非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997139471273710437136371138712420.21
211.117078571080709320.30
单位质量响应值RSD%判断
6482.446384.521.08数据可信
供试品溶液-2批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114157-1415719.74427.0617.3119.7427.0617.32
221875-2187530.50930.51
320521-2052128.62028.62
421187-2118729.54929.55
516320-1632022.76122.76
622370-2237031.19931.20
10min135590-3559049.63754.115.3049.6754.165.32
240541-4054156.54256.59
339243-3924354.73154.78
439569-3956955.18655.24
537051-3705151.67451.71
640788-4078856.88656.94
15min146031-4603164.19865.781.7764.3165.911.79
247977-4797766.91267.06
346601-4660164.99365.13
447472-4747266.20866.35
546762-4676265.21865.34
648142-4814267.14367.29
20min151006-5100671.13772.180.8271.3672.430.83
252095-5209572.65672.91
351735-5173572.15472.40
452027-5202772.56172.81
551593-5159371.95672.19
652078-5207872.63272.89
30min155929-5592978.00378.180.9578.3478.540.95
255968-5596878.05778.43
355132-5513276.89177.26
456478-5647878.76979.14
556638-5663878.99279.34
656175-5617578.34678.73
45min159633-5963383.16983.260.6183.6483.750.60
259190-5919082.55183.06
359576-5957683.08983.58
459653-5965383.19783.70
560287-6028784.08184.57
659841-5984183.45983.97
60min161252-6125285.42785.420.4886.0486.050.47
261207-6120785.36486.01
360886-6088684.91685.55
461271-6127185.45386.10
561762-6176286.13886.76
661100-6110085.21585.86
极限163103-6310388.00887.520.8388.7688.300.82
262744-6274487.50888.30
361883-6188386.30787.08
462687-6268787.42888.21
563425-6342588.45789.23
662664-6266487.39688.19
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
111.055443065435885441485453985443105443500.13
211.215467555478075472810.14
单位质量响应值RSD%判断
49262.4448820.790.64数据可信
供试品溶液-2批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133060-13306024.39532.5416.2624.3932.5416.27
2198965-19896536.47836.48
3186582-18658234.20834.21
4191050-19105035.02735.03
5150588-15058827.60827.61
6204637-20463737.51837.52
10min1291155-29115553.38057.254.6153.4257.314.62
2327619-32761960.06560.13
3314524-31452457.66457.72
4316571-31657158.03958.10
5299142-29914254.84454.89
6324710-32471059.53259.59
15min1351799-35179964.49866.652.0064.6366.802.01
2370139-37013967.86068.02
3364103-36410366.75466.91
4369444-36944467.73367.89
5358118-35811865.65765.79
6367632-36763267.40167.56
20min1384528-38452870.49971.350.8470.7471.600.85
2393427-39342772.13072.40
3390525-39052571.59871.86
4389203-38920371.35671.62
5386370-38637070.83671.08
6390855-39085571.65971.93
30min1417689-41768976.57876.910.5976.9377.280.59
2422544-42254477.46877.86
3421565-42156577.28977.67
4419961-41996176.99577.38
5419208-41920876.85777.22
6415927-41592776.25576.65
45min1446922-44692281.93881.950.4282.4282.460.41
2449303-44930382.37482.90
3447840-44784082.10682.62
4445642-44564281.70382.22
5448126-44812682.15882.65
6444182-44418281.43581.96
60min1461728-46172884.65285.140.4885.2785.780.49
2464430-46443085.14885.81
3464023-46402385.07385.72
4462581-46258184.80985.46
5465496-46549685.34385.97
6468007-46800785.80386.46
极限1476481-47648187.35787.170.4888.1287.960.47
2475953-47595387.26088.06
3476529-47652987.36688.16
4473760-47376086.85887.65
5478237-47823787.67988.45
6471879-47187986.51387.31
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997273872827721077245772342724940.41
211.117182972100719640.27
单位质量响应值RSD%判断
6596.366477.411.29数据可信
供试品溶液-3批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117458-1745823.96424.3912.8623.9624.3812.86
216604-1660422.79122.79
318472-1847225.35625.36
420023-2002327.48527.48
514024-1402419.25019.25
620009-2000927.46527.47
10min137753-3775351.82252.913.3151.8652.953.32
237962-3796252.10852.15
339025-3902553.56853.61
440397-4039755.45155.50
536833-3683350.55950.59
639287-3928753.92753.97
15min146359-4635963.63564.561.3763.7664.691.37
246839-4683964.29364.42
347624-4762465.37165.50
447897-4789765.74665.88
546357-4635763.63263.75
647131-4713164.69464.83
20min150793-5079369.72170.290.6569.9570.530.66
251163-5116370.22970.46
351411-5141170.56970.81
451739-5173971.01971.27
551009-5100970.01770.24
651130-5113070.18470.43
30min155024-5502475.52976.410.8975.8876.770.89
255277-5527775.87676.22
355762-5576276.54276.90
456254-5625477.21777.58
556188-5618877.12677.47
655512-5551276.19876.56
45min158354-5835480.10081.111.2580.5781.591.25
258696-5869680.56981.04
359249-5924981.32881.81
459761-5976182.03182.53
560109-6010982.50982.98
658373-5837380.12680.61
60min160080-6008082.46983.931.5583.0884.541.53
260851-6085183.52784.14
361290-6129084.13084.75
461617-6161784.57885.21
562673-6267386.02886.63
660345-6034582.83283.45
极限161509-6150984.43085.371.0285.1886.121.02
261652-6165284.62785.38
362309-6230985.52886.29
462885-6288586.31987.09
562972-6297286.43887.19
661821-6182184.85885.62
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
111.055589445583085582365586035589615586100.07
