非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103063533068183061603061723059813062970.11
211.193050503047253048880.08
单位质量响应值RSD%判断
27594.3227246.470.90数据可信
供试品溶液-6020401批-恩格列净-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%
5min136382-3638258.69465.2915.6758.6965.2815.67
243157-4315769.62469.62
329351-2935147.35147.35
444570-4457071.90471.90
543932-4393270.87570.87
645423-4542373.28073.28
10min157864-5786493.35192.866.0894.0093.596.15
258343-5834394.12494.90
350651-5065181.71482.24
459559-5955996.08596.88
560312-6031297.30098.09
658643-5864394.60895.42
15min160879-6087998.21597.421.2099.9099.181.29
259750-5975096.39398.21
359352-5935295.75197.19
460476-6047697.56599.43
560546-6054697.67899.55
661312-6131298.913100.78
20min159743-5974396.38297.621.2199.16100.461.17
260677-6067797.889100.78
360965-6096598.354100.85
460131-6013197.00899.96
559889-5988996.61899.57
661652-6165299.462102.43
30min160007-6000796.80897.791.75100.66101.721.55
259967-5996796.744100.72
362619-62619101.022104.61
459896-5989696.629100.66
560251-6025197.202101.23
660957-6095798.341102.41
45min158413-5841394.23794.921.9899.1699.941.75
258203-5820393.89898.95
361129-6112998.618103.33
457905-5790593.41798.52
558577-5857794.50199.61
658808-5880894.874100.04
60min158423-5842394.25394.362.07100.23100.431.81
258156-5815693.82299.92
360882-6088298.220104.03
458080-5808093.69999.84
557536-5753692.82298.98
657857-5785793.34099.56
90min158114-5811493.75494.172.52100.78101.292.26
258067-5806793.678100.82
360959-6095998.344105.24
457185-5718592.25599.44
556914-5691491.81899.01
659005-5900595.192102.45
120min156697-5669791.46893.181.9999.53101.331.77
258009-5800993.585101.76
359915-5991596.660104.65
457481-5748192.733100.94
557010-5701091.973100.18
657418-5741892.631100.94
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156512-5651291.17092.372.15100.25101.561.98
256582-5658291.283100.50
358510-5851094.393103.46
456561-5656191.249100.49
556237-5623790.72699.96
659116-5911695.371104.71
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201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%
111.043990353994003990603986093985333989270.09
211.043977783970613974200.13
单位质量响应值RSD%判断
36134.6935998.190.27数据可信
供试品溶液-6020401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%
5min17542-75429.41012.8032.159.4112.8032.16
29193-919311.47011.47
35597-55976.9836.98
412676-1267615.81615.82
513153-1315316.41116.41
613410-1341016.73216.73
10min122691-2269128.31229.9824.4328.4230.1324.46
221350-2135026.63826.77
314151-1415117.65617.73
428527-2852735.59335.77
529499-2949936.80636.99
627968-2796834.89635.08
15min135873-3587344.75942.7218.8745.1843.2018.94
231327-3132739.08739.51
322462-2246228.02628.30
438479-3847948.01048.58
539621-3962149.43550.03
637690-3769047.02647.60
20min145110-4511056.28452.6716.6557.2053.6216.73
239063-3906348.73949.60
329267-2926736.51637.10
445950-4595057.33258.44
547980-4798059.86561.01
645907-4590757.27858.37
30min158640-5864073.16567.5013.6074.7169.0313.72
248837-4883760.93462.33
341570-4157051.86752.86
457703-5770371.99673.74
560610-6061075.62377.43
657214-5721471.38673.12
45min168383-6838385.32278.6211.4987.6880.9111.64
257760-5776072.06774.14
351141-5114163.80965.38
465981-6598182.32584.87
570345-7034587.77090.42
664458-6445880.42482.95
60min172628-7262890.61886.828.0693.9289.988.29
269663-6966386.91989.80
359257-5925773.93576.21
471408-7140889.09692.55
575706-7570694.45998.08
668855-6885585.91189.33
90min175525-7552594.23393.692.5098.5497.822.89
275505-7550594.20898.05
372091-7209189.94893.05
474664-7466493.15897.60
577907-7790797.205101.88
674863-7486393.40797.78
120min174700-7470093.20394.751.9998.5699.922.18
277071-7707196.162101.05
374833-7483393.36997.47
476505-7650595.455100.94
578106-7810697.453103.20
674427-7442792.86398.27
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175749-7574994.51294.541.14100.90100.761.66
275379-7537994.051100.01
374351-7435192.76897.90
476074-7607494.918101.46
576914-7691495.966102.80
676157-7615795.021101.46
