托伐普坦口崩片项目信息
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101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.457965277972297959837961057962237964130.07
216.528035308039908037600.05
单位质量响应值RSD%判断
48414.1648653.750.35数据可信
供试品溶液-3G80SDA2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%
5min174293-742939.1859.192.249.189.192.23
271817-718178.8788.88
373757-737579.1189.12
473988-739889.1479.15
575419-754199.3249.32
676756-767569.4899.49
10min1147561-14756118.24218.150.6118.2618.160.61
2145171-14517117.94717.96
3146441-14644118.10418.12
4147224-14722418.20118.22
5147146-14714618.19118.21
6147280-14728018.20818.22
15min1204361-20436125.26424.890.8725.3124.930.87
2199587-19958724.67424.72
3202039-20203924.97725.02
4201321-20132124.88824.93
5199911-19991124.71424.76
6200604-20060424.80024.85
20min1244436-24443630.21929.820.8930.3129.910.90
2238752-23875229.51629.60
3242834-24283430.02030.11
4240650-24065029.75029.84
5241291-24129129.83029.92
6239312-23931229.58529.67
30min1301562-30156237.28136.880.7937.4237.020.79
2297327-29732736.75736.89
3300875-30087537.19637.33
4295688-29568836.55536.69
5297434-29743436.77036.91
6297053-29705336.72336.86
45min1356132-35613244.02743.760.6944.2343.960.69
2357652-35765244.21544.41
3350968-35096843.38943.59
4353068-35306843.64843.85
5352897-35289743.62743.83
6353263-35326343.67243.87
60min1393885-39388548.69448.250.8348.9748.520.83
2393484-39348448.64548.91
3388366-38836648.01248.28
4390660-39066048.29648.57
5390030-39003048.21848.49
6385280-38528047.63047.90
90min1434687-43468753.73853.121.2054.0953.471.19
2427386-42738652.83653.19
3434564-43456453.72354.07
4426865-42686552.77153.12
5432853-43285353.51253.86
6421956-42195652.16552.51
120min1426370-42637052.71055.432.7653.1555.872.74
2454763-45476356.22056.66
3457059-45705956.50456.95
4460565-46056556.93857.38
5445677-44567755.09755.54
6445572-44557255.08455.52
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1485919-48591960.07259.091.5960.6059.631.58
2478933-47893359.20859.74
3475677-47567758.80659.34
4481629-48162959.54260.08
5481731-48173159.55460.09
6464138-46413857.37957.91
240min1494052-49405261.07760.310.6761.7160.940.66
2485865-48586560.06560.70
3488298-48829860.36661.00
4485618-48561860.03560.67
5487680-48768060.29060.92
6485624-48562460.03660.66
300min1498152-49815261.58460.761.0962.3261.491.08
2495915-49591561.30862.04
3492741-49274160.91561.65
4487650-48765060.28661.02
5490625-49062560.65461.39
6483711-48371159.79960.52
360min1477491-47749159.03060.991.9759.8761.831.94
2501901-50190162.04862.88
3502605-50260562.13562.97
4498880-49888061.67462.51
5490456-49045660.63361.47
6488898-48889860.44061.26
极限1492140-49214060.84161.291.6761.7862.231.65
2499266-49926661.72262.66
3495577-49557761.26662.20
4502410-50241062.11163.05
5503885-50388562.29363.23
6481507-48150759.52760.45
托伐普坦口崩片项目信息
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101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.457972367971247983237960377949077967250.17
216.528039458037018038230.03
单位质量响应值RSD%判断
48433.1348657.570.33数据可信
供试品溶液-3G80SDA2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%
5min178574-785749.7119.173.909.719.173.89
275917-759179.3839.38
372612-726128.9758.97
470363-703638.6978.70
572842-728429.0039.00
675028-750289.2739.27
10min1149747-14974718.50818.172.7718.5218.182.77
2151455-15145518.71918.73
3145222-14522217.94917.96
4139959-13995917.29817.31
5147065-14706518.17718.19
6148582-14858218.36418.38
15min1202662-20266225.04824.901.8425.1024.941.84
2206487-20648725.52125.57
3200062-20006224.72724.77
4195576-19557624.17224.22
5200487-20048724.77924.82
6203412-20341225.14125.19
20min1242592-24259229.98429.981.1230.0730.071.12
2246467-24646730.46230.55
3241410-24141029.83729.92
4238294-23829429.45229.54
5243794-24379430.13230.22
6242925-24292530.02530.11
30min1300980-30098037.20036.971.1037.3437.111.10
2304088-30408837.58437.72
3297781-29778136.80536.94
4294337-29433736.37936.51
5299257-29925736.98737.12
6298297-29829736.86837.01
45min1350850-35085043.36443.691.0243.5643.891.02
2359065-35906544.37944.58
3352680-35268043.59043.79
4348824-34882443.11343.31
5354080-35408043.76343.96
6355434-35543443.93044.13
60min1392567-39256748.52048.200.5248.7948.480.52
2390255-39025548.23448.51
3391975-39197548.44748.72
4387339-38733947.87448.14
5389278-38927848.11348.38
6388697-38869748.04248.31
90min1430498-43049853.20853.340.6553.5653.700.65
2432144-43214453.41153.77
3429291-42929153.05953.41
4428612-42861252.97553.32
5432798-43279853.49253.84
6436292-43629253.92454.28
120min1441973-44197354.62655.721.2555.0756.161.24
2458491-45849156.66857.11
3453452-45345256.04556.48
4451930-45193055.85756.29
5447347-44734755.29055.73
6451923-45192355.85656.30
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1476840-47684058.93658.182.4659.4758.722.43
2453732-45373256.08056.62
3482616-48261659.65060.18
4459232-45923256.75957.29
5478409-47840959.13059.66
6473749-47374958.55459.09
240min1472145-47214558.35560.251.6858.9960.881.66
2495625-49562561.25761.89
3492884-49288460.91961.55
4487746-48774660.28460.90
5487902-48790260.30360.93
6488320-48832060.35560.99
300min1499965-49996561.79459.633.1262.5260.363.08
2483882-48388259.80660.54
3489581-48958160.51061.24
4461557-46155757.04757.77
5492616-49261660.88661.62
6467284-46728457.75558.49
360min1486987-48698760.19061.431.2461.0262.261.22
2505500-50550062.47863.31
3500280-50028061.83362.67
4498247-49824761.58262.40
5495591-49559161.25362.09
6495751-49575161.27362.10
极限1470690-47069058.17660.241.9159.1161.171.88
2490671-49067160.64561.59
3496945-49694561.42162.36
4493345-49334560.97661.89
5483620-48362059.77460.71
6489027-48902760.44261.37
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