盐酸奥洛他定片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.982260112260742259532257672260392259690.06
211.082276802274822275810.07
单位质量响应值RSD%判断
20580.0520539.800.14数据可信
供试品溶液-24111801批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1205079-20507989.59391.7610.2689.5991.7610.27
2212189-21218992.69992.70
3214495-21449593.70693.71
4175898-17589876.84476.84
5243299-243299106.290106.29
6209313-20931391.44291.44
10min1224978-22497898.286100.6010.1898.44100.7510.18
2233098-233098101.833101.99
3232178-232178101.432101.59
4193542-19354284.55384.68
5267122-267122116.697116.87
6230676-230676100.775100.93
15min1230671-230671100.773103.1910.16101.09103.5210.16
2239413-239413104.592104.92
3238706-238706104.283104.61
4198567-19856786.74887.02
5273787-273787119.609119.98
6236136-236136103.161103.48
20min1234420-234420102.411104.999.54102.89105.489.54
2242230-242230105.823106.32
3242178-242178105.800106.30
4205413-20541389.73990.15
5277242-277242121.119121.69
6240431-240431105.037105.53
30min1241234-241234105.388106.609.65106.04107.279.65
2246243-246243107.576108.25
3247251-247251108.016108.69
4206011-20601190.00090.56
5280094-280094122.365123.14
6243237-243237106.263106.93
45min1242787-242787106.066108.259.82106.89109.109.83
2250783-250783109.559110.41
3253617-253617110.798111.65
4208758-20875891.20091.91
5284739-284739124.394125.37
6246064-246064107.498108.34
60min1245807-245807107.386108.529.68108.39109.559.69
2249535-249535109.014110.05
3249777-249777109.120110.16
4211063-21106392.20793.07
5286941-286941125.356126.54
6247350-247350108.060109.08
极限1242296-242296105.852108.759.76107.03109.959.76
2250545-250545109.456110.67
3252138-252138110.151111.37
4211402-21140292.35593.37
5287405-287405125.559126.95
6249767-249767109.116110.32
盐酸奥洛他定片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.982275282273702287122282912284052280610.26
211.082276052283262279660.23
单位质量响应值RSD%判断
20770.5820574.550.68数据可信
供试品溶液-24111901批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1200990-20099087.33086.395.1487.3386.395.14
2189919-18991982.52082.52
3201880-20188087.71787.72
4199559-19955986.70886.71
5214827-21482793.34293.34
6185765-18576580.71580.71
10min1223079-22307996.92895.305.6397.0795.455.63
2204542-20454288.87389.01
3225473-22547397.96898.11
4219344-21934495.30595.45
5237282-237282103.099103.25
6206333-20633389.65189.79
15min1231576-231576100.61998.565.49100.9398.875.49
2211749-21174992.00592.29
3233219-233219101.333101.64
4227443-22744398.82499.13
5243984-243984106.011106.34
6213086-21308692.58692.87
20min1235275-235275102.227100.145.39102.70100.615.39
2215528-21552893.64794.09
3236483-236483102.752103.23
4230709-230709100.243100.71
5247951-247951107.734108.24
6216939-21693994.26094.70
30min1240522-240522104.506102.635.52105.15103.275.52
2219886-21988695.54096.14
3245216-245216106.546107.20
4236445-236445102.735103.37
5253057-253057109.953110.64
6222109-22210996.50697.10
45min1244332-244332106.162103.965.41106.98104.765.41
2223212-22321296.98597.74
3244684-244684106.315107.14
4240167-240167104.352105.16
5257571-257571111.914112.78
6225559-22555998.00598.76
60min1247654-247654107.605105.205.63108.60106.185.63
2226465-22646598.39999.31
3247050-247050107.343108.35
4241476-241476104.921105.90
5262493-262493114.053115.11
6227532-22753298.86299.78
极限1252831-252831109.855105.875.17111.03107.025.18
2230017-23001799.942101.02
3247082-247082107.357108.54
4243350-243350105.735106.89
5260305-260305113.102114.35
6228374-22837499.228100.31
盐酸奥洛他定片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.982281452277602274872274732279242277580.13
211.082281662282842282250.04
单位质量响应值RSD%判断
20742.9920597.920.50数据可信
供试品溶液-24111901-1批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1191884-19188483.38183.162.9583.3883.162.95
2195354-19535484.88984.89
3196387-19638785.33885.34
4183110-18311079.56879.57
5195704-19570485.04185.04
6185841-18584180.75580.76
10min1210058-21005891.27890.953.2291.4291.093.22
2213850-21385092.92693.07
3216179-21617993.93894.08
4199819-19981986.82986.96
5213674-21367492.85092.99
6202265-20226587.89288.03
15min1217648-21764894.57694.233.1394.8794.523.13
2221754-22175496.36196.66
3223891-22389197.28997.59
4207343-20734390.09990.38
5220707-22070795.90696.20
6209723-20972391.13391.41
20min1223038-22303896.91996.412.9597.3796.862.95
2226361-22636198.36398.82
3228355-22835599.22999.69
4212493-21249392.33692.76
5225852-22585298.14198.60
6215081-21508193.46193.89
30min1227892-22789299.02898.733.1599.6499.343.15
2232659-232659101.099101.72
3234442-234442101.874102.50
4217177-21717794.37294.95
5231308-231308100.512101.13
6219727-21972795.48096.07
45min1231930-231930100.783100.373.04101.56101.143.04
2235108-235108102.163102.95
3238556-238556103.662104.46
4221264-22126496.14896.89
5235531-235531102.347103.13
6223501-22350197.12097.87
60min1233581-233581101.500101.203.02102.44102.143.02
2238267-238267103.536104.50
3239542-239542104.090105.06
4223793-22379397.24798.15
5237562-237562103.230104.19
6224628-22462897.61098.52
极限1235207-235207102.207101.673.03103.32102.783.03
2239541-239541104.090105.22
3240878-240878104.671105.81
4223826-22382697.26198.32
5237709-237709103.294104.42
6226655-22665598.49099.56
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