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103064633066603060303062123062053063140.09
211.193061333060393060860.03
单位质量响应值RSD%判断
27595.8627353.530.63数据可信
供试品溶液-6020502批-恩格列净-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%
5min153079-5307985.46078.5515.0685.4678.5515.06
248645-4864578.32178.32
357392-5739292.40492.40
453532-5353286.19086.19
539024-3902462.83162.83
641068-4106866.12266.12
10min159889-5988996.42593.153.7397.3794.033.75
256285-5628590.62291.49
359904-5990496.44997.48
456789-5678991.43492.39
559409-5940995.65296.35
654868-5486888.34189.08
15min159093-5909395.14394.691.4597.1696.601.46
257545-5754592.65194.53
359908-5990896.45598.55
458209-5820993.72095.69
558727-5872794.55496.31
659399-5939995.63697.35
20min159574-5957495.91894.771.8799.0097.731.76
257564-5756492.68195.59
358416-5841694.05397.22
457834-5783493.11696.13
560385-6038597.223100.03
659390-5939095.62198.40
30min159127-5912795.19894.131.4399.3498.151.34
257292-5729292.24396.18
357710-5771092.91697.13
458692-5869294.49898.55
558492-5849294.17698.07
659483-5948395.77199.61
45min159118-5911895.18393.931.90100.3998.991.85
256242-5624290.55395.51
358810-5881094.68899.94
458195-5819593.69798.80
558428-5842894.07299.01
659257-5925795.407100.31
60min163549-63549102.31894.314.37108.58100.424.17
256418-5641890.83696.80
357464-5746492.52098.82
457300-5730092.25698.40
557943-5794393.29299.28
658786-5878694.649100.61
90min157375-5737592.37792.031.7799.7799.181.69
255298-5529889.03396.01
356854-5685491.53898.87
458108-5810893.557100.72
557469-5746992.52899.55
657844-5784493.132100.15
120min156528-5652891.01390.171.7999.4498.341.66
254700-5470088.07096.04
355375-5537589.15797.50
455451-5545189.27997.48
556537-5653791.02899.08
657427-5742792.461100.51
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155468-5546889.30789.431.6498.7498.601.52
254079-5407987.07096.01
355167-5516788.82298.16
455565-5556589.46398.66
556654-5665491.216100.28
656332-5633290.69899.78
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201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%
111.043990483993893986163987353988653989310.08
211.043988703986473987580.04
单位质量响应值RSD%判断
36135.0536119.380.04数据可信
供试品溶液-6020502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%
5min116442-1644220.48018.6827.7920.4818.6827.79
217933-1793322.33722.34
318970-1897023.62923.63
417170-1717021.38721.39
59974-997412.42412.42
69486-948611.81611.82
10min131834-3183439.65234.8418.1039.8835.0418.15
230227-3022737.65137.90
332484-3248440.46240.72
429869-2986937.20537.44
523320-2332029.04729.19
620073-2007325.00325.13
15min143074-4307453.65345.9516.9354.3246.5416.97
239223-3922348.85649.52
341410-4141051.58052.29
439566-3956649.28349.93
529023-2902336.15136.61
629039-2903936.17136.58
20min152306-5230665.15254.7914.8666.4255.8914.93
246316-4631657.69158.90
346854-4685458.36159.65
446273-4627357.63858.84
536383-3638345.31946.18
635772-3577244.55845.37
30min164323-6432380.12168.0313.5382.1169.7413.61
257708-5770871.88173.73
356798-5679870.74772.68
457289-5728971.35973.20
544983-4498356.03157.40
646595-4659558.03959.34
45min173446-7344691.48481.699.6294.3684.169.76
267873-6787384.54287.19
367733-6773384.36887.09
467147-6714783.63886.27
554867-5486768.34270.33
662432-6243277.76579.72
60min180930-80930100.80689.957.85104.7093.337.99
274060-7406092.24995.84
371390-7139088.92392.58
472515-7251590.32593.89
563310-6331078.85981.61
671101-7110188.56391.38
90min177385-7738596.39194.452.83101.4198.833.16
276166-7616694.87299.49
375476-7547694.01398.66
478519-7851997.803102.37
572286-7228690.03993.66
675121-7512193.57197.37
120min176437-7643795.21094.241.38101.3099.671.61
276074-7607494.758100.43
374700-7470093.04698.74
475996-7599694.660100.31
574058-7405892.24796.87
676693-7669395.529100.37
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174883-7488393.27494.351.20100.42100.820.75
275163-7516393.623100.34
374767-7476793.13099.85
476330-7633095.077101.78
576533-7653395.329100.98
676783-7678395.641101.54
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103052853061723062353061473056573058990.14
