比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.083823713824813829153828363824243826050.07
2 11.063820443822023821230.03
单位质量响应值RSD%判断
34531.1434550.000.04数据可信
供试品溶液-2024122121批-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%
5min1202124-20212452.45552.401.6352.4652.401.63
2196839-19683951.08451.08
3199239-19923951.70751.71
4203616-20361652.84352.84
5205660-20566053.37353.37
6203909-20390952.91952.92
10min1277288-27728871.96271.661.6672.0571.751.66
2270827-27082770.28570.37
3270653-27065370.24070.33
4277019-27701971.89271.98
5282272-28227273.25573.34
6278791-27879172.35272.44
15min1315786-31578681.95380.832.4982.1681.042.49
2302449-30244978.49278.69
3302152-30215278.41578.62
4310905-31090580.68680.89
5316904-31690482.24382.45
6320569-32056983.19483.40
20min1337445-33744587.57486.152.7987.9286.492.79
2320674-32067483.22283.55
3320250-32025083.11283.45
4335335-33533587.02687.37
5335560-33556087.08587.43
6342443-34244388.87189.22
30min1355551-35555192.27391.123.0892.7691.603.08
2336763-33676387.39787.87
3338532-33853287.85688.33
4358548-35854893.05193.54
5354475-35447591.99492.49
6362673-36267394.12194.62
45min1366306-36630695.06493.903.3395.7194.543.33
2346907-34690790.03090.65
3347429-34742990.16590.78
4372390-37239096.64397.29
5363437-36343794.32094.97
6374526-37452697.19797.85
60min1373166-37316696.84495.333.4097.6596.133.39
2352359-35235991.44592.21
3352093-35209391.37692.14
4379186-37918698.40799.21
5367813-36781395.45596.26
6379444-37944498.47499.29
极限1389069-389069100.972100.810.89101.94101.760.88
2394793-394793102.457103.38
3384543-38454399.797100.72
4387586-387586100.587101.55
5386998-386998100.434101.40
6387728-387728100.624101.60
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.083817423818193817753819603817823818160.03
2 11.063826993828283827640.03
单位质量响应值RSD%判断
34459.9334607.960.31数据可信
供试品溶液-2024122221批-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%
5min1224252-22425258.21057.811.4658.2157.801.46
2226539-22653958.80358.80
3218342-21834256.67556.68
4219108-21910856.87456.87
5223572-22357258.03358.03
6224369-22436958.24058.24
10min1299821-29982177.82579.611.7177.9279.711.71
2311583-31158380.87880.98
3301373-30137378.22878.32
4309872-30987280.43480.53
5311775-31177580.92881.02
6305857-30585779.39279.49
15min1333977-33397786.69189.511.9686.9289.741.95
2351042-35104291.12191.35
3343450-34345089.15089.37
4349489-34948990.71890.95
5350355-35035590.94291.17
6340776-34077688.45688.69
20min1347748-34774890.26694.252.4990.6494.632.49
2369629-36962995.94596.33
3364304-36430494.56394.94
4369599-36959995.93896.32
5370139-37013996.07896.46
6357085-35708592.68993.07
30min1358881-35888193.15598.052.7393.6898.592.72
2384293-38429399.752100.30
3381653-38165399.06699.60
4384757-38475799.872100.41
5384146-38414699.714100.26
6372677-37267796.73697.27
45min1361331-36133193.79199.723.1194.47100.433.10
2391472-391472101.615102.33
3388449-388449100.830101.53
4391111-391111101.521102.23
5391905-391905101.728102.44
6380877-38087798.86599.56
60min1363692-36369294.404100.132.9695.24101.002.95
2393189-393189102.061102.94
3388689-388689100.893101.76
4392463-392463101.872102.75
5392802-392802101.960102.84
6383770-38377099.616100.47
极限1387247-387247100.518101.680.96101.51102.720.97
2394848-394848102.491103.54
3388807-388807100.923101.96
4393584-393584102.163103.21
5396549-396549102.933103.98
6389362-389362101.067102.09
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.083831763829573831863830633832833831330.04
2 11.063848743848663848700.01
单位质量响应值RSD%判断
34578.7934798.370.45数据可信
供试品溶液-2024122321批-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%
5min1196554-19655450.79352.262.9350.7952.262.92
2198263-19826351.23451.23
3201018-20101851.94651.95
4213395-21339555.14555.14
5201670-20167052.11552.11
6202446-20244652.31552.32
10min1267140-26714069.03371.344.5869.1271.424.57
2264210-26421068.27668.36
3271637-27163770.19570.28
4299478-29947877.39077.48
5278735-27873572.03072.12
6275133-27513371.09971.19
15min1300070-30007077.54380.145.2177.7480.345.21
2294491-29449176.10176.30
3306361-30636179.16979.37
4340435-34043587.97488.19
5313245-31324580.94881.15
6306031-30603179.08379.29
20min1321027-32102782.95985.365.5683.2985.715.56
2309964-30996480.10080.43
3324557-32455783.87184.21
4362317-36231793.62994.00
5339870-33987087.82888.17
6324286-32428683.80184.14
30min1341398-34139888.22390.255.3788.6990.735.37
2327146-32714684.54085.00
3346256-34625689.47889.95
4382733-38273398.90499.43
5355099-35509991.76392.25
6342843-34284388.59689.07
45min1360834-36083493.24594.154.3093.8694.784.30
2343340-34334088.72589.33
3362239-36223993.60894.23
4390451-390451100.899101.59
5371032-37103295.88196.52
6358083-35808392.53493.16
60min1370582-37058295.76496.203.6896.5397.003.69
2350765-35076590.64391.39
3372717-37271796.31697.10
4393122-393122101.589102.45
5377328-37732897.50898.31
6369201-36920195.40896.19
极限1396710-396710102.516100.791.39103.45101.741.37
2395010-395010102.077102.98
3385915-38591599.727100.67
4392646-392646101.466102.49
5384896-38489699.463100.43
6384941-38494199.475100.41
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