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)1.5
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%
1 10.811869041860181870491867301869281867260.23
2 10.761851791855421853600.14
单位质量响应值RSD%判断
17273.4517226.770.20数据可信
供试品溶液-BXK34K1批-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%
5min165332-6533234.05932.309.8634.0632.309.87
268722-6872235.82635.83
364557-6455733.65533.65
463391-6339133.04733.05
557956-5795630.21430.21
651737-5173726.97226.97
10min1146010-14601076.11876.093.4876.1776.143.48
2152130-15213079.30879.37
3150414-15041478.41478.47
4147013-14701376.64176.70
5140113-14011373.04473.09
6140014-14001472.99273.04
15min1168430-16843087.80688.311.4987.9988.491.50
2171414-17141489.36189.55
3172507-17250789.93190.12
4170680-17068088.97989.16
5166022-16602286.55086.72
6167373-16737387.25587.42
20min1177228-17722892.39292.830.8292.7293.160.83
2177879-17787992.73293.07
3179706-17970693.68494.02
4179739-17973993.70194.03
5175976-17597691.74092.06
6177843-17784392.71393.03
30min1181830-18183094.79295.600.5695.2896.080.56
2183098-18309895.45395.95
3184310-18431096.08496.58
4184325-18432596.09296.58
5184043-18404395.94596.41
6182702-18270295.24695.71
45min1184723-18472396.30096.740.5396.9497.380.53
2184361-18436196.11196.77
3186256-18625697.09997.75
4187002-18700297.48898.14
5185527-18552796.71997.35
6185501-18550196.70597.33
60min1184540-18454096.20496.520.3297.0197.320.32
2184514-18451496.19197.01
3185772-18577296.84797.66
4185287-18528796.59497.40
5185842-18584296.88397.67
6184911-18491196.39897.18
极限1184308-18430896.08396.280.4797.0597.240.47
2183413-18341395.61796.59
3185537-18553796.72497.70
4185766-18576696.84397.81
5184494-18449496.18097.13
6184575-18457596.22397.17
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)1.5
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%
1 10.811857391856861850431854821849241853750.21
2 10.761847711843981845840.15
单位质量响应值RSD%判断
17148.4717154.650.03数据可信
供试品溶液-BXK34K1批-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%
5min160364-6036431.65032.673.1631.6532.673.16
261579-6157932.28732.29
363761-6376133.43133.43
459896-5989631.40431.40
563715-6371533.40733.41
664561-6456133.85033.85
10min1140022-14002273.41576.933.4473.4776.993.44
2146204-14620476.65776.71
3154989-15498981.26381.32
4146122-14612276.61476.67
5149105-14910578.17878.23
6143934-14393475.46775.52
15min1166004-16600487.03889.752.3587.2189.932.35
2170421-17042189.35489.54
3175971-17597192.26492.46
4175573-17557392.05592.24
5171175-17117589.74989.94
6167881-16788188.02288.20
20min1175949-17594992.25293.661.2692.5793.991.26
2178921-17892193.81194.14
3181525-18152595.17695.52
4180166-18016694.46494.80
5179189-17918993.95194.29
6176022-17602292.29192.62
30min1182142-18214295.50096.220.9595.9796.710.95
2183547-18354796.23696.72
3185671-18567197.35097.85
4184995-18499596.99597.49
5183700-18370096.31696.81
6181026-18102694.91495.40
45min1183661-18366196.29697.041.0096.9397.691.00
2186230-18623097.64398.29
3186445-18644597.75698.42
4187377-18737798.24498.90
5184055-18405596.50397.16
6182755-18275595.82196.46
60min1184329-18432996.64697.150.8997.4497.960.89
2186048-18604897.54898.36
3187036-18703698.06698.89
4186939-18693998.01598.83
5184468-18446896.71997.53
6182923-18292395.90996.71
极限1183066-18306695.98496.890.9596.9497.860.95
2185833-18583397.43598.41
3186389-18638997.72698.72
4186821-18682197.95398.93
5183127-18312796.01696.99
6183527-18352796.22697.19
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)1.5
