比拉斯汀口腔崩解片项目信息
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DIBSF0200923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%
111.21 3903743903983897383900243900263901120.08
211.233901033908273904650.14
单位质量响应值RSD%判断
34800.3634769.810.07数据可信
供试品溶液-24071501批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1386414-38641499.57898.071.3699.5898.071.36
2377965-37796597.40097.40
3387166-38716699.77199.77
4380345-38034598.01498.01
5376721-37672197.08097.08
6374806-37480696.58696.59
10min1389817-389817100.45599.061.12100.6299.221.12
2383522-38352298.83298.99
3387566-38756699.874100.04
4386305-38630599.55099.71
5378749-37874997.60297.76
6380478-38047898.04898.21
15min1389588-389588100.39698.991.26100.7399.321.26
2384966-38496699.20499.53
3387678-38767899.903100.24
4385833-38583399.42899.76
5379566-37956697.81398.14
6377147-37714797.19097.51
20min1388856-388856100.20799.011.08100.7199.511.09
2386081-38608199.49299.98
3386878-38687899.697100.20
4385184-38518499.26199.76
5380232-38023297.98598.47
6378132-37813297.44397.93
30min1387269-38726999.79898.860.86100.4799.520.86
2384056-38405698.97099.63
3385917-38591799.450100.11
4384957-38495799.20299.86
5381182-38118298.22998.88
6378387-37838797.50998.16
45min1390561-390561100.64698.711.24101.4899.541.24
2382746-38274698.63299.46
3384735-38473599.14599.98
4384334-38433499.04299.87
5378716-37871697.59498.41
6377305-37730597.23098.04
极限1386796-38679699.67698.801.47100.6899.791.46
2382658-38265898.61099.60
3392144-392144101.054102.05
4383580-38358098.84799.84
5378590-37859097.56198.54
6376636-37663697.05898.03
比拉斯汀口腔崩解片项目信息
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DIBSF0200923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%
111.21 3910643916153908973913733906673911230.10
211.233902733900803901760.04
单位质量响应值RSD%判断
34890.5434744.080.30数据可信
供试品溶液-24071502批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1377214-37721497.11797.680.6297.1297.680.61
2378686-37868697.49697.50
3378028-37802897.32797.33
4378392-37839297.42197.42
5383613-38361398.76598.76
6380386-38038697.93497.93
10min1383294-38329498.68395.718.4698.8495.888.44
2383354-38335498.69898.86
3383828-38382898.82098.98
4307879-30787979.26679.43
5389963-389963100.400100.56
6382273-38227398.42098.58
15min1382560-38256098.49499.070.8098.8299.390.80
2382184-38218498.39798.72
3389548-389548100.293100.62
4385099-38509999.14799.44
5387243-38724399.699100.03
6382169-38216998.39398.72
20min1382063-38206398.36698.710.3898.8699.200.39
2383252-38325298.67299.16
3384507-38450798.99599.49
4382831-38283198.56399.02
5385733-38573399.31199.81
6382095-38209598.37498.87
30min1380686-38068698.01198.510.5298.6799.160.52
2382265-38226598.41899.07
3381040-38104098.10298.76
4381684-38168498.26898.89
5385028-38502899.12999.79
6385085-38508599.14499.80
45min1380068-38006897.85298.320.6698.6799.140.64
2380615-38061597.99398.81
3381093-38109398.11698.94
4386466-38646699.499100.29
5382997-38299798.60699.43
6380047-38004797.84798.67
极限1379030-37903097.58598.040.3698.5799.020.36
2379984-37998497.83098.81
3381292-38129298.16799.15
4380487-38048797.96098.91
5383003-38300398.60899.60
6381056-38105698.10699.09
比拉斯汀口腔崩解片项目信息
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DIBSF0200923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%
111.21 3899973895033899093901413903523899800.09
211.233901393900653901020.02
单位质量响应值RSD%判断
34788.5834737.490.11数据可信
供试品溶液-24071501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%
5min1281896-28189672.69075.755.3472.6975.745.34
2285909-28590973.72573.72
3283532-28353273.11273.11
4286911-28691173.98373.98
5322161-32216183.07383.07
6302061-30206177.89077.89
10min1359962-35996292.82092.301.8392.9492.431.83
2349487-34948790.11990.24
3352224-35222490.82590.95
4357717-35771792.24192.36
5367884-36788494.86395.00
6360429-36042992.94093.07
15min1372424-37242496.03395.541.4096.3195.821.41
2362602-36260293.50193.77
3367511-36751194.76695.04
4369172-36917295.19595.47
5377045-37704597.22597.52
6374311-37431196.52096.80
20min1376209-37620997.00996.341.0297.4596.781.03
2366762-36676294.57395.00
3371635-37163595.83096.26
4374522-37452296.57497.01
5376072-37607296.97497.43
6376438-37643897.06897.51
30min1380367-38036798.08296.611.1298.6897.211.12
2368378-36837894.99095.58
3371702-37170295.84796.44
4375333-37533396.78397.38
5375152-37515296.73797.36
6377071-37707197.23297.84
45min1382324-38232498.58697.251.0899.3598.011.09
2370673-37067395.58296.33
3374467-37446796.56097.31
4378299-37829997.54898.31
5379496-37949697.85798.64
6377533-37753397.35198.12
极限1381912-38191298.48097.211.1199.4198.141.11
2370583-37058395.55996.46
3374426-37442696.55097.46
4377432-37743297.32598.25
5380813-38081398.19799.14
6376826-37682697.16898.10
比拉斯汀口腔崩解片项目信息