211.215587935580135584030.10
单位质量响应值RSD%判断
50552.9449812.931.05数据可信
供试品溶液-3批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156356-15635628.01528.4412.4628.0128.4412.46
2148377-14837726.58526.59
3162280-16228029.07629.08
4179545-17954532.17032.17
5127100-12710022.77322.77
6178625-17862532.00532.00
10min1301760-30176054.06855.162.9954.1155.203.00
2304581-30458154.57354.62
3310257-31025755.59055.64
4321081-32108157.52957.58
5295360-29536052.92152.96
6314013-31401356.26356.32
15min1355463-35546363.69064.370.9563.8364.510.96
2358102-35810264.16364.30
3360749-36074964.63764.78
4364991-36499165.39765.55
5356738-35673863.91864.04
6359402-35940264.39664.54
20min1382014-38201468.44768.790.8368.6969.030.83
2383642-38364268.73968.98
3383818-38381868.77069.02
4389648-38964869.81570.07
5380298-38029868.14068.37
6384040-38404068.81069.06
30min1411550-41155073.73973.990.5674.1074.350.57
2412182-41218273.85274.21
3413930-41393074.16674.53
4417235-41723574.75875.13
5411266-41126673.68874.03
6411574-41157473.74374.11
45min1437651-43765178.41678.750.6478.9079.240.64
2442778-44277879.33479.81
3441415-44141579.09079.58
4441798-44179879.15979.66
5436194-43619478.15578.62
6437271-43727178.34878.84
60min1450690-45069080.75281.150.5281.3681.770.52
2453014-45301481.16881.78
3454454-45445481.42682.05
4455686-45568681.64782.28
5454016-45401681.34881.95
6449630-44963080.56281.18
极限1462649-46264982.89583.370.6383.6484.120.64
2462097-46209782.79683.54
3465141-46514183.34184.10
4468924-46892484.01984.79
5464400-46440083.20983.94
6468622-46862283.96584.72
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.997239472297726597262172542725030.22
211.117391273749738300.16
单位质量响应值RSD%判断
6597.186645.360.52数据可信
供试品溶液-6041601批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119021-1902125.77517.6627.0125.7717.6626.99
29797-979713.27613.28
310500-1050014.22814.23
410515-1051514.24814.25
514495-1449519.64219.64
613875-1387518.80118.80
10min137497-3749750.81144.998.4650.8545.028.46
229877-2987740.48540.51
330893-3089341.86241.89
433433-3343345.30445.33
535145-3514547.62447.66
632354-3235443.84243.87
15min146151-4615162.53757.994.7362.6758.104.74
240244-4024454.53354.62
341552-4155256.30556.40
442803-4280358.00158.10
543718-4371859.24159.35
642310-4231057.33357.44
20min150275-5027568.12665.462.6368.3665.672.64
246327-4632762.77662.96
348241-4824165.36965.56
447967-4796764.99865.19
548498-4849865.71865.93
648559-4855965.80066.00
30min154996-5499674.52373.761.0474.8774.071.06
253424-5342472.39372.68
354330-5433073.62073.92
454692-5469274.11174.42
554324-5432473.61273.93
654832-5483274.30174.61
45min158674-5867479.50779.480.6579.9879.920.65
258161-5816178.81279.22
358929-5892979.85280.27
459068-5906880.04180.47
558233-5823378.90979.35
658865-5886579.76680.20
60min160306-6030681.71882.590.6982.3283.150.67
261043-6104382.71783.25
360826-6082682.42382.97
460973-6097382.62283.18
561602-6160283.47484.05
660942-6094282.58083.15
极限161815-6181583.76383.910.8184.5084.620.79
262147-6214784.21384.89
362306-6230684.42885.12
462561-6256184.77485.47
561386-6138683.18283.90
661342-6134283.12283.83
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
111.055654505640485653985649355645475648760.11
211.215795835793215794520.04
单位质量响应值RSD%判断
51120.0051690.630.79数据可信
供试品溶液-6041601批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172368-17236830.14920.3228.1230.1520.3228.13
286072-8607215.05515.05
392635-9263516.20316.20
493855-9385516.41616.42
5129415-12941522.63622.64
6122637-12263721.45021.45
10min1314598-31459855.02648.138.6355.0848.178.64
2250078-25007843.74143.77
3255877-25587744.75544.78
4277045-27704548.45848.49
5287905-28790550.35750.40
6265600-26560046.45646.49
15min1357325-35732562.50058.873.6562.6458.983.67
2321575-32157556.24756.34
3329357-32935757.60857.71
4335410-33541058.66658.77
5342412-34241259.89160.01
6333263-33326358.29158.40
20min1382264-38226466.86265.131.6467.1165.351.67
2363417-36341763.56563.76
3371222-37122264.93065.13
4370431-37043164.79265.00
5372814-37281465.20965.43
6374129-37412965.43965.65
30min1413662-41366272.35372.260.9972.7172.580.98
2409832-40983271.68471.98
3419602-41960273.39273.70
4414661-41466172.52872.84
5407963-40796371.35771.69
6413007-41300772.23972.56
45min1441594-44159477.23977.640.7077.7278.080.68
2444786-44478677.79778.21
3445532-44553277.92878.36
4447252-44725278.22978.66
5438828-43882876.75577.20
6445211-44521177.87278.31
60min1458041-45804180.11680.760.7380.7281.330.70
2463206-46320681.01981.57
3463086-46308680.99881.56
4466055-46605581.51782.08
5457438-45743880.01080.59
6462529-46252980.90181.47
极限1470498-47049882.29582.501.1883.0383.201.16
2475120-47512083.10383.78
3477037-47703783.43884.13
4476855-47685583.40684.11
5466090-46609081.52482.23
6464325-46432581.21581.92
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