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%
1 10.811850881855461850771852831853481852680.11
2 10.761843891843771843830.01
单位质量响应值RSD%判断
17138.5817135.970.02数据可信
供试品溶液-BXK3152批-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%
5min156859-5685929.83729.738.9229.8429.748.92
256447-5644729.62129.62
364022-6402233.59633.60
451477-5147727.01327.01
550897-5089726.70826.71
660283-6028331.63431.63
10min1139615-13961573.26375.062.6973.3175.112.69
2143797-14379775.45875.51
3149600-14960078.50378.56
4142283-14228374.66374.71
5138926-13892672.90272.95
6144037-14403775.58475.64
15min1166403-16640387.32089.081.2887.4989.261.28
2170862-17086289.66089.84
3171519-17151990.00590.19
4171865-17186590.18690.36
5167962-16796288.13888.30
6169953-16995389.18389.36
20min1176439-17643992.58794.051.1692.9094.381.16
2179668-17966894.28194.61
3182108-18210895.56195.90
4180641-18064194.79295.11
5177496-17749693.14193.45
6179039-17903993.95194.28
30min1183038-18303896.04997.310.8996.5297.790.89
2185822-18582297.51097.99
3184931-18493197.04397.54
4188157-18815798.73699.21
5185315-18531597.24497.71
6185353-18535397.26497.75
45min1184866-18486697.00998.340.8097.6498.980.79
2188461-18846198.89599.54
3186342-18634297.78398.44
4188595-18859598.96599.61
5188125-18812598.71999.35
6188061-18806198.68599.33
60min1184645-18464596.89398.250.8197.6999.050.80
2187846-18784698.57299.38
3186985-18698598.12198.94
4189175-18917599.270100.08
5186974-18697498.11598.91
6187732-18773298.51399.32
极限1181375-18137595.17797.771.4496.1398.741.43
2188140-18814098.72799.70
3185455-18545597.31898.30
4188558-18855898.94699.92
5187685-18768598.48899.45
6186690-18669097.96698.94
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)1.5
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%
1 10.811842801838451833021840321840881839090.21
2 10.761829131838851833990.38
单位质量响应值RSD%判断
17012.8617044.520.14数据可信
供试品溶液-BXK3152批-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%
5min156634-5663429.90831.4113.7929.9131.4113.79
253614-5361428.31328.31
375299-7529939.76539.77
461187-6118732.31332.31
555774-5577429.45429.45
654337-5433728.69528.70
10min1143213-14321375.63076.364.4175.6876.414.41
2135464-13546471.53871.59
3154211-15421181.43881.50
4148688-14868878.52278.58
5144270-14427076.18976.24
6141701-14170174.83274.88
15min1167741-16774188.58490.041.6888.7690.221.69
2166840-16684088.10888.27
3174608-17460892.21092.41
4172098-17209890.88591.07
5171112-17111290.36490.54
6170583-17058390.08490.26
20min1175807-17580792.84394.471.0693.1794.801.07
2177697-17769793.84194.15
3181259-18125995.72296.08
4179540-17954094.81595.15
5179316-17931694.69695.02
6179661-17966194.87995.20
30min1183235-18323596.76697.830.5997.2498.320.60
2185583-18558398.00698.48
3186442-18644298.46098.97
4185768-18576898.10498.60
5185414-18541497.91798.40
6185087-18508797.74498.22
45min1183263-18326396.78198.701.0197.4299.351.01
2187972-18797299.26899.90
3187815-18781599.18599.86
4188108-18810899.339100.00
5187749-18774999.15099.80
6186508-18650898.49499.14
60min1184215-18421597.28399.041.0398.0899.851.02
2190040-190040100.360101.16
3188262-18826299.421100.27
4187853-18785399.205100.03
5187823-18782399.189100.00
6187011-18701198.76099.57
极限1185035-18503597.71798.480.5498.6899.460.54
2187817-18781799.186100.15
3187276-18727698.90099.91
4186668-18666898.57999.57
5186143-18614398.30299.28
6185988-18598898.22099.19
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