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%
111.243697037288370113706236996370650.35
211.373784138066379540.42
单位质量响应值RSD%判断
3297.603338.080.87数据可信
供试品溶液-6042701批-多替诺雷-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122551-2255160.98558.908.4460.9858.908.44
219435-1943552.55852.56
320395-2039555.15455.15
422025-2202559.56259.56
524735-2473566.89166.89
621539-2153958.24858.25
10min132231-3223187.16286.461.8687.2686.551.87
230986-3098683.79583.88
331602-3160285.46185.55
432399-3239987.61787.72
532604-3260488.17188.28
631998-3199886.53286.63
15min134219-3421992.53891.791.5792.7992.041.58
232929-3292989.05089.28
333808-3380891.42791.66
434392-3439293.00693.25
534114-3411492.25492.51
634197-3419792.47992.72
20min134498-3449893.29393.581.3893.6993.981.38
233715-3371591.17591.55
334650-3465093.70494.09
435046-3504694.77595.18
534862-3486294.27794.69
634857-3485794.26494.66
30min135181-3518195.14095.161.5495.7095.711.55
234152-3415292.35792.88
335343-3534395.57896.12
435726-3572696.61497.17
535450-3545095.86796.44
635277-3527795.40095.95
45min135585-3558596.23296.401.6296.9597.111.63
234633-3463393.65894.34
335672-3567296.46897.17
436418-3641898.48599.20
535805-3580596.82797.56
635763-3576396.71497.43
60min135984-3598497.31296.851.1798.1997.721.17
234984-3498494.60795.44
335872-3587297.00997.87
436008-3600897.37698.26
535902-3590297.09097.98
636126-3612697.69698.57
极限135952-3595297.22597.261.4498.2698.291.44
234956-3495694.53195.53
336225-3622597.96398.99
436280-3628098.11299.16
536015-3601597.39598.45
636353-3635398.30999.34
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%
111.342680742677162674192666072662442672120.29
211.392737752735352736550.07
单位质量响应值RSD%判断
23563.6724025.901.38数据可信
供试品溶液-6042701批-非布司他-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1188943-18894371.40068.708.0771.4068.708.07
2162907-16290761.56161.56
3170149-17014964.29864.30
4184430-18443069.69569.69
5204631-20463177.32877.33
6179795-17979567.94367.94
10min1249580-24958094.31494.421.9394.4394.531.94
2240915-24091591.04091.14
3250216-25021694.55594.66
4255164-25516496.42496.54
5252427-25242795.39095.52
6250836-25083694.78994.90
15min1263559-26355999.59798.791.6499.8799.071.64
2252801-25280195.53195.79
3264024-26402499.772100.04
4263373-26337399.52699.80
5262637-26263799.24899.54
6262221-26222199.09199.36
20min1264404-26440499.916100.091.79100.36100.521.79
2255759-25575996.64997.06
3269232-269232101.741102.17
4266900-266900100.859101.30
5266134-266134100.570101.02
6266760-266760100.806101.24
30min1268391-268391101.423101.471.83102.03102.081.83
2259152-25915297.93198.51
3273433-273433103.328103.93
4270793-270793102.330102.94
5269207-269207101.731102.35
6270163-270163102.092102.70
45min1269135-269135101.704102.671.95102.48103.441.94
2262821-26282199.318100.06
3276712-276712104.567105.34
4276423-276423104.458105.24
5270912-270912102.375103.17
6274079-274079103.572104.35
60min1268731-268731101.551102.641.82102.50103.581.82
2263670-26367099.639100.54
3277550-277550104.884105.83
4273261-273261103.263104.22
5271379-271379102.552103.51
6275076-275076103.949104.90
极限1268798-268798101.576102.781.81102.69103.891.81
2264205-26420599.841100.91
3277792-277792104.975106.10
4273927-273927103.515104.64
5271590-271590102.632103.76
6275557-275557104.131105.25
