贝派度酸片项目信息
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BEMA-231010D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.273111643114603115483117173115433114860.07
210.243116703117043116870.01
单位质量响应值RSD%判断
30329.7030438.180.26数据可信
供试品溶液-1996054批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168702-6870222.54822.647.8322.5522.647.82
277672-7767225.49225.49
363396-6339620.80720.81
471698-7169823.53123.53
563380-6338020.80120.80
669018-6901822.65222.65
10min1205195-20519567.34565.434.3067.3865.474.30
2209797-20979768.85668.90
3191963-19196363.00263.04
4198952-19895265.29665.34
5186977-18697761.36661.40
6203304-20330466.72566.76
15min1259584-25958485.19684.501.1485.3584.651.14
2255841-25584183.96784.12
3254309-25430983.46483.60
4258654-25865484.89085.04
5254873-25487383.65083.79
6261604-26160485.85986.01
20min1277702-27770291.14290.910.9391.4391.190.93
2273111-27311189.63589.93
3275572-27557290.44390.72
4278228-27822891.31591.60
5276568-27656890.77091.05
6280711-28071192.13092.42
30min1289357-28935794.96794.731.0295.4195.161.02
2283200-28320092.94693.39
3288154-28815494.57295.00
4290034-29003495.18995.63
5289113-28911394.88795.31
6291903-29190395.80396.25
45min1293714-29371496.39796.031.0897.0096.631.07
2286679-28667994.08894.69
3292078-29207895.86096.45
4293612-29361296.36496.96
5293748-29374896.40896.99
6295813-29581397.08697.69
60min1294623-29462396.69596.281.0797.4697.041.06
2287307-28730794.29495.05
3293168-29316896.21896.96
4294032-29403296.50297.26
5294845-29484596.76897.51
6296175-29617597.20597.97
极限1295036-29503696.83196.590.8597.7597.500.84
2289717-28971795.08596.00
3293924-29392496.46697.37
4294906-29490696.78897.71
5295019-29501996.82597.73
6297158-29715897.52798.46
贝派度酸片项目信息
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BEMA-231010D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.273108673113573115803116023112283113270.10
210.243119123116103117610.07
单位质量响应值RSD%判断
30314.2230445.410.31数据可信
供试品溶液-1996054批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165893-6589321.62924.508.6621.6324.508.66
277341-7734125.38725.39
384186-8418627.63427.63
473493-7349324.12424.12
569611-6961122.85022.85
677340-7734025.38725.39
10min1202811-20281166.57268.032.6066.6168.072.61
2207875-20787568.23468.28
3217135-21713571.27471.32
4207392-20739268.07668.12
5202132-20213266.34966.39
6206188-20618867.68067.72
15min1260131-26013185.38785.271.1185.5385.421.11
2256290-25629084.12684.28
3263150-26315086.37886.54
4262772-26277286.25486.41
5259324-25932485.12285.27
6256920-25692084.33384.49
20min1278473-27847391.40891.191.2091.7091.491.20
2273286-27328689.70590.00
3280217-28021791.98092.29
4281805-28180592.50192.80
5278776-27877691.50791.80
6274353-27435390.05590.35
30min1291879-29187995.80895.001.3996.2595.451.39
2284257-28425793.30693.75
3291352-29135295.63596.10
4293668-29366896.39596.85
5290853-29085395.47195.91
6284536-28453693.39893.84
45min1296071-29607197.18496.291.3597.7996.891.35
2287933-28793394.51395.11
3294967-29496796.82297.44
4297601-29760197.68698.30
5294484-29448496.66397.27
6288955-28895594.84895.45
60min1297855-29785597.77096.741.3998.5397.501.39
2289101-28910194.89695.65
3296615-29661597.36398.15
4298699-29869998.04798.82
5295912-29591297.13297.90
6290092-29009295.22195.98
极限1298244-29824497.89796.861.4498.8297.781.43
2289684-28968495.08896.00
3297294-29729497.58698.53
4299157-29915798.19799.14
5296187-29618797.22298.15
6289864-28986495.14796.06
贝派度酸片项目信息
