非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843739933732843734513725773735313733670.14
210.813709753717003713380.14
单位质量响应值RSD%判断
34443.4534351.340.19数据可信
供试品溶液-2025082921批-含0.1%吐温20的醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1254154-25415466.44669.6011.3866.4569.6011.38
2307826-30782680.47880.48
3237549-23754962.10562.10
4266898-26689869.77869.78
5296178-29617877.43277.43
6234810-23481061.38861.39
10min1327947-32794785.73887.541.8485.8587.661.84
2343023-34302389.68089.81
3332115-33211586.82886.93
4337587-33758788.25888.37
5339591-33959188.78288.91
6328859-32885985.97786.08
15min1344810-34481090.14791.300.7690.4091.560.77
2352811-35281192.23992.52
3348631-34863191.14691.39
4350677-35067791.68191.94
5349368-34936891.33891.62
6348963-34896391.23291.48
20min1351443-35144391.88192.730.5192.2893.150.52
2356554-35655493.21793.65
3354351-35435192.64193.04
4356037-35603793.08293.50
5354589-35458992.70393.13
6355255-35525592.87793.28
30min1356258-35625893.14094.030.4893.7094.600.48
2360409-36040994.22594.82
3360677-36067794.29594.85
4360810-36081094.33094.90
5360093-36009394.14294.73
6359693-35969394.03894.59
45min1358872-35887293.82394.770.5794.5495.500.57
2363020-36302094.90895.66
3363481-36348195.02895.74
4364586-36458695.31796.05
5361383-36138394.48095.22
6363574-36357495.05295.76
60min1360260-36026094.18694.990.5095.0595.870.51
2363611-36361195.06295.97
3363778-36377895.10695.98
4365766-36576695.62596.51
5363771-36377195.10496.00
6362714-36271494.82895.70
极限1360775-36077594.32195.050.4195.3596.100.42
2363546-36354695.04596.11
3364842-36484295.38496.41
4364821-36482195.37896.43
5363905-36390595.13996.20
6363588-36358895.05696.08
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843731333731553727793726283715723726530.18
210.813707533711113709320.07
单位质量响应值RSD%判断
34377.5834313.780.14数据可信
供试品溶液-2025082921批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1267126-26712669.94269.1220.2269.9469.1220.22
2303670-30367079.51179.51
3207231-20723154.26054.26
4301640-30164078.97978.98
5189921-18992149.72749.73
6314259-31425982.28382.28
10min1331099-33109986.69287.983.5486.8188.103.55
2338923-33892388.74188.87
3321154-32115484.08884.18
4351568-35156892.05292.18
5326527-32652785.49585.58
6346921-34692190.83590.97
15min1345364-34536490.42792.142.0390.6992.412.04
2346854-34685490.81891.10
3349294-34929491.45691.69
4363375-36337595.14395.43
5348646-34864691.28791.51
6357967-35796793.72794.02
20min1348655-34865591.28993.641.9091.7094.061.91
2352273-35227392.23692.67
3357768-35776893.67594.06
4367405-36740596.19896.64
5357149-35714993.51393.89
6362662-36266294.95795.40
30min1353007-35300792.42994.842.0292.9995.422.02
2355234-35523493.01293.60
3364466-36446695.42995.97
4372745-37274597.59798.20
5361533-36153394.66195.19
6366415-36641595.93996.54
45min1358510-35851093.86995.751.7694.5996.481.76
2358193-35819393.78694.53
3368166-36816696.39897.10
4374982-37498298.18298.95
5366268-36626895.90196.59
6368071-36807196.37397.14
60min1356617-35661793.37495.842.0494.2596.722.04
2358573-35857393.88694.78
3369043-36904396.62797.49
4376692-37669298.63099.56
5365962-36596295.82196.67
6369212-36921296.67297.60
极限1356036-35603693.22295.822.0494.2596.872.03
2358332-35833293.82394.88
3368937-36893796.60097.62
4375525-37552598.32599.42
5366709-36670996.01697.03
6370260-37026096.94698.03
