利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
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%
111.754784234809724779444772864760334781320.39
211.754782314784064783180.03
单位质量响应值RSD%判断
40692.0940707.910.03数据可信
长期24月-供试品溶液-2024010711批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1342996-34299662.95361.624.7262.9561.624.72
2344371-34437163.20563.21
3344047-34404763.14663.15
4337349-33734961.91661.92
5341899-34189962.75162.75
6303841-30384155.76655.77
10min1396037-39603772.68872.530.9872.8372.670.99
2399543-39954373.33173.47
3397284-39728472.91773.06
4393446-39344672.21272.35
5396495-39649572.77272.91
6388413-38841371.28971.41
15min1421436-42143677.35077.210.3577.6577.500.36
2422312-42231277.51077.81
3421845-42184577.42577.73
4419058-41905876.91377.21
5420467-42046777.17277.47
6418841-41884176.87377.16
20min1435911-43591180.00678.593.6280.4879.063.60
2435985-43598580.02080.50
3435425-43542579.91780.39
4430386-43038678.99279.46
5396892-39689272.84573.32
6434544-43454479.75580.21
30min1450723-45072382.72582.770.3783.3883.420.36
2452286-45228683.01283.67
3451050-45105082.78583.44
4447990-44799082.22382.87
5451309-45130982.83283.47
6452577-45257783.06583.70
45min1461649-46164984.73085.140.4285.5785.980.41
2464484-46448485.25186.09
3465468-46546885.43186.27
4462949-46294984.96985.80
5462350-46235084.85985.68
6466546-46654685.62986.44
60min1476230-47623087.40686.670.6488.4387.690.64
2473188-47318886.84887.88
3472572-47257286.73587.76
4467171-46717185.74486.76
5470886-47088686.42687.43
6473247-47324786.85987.86
极限1471899-47189986.61187.460.8187.8388.670.79
2478040-47804087.73988.96
3476430-47643087.44388.66
4473636-47363686.93088.14
5476167-47616787.39588.59
6482906-48290688.63289.83
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
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%
111.754786144785454787294788504790794787630.05
211.754799274804874802070.09
单位质量响应值RSD%判断
40745.7940868.680.22数据可信
长期24月-供试品溶液-2024010811批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1301873-30187355.26057.805.1355.2657.805.13
2302757-30275755.42255.42
3301051-30105155.10955.11
4323327-32332759.18759.19
5325856-32585659.65059.65
6339672-33967262.17962.18
10min1371526-37152668.01070.583.4668.1370.703.46
2377432-37743269.09169.21
3371708-37170868.04368.17
4396975-39697572.66972.80
5397328-39732872.73372.87
6398307-39830772.91373.05
15min1408614-40861474.79976.632.2775.0776.912.28
2412017-41201775.42275.70
3409892-40989275.03375.31
4425672-42567277.92278.21
5430571-43057178.81979.11
6424778-42477877.75878.06
20min1431691-43169179.02479.701.4679.4680.151.47
2429648-42964878.65079.09
3428829-42882978.50078.94
4438463-43846380.26380.73
5444944-44494481.45081.92
6438695-43869580.30680.78
30min1454364-45436483.17483.151.4383.7983.791.44
2446806-44680681.79182.41
3449839-44983982.34682.96
4454190-45419083.14283.79
5465908-46590885.28785.94
6454363-45436383.17483.83
45min1469482-46948285.94285.631.2686.7486.441.26
2459437-45943784.10384.90
3464962-46496285.11485.91
4468916-46891685.83886.67
5477209-47720987.35688.20
6466620-46662085.41886.25
60min1474392-47439286.84086.641.3087.8387.651.30
2465309-46530985.17886.17
3472574-47257486.50887.49
4471682-47168286.34487.36
5484171-48417188.63189.66
6471812-47181286.36887.39
极限1480175-48017587.89987.361.4589.0888.561.44
2468309-46830985.72786.90
3476056-47605687.14588.32
4478077-47807787.51588.73
5488329-48832989.39290.62
6472343-47234386.46587.68
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
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%
111.754775164774874767304759114773744770040.15
211.754813584807084810330.10
单位质量响应值RSD%判断
40596.0940938.980.60数据可信
长期24月-供试品溶液-2024010911批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1360728-36072866.09967.073.4666.1067.073.46
2356981-35698165.41265.41
3357589-35758965.52465.52
4390492-39049271.55371.55
5362135-36213566.35766.36
6368176-36817667.46467.46
10min1414785-41478576.00476.171.4076.1576.321.40
2412473-41247375.58075.73
3410685-41068575.25375.40
4426652-42665278.17978.34
5412582-41258275.60075.75
6416819-41681976.37776.53
15min1437411-43741180.15080.310.6180.4780.620.61
2438975-43897580.43780.75
3437395-43739580.14780.46
4443237-44323781.21881.55
5435919-43591979.87780.19
6436630-43663080.00780.33
20min1451918-45191882.80882.150.8983.3082.640.89
2441924-44192480.97781.47
3449044-44904482.28282.77
4452952-45295282.99883.51
5446907-44690781.89082.38
6447096-44709681.92582.42
30min1461681-46168184.59783.701.8185.2884.381.80
2466108-46610885.40886.08
3457171-45717183.77184.44
4462131-46213184.68085.38
5447419-44741981.98482.66
6446219-44621981.76482.44
45min1478330-47833087.64883.466.4588.5184.326.38
2463501-46350184.93185.79
3478607-47860787.69988.56
4426592-42659278.16879.05
5474693-47469386.98187.84
6411010-41101075.31276.17
60min1460424-46042484.36780.926.7485.4381.976.67
2475736-47573687.17388.22
3437306-43730680.13181.19
4449498-44949882.36583.42
5438079-43807980.27281.32
6388591-38859171.20472.23
极限1489850-48985089.75985.556.2391.0186.786.14
2487611-48761189.34990.59
3432390-43239079.23080.46
4427910-42791078.40979.65
5489291-48929189.65690.89
6474370-47437086.92288.11
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