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%
110.993746743751093752573749223744583748840.09
211.073741373739573740470.04
单位质量响应值RSD%判断
34111.3733789.250.68数据可信
供试品溶液-24062601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%
5min1194339-19433951.31354.404.2051.3154.404.20
2215426-21542656.88156.88
3212783-21278356.18356.18
4212389-21238956.07956.08
5199465-19946552.66752.67
6201701-20170153.25753.26
10min1253374-25337466.90170.983.0466.9971.073.03
2273070-27307072.10172.20
3275372-27537272.70972.80
4274271-27427172.41872.51
5269517-26951771.16371.25
6267317-26731770.58270.67
15min1278237-27823773.46577.532.8273.6677.742.82
2293074-29307477.38377.60
3301125-30112579.50979.72
4298701-29870178.86979.08
5298310-29831078.76578.97
6292323-29232377.18577.39
20min1290407-29040776.67980.702.6977.0081.042.69
2304018-30401880.27380.62
3312075-31207582.40082.75
4310896-31089682.08982.43
5311285-31128582.19182.53
6305198-30519880.58480.92
30min1301756-30175679.67583.582.5680.1284.052.56
2313809-31380982.85883.34
3322198-32219885.07385.56
4323342-32334285.37585.86
5321338-32133884.84685.32
6316741-31674183.63284.10
45min1309830-30983081.80785.652.5282.3986.262.52
2320355-32035584.58685.20
3329850-32985087.09387.72
4332195-33219587.71288.34
5327589-32758986.49687.11
6326473-32647386.20286.81
60min1314392-31439283.01286.932.6583.7387.692.64
2323631-32363185.45186.21
3334932-33493288.43589.21
4337905-33790589.22089.99
5332214-33221487.71788.48
6332333-33233387.74988.50
极限1366874-36687496.86998.821.4897.7299.711.49
2370078-37007897.71598.61
3378516-37851699.943100.86
4371268-37126898.02998.95
5378354-37835499.900100.81
6380382-380382100.436101.33
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%
110.993746553749343747053751203755423749910.10
211.073756473754643755560.04
单位质量响应值RSD%判断
34121.1133925.560.41数据可信
供试品溶液-24071001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%
5min1204939-20493953.99556.304.0153.9956.304.02
2221084-22108458.24958.25
3218943-21894357.68557.68
4219951-21995157.95057.95
5216197-21619756.96156.96
6200940-20094052.94152.94
10min1274564-27456472.33973.593.4972.4373.683.49
2288939-28893976.12676.22
3290452-29045276.52576.62
4282637-28263774.46674.56
5273895-27389572.16372.26
6265358-26535869.91370.00
15min1298916-29891678.75579.703.3778.9779.923.37
2313207-31320782.52082.74
3314685-31468582.91083.13
4304590-30459080.25080.47
5294230-29423077.52077.74
6289479-28947976.26976.47
20min1309214-30921481.46882.493.5481.8182.843.54
2323663-32366385.27585.64
3327644-32764486.32486.69
4314946-31494682.97883.33
5303035-30303579.84080.18
6300093-30009379.06579.40
30min1320417-32041784.42085.183.2884.9085.673.28
2333404-33340487.84188.35
3337679-33767988.96889.47
4323715-32371585.28985.78
5313352-31335282.55883.04
6311256-31125682.00682.47
45min1326442-32644286.00787.073.2586.6387.703.25
2343244-34324490.43491.08
3343669-34366990.54691.20
4329569-32956986.83187.47
5319823-31982384.26384.88
6320104-32010484.33784.94
60min1330547-33054787.08987.882.9187.8588.652.92
2343271-34327190.44191.24
3347336-34733691.51292.32
4331601-33160187.36688.15
5323928-32392885.34586.10
6324571-32457185.51486.26
极限1368576-36857697.10897.780.8398.0198.700.85
2372621-37262198.17499.13
3374723-37472398.72899.69
4374167-37416798.58199.51
5367905-36790596.93197.83
6368755-36875597.15598.04