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BEMA-231010D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.273111243110183110333109143111433110460.03
210.243112783113283113030.02
单位质量响应值RSD%判断
30286.8530400.680.27数据可信
供试品溶液-1996054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%
5min1108380-10838035.61729.5413.3235.6229.5413.32
292358-9235830.35230.35
387321-8732128.69728.70
482773-8277327.20227.20
573140-7314024.03624.04
695437-9543731.36431.36
10min1250470-25047082.31377.403.4682.3777.453.47
2235451-23545177.37877.43
3233132-23313276.61576.66
4229049-22904975.27475.32
5227889-22788974.89274.93
6237084-23708477.91477.97
15min1284275-28427593.42393.200.3293.6293.380.31
2282193-28219392.73992.92
3284382-28438293.45893.63
4284134-28413493.37693.55
5283770-28377093.25793.42
6282877-28287792.96393.15
20min1289581-28958195.16795.640.5695.5295.980.55
2289283-28928395.06995.40
3291752-29175295.88096.21
4293386-29338696.41796.74
5292076-29207695.98696.31
6290073-29007395.32895.67
30min1290856-29085695.58696.170.5896.1096.660.57
2290922-29092295.60796.10
3293361-29336196.40996.90
4295108-29510896.98397.47
5293652-29365296.50496.98
6291918-29191895.93596.43
45min1291387-29138795.76096.170.4796.4396.820.46
2291519-29151995.80396.46
3292647-29264796.17496.83
4294599-29459996.81697.46
5293921-29392196.59397.23
6291709-29170995.86696.52
60min1290290-29029095.40096.050.5796.2396.860.55
2290856-29085695.58696.40
3292899-29289996.25797.07
4294730-29473096.85997.67
5293121-29312196.33097.13
6291686-29168695.85896.67
极限1290997-29099795.63296.080.4496.6297.060.43
2290885-29088595.59596.57
3292919-29291996.26497.24
4294076-29407696.64497.62
5293180-29318096.34997.31
6292171-29217196.01896.99
贝派度酸片项目信息
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BEMA-231010D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.273123173122433123323119453114483120570.13
210.243131033130393130710.02
单位质量响应值RSD%判断
30385.3030573.340.44数据可信
供试品溶液-1996054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%
5min181385-8138526.62730.589.6926.6330.589.69
2105319-10531934.45834.46
390843-9084329.72229.72
497523-9752331.90731.91
599897-9989732.68432.68
685829-8582928.08128.08
10min1238666-23866678.08680.353.8878.1380.403.88
2258587-25858784.60384.66
3242806-24280679.44079.49
4252849-25284982.72682.78
5248000-24800081.14081.19
6232567-23256776.09076.14
15min1281470-28147092.09093.100.8492.2693.280.84
2285549-28554993.42593.62
3283009-28300992.59492.78
4288250-28825094.30894.50
5283690-28369092.81693.01
6285374-28537493.36793.54
20min1288789-28878994.48595.210.7794.8195.550.77
2289606-28960694.75295.11
3289720-28972094.78995.13
4293626-29362696.06796.42
5290256-29025694.96595.31
6293968-29396896.17996.51
30min1290536-29053695.05695.730.8195.5496.230.80
2291095-29109595.23995.75
3290994-29099495.20695.70
4295611-29561196.71797.23
5291750-29175095.45495.96
6295517-29551796.68697.18
45min1291482-29148295.36696.060.7796.0196.720.77
2292367-29236795.65596.33
3292275-29227595.62596.28
4296530-29653097.01797.69
5292627-29262795.74096.40
6296426-29642696.98397.63
60min1290933-29093395.18695.890.7695.9996.710.75
2292197-29219795.60096.43
3291844-29184495.48496.30
4295709-29570996.74997.58
5291809-29180995.47396.29
6296048-29604896.86097.67
极限1291070-29107095.23195.790.7696.1996.770.76
2291500-29150095.37296.36
3291274-29127495.29896.27
4295546-29554696.69597.69
5291660-29166095.42496.40
6295691-29569196.74397.72
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