.2649.9241.5217.27
227270-2727036.67236.79
324409-2440932.82432.92
436758-3675849.43149.60
527284-2728436.69136.81
631937-3193742.94843.08
15min145516-4551661.20851.9913.5161.6452.3513.54
234651-3465146.59746.92
333774-3377445.41845.69
443797-4379758.89759.34
534103-3410345.86146.18
640109-4010953.93754.31
20min151008-5100868.59459.8911.4369.3660.5411.47
239524-3952453.15053.73
340704-4070454.73755.27
449414-4941466.45067.22
540068-4006853.88254.46
646516-4651662.55363.23
30min157584-5758477.43772.098.3278.5973.078.38
248705-4870565.49766.37
351892-5189269.78370.61
457372-5737277.15278.29
548476-4847665.18966.06
657616-5761677.48078.50
45min164649-6464986.93883.215.9188.5284.605.99
258005-5800578.00379.24
361840-6184083.16084.38
464636-6463686.92088.49
556877-5687776.48677.72
665276-6527687.78189.23
60min169183-6918393.03591.665.6695.1093.505.65
264203-6420386.33888.01
372358-7235897.30498.99
469282-6928293.16895.22
562730-6273084.35786.02
671193-7119395.73897.68
90min172189-7218997.07797.033.1999.6699.393.23
270703-7070395.07997.23
374384-74384100.029102.25
472625-7262597.664100.23
568491-6849192.10494.23
674553-74553100.256102.73
120min176171-76171102.432100.202.82105.55103.092.82
273814-7381499.262101.94
377242-77242103.872106.65
475354-75354101.333104.44
571956-7195696.76499.40
672509-7250997.508100.54
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174534-74534100.231102.071.56103.92105.521.53
275837-75837101.983105.21
377291-77291103.938107.29
475864-75864102.019105.69
574694-74694100.446103.62
677200-77200103.816107.39
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%
110.541607633160727616081561605945160738716072790.06
210.561629369163002616296980.03
单位质量响应值RSD%判断
152493.26154327.460.85数据可信
供试品溶液-6012301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%
5min117234-172344.9493.7620.234.953.7620.20
211928-119283.4253.43
310384-103842.9822.98
415232-152324.3744.37
512939-129393.7163.72
610927-109273.1383.14
10min169298-6929819.90117.0318.6119.9317.0518.61
265889-6588918.92218.94
343657-4365712.53712.55
470086-7008620.12720.15
549212-4921214.13314.15
657736-5773616.58116.60
15min198305-9830528.23125.2210.4828.3725.3410.50
294249-9424927.06727.19
372571-7257120.84120.93
491172-9117226.18326.32
582550-8255023.70723.81
688156-8815625.31725.43
20min1103168-10316829.62828.706.1129.9228.956.17
2102276-10227629.37229.65
388108-8810825.30325.50
4103783-10378329.80530.09
598600-9860028.31628.55
6103625-10362529.75930.01
30min1111356-11135631.97932.303.1732.4432.723.22
2114916-11491633.00233.44
3105803-10580330.38530.73
4114733-11473332.94933.40
5113022-11302232.45832.85
6114962-11496233.01533.43
45min1119251-11925134.24734.552.1434.8835.142.19
2122264-12226435.11235.73
3115637-11563733.20933.72
4120628-12062834.64235.27
5121484-12148434.88835.46
6122493-12249335.17835.78
60min1123843-12384335.56536.221.2836.3937.011.26
2125109-12510935.92936.75
3125680-12568036.09336.79
4128411-12841136.87737.70
5126487-12648736.32537.09
6127198-12719836.52937.32
90min1124302-12430235.69736.841.6636.7237.831.57
2128050-12805036.77437.79
3129134-12913437.08537.98
4128277-12827736.83937.87
5129476-12947637.18338.15
6130417-13041737.45338.45
120min1130464-13046437.46737.362.1138.6938.552.05
2130680-13068037.52938.75
3130980-13098037.61538.72
4132371-13237138.01439.25
5131357-13135737.72338.89
6124655-12465535.79937.00
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1129842-12984237.28838.301.4838.7239.701.43
2133878-13387838.44739.88
3133284-13328438.27739.59
4135697-13569738.97040.41
5133040-13304038.20739.59
6134370-13437038.58939.99
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%
1113721273727383728103728493731793727410.11
211.033768073769103768580.02
单位质量响应值RSD%判断
33885.5534166.640.59数据可信
供试品溶液-6012302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%
