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 3906043905623905623906113902863905250.04
211.233912583914133913360.03
单位质量响应值RSD%判断
34837.2034847.370.03数据可信
供试品溶液-24031901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%
5min1265755-26575568.37266.452.8568.3766.442.85
2264123-26412367.95267.95
3247136-24713663.58263.58
4254918-25491865.58465.58
5254179-25417965.39465.39
6263481-26348167.78767.79
10min1325836-32583683.82982.954.4583.9483.064.44
2325506-32550683.74483.86
3307598-30759879.13779.24
4314526-31452680.91981.03
5313302-31330280.60480.71
6347685-34768589.45089.56
15min1349118-34911889.81988.241.8490.0788.481.84
2347358-34735889.36689.62
3331974-33197485.40885.65
4339580-33958087.36587.61
5344531-34453188.63988.88
6345238-34523888.82189.08
20min1358972-35897292.35490.571.8892.7690.971.89
2359131-35913192.39592.80
3343562-34356288.38988.77
4350875-35087590.27190.66
5345547-34554788.90089.29
6354248-35424891.13991.55
30min1365963-36596394.15392.461.7694.7193.011.76
2365046-36504693.91794.47
3350261-35026190.11390.64
4359817-35981792.57193.11
5353514-35351490.95091.49
6361695-36169593.05593.62
45min1367170-36717094.46392.851.8095.1893.551.80
2366629-36662994.32495.04
3351146-35114690.34191.02
4362343-36234393.22193.92
5354976-35497691.32692.02
6363049-36304993.40394.12
极限1367036-36703694.42992.971.6195.3093.821.61
2366424-36642494.27195.14
3353072-35307290.83691.66
4362200-36220093.18494.03
5355507-35550791.46392.31
6363975-36397593.64194.51
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 3913163913003914003917393919403915390.08
211.233912473912203912340.01
单位质量响应值RSD%判断
34927.6534838.290.19数据可信
供试品溶液-24031903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%
5min1316493-31649381.33079.121.5181.3379.121.51
2306830-30683078.84778.85
3302318-30231877.68877.69
4306968-30696878.88378.88
5307175-30717578.93678.94
6307448-30744879.00679.01
10min1359556-35955692.39787.272.9192.5387.402.90
2337216-33721686.65686.79
3335340-33534086.17486.30
4334989-33498986.08386.21
5333658-33365885.74185.87
6336955-33695586.58986.72
15min1349238-34923889.74587.831.1090.0388.111.10
2340995-34099587.62787.90
3340662-34066287.54187.81
4340243-34024387.43487.71
5338823-33882387.06987.34
6340850-34085087.59087.87
20min1348952-34895289.67288.281.3290.1188.711.32
2340830-34083087.58488.01
3340973-34097387.62188.04
4349821-34982189.89590.32
5340414-34041487.47887.90
6340334-34033487.45787.88
30min1349466-34946689.80487.991.0590.3988.561.05
2341571-34157187.77588.34
3341223-34122387.68588.25
4341494-34149487.75588.33
5339305-33930587.19387.76
6341335-34133587.71488.28
45min1348327-34832789.51188.061.0190.2588.781.01
2341662-34166287.79888.51
3341173-34117387.67388.38
4340647-34064787.53788.25
5339016-33901687.11887.83
6345270-34527088.72589.44
极限1347968-34796889.41987.971.0890.3188.841.08
2345903-34590388.88889.75
3340178-34017887.41788.27
4340829-34082987.58488.45
5338798-33879887.06287.92
6340390-34039087.47188.33
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