盐酸奥洛他定口崩片项目信息
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%
111.062322112322462324462320402325662323020.09
211.092313012319382316200.20
单位质量响应值RSD%判断
21003.8020885.480.40数据可信
供试品溶液-770ABI批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207716-20771689.07990.031.5489.0890.031.54
2214374-21437491.93491.93
3211028-21102890.49990.50
4206846-20684688.70688.71
5206935-20693588.74488.74
6212703-21270391.21791.22
10min1223980-22398096.05397.651.8096.2097.801.80
2233452-233452100.115100.27
3228668-22866898.06498.21
4224675-22467596.35196.50
5224135-22413596.12096.27
6231374-23137499.22499.38
15min1226079-22607996.95498.341.7197.2698.651.71
2235170-235170100.852101.17
3228185-22818597.85798.17
4226942-22694297.32497.63
5226213-22621397.01197.32
6233223-233223100.017100.33
20min1226854-22685497.28698.692.1797.7699.172.17
2235118-235118100.830101.32
3228573-22857398.02398.50
4226451-22645197.11397.58
5226109-22610996.96697.44
6237649-237649101.915102.40
30min1226604-22660497.17998.411.6697.8199.051.66
2235115-235115100.829101.48
3228581-22858198.02798.67
4226774-22677497.25297.88
5226399-22639997.09197.72
6233328-233328100.062100.72
极限1226016-22601696.92798.301.7297.7299.101.72
2235136-235136100.838101.66
3228462-22846297.97698.78
4226235-22623597.02097.82
5226438-22643897.10897.90
6233028-23302899.934100.75
盐酸奥洛他定口崩片项目信息
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%
111.062337352340942337652338442335862338050.08
211.092307602307832307720.01
单位质量响应值RSD%判断
21139.6920809.021.12数据可信
供试品溶液-770ABI批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1211509-21150990.58289.981.8290.5889.981.82
2212837-21283791.15091.15
3209960-20996089.91889.92
4213899-21389991.60591.61
5209256-20925689.61789.62
6203160-20316087.00687.01
10min1230033-23003398.51597.491.6698.6797.641.66
2229160-22916098.14198.29
3226769-22676997.11797.27
4231210-23121099.01999.17
5227978-22797897.63597.78
6220624-22062494.48594.63
15min1232976-23297699.77598.381.79100.0998.691.80
2231004-23100498.93199.25
3229151-22915198.13798.45
4233566-233566100.028100.35
5229395-22939598.24298.55
6222177-22217795.15095.45
20min1233387-23338799.95198.311.68100.4398.781.68
2230672-23067298.78899.27
3228972-22897298.06098.54
4231987-23198799.35299.84
5229896-22989698.45698.93
6222384-22238495.23995.70
30min1233766-233766100.11498.311.85100.7698.951.85
2231135-23113598.98799.63
3229435-22943598.25998.90
4232397-23239799.527100.18
5228772-22877297.97598.61
6221774-22177494.97895.60
极限1234311-234311100.34798.312.03101.1699.122.02
2231136-23113698.98799.80
3228608-22860897.90598.71
4233584-233584100.036100.85
5228132-22813297.70198.50
6221593-22159394.90095.68
盐酸奥洛他定口崩片项目信息
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%
111.062318292317912317412316332317492317490.04
211.092310642306832308740.12
单位质量响应值RSD%判断
20953.8020818.210.46数据可信
供试品溶液-771ABI批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1213193-21319391.68490.862.5791.6890.862.57
2217949-21794993.73093.73
3208341-20834189.59889.60
4204070-20407087.76187.76
5216351-21635193.04293.04
6207761-20776189.34889.35
10min1229608-22960898.74497.552.4298.9097.702.42
2233694-233694100.501100.66
3224901-22490196.71996.87
4217734-21773493.63793.78
5229490-22949098.69398.85
6225541-22554196.99597.14
15min1232046-23204699.79298.552.50100.1198.862.50
2235228-235228101.161101.48
3228122-22812298.10598.42
4218905-21890594.14194.44
5232518-23251899.995100.31
6228102-22810298.09698.41
20min1232910-232910100.16499.092.39100.6599.572.39
2236839-236839101.853102.35
3228964-22896498.46798.94
4220988-22098895.03795.50
5233732-233732100.517101.00
6229081-22908198.51798.99
30min1242839-242839104.43499.873.33105.08100.513.32
2238273-238273102.470103.13
3228243-22824398.15798.79
4221353-22135395.19495.81
5233822-233822100.556101.21
6228830-22883098.40999.05
极限1232168-23216899.84599.132.15100.6799.942.16
2236488-236488101.702102.54
3227946-22794698.02998.83
4222557-22255795.71196.49
5234215-234215100.725101.55
6229654-22965498.76399.57
盐酸奥洛他定口崩片项目信息