5min115984-1598421.11818.3824.6821.1218.3824.68
213484-1348417.81517.82
38930-893011.79811.80
411869-1186915.68115.68
518942-1894225.02625.03
614243-1424318.81818.82
10min126411-2641134.89532.6615.3035.0132.7615.33
223710-2371031.32631.42
320182-2018226.66526.73
422056-2205629.14129.23
531035-3103541.00441.14
624911-2491132.91333.02
15min133967-3396744.87842.9812.4445.1943.2612.47
231686-3168641.86442.14
327856-2785636.80437.02
429472-2947238.93939.19
539439-3943952.10752.47
632752-3275243.27243.56
20min141004-4100454.17552.2712.8554.7452.7912.87
239888-3988852.70153.21
333670-3367044.48544.90
434659-3465945.79246.26
547778-4777863.12563.78
640371-4037153.33953.87
30min150242-5024266.38065.3211.5867.2466.1311.62
248282-4828263.79164.59
343795-4379557.86358.53
444170-4417058.35859.08
559476-5947678.58179.59
650670-5067066.94667.77
45min161900-6190081.78377.507.7883.0178.677.85
257267-5726775.66276.81
355539-5553973.37974.37
452988-5298870.00971.05
565697-6569786.80088.24
658553-5855377.36178.56
60min166928-6692888.42685.694.8590.1187.304.97
265001-6500185.88087.45
362220-6222082.20683.60
460320-6032079.69681.13
568948-6894891.09593.02
665725-6572586.83788.46
90min171222-7122294.10093.543.6396.2895.623.74
272026-7202695.16297.21
369883-6988392.33094.18
466370-6637087.68989.56
574053-7405397.840100.27
671244-7124494.12996.24
120min174157-7415797.97797.061.54100.6899.661.59
274640-7464098.615101.19
373753-7375397.44499.81
471367-7136794.29196.65
573385-7338596.95799.93
673470-7347097.07099.70
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178923-78923104.274100.512.07107.52103.652.03
275152-7515299.292102.42
375949-75949100.345103.25
474991-7499199.079101.97
574749-7474998.759102.27
676686-76686101.319104.49
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%
110.541634614163624416378451636953163800016367310.09
210.561653916165515616545360.06
单位质量响应值RSD%判断
155287.57156679.550.64数据可信
供试品溶液-6012302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%
5min111569-115693.2683.7624.713.273.7624.65
217286-172864.8824.88
38949-89492.5282.53
411103-111033.1363.14
516468-164684.6514.65
614497-144974.0954.09
10min132146-321469.07910.5021.139.1010.5221.11
237136-3713610.48910.52
333040-330409.3329.35
434064-340649.6219.64
552837-5283714.92314.95
633834-338349.5569.58
15min152892-5289214.93917.1621.3915.0117.2421.37
255768-5576815.75115.84
352650-5265014.87014.94
451170-5117014.45214.52
584194-8419423.78023.89
667802-6780219.15019.23
20min179712-7971222.51422.7817.8522.6722.9617.84
278980-7898022.30722.48
369534-6953419.63919.79
462019-6201917.51717.67
5101041-10104128.53828.78
692733-9273326.19126.37
30min1100985-10098528.52228.7011.1628.8029.0011.22
2103709-10370929.29129.59
390677-9067725.61125.87
486913-8691324.54824.80
5115784-11578432.70233.10
6111680-11168031.54331.87
45min1117337-11733733.14132.545.8033.5833.005.91
2116126-11612632.79933.26
3112251-11225131.70432.10
4103481-10348129.22729.61
5122322-12232234.54935.13
6119759-11975933.82534.33
60min1123024-12302434.74734.593.2835.3735.233.40
2124807-12480735.25035.89
3120777-12077734.11234.69
4115185-11518532.53333.08
5125005-12500535.30636.08
6125985-12598535.58336.27
90min1126419-12641935.70635.913.8836.5236.753.98
2130273-13027336.79437.63
3127802-12780236.09636.86
4117816-11781633.27634.00
5131626-13162637.17638.15
6128991-12899136.43237.32
120min1130248-13024836.78736.551.6937.8037.581.77
2130397-13039736.82937.87
3131132-13113237.03738.00
4125091-12509135.33136.24
5130006-13000636.71937.89
6129519-12951936.58137.67
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1138443-13844339.10237.881.8340.3239.121.82
2133383-13338337.67338.92
3134712-13471238.04839.22
4131027-13102737.00738.12
5133762-13376237.78039.16
6133400-13340037.67738.97
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