211.193073893056153065020.41
单位质量响应值RSD%判断
27558.4727390.710.44数据可信
供试品溶液-6020403批-恩格列净-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%
5min150238-5023880.88666.4626.6980.8966.4626.70
232620-3262052.52052.52
346495-4649574.85974.86
424440-2444039.35039.35
553132-5313285.54585.55
640739-4073965.59265.59
10min161062-6106298.31392.169.1799.2192.909.30
251920-5192083.59484.18
360998-6099898.21099.04
449324-4932479.41479.85
561013-6101398.23499.18
659122-5912295.18995.92
15min160605-6060597.57797.281.5599.5799.041.76
258858-5885894.76496.28
361026-6102698.255100.18
459775-5977596.24197.56
561344-6134498.767100.81
660908-6090898.06599.85
20min161539-6153999.08198.121.10102.16100.961.31
260079-6007996.73099.30
360847-6084797.967100.98
460662-6066297.669100.06
561910-6191099.678102.82
660599-6059997.567100.44
30min161172-6117298.49097.491.76102.67101.431.78
259919-5991996.472100.11
359501-5950195.79999.90
460063-6006396.704100.18
560262-6026297.025101.27
662401-62401100.469104.43
45min159900-5990096.44296.110.51101.71101.120.57
259553-5955395.883100.60
359128-5912895.199100.37
459873-5987396.398100.95
559851-5985196.363101.69
659842-5984296.349101.42
60min157467-5746792.52594.581.1498.87100.671.00
258698-5869894.507100.28
358849-5884994.750100.98
459265-5926595.420101.04
559268-5926895.424101.82
658919-5891994.862101.01
90min158766-5876694.61693.980.92101.99101.110.88
258551-5855194.270101.10
357320-5732092.28899.57
458549-5854994.267100.95
558697-5869794.505101.96
658324-5832493.904101.11
120min157624-5762492.77792.640.66101.20100.820.89
257148-5714892.01199.89
357446-5744692.491100.79
457201-5720192.09699.82
558195-5819593.697102.20
657624-5762492.777101.02
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157435-5743592.47392.300.66101.93101.510.53
256995-5699591.765100.66
357378-5737892.381101.71
458000-5800093.383102.13
557028-5702891.818101.36
657137-5713791.993101.27
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201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%
111.043975693986733986183982883978103981920.13
211.043998824004514001660.11
单位质量响应值RSD%判断
36068.1236246.920.35数据可信
供试品溶液-6020403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%
5min112981-1298116.15613.1731.9316.1613.1831.92
26659-66598.2888.29
313065-1306516.26016.26
45838-58387.2667.27
512671-1267115.77015.77
612295-1229515.30215.30
10min129377-2937736.56131.8528.3336.7432.0028.36
215815-1581519.68319.77
330749-3074938.26938.45
416772-1677220.87420.95
529468-2946836.67536.85
631382-3138239.05739.23
15min139166-3916648.74545.4121.4949.3345.9121.57
225919-2591932.25832.57
341231-4123151.31551.92
427347-2734734.03534.35
540728-4072850.68951.27
644515-4451555.40256.01
20min148054-4805459.80655.7618.2560.9356.7718.38
234216-3421642.58443.25
349353-4935361.42362.60
434685-3468543.16843.86
549659-4965961.80462.95
652860-5286065.78867.01
30min159937-5993774.59569.7515.6176.3971.3815.77
244844-4484455.81156.95
359420-5942073.95275.81
445459-4545956.57757.75
560745-6074575.60177.43
665871-6587181.98183.93
45min169132-6913286.03981.8712.3888.6684.2612.59
254557-5455767.90069.66
369538-6953886.54489.22
456372-5637270.15871.96
572717-7271790.50193.17
672356-7235690.05292.91
60min171828-7182889.39488.678.0592.9791.988.38
262075-6207577.25679.77
373823-7382391.87795.52
466883-6688383.24085.82
576093-7609394.70298.38
676784-7678495.56299.42
90min176395-7639595.07894.732.1199.6599.022.61
273337-7333791.27294.65
375907-7590794.47199.13
475863-7586394.41697.92
577025-7702595.862100.59
678144-7814497.255102.18
120min175634-7563494.13194.491.3399.7699.841.85
274269-7426992.43296.82
376157-7615794.782100.49
475866-7586694.42098.97
576275-7627594.929100.72
677356-7735696.274102.28
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175902-7590294.46594.501.34101.14100.891.46
274866-7486693.17598.59
375978-7597894.559101.32
477194-7719496.073101.67
574732-7473293.00999.86
676903-7690395.711102.78
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103073183079513080023077423078313077690.09