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%
111.243838038375382613807338323382820.34
211.373810238085380940.04
单位质量响应值RSD%判断
3405.873350.401.17数据可信
供试品溶液-6042702批-多替诺雷-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124120-2412064.06557.1715.2864.0757.1715.28
217894-1789447.52847.53
323353-2335362.02862.03
424962-2496266.30266.30
521647-2164757.49757.50
617173-1717345.61345.61
10min132530-3253086.40384.531.9886.5184.631.99
230884-3088482.03182.11
332506-3250686.34086.44
431840-3184084.57184.68
531718-3171884.24784.34
631479-3147983.61283.69
15min133264-3326488.35389.531.6488.6089.771.64
232804-3280487.13187.35
334186-3418690.80291.05
433986-3398690.27190.52
533879-3387989.98690.22
634125-3412590.64090.86
20min133863-3386389.94491.431.6190.3491.821.61
233648-3364889.37389.73
334730-3473092.24792.65
434571-3457191.82492.23
534624-3462491.96592.35
635096-3509693.21993.59
30min134392-3439291.34992.562.0991.9093.102.09
233719-3371989.56190.07
335120-3512093.28393.84
434976-3497692.90093.46
534996-3499692.95393.49
635875-3587595.28895.81
45min134544-3454491.75393.362.3192.4594.052.29
234033-3403390.39591.05
335333-3533393.84894.56
434969-3496992.88293.59
535765-3576594.99695.69
636250-3625096.28496.96
60min134853-3485392.57493.531.8893.4394.381.87
234137-3413790.67291.48
335402-3540294.03294.90
435180-3518093.44294.31
535716-3571694.86695.72
635984-3598495.57896.42
极限134817-3481792.47894.041.8193.4995.051.80
234662-3466292.06693.03
335878-3587895.29696.32
435038-3503893.06594.09
535893-3589395.33696.35
636143-3614396.00097.00
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%
111.342762802757802754712746542754672755300.22
211.392776072782562779320.17
单位质量响应值RSD%判断
24297.1824401.400.31数据可信
供试品溶液-6042702批-非布司他-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199495-19949573.66466.8314.9673.6666.8314.96
2150755-15075555.66755.67
3196971-19697172.73272.73
4211015-21101577.91877.92
5182022-18202267.21267.21
6145683-14568353.79453.79
10min1252098-25209893.08892.451.8493.2192.561.85
2241371-24137189.12789.22
3254309-25430993.90494.03
4250530-25053092.50992.64
5252636-25263693.28793.40
6251237-25123792.77092.86
15min1252682-25268293.30495.762.1193.5896.022.11
2252695-25269593.30893.55
3262455-26245596.91297.19
4259326-25932695.75796.04
5264275-26427597.58497.85
6264524-26452497.67697.92
20min1255230-25523094.24497.162.4494.6897.592.43
2255517-25551794.35094.75
3266039-26603998.23698.67
4263462-26346297.28497.73
5268998-26899899.32899.76
6269557-26955799.53599.94
30min1256464-25646494.70097.872.6295.2998.462.61
2258189-25818995.33795.89
3269079-26907999.35899.96
4262645-26264596.98297.59
5272780-272780100.725101.32
6271202-271202100.142100.72
45min1256531-25653194.72598.262.7395.4799.012.72
2259815-25981595.93796.65
3269540-26954099.528100.30
4263718-26371897.37998.15
5275008-275008101.547102.31
6272005-272005100.439101.18
60min1256862-25686294.84798.312.7095.7599.222.69
2260006-26000696.00896.88
3270038-27003899.712100.65
4263673-26367397.36298.29
5275018-275018101.551102.48
6271886-271886100.395101.30
极限1255863-25586394.47898.182.8595.5499.262.84
2259657-25965795.87996.91
3270133-27013399.747100.85
4262697-26269797.00298.09
5274710-274710101.437102.54
6272283-272283100.541101.62
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%
