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%
111.012316062318912317312312602317712316520.11
211.002313262310382311820.09
单位质量响应值RSD%判断
21040.1521016.550.08数据可信
供试品溶液-777ABL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%
5min1200131-20013185.48486.331.7785.4886.331.77
2204682-20468287.42787.43
3199313-19931385.13485.13
4204696-20469687.43387.43
5197537-19753784.37684.38
6206282-20628288.11188.11
10min1211223-21122390.22190.841.6090.3690.991.60
2215773-21577392.16592.31
3208747-20874789.16489.31
4214731-21473191.72091.87
5209176-20917689.34789.49
6216438-21643892.44992.60
15min1214969-21496991.82192.971.4692.1193.261.46
2220207-22020794.05994.36
3214083-21408391.44391.73
4219024-21902493.55393.85
5215737-21573792.14992.44
6221909-22190994.78695.09
20min1216625-21662592.52993.641.5892.9794.081.58
2221967-22196794.81195.27
3216126-21612692.31692.76
4221311-22131194.53094.98
5215701-21570192.13492.58
6223563-22356395.49295.95
30min1220357-22035794.12394.961.6294.7295.561.62
2225306-22530696.23796.85
3219149-21914993.60794.20
4224470-22447095.88096.49
5217996-21799693.11493.71
6226584-22658496.78397.40
45min1221748-22174894.71795.661.5795.4796.421.57
2226572-22657296.77797.55
3220779-22077994.30395.06
4225959-22595996.51697.29
5220144-22014494.03294.78
6228505-22850597.60398.38
60min1222893-22289395.20696.341.4896.1297.261.48
2227318-22731897.09698.03
3223862-22386295.62096.53
4226991-22699196.95697.89
5221641-22164194.67195.58
6230528-23052898.46799.41
极限1223233-22323395.35196.671.4996.4297.761.49
2227685-22768597.25398.35
3225534-22553496.33497.40
4230036-23003698.25799.35
5221880-22188094.77395.84
6229611-22961198.07699.18
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%
111.012310312320292310372313432308072312490.21
211.002315892309452312670.20
单位质量响应值RSD%判断
21003.5421024.270.07数据可信
供试品溶液-777ABL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%
5min1203799-20379987.11087.011.5087.1187.011.50
2205786-20578687.95987.96
3207247-20724788.58488.58
4203980-20398087.18787.19
5202034-20203486.35686.36
6198555-19855584.86984.87
10min1212370-21237090.77491.491.4590.9291.641.45
2216008-21600892.32992.48
3218669-21866993.46693.61
4214774-21477491.80191.95
5212563-21256390.85691.00
6209878-20987889.70889.85
15min1216285-21628592.44793.221.6092.7493.511.60
2219641-21964193.88194.18
3222486-22248695.09795.40
4220689-22068994.32994.63
5216443-21644392.51592.81
6212978-21297891.03391.32
20min1219210-21921093.69794.261.2694.1594.721.26
2222246-22224694.99595.45
3224646-22464696.02196.48
4221263-22126394.57595.03
5218990-21899093.60394.05
6216837-21683792.68393.13
30min1222271-22227195.00695.431.3995.6196.041.39
2225190-22519096.25396.87
3227533-22753397.25597.88
4224299-22429995.87296.49
5221654-22165494.74295.35
6218645-21864593.45694.05
45min1223717-22371795.62496.221.3896.3996.991.38
2227241-22724197.13097.91
3229513-22951398.10198.89
4225852-22585296.53697.31
5223626-22362695.58596.35
6220736-22073694.34995.10
60min1224652-22465296.02396.701.4796.9597.631.47
2228870-22887097.82698.76
3230470-23047098.51099.46
4227525-22752597.25198.19
5224364-22436495.90096.82
6221543-22154394.69495.60
极限1224611-22461196.00696.831.4297.0997.921.42
2229238-22923897.98499.08
3230500-23050098.52399.63
4227678-22767897.31798.41
5225358-22535896.32597.41
6221820-22182094.81395.88
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%
