他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.585163875176785170365175975163375170070.13
212.585207075213975210520.10
单位质量响应值RSD%判断
41097.5441419.080.56数据可信
长期24月-供试品溶液-2022031901批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182632-18263235.38833.7914.3435.3933.7914.34
2130774-13077425.34025.34
3173786-17378633.67433.67
4208289-20828940.36040.36
5176068-17606834.11634.12
6174703-17470333.85233.85
10min1405964-40596478.66374.3511.9478.7374.4111.94
2301603-30160358.44158.49
3391165-39116575.79575.86
4418214-41821481.03681.12
5423000-42300081.96482.03
6362218-36221870.18670.25
15min1471416-47141691.34590.015.4691.5790.225.48
2423776-42377682.11482.28
3463012-46301289.71789.94
4473736-47373691.79592.04
5500810-50081097.04197.27
6454347-45434788.03888.25
20min1494854-49485495.88794.982.7796.3095.372.79
2470389-47038991.14691.48
3485458-48545894.06694.46
4492419-49241995.41595.84
5511610-51161099.13399.56
6486180-48618094.20694.59
30min1507591-50759198.35598.241.1898.9698.821.21
2499734-49973496.83297.35
3502849-50284997.43698.02
4506274-50627498.09998.72
5517275-517275100.231100.86
6508161-50816198.46599.04
45min1512708-51270899.34699.780.70100.15100.560.71
2513793-51379399.556100.26
3512804-51280499.365100.15
4512250-51225099.257100.07
5521487-521487101.047101.87
6516686-516686100.117100.89
极限1522902-522902101.321101.220.43102.32102.200.43
2524031-524031101.540102.45
3519089-519089100.583101.56
4520688-520688100.892101.90
5525229-525229101.772102.80
6522245-522245101.194102.16
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.585184105190085188395194925194685190430.09
212.585180305190485185390.14
单位质量响应值RSD%判断
41259.3841219.320.07数据可信
长期24月-供试品溶液-2022032001批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199027-19902738.58242.9150.1938.5842.9150.19
2167223-16722332.41732.42
3133805-13380525.93925.94
4130897-13089725.37525.37
5419462-41946281.31481.31
6277625-27762553.81953.82
10min1403731-40373178.26579.8220.8978.3479.9020.90
2509194-50919498.70998.77
3327056-32705663.40163.45
4305638-30563859.24959.30
5506271-50627198.14398.31
6418620-41862081.15181.26
15min1468636-46863690.84790.7810.3891.0891.0210.42
2520272-520272100.857101.12
3421464-42146481.70281.88
4399809-39980977.50477.67
5510776-51077699.01699.37
6488710-48871094.73895.01
20min1483151-48315193.66194.956.1594.0895.386.20
2522939-522939101.374101.84
3466908-46690890.51290.85
4445005-44500586.26686.59
5511436-51143699.14499.70
6509437-50943798.75699.22
30min1492934-49293495.55798.133.5596.1698.743.60
2525227-525227101.817102.48
3496343-49634396.21896.74
4484060-48406093.83794.33
5510997-51099799.05999.81
6527675-527675102.292102.95
45min1496852-49685296.31799.262.6797.11100.072.71
2525351-525351101.841102.71
3507086-50708698.30199.02
4499786-49978696.88597.57
5512235-51223599.299100.25
6530797-530797102.897103.76
极限1506161-50616198.121101.002.0299.11102.012.02
2528621-528621102.475103.55
3519566-519566100.720101.63
4520198-520198100.842101.72
5515060-51506099.846101.00
6536341-536341103.972105.04
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.585188575197115197635191035195655194000.08
212.585205105209355207220.06
单位质量响应值RSD%判断
41287.7641392.850.18数据可信
长期24月-供试品溶液-2022032101批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1244322-24432247.24731.7331.7747.2531.7331.77
2167297-16729732.35232.35
3121611-12161123.51723.52
4113973-11397322.04022.04
5131395-13139525.40925.41
6205921-20592139.82139.82
10min1462277-46227789.39570.4023.7089.4970.4623.70
2402803-40280377.89477.96
3292261-29226156.51856.56
4267825-26782551.79251.84
5304887-30488758.95959.01
6454248-45424887.84387.92
15min1492930-49293095.32385.6913.1095.6085.8913.13
2482883-48288393.38093.60
3407963-40796378.89279.05
4370234-37023471.59671.74
5397214-39721476.81376.98
6507375-50737598.11698.37
20min1498799-49879996.45890.948.6196.9291.328.65
2501653-50165397.01097.42
3454484-45448487.88888.21
4413010-41301079.86880.16
5439548-43954885.00085.32
6514113-51411399.41999.87
30min1502705-50270597.21394.745.2597.8795.305.31
2509661-50966198.55999.16
3486525-48652594.08594.58
4450935-45093587.20287.65
5470667-47066791.01891.51
6519003-519003100.365101.02
45min1504414-50441497.54496.393.7798.4097.133.83
2511510-51151098.91699.71
3503421-50342197.35298.03
4466206-46620690.15590.78
5487372-48737294.24894.92
6517647-517647100.103100.95
极限1506876-50687698.02098.503.1099.0799.443.13
2514487-51448799.492100.49
3524815-524815101.489102.37
4480068-48006892.83693.64
5509952-50995298.61599.48
6520046-520046100.567101.62
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.585272585281475281965279025281635279330.08
212.585275535283865279700.12
单位质量响应值RSD%判断
41966.0641969.000.01数据可信
长期24月-供试品溶液-D426239批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130633-13063324.88436.2838.7824.8836.2838.78
2293152-29315255.84355.84
3261012-26101249.72049.72
4119727-11972722.80722.81
5202761-20276138.62438.62
6135561-13556125.82325.82
10min1349626-34962666.60070.8917.7066.6570.9717.72
2477916-47791691.03891.15
3417551-41755179.53979.64
4301127-30112757.36257.41
5368226-36822670.14370.22
6318580-31858060.68660.74
15min1412340-41234078.54782.629.7378.7382.839.77
2501371-50137195.50695.80
3464371-46437188.45888.72
4387406-38740673.79773.96
5430872-43087282.07782.29
6405943-40594377.32877.50
20min1438627-43862783.55488.226.5883.8988.606.63
2508344-50834496.83597.32
3488706-48870693.09493.53
4427787-42778781.48981.80
5461349-46134987.88288.26
6453795-45379586.44386.77
30min1460520-46052087.72592.474.5288.2393.024.57
2511961-51196197.52498.20
3508063-50806396.78197.40
4461696-46169687.94988.42
5484708-48470892.33292.89
6485657-48565792.51393.01
45min1473373-47337390.17394.723.3290.8695.463.37
2514796-51479698.06498.94
3513457-51345797.80898.62
4483394-48339492.08292.73
5496323-49632394.54595.29
6502125-50212595.65096.34
极限1487280-48728092.82296.672.4393.6897.602.47
2520583-52058399.166100.24
3515424-51542498.18399.19
4504411-50441196.08596.92
5501559-50155995.54296.47
6515695-51569598.23599.11
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