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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.7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%
110.424908848634486174897848732488100.44
210.414877948828488040.08
单位质量响应值RSD%判断
4684.264688.180.06数据可信
供试品溶液-25082701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%
5min112654-1265424.22918.7245.8524.2318.7245.85
25605-560510.73210.73
313520-1352025.88825.89
415057-1505728.83128.83
57135-713513.66213.66
64689-46898.9788.98
10min126234-2623450.23245.6413.6650.2745.6813.68
221829-2182941.79741.82
326813-2681351.34151.38
426947-2694751.59751.65
521974-2197442.07542.10
619231-1923136.82336.84
15min132497-3249762.22459.206.1362.3559.316.16
230164-3016457.75757.84
332842-3284262.88563.01
432185-3218561.62761.76
529793-2979357.04757.14
628038-2803853.68653.76
20min135946-3594668.82866.383.5269.0666.593.55
234473-3447366.00866.19
335582-3558268.13168.36
435392-3539267.76768.00
533903-3390364.91665.10
632718-3271862.64762.81
30min139255-3925575.16474.341.4675.5174.661.48
239216-3921675.08975.38
339429-3942975.49775.84
438548-3854873.81074.16
538531-3853173.77874.07
637973-3797372.70972.98
45min142856-4285682.05980.491.4282.5380.931.44
242444-4244481.27081.69
342345-4234581.08181.55
441665-4166579.77980.25
541523-4152379.50779.93
641371-4137179.21679.61
60min144141-4414184.52083.771.3985.1284.351.39
244618-4461885.43385.99
344053-4405384.35184.96
443144-4314482.61083.22
543318-4331882.94483.50
643225-4322582.76683.29
极限145119-4511986.39285.680.9087.1486.390.90
245359-4535986.85287.55
344486-4448685.18085.93
444502-4450285.21185.95
544357-4435784.93385.62
644654-4465485.50286.16
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对照品来源中检院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%
19.863885173866653877413887773869993877400.24
210.093879243895343887290.30
单位质量响应值RSD%判断
39324.5438526.161.46数据可信
供试品溶液-25082701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%
5min1118358-11835827.34121.2544.0427.3421.2544.04
255218-5521812.75612.76
3124549-12454928.77128.77
4140021-14002132.34632.35
569607-6960716.08016.08
644156-4415610.20010.20
10min1223480-22348051.62547.4311.9251.6747.4611.94
2189323-18932343.73543.76
3227389-22738952.52852.58
4228822-22882252.85952.91
5191993-19199344.35144.38
6170834-17083439.46339.48
15min1265232-26523261.27058.575.1961.4058.685.21
2248301-24830157.35957.45
3265009-26500961.21861.35
4263314-26331460.82760.97
5246165-24616556.86556.97
6233124-23312453.85353.94
20min1285456-28545665.94264.272.7766.1864.482.80
2277710-27771064.15264.34
3285072-28507265.85366.09
4282305-28230565.21465.46
5272760-27276063.00963.20
6265991-26599161.44561.62
30min1310166-31016671.65070.801.4571.9971.121.46
2311133-31113371.87372.17
3309531-30953171.50371.85
4305165-30516570.49570.85
5302585-30258569.89970.20
6300462-30046269.40869.68
45min1329811-32981176.18875.571.2676.6576.011.26
2333058-33305876.93877.35
3329187-32918776.04476.51
4323928-32392874.82975.30
5323289-32328974.68175.10
6323563-32356374.74575.14
60min1341535-34153578.89678.451.2579.4979.021.24
2346565-34656580.05880.60
3340625-34062578.68679.28
4335071-33507177.40378.00
5336075-33607577.63578.18
6337799-33779978.03378.55
极限1348262-34826280.45079.961.1481.1780.651.13
2352527-35252781.43582.11
3346603-34660380.06780.79
4342425-34242579.10279.83
5342243-34224379.06079.73
6344680-34468079.62380.27
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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.7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%
110.424866148708487744911049079488660.44
210.414943049736495830.44
单位质量响应值RSD%判断
4689.644763.021.10数据可信
供试品溶液-25090201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%
5min17599-759914.42824.9039.3714.4324.9039.37
211945-1194522.67922.68
319555-1955537.12837.13
411006-1100620.89620.90
59156-915617.38417.38
619430-1943036.89036.89
10min115778-1577829.95743.9221.2829.9843.9621.30
220921-2092139.72139.76
328659-2865954.41354.47
423102-2310243.86243.90
521745-2174541.28641.31
628581-2858154.26554.33
15min123055-2305543.77355.7813.1643.8555.9013.18
227330-2733051.89051.99
333364-3336463.34663.50
430188-3018857.31657.42
529236-2923655.50855.61
633108-3310862.86063.01
20min129108-2910855.26563.788.4055.4163.998.44
231897-3189760.56160.75
336670-3667069.62369.88
433980-3398064.51564.72
533625-3362563.84164.03
636273-3627368.86969.13
30min136527-3652769.35173.793.8569.5974.103.90