211.193067653070423069040.07
单位质量响应值RSD%判断
27726.9427426.630.78数据可信
供试品溶液-6020501批-恩格列净-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%
5min141041-4104165.83464.3021.2865.8364.3021.28
225973-2597341.66441.66
340251-4025164.56764.57
451460-5146082.54882.55
536842-3684259.09959.10
644925-4492572.06572.06
10min157634-5763492.45291.9316.2093.1892.6516.24
241703-4170366.89667.36
361918-6191899.324100.04
468668-68668110.151111.07
552686-5268684.51485.17
661261-6126198.27099.07
15min160858-6085897.62399.819.9399.38101.5510.06
251107-5110781.98183.19
362898-62898100.896102.72
469247-69247111.080113.22
563171-63171101.333102.93
666045-66045105.944107.84
20min161058-6105897.944102.676.83100.79105.517.00
257164-5716491.69893.81
363563-63563101.962104.90
469042-69042110.751114.13
565941-65941105.777108.50
667245-67245107.869110.94
30min160908-6090897.703103.475.55101.64107.465.73
260731-6073197.419100.56
363428-63428101.746105.82
469761-69761111.905116.51
564892-64892104.094107.99
667288-67288107.938112.21
45min159690-5969095.750101.855.21100.77106.985.37
260197-6019796.563100.78
362048-6204899.532104.74
467261-67261107.894113.74
564977-64977104.231109.28
666777-66777107.118112.59
60min159870-5987096.03899.123.23102.12105.393.57
259486-5948695.422100.71
361672-6167298.929105.24
464688-64688103.767110.82
561690-6169098.958105.17
663344-63344101.611108.27
90min158529-5852993.88798.794.26101.04106.164.47
259538-5953895.506101.86
361236-6123698.230105.64
465640-65640105.294113.50
561014-6101497.873105.18
663553-63553101.946109.73
120min157756-5775692.64799.234.53100.84107.694.46
263103-63103101.224108.64
359759-5975995.860104.36
464816-64816103.972113.34
561168-6116898.120106.52
664548-64548103.542112.46
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156884-5688491.24896.374.07100.47105.944.29
257457-5745792.168100.71
360615-6061597.233106.80
462966-62966101.005111.53
560494-6049497.039106.53
662059-6205999.550109.62
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号250201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%
111.044002624009424010284006664007254007250.08
211.043988313991643989980.06
单位质量响应值RSD%判断
36297.5536141.120.31数据可信
供试品溶液-6020501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%
5min111367-1136714.12311.0333.5014.1211.0333.50
25218-52186.4836.48
39811-981112.19012.19
412326-1232615.31415.31
55441-54416.7606.76
69105-910511.31211.31
10min127728-2772834.45028.0226.1434.6128.1426.17
215039-1503918.68518.76
324298-2429830.18930.32
429245-2924536.33536.51
516036-1603619.92420.00
622970-2297028.53928.66
15min138428-3842847.74441.6419.2848.2842.0719.36
224122-2412229.97030.25
335348-3534843.91844.39
441032-4103250.98051.55
527577-2757734.26334.56
634571-3457142.95243.40
20min146231-4623157.43952.2315.3258.5153.1315.46
232196-3219640.00140.61
344235-4423554.95955.92
449674-4967461.71762.86
536712-3671245.61246.29
643193-4319353.66554.58
30min158136-5813672.23067.5712.6773.9469.0512.83
244670-4467055.50056.56
355351-5535168.77070.34
463673-6367379.11080.94
548220-4822059.91061.09
656257-5625769.89671.41
45min168149-6814984.67181.409.3887.1883.629.59
256343-5634370.00371.68
365835-6583581.79684.13
473911-7391191.83094.53
560916-6091675.68477.53
667925-6792584.39286.69
60min175733-7573394.09389.027.9697.5592.158.21
262861-6286178.10180.55
371568-7156888.91992.16
478637-7863797.701101.43
567596-6759683.98486.67
673503-7350391.32394.55
90min177695-7769596.53197.305.25101.03101.425.44
271370-7137088.67391.99
376686-7668695.27799.51
482901-82901102.999107.81
579716-7971699.042102.67
681511-81511101.272105.52
120min177013-7701395.68499.754.09101.25104.963.94
279175-7917598.370102.67
376299-7629994.797100.09
482083-82083101.983107.94
582900-82900102.998107.72
684265-84265104.694110.06
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176587-7658795.15498.723.51101.79105.043.35
277509-7750996.300101.70
377368-7736896.125102.47
479746-7974699.079106.17
583169-83169103.332109.20
682372-82372102.342108.88
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