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%
110.882251222253382249182253822251182251760.09
210.922245812240152242980.18
单位质量响应值RSD%判断
20696.3220540.110.54数据可信
供试品溶液-25022101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%
5min1194384-19438484.68284.951.4584.6884.951.45
2198355-19835586.41186.41
3190413-19041382.95282.95
4197584-19758486.07686.08
5194694-19469484.81784.82
6194602-19460284.77684.78
10min1205493-20549389.52190.511.0189.6690.651.01
2210469-21046991.68991.83
3206785-20678590.08490.22
4210258-21025891.59791.74
5206957-20695790.15990.30
6206602-20660290.00490.15
15min1210356-21035691.64092.931.2291.9393.221.21
2216084-21608494.13594.43
3210166-21016691.55791.85
4214717-21471793.53993.84
5213047-21304792.81293.10
6215548-21554893.90194.19
20min1215651-21565193.94694.561.3694.3995.001.35
2219813-21981395.75996.21
3213078-21307892.82593.27
4221106-22110696.32396.77
5216731-21673194.41794.86
6215955-21595594.07994.53
30min1217981-21798194.96195.891.1795.5696.501.17
2223494-22349497.36397.98
3216655-21665594.38494.98
4222281-22228196.83597.45
5220606-22060696.10596.71
6219661-21966195.69396.30
极限1223496-22349697.36498.311.5298.1299.071.52
2231486-231486100.845101.62
3222082-22208296.74897.50
4227822-22782299.248100.02
5224455-22445597.78298.55
6224599-22459997.84498.61
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%
110.882252172251672254592252012252942252680.06
210.922238932243722241320.16
单位质量响应值RSD%判断
20704.7820524.910.62数据可信
供试品溶液-25022101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%
5min1216823-21682394.47393.700.9294.4793.700.92
2215179-21517993.75693.76
3211258-21125892.04892.05
4215722-21572293.99393.99
5216271-21627194.23294.23
6215003-21500393.68093.68
10min1235313-235313102.529101.951.01102.69102.111.01
2235649-235649102.676102.83
3230356-230356100.369100.52
4234504-234504102.177102.33
5236286-236286102.953103.11
6231848-231848101.019101.18
15min1238393-238393103.871102.811.04104.20103.141.04
2237367-237367103.424103.75
3232625-232625101.358101.68
4236175-236175102.905103.23
5237919-237919103.665103.99
6233280-233280101.643101.97
20min1237826-237826103.624102.711.11104.13103.211.11
2237428-237428103.451103.95
3231663-231663100.939101.43
4236326-236326102.970103.47
5237810-237810103.617104.12
6233340-233340101.669102.16
30min1238313-238313103.836102.741.13104.51103.401.13
2237455-237455103.462104.13
3231918-231918101.050101.71
4236068-236068102.858103.53
5237834-237834103.628104.30
6233149-233149101.586102.25
极限1238785-238785104.042102.851.24104.89103.691.24
2238549-238549103.939104.78
3232206-232206101.175102.00
4235874-235874102.774103.62
5238061-238061103.726104.57
6232854-232854101.458102.29
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%
110.882246702249072249142251432244352248140.13
210.922242232238822240520.11
单位质量响应值RSD%判断
20663.0520517.580.50数据可信
供试品溶液-25022101批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1184784-18478480.60879.990.6280.6179.990.62
2183685-18368580.12980.13
3183845-18384580.19980.20
4183533-18353380.06380.06
5181389-18138979.12779.13
6182977-18297779.82079.82
10min1204318-20431889.13088.050.8289.2688.180.81
2200377-20037787.41087.54
3202599-20259988.38088.51
4199974-19997487.23587.37
5201163-20116387.75387.89
6202606-20260688.38388.52
15min1213065-21306592.94591.600.8593.2391.880.85
2208388-20838890.90591.18
3209733-20973391.49291.77
4208235-20823590.83891.12
5209768-20976891.50791.79
6210636-21063691.88692.17
20min1217481-21748194.87293.300.9495.3193.730.94
2211924-21192492.44892.88
3213209-21320993.00893.44
4213118-21311892.96893.40
5212678-21267892.77793.21
6214817-21481793.71094.14
30min1222691-22269197.14495.460.9697.7496.050.96
2217316-21731694.80095.38
3218392-21839295.26995.86
4217487-21748794.87495.46
5217465-21746594.86595.45
6219667-21966795.82596.41
极限1230529-230529100.56498.521.12101.3299.271.12
2224408-22440897.89398.64
3225436-22543698.34299.09
4225360-22536098.30999.05
5223168-22316897.35398.10
6226232-22623298.68999.44
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%
110.882253402252372256482256212255682254830.09
210.922245702248652247180.10
单位质量响应值RSD%判断
20724.5420578.570.50数据可信
供试品溶液-25022101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%
5min1237569-237569103.327102.391.41103.33102.391.41
2235235-235235102.312102.31
3232429-232429101.092101.09
4231755-231755100.799100.80
5240669-240669104.676104.68
6234819-234819102.131102.13
10min1237156-237156103.148102.611.25103.32102.781.25
2234759-234759102.105102.28
3233788-233788101.683101.85
4233002-233002101.341101.51
5241159-241159104.889105.06
6235712-235712102.520102.69
15min1239289-239289104.075102.671.42104.42103.021.42
2234536-234536102.008102.35
3233292-233292101.467101.81
4233159-233159101.409101.75
5241168-241168104.893105.24
6234966-234966102.195102.54
20min1238655-238655103.800102.401.43104.32102.911.43
2234129-234129101.831102.34
3232774-232774101.242101.75
4231843-231843100.837101.34
5240354-240354104.539105.06
6234853-234853102.146102.66
30min1236008-236008102.648101.951.31103.34102.631.31
2233266-233266101.456102.14
3231864-231864100.846101.52
4231224-231224100.568101.24
5239528-239528104.179104.88
6234470-234470101.980102.66
极限1235010-235010102.214101.841.07103.08102.691.07
2232837-232837101.269102.12
3231986-231986100.899101.74
4232574-232574101.155102.00
5238775-238775103.852104.72
6233684-233684101.638102.49
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