238397-3839772.90273.19
340474-4047476.84577.22
438757-3875773.58573.90
538499-3849973.09573.39
640523-4052376.93877.31
45min142437-4243780.57281.261.4480.9381.701.49
242465-4246580.62581.04
343780-4378083.12283.62
442727-4272781.12381.56
542123-4212379.97680.39
643275-4327582.16382.66
60min144972-4497285.38585.201.0585.8785.771.08
244885-4488585.22085.77
345447-4544786.28786.93
444549-4454984.58285.15
544148-4414883.82184.37
645233-4523385.88186.52
极限146618-4661888.51087.461.0889.1488.171.07
246265-4626587.84088.53
346488-4648888.26389.05
445527-4552786.43987.15
545422-4542286.24086.93
646053-4605387.43888.22
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对照品来源中检院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%
19.863878823890193892913904103902873893780.27
210.093906443918323912380.22
单位质量响应值RSD%判断
39490.6738774.831.30数据可信
供试品溶液-25090201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%
5min1103579-10357923.80020.3824.6023.8020.3924.59
274020-7402017.00817.01
3112197-11219725.78025.78
470050-7005016.09616.10
563525-6352514.59614.60
6108934-10893425.03025.03
10min1220700-22070050.71145.3014.3650.7545.3414.36
2186265-18626542.79942.83
3225815-22581551.88751.93
4163989-16398937.68137.71
5166853-16685338.33938.36
6219300-21930050.39050.43
15min1266182-26618261.16257.556.4861.2957.666.50
2248666-24866657.13757.24
3265281-26528160.95561.08
4226973-22697352.15352.24
5235994-23599454.22654.31
6259627-25962759.65659.78
20min1291160-29116066.90164.033.6367.1364.243.65
2279026-27902664.11364.31
3286213-28621365.76566.00
4262831-26283160.39260.57
5272202-27220262.54562.72
6280578-28057864.47064.70
30min1318557-31855773.19770.752.2273.5371.062.24
2309432-30943271.10071.40
3310354-31035471.31271.65
4297909-29790968.45268.73
5305505-30550570.19870.48
6305647-30564770.23070.56
45min1338997-33899777.89375.741.8878.3576.171.89
2332272-33227276.34876.77
3331748-33174876.22876.69
4322958-32295874.20874.60
5328935-32893575.58175.98
6322798-32279874.17174.62
60min1353211-35321181.15978.831.7881.7579.391.79
2345195-34519579.31779.86
3342901-34290178.79079.38
4336906-33690677.41377.93
5343526-34352678.93479.46
6336724-33672477.37177.94
极限1360790-36079082.90180.461.8483.6381.151.85
2352042-35204280.89181.57
3349044-34904480.20280.92
4343179-34317978.85479.50
5352030-35203080.88881.55
6344037-34403779.05179.75
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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.7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%
110.424901649079482714907448891488660.70
210.414924648978491120.39
单位质量响应值RSD%判断
4689.644717.770.43数据可信
供试品溶液-J049F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%
5min115311-1531129.20830.045.2529.2130.045.24
216444-1644431.37031.37
315842-1584230.22130.22
414294-1429427.26827.27
516225-1622530.95230.95
616364-1636431.21731.22
10min126699-2669950.93352.092.8950.9852.142.89
226922-2692251.35851.41
327559-2755952.57352.62
426332-2633250.23350.28
527958-2795853.33453.39
628374-2837454.12854.18
15min133796-3379664.47165.382.7264.6065.522.72
233734-3373464.35364.49
334118-3411865.08665.22
433440-3344063.79263.92
534546-3454665.90266.04
636013-3601368.70168.84
20min137899-3789972.29973.182.6472.5473.422.63
237676-3767671.87372.12
338116-3811672.71272.96
437547-3754771.62771.86
538660-3866073.75074.00
640257-4025776.79777.05
30min142615-4261581.29582.062.1881.6682.432.18
242418-4241880.91981.28
342318-4231880.72881.10
442716-4271681.48881.84
543207-4320782.42482.80
644817-4481785.49685.88
45min146250-4625088.22989.162.4788.7389.662.47
246258-4625888.24588.74
345302-4530286.42186.92
446808-4680889.29489.78
547084-4708489.82090.33
648733-4873392.96693.49
60min147810-4781091.20592.472.0291.8593.132.02
247818-4781891.22191.87
347474-4747490.56491.21
448684-4868492.87393.51
548973-4897393.42494.08
650094-5009495.56296.24
极限150400-5040096.14696.190.8896.9497.000.89
250529-5052996.39297.19
349692-4969294.79695.59
450424-5042496.19296.99
550416-5041696.17796.99
651083-5108397.44998.29
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对照品来源中检院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%
19.863878013899033856453896363886873883340.45
210.093888703894633891660.11
单位质量响应值RSD%判断
39384.7938569.471.48数据可信
供试品溶液-J049F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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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