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843703943702483707573708893703233705220.08
210.813708383707683708030.02
单位质量响应值RSD%判断
34181.0034301.850.25数据可信
供试品溶液-2025083021批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1301720-30172079.24179.872.0879.2479.882.08
2293519-29351977.08777.09
3309925-30992581.39681.40
4302051-30205179.32879.33
5309214-30921481.20981.21
6308339-30833980.97980.98
10min1351832-35183292.40292.131.0492.5392.271.04
2345580-34558090.76090.89
3349426-34942691.77091.91
4350342-35034292.01092.14
5356751-35675193.69493.83
6350931-35093192.16592.30
15min1364867-36486795.82595.520.6896.1195.800.68
2361413-36141394.91895.20
3362582-36258295.22595.51
4363364-36336495.43095.72
5368055-36805596.66296.95
6361939-36193995.05695.34
20min1372581-37258197.85197.240.7098.3097.680.70
2368030-36803096.65697.09
3367961-36796196.63897.08
4369360-36936097.00597.45
5374204-37420498.27798.73
6369318-36931896.99497.44
30min1377089-37708999.03598.520.7199.6499.120.71
2373801-37380198.17198.77
3371384-37138497.53798.14
4374349-37434998.31598.92
5379033-37903399.545100.16
6375065-37506598.50399.11
45min1379613-37961399.69899.490.78100.47100.260.78
2376386-37638698.85099.61
3375659-37565998.65999.43
4378962-37896299.527100.30
5383947-383947100.836101.62
6378320-37832099.358100.13
60min1382682-382682100.50499.950.93101.44100.880.93
2379156-37915699.578100.51
3375492-37549298.61599.55
4381980-381980100.319101.26
5385475-385475101.237102.19
6378568-37856899.423100.36
极限1382914-382914100.565100.210.72101.67101.310.73
2380385-38038599.901100.99
3377614-37761499.173100.27
4382031-382031100.333101.44
5385781-385781101.318102.44
6380640-38064099.968101.07
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843697683700823693353697133700463697890.09
210.813668013668883668440.02
单位质量响应值RSD%判断
34113.3833935.620.37数据可信
供试品溶液-2025083021批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1315962-31596283.51070.6028.5083.5170.6028.50
2122719-12271932.43532.44
3307795-30779581.35281.35
4240174-24017463.47963.48
5309968-30996881.92681.93
6306154-30615480.91880.92
10min1351870-35187093.00190.354.2193.1490.474.24
2315102-31510283.28383.34
3348568-34856892.12892.26
4335697-33569788.72788.83
5350868-35086892.73692.87
6348996-34899692.24292.38
15min1364306-36430696.28894.751.5996.5895.021.62
2348216-34821692.03592.23
3357546-35754694.50194.79
4357526-35752694.49694.75
5361620-36162095.57895.87
6361665-36166595.59095.88
20min1368128-36812897.29896.550.4897.7596.980.51
2362910-36291095.91996.27
3365174-36517496.51796.96
4364314-36431496.29096.70
5365788-36578896.68097.13
6365509-36550996.60697.05
30min1373837-37383798.80798.370.2999.4298.960.29
2372142-37214298.35998.87
3370776-37077697.99898.61
4371517-37151798.19498.77
5372718-37271898.51199.12
6372133-37213398.35798.97
45min1377717-37771799.83399.250.36100.61100.000.35
2375989-37598999.376100.05
3374143-37414398.88899.66
4375190-37519099.16599.90
5374276-37427698.92399.70
6375717-37571799.304100.08
60min1379403-379403100.27899.680.46101.23100.600.47
2377532-37753299.784100.62
3375696-37569699.299100.23
4374679-37467999.03099.93
5377399-37739999.749100.69
6378176-37817699.954100.89
极限1378574-378574100.05999.770.51101.17100.850.48
2380116-380116100.467101.47
3375425-37542599.227100.33
4375826-37582699.333100.40
5376262-37626299.448100.55
6378667-378667100.084101.19
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