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%
111.062319882322642320332315512319832319640.12
211.092315032312272313650.09
单位质量响应值RSD%判断
20973.2420862.490.38数据可信
供试品溶液-771ABI批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204672-20467287.88590.192.3287.8990.192.32
2213161-21316191.53191.53
3207198-20719888.97088.97
4214809-21480992.23892.24
5205247-20524788.13288.13
6215126-21512692.37492.37
10min1218824-21882493.96297.673.0594.1197.823.05
2231866-23186699.56399.72
3222206-22220695.41595.56
4234598-234598100.736100.89
5222997-22299795.75495.90
6234310-234310100.612100.77
15min1220786-22078694.80598.582.9895.1198.902.98
2235591-235591101.162101.48
3224381-22438196.34896.66
4234074-234074100.511100.83
5225576-22557696.86297.17
6237093-237093101.807102.13
20min1221819-22181995.24899.063.0295.7199.543.01
2237930-237930102.166102.65
3225153-22515396.68097.15
4233727-233727100.362100.85
5227216-22721697.56698.03
6238317-238317102.333102.82
30min1223654-22365496.03699.142.8696.6699.782.86
2237248-237248101.874102.53
3225138-22513896.67497.30
4234442-234442100.669101.33
5226331-22633197.18697.82
6238501-238501102.412103.07
极限1223579-22357996.00499.242.8696.78100.052.86
2237415-237415101.945102.77
3225049-22504996.63597.43
4234852-234852100.845101.67
5227283-22728397.59598.39
6238565-238565102.439103.27
盐酸奥洛他定口崩片项目信息
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%
111.062307332313592312272316162314222312710.15
211.092336612339842338220.10
单位质量响应值RSD%判断
20910.5821084.040.59数据可信
供试品溶液-790ACE批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193088-19308882.59887.056.8482.6087.056.84
2189681-18968181.14181.14
3192399-19239982.30482.30
4206066-20606688.15088.15
5219321-21932193.82093.82
6220448-22044894.30294.30
10min1220092-22009294.15095.953.7894.2996.093.78
2216559-21655992.63992.77
3214594-21459491.79891.94
4227021-22702197.11497.26
5233853-233853100.037100.19
6233628-23362899.941100.10
15min1224098-22409895.86498.243.5596.1698.553.56
2222329-22232995.10795.40
3220693-22069394.40794.70
4234652-234652100.379100.69
5237526-237526101.608101.93
6238619-238619102.076102.40
20min1226942-22694297.08098.072.8197.5398.542.82
2224226-22422695.91996.37
3220636-22063694.38394.83
4231259-23125998.92799.40
5235998-235998100.954101.45
6236526-236526101.180101.67
30min1227112-22711297.15398.503.2197.7799.133.22
2224897-22489796.20696.81
3221047-22104794.55995.16
4231346-23134698.96499.61
5240757-240757102.990103.65
6236375-236375101.116101.78
极限1227085-22708597.14298.332.7097.9299.122.71
2225702-22570296.55097.32
3221328-22132894.67995.44
4231803-23180399.16099.97
5236843-236843101.316102.15
6236349-236349101.105101.94
盐酸奥洛他定口崩片项目信息
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%
111.062316952318192340502311742321732321820.48
211.092318632317002317820.05
单位质量响应值RSD%判断
20992.9520900.090.32数据可信
供试品溶液-790ACE批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180850-18085077.55087.056.1577.5587.056.15
2200085-20008585.79885.80
3202661-20266186.90386.90
4205100-20510087.94987.95
5213423-21342391.51891.52
6215889-21588992.57592.58
10min1209946-20994690.02795.813.2590.1695.963.25
2229713-22971398.50398.65
3224590-22459096.30696.45
4221818-22181895.11795.26
5229181-22918198.27598.43
6225418-22541896.66196.82
15min1219863-21986394.27998.452.6194.5698.752.62
2237293-237293101.753102.06
3228575-22857598.01598.32
4228229-22822997.86798.17
5234339-234339100.487100.80
6229225-22922598.29498.61
20min1219769-21976994.23998.032.4694.6898.502.46
2236841-236841101.559102.04
3229740-22974098.51498.98
4226525-22652597.13697.60
5230866-23086698.99799.48
6227911-22791197.73098.21
30min1220565-22056594.58098.442.6495.1799.072.64
2238055-238055102.080102.73
3229797-22979798.53999.17
4225730-22573096.79597.43
5233441-233441100.101100.75
6229814-22981498.54699.19
极限1222379-22237995.35898.392.5796.1199.182.57
2238861-238861102.426103.24
3229138-22913898.25699.05
4225223-22522396.57897.37
5233250-233250100.020100.84
6227822-22782297.69298.50
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