111.012312122312042313852317852308832312940.15
211.002316522314682315600.06
单位质量响应值RSD%判断
21007.6321050.910.15数据可信
供试品溶液-777ABL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%
5min1214112-21411291.45193.231.5791.4593.231.57
2221506-22150694.61094.61
3214476-21447691.60791.61
4217471-21747192.88692.89
5220758-22075894.29094.29
6221330-22133094.53494.53
10min1225053-22505396.12597.641.7996.2897.801.79
2234227-234227100.043100.20
3223960-22396095.65895.81
4226265-22626596.64296.80
5230903-23090398.62398.78
6231197-23119798.74998.91
15min1226305-22630596.65998.131.8896.9798.451.88
2235675-235675100.661100.99
3224416-22441695.85296.16
4227576-22757697.20297.52
5232270-23227099.20799.53
6232254-23225499.20099.52
20min1226742-22674296.84698.241.9197.3298.721.91
2236803-236803101.143101.64
3224874-22487496.04896.52
4227750-22775097.27697.75
5232178-23217899.16899.65
6231643-23164398.93999.43
30min1226084-22608496.56598.181.9197.2098.831.91
2236337-236337100.944101.60
3224964-22496496.08696.72
4227523-22752397.17997.82
5232392-23239299.25999.91
6231928-23192899.06199.71
45min1226492-22649296.73998.001.9697.5498.811.96
2236027-236027100.812101.64
3223756-22375695.57196.36
4227018-22701896.96497.77
5231688-23168898.95899.78
6231709-23170998.96799.78
60min1226038-22603896.54597.801.8497.5098.771.84
2235031-235031100.386101.38
3223920-22392095.64196.59
4226324-22632496.66797.63
5231188-23118898.74599.73
6231300-23130098.79399.78
极限1225168-22516896.17497.751.8797.2998.881.87
2234919-234919100.338101.50
3223930-22393095.64596.76
4226756-22675696.85297.98
5230388-23038898.40399.55
6231939-23193999.066100.21
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%
111.012308312311022311952315902316222312680.15
211.002307002315882311440.28
单位质量响应值RSD%判断
21005.2721013.090.03数据可信
供试品溶液-777ABL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%
5min1213619-21361991.32893.923.0091.3393.922.99
2216235-21623592.44692.45
3222212-22221295.00295.00
4215488-21548892.12792.13
5218869-21886993.57293.57
6231622-23162299.02599.02
10min1226387-22638796.78798.182.0796.9498.342.07
2229907-22990798.29298.45
3230924-23092498.72698.88
4225140-22514096.25496.41
5227268-22726897.16397.32
6238281-238281101.872102.04
15min1228395-22839597.64598.982.1597.9699.302.15
2231503-23150398.97499.29
3232456-23245699.38199.70
4226477-22647796.82597.14
5229591-22959198.15698.47
6240636-240636102.878103.21
20min1228703-22870397.77798.932.1898.2599.422.18
2231240-23124098.86199.34
3231971-23197199.17499.66
4226380-22638096.78497.26
5229327-22932798.04498.53
6240842-240842102.967103.47
30min1228427-22842797.65999.182.5598.3099.842.55
2231037-23103798.77599.42
3234468-234468100.241100.90
4225960-22596096.60497.24
5229492-22949298.11498.76
6242585-242585103.712104.39
45min1227857-22785797.41598.872.2298.2299.692.23
2231252-23125298.86799.68
3232476-23247699.390100.21
4225930-22593096.59197.39
5229457-22945798.09998.91
6240589-240589102.858103.71
60min1227745-22774597.36798.742.2898.3399.722.28
2231694-23169499.056100.03
3231683-23168399.051100.04
4225263-22526396.30697.26
5228877-22887797.85198.82
6240457-240457102.802103.82
极限1227159-22715997.11798.412.2598.2499.552.26
2230496-23049698.54399.69
3230941-23094198.73499.89
4224321-22432195.90397.02
5228620-22862097.74198.88
6239527-239527102.404103.60
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