111.243947239278392493915039399393100.33
211.373863338471385520.30
单位质量响应值RSD%判断
3497.333390.682.19数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-6042703批-多替诺雷-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117608-1760845.88247.7813.5945.8847.7813.59
217910-1791046.66946.67
318545-1854548.32448.32
418037-1803747.00047.00
522793-2279359.39359.39
615125-1512539.41239.41
10min130863-3086380.42280.542.8480.5080.622.85
231144-3114481.15481.23
331614-3161482.37982.46
430900-3090080.51880.60
531671-3167182.52782.63
629261-2926176.24776.31
15min133334-3333486.86087.041.3387.0787.251.34
233763-3376387.97888.19
333951-3395188.46888.69
433516-3351687.33587.55
533128-3312886.32486.56
632724-3272485.27185.46
20min133954-3395488.47688.791.3588.8389.151.34
234388-3438889.60789.97
334755-3475590.56390.93
434152-3415288.99289.35
533502-3350287.29887.68
633703-3370387.82288.16
30min134735-3473590.51190.331.3891.0190.841.37
234818-3481890.72791.24
335183-3518391.67892.19
435034-3503491.29091.80
533890-3389088.30988.84
634332-3433289.46189.94
45min135269-3526991.90391.451.5192.5692.111.50
235486-3548692.46893.13
335554-3555492.64593.31
435408-3540892.26592.92
534326-3432689.44590.12
634540-3454090.00390.63
60min135245-3524591.84091.821.2092.6592.631.19
235635-3563592.85693.67
335562-3556292.66693.49
435424-3542492.30693.12
534490-3449089.87390.69
635071-3507191.38792.17
极限135205-3520591.73691.961.5892.7092.921.56
235753-3575393.16494.13
335693-3569393.00793.99
435480-3548092.45293.42
534237-3423789.21390.19
635379-3537992.18993.12
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%
111.342798062797452794782789432789872793920.15
211.392795532785022790280.27
单位质量响应值RSD%判断
24637.7424497.630.41数据可信
供试品溶液-6042703批-非布司他-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148113-14811354.20556.0012.5754.2156.0012.57
2147881-14788154.12054.12
3156058-15605857.11357.11
4150652-15065255.13455.13
5187213-18721368.51568.51
6128229-12822946.92846.93
10min1244418-24441889.45088.832.5689.5488.922.56
2243942-24394289.27689.37
3248090-24809090.79490.89
4243854-24385489.24489.34
5245525-24552589.85589.97
6230488-23048884.35284.43
15min1257550-25755094.25694.131.4394.5094.381.42
2260320-26032095.27095.51
3260761-26076195.43195.68
4259203-25920394.86195.10
5253005-25300592.59392.86
6252436-25243692.38492.60
20min1260644-26064495.38895.241.3595.7895.641.34
2263149-26314996.30596.70
3262924-26292496.22396.63
4262695-26269596.13996.54
5254724-25472493.22293.64
6257316-25731694.17094.54
30min1262887-26288796.20996.051.5596.7696.601.55
2266171-26617197.41197.97
3263851-26385196.56297.13
4266240-26624097.43698.00
5255734-25573493.59194.16
6259804-25980495.08195.61
45min1264044-26404496.63396.421.8297.3597.131.81
2268727-26872798.34699.07
3263428-26342896.40797.13
4267536-26753697.91198.63
5255325-25532593.44294.17
6261674-26167495.76596.45
60min1264395-26439596.76196.451.8997.6497.321.88
2269221-26922198.52799.41
3263108-26310896.29097.18
4267681-26768197.96498.85
5255173-25517393.38694.27
6261629-26162995.74996.60
极限1263416-26341696.40396.241.9297.4497.281.90
2267375-26737597.85298.90
3262203-26220395.95997.01
4267878-26787898.03699.08
5253899-25389992.92093.96
6263109-26310996.29097.30
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