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DIBSF0200923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%
111.21 3907513907343898883906853905383905190.10
211.233906733899013902870.14
单位质量响应值RSD%判断
34836.6634753.960.17数据可信
供试品溶液-24071502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%
5min1289698-28969874.63278.344.0274.6378.344.02
2303838-30383878.27578.28
3291211-29121175.02275.02
4306455-30645578.94978.95
5321658-32165882.86682.87
6311642-31164280.28680.29
10min1353228-35322890.99993.301.9891.1293.431.98
2371383-37138395.67695.81
3355091-35509191.47991.60
4360504-36050492.87393.01
5367381-36738194.64594.78
6365324-36532494.11594.25
15min1366963-36696394.53796.291.4594.8196.581.45
2381209-38120998.20898.50
3369485-36948595.18795.46
4371439-37143995.69195.98
5375626-37562696.76997.07
6377871-37787197.34897.64
20min1369171-36917195.10696.381.4595.5496.821.45
2382910-38291098.64699.10
3368521-36852194.93995.37
4371874-37187495.80396.25
5376237-37623796.92797.38
6375972-37597296.85897.31
30min1368596-36859694.95896.481.5495.5597.081.54
2382600-38260098.56699.18
3369581-36958195.21295.81
4371761-37176195.77496.38
5374137-37413796.38697.00
6380263-38026397.96498.58
45min1370879-37087995.54696.481.1896.3097.251.18
2381665-38166598.32599.11
3370146-37014695.35796.11
4371857-37185795.79896.56
5376099-37609996.89197.67
6376326-37632696.95097.73
极限1367934-36793494.78896.131.4295.7097.061.42
2381957-38195798.40099.35
3368586-36858694.95695.87
4370471-37047195.44196.37
5375189-37518996.65797.60
6374667-37466796.52297.46
比拉斯汀口腔崩解片项目信息
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DIBSF0200923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%
111.21 3909103905723910933899333908503906720.12
211.233907173910323908740.06
单位质量响应值RSD%判断
34850.3134806.230.09数据可信
供试品溶液-24071501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%
5min1301336-30133677.55777.681.0377.5677.681.03
2305142-30514278.53778.54
3298592-29859276.85176.85
4306029-30602978.76578.76
5299272-29927277.02677.03
6300472-30047277.33577.33
10min1350506-35050690.21290.481.2590.3490.611.25
2358933-35893392.38192.51
3348577-34857789.71689.84
4354693-35469391.29091.42
5348319-34831989.64989.78
6348192-34819289.61789.75
15min1367965-36796594.70694.801.2294.9995.081.22
2375852-37585296.73697.02
3364377-36437793.78294.06
4371319-37131995.56995.85
5365314-36531494.02394.30
6365165-36516593.98594.26
20min1373737-37373796.19196.341.3696.6396.781.36
2383227-38322798.63499.08
3370158-37015895.27095.70
4376964-37696497.02297.46
5371403-37140395.59196.03
6370378-37037895.32795.76
30min1378035-37803597.29897.421.3397.9098.021.33
2387334-38733499.691100.30
3374074-37407496.27896.87
4381042-38104298.07298.68
5375774-37577496.71697.31
6374806-37480696.46797.06
45min1377983-37798397.28497.661.3898.0498.421.38
2389003-389003100.121100.90
3375085-37508596.53897.29
4381768-38176898.25899.03
5376519-37651996.90797.66
6376380-37638096.87297.63
极限1377924-37792497.26997.351.3798.1998.281.37
2387387-38738799.705100.65
3372770-37277095.94396.86
4380301-38030197.88198.81
5374723-37472396.44597.36
6376355-37635596.86597.78
比拉斯汀口腔崩解片项目信息
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DIBSF0200923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%
111.21 3906003905893906143901363894503902780.13
211.233887143884903886020.05
单位质量响应值RSD%判断
34815.1734603.920.44数据可信
供试品溶液-24071502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%
5min1300090-30009077.50175.911.3577.5075.911.35
2297603-29760376.85976.86
3292757-29275775.60775.61
4291584-29158475.30475.30
5290566-29056675.04275.04
6290979-29097975.14875.15
10min1350532-35053290.52888.661.1190.6688.791.11
2344561-34456188.98689.11
3341022-34102288.07288.20
4340682-34068287.98588.11
5341300-34130088.14488.27
6341726-34172688.25488.38
15min1367222-36722294.83993.051.0095.1293.331.00
2361270-36127093.30293.58
3358028-35802892.46492.74
4358620-35862092.61792.89
5358049-35804992.47092.74
6358652-35865292.62592.90
20min1373783-37378396.53394.910.8896.9795.340.88
2367777-36777794.98295.41
3366034-36603494.53294.96
4366555-36655594.66695.09
5364901-36490194.23994.67
6365917-36591794.50294.93
30min1377606-37760697.52095.900.8998.1296.480.89
2371881-37188196.04296.63
3369530-36953095.43596.02
4369140-36914095.33495.92
5370985-37098595.81196.39
6368764-36876495.23795.82
45min1378031-37803197.63096.240.7998.3996.990.79
2373654-37365496.50097.25
3369640-36964095.46396.21
4371166-37116695.85796.60
5371758-37175896.01096.75
6371701-37170195.99596.74
极限1379839-37983998.09796.210.9899.0297.120.98
2372158-37215896.11397.02
3370381-37038195.65596.56
4370950-37095095.80296.70
5371007-37100795.81696.72
6370842-37084295.77496.68
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