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%
110.993755253752423752003753653751673753000.04
211.073757883754233756060.07
单位质量响应值RSD%判断
34149.2333930.080.46数据可信
供试品溶液-24071002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%
5min1212848-21284856.05256.933.1256.0556.933.12
2218726-21872657.60057.60
3204522-20452253.85953.86
4216643-21664357.05157.05
5221704-22170458.38458.38
6222711-22271158.64958.65
10min1268328-26832870.66272.873.9870.7672.973.98
2276717-27671772.87172.97
3263102-26310269.28669.38
4272891-27289171.86471.96
5289355-28935576.20076.30
6289987-28998776.36676.46
15min1290798-29079876.58078.823.9976.7979.033.98
2298001-29800178.47678.69
3286567-28656775.46575.67
4292538-29253877.03877.25
5313205-31320582.48082.70
6314612-31461282.85183.08
20min1301017-30101779.27181.544.0179.6181.894.01
2307362-30736280.94281.29
3296067-29606777.96778.30
4303562-30356279.94180.28
5324169-32416985.36885.73
6325670-32567085.76386.13
30min1311412-31141282.00884.023.7982.4884.503.79
2316463-31646383.33883.82
3306123-30612380.61581.08
4312145-31214582.20182.68
5333048-33304887.70688.21
6335012-33501288.22388.73
45min1317468-31746883.60385.863.8984.2186.483.88
2323097-32309785.08585.71
3313533-31353382.56783.16
4318386-31838683.84584.46
5340309-34030989.61890.27
6343361-34336190.42291.07
60min1321963-32196384.78786.883.7485.5387.653.73
2328183-32818386.42587.19
3317733-31773383.67384.41
4321316-32131684.61685.37
5343485-34348590.45491.25
6346808-34680891.32992.13
极限1368284-36828496.98597.600.9397.8798.510.95
2371451-37145197.81998.73
3370719-37071997.62698.50
4365656-36565696.29397.19
5371821-37182197.91698.87
6375766-37576698.95599.91
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%
110.993741553743973748563749123750143746670.10
211.073763153764513763830.03
单位质量响应值RSD%判断
34091.6334000.270.19数据可信
供试品溶液-3401B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%
5min1180464-18046447.51546.722.8047.5146.722.80
2179585-17958547.28347.28
3182653-18265348.09148.09
4177853-17785346.82746.83
5168570-16857044.38344.38
6175637-17563746.24446.24
10min1251354-25135466.17965.483.5766.2665.563.57
2256950-25695067.65367.73
3256901-25690167.64067.72
4243322-24332264.06564.14
5233881-23388161.57961.65
6249866-24986665.78865.86
15min1283084-28308474.53474.303.2574.7274.483.25
2292042-29204276.89277.08
3290256-29025676.42276.61
4274066-27406672.15972.34
5268649-26864970.73370.91
6284979-28497975.03375.22
20min1298638-29863878.62979.093.0978.9479.403.09
2310572-31057281.77182.09
3307911-30791181.07081.39
4292074-29207476.90177.21
5287421-28742175.67675.97
6305772-30577280.50780.82
30min1315826-31582683.15484.022.7083.6084.462.70
2328578-32857886.51286.97
3325051-32505185.58386.04
4310078-31007881.64182.07
5309002-30900281.35881.78
6326207-32620785.88886.33
45min1327073-32707386.11687.162.2086.7087.742.21
2339307-33930789.33789.94
3335244-33524488.26788.86
4322421-32242184.89185.46
5324408-32440885.41485.97
6337717-33771788.91889.51
60min1334258-33425888.00788.891.9588.7389.611.95
2344478-34447890.69891.45
3340836-34083689.73990.48
4328993-32899386.62187.33
5332551-33255187.55888.26
6344454-34445490.69291.43
极限1359787-35978794.72996.241.3295.6097.111.31
2362489-36248995.44096.34
3368089-36808996.91597.81
4361536-36153695.18996.04
5370611-37061197.57998.42
6370557-37055797.56598.45
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