厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167220897222257212287197787221597214960.15
212.167210977212307211640.02
单位质量响应值RSD%判断
59333.5559306.250.04数据可信
长期36月-供试品溶液-20210227批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1154310-15431021.67817.7811.7721.6817.7811.78
2117639-11763916.52616.53
3111365-11136515.64515.64
4127141-12714117.86117.86
5121332-12133217.04517.04
6127787-12778717.95217.95
10min1458878-45887864.46462.764.7764.5762.854.77
2444118-44411862.39062.47
3414569-41456958.23958.32
4478375-47837567.20367.29
5438137-43813761.55061.64
6446560-44656062.73362.82
15min1629038-62903888.36889.321.4288.8089.721.42
2636073-63607389.35689.75
3626846-62684688.06088.43
4644685-64468590.56690.99
5648475-64847591.09991.49
6629556-62955688.44188.84
20min1685340-68534096.27796.310.9097.1597.160.90
2685130-68513096.24897.09
3681745-68174595.77296.58
4685229-68522996.26297.14
5696956-69695697.90998.76
6678934-67893495.37796.22
30min1675426-67542694.88596.381.0396.2497.701.02
2687570-68757096.59197.91
3682619-68261995.89597.18
4695895-69589597.76099.12
5690378-69037896.98598.32
6684368-68436896.14197.46
45min1679324-67932495.43295.891.8297.2697.701.79
2672436-67243694.46596.27
3672599-67259994.48896.26
4676679-67667995.06196.91
5703923-70392398.888100.71
6690514-69051497.00498.81
60min1699721-69972198.29899.040.80100.60101.340.79
2710330-71033099.788102.07
3703505-70350598.829101.07
4711939-711939100.014102.34
5706483-70648399.248101.56
6698158-69815898.078100.37
极限1691439-69143997.13498.501.9199.93101.291.85
2712659-712659100.115102.89
3708761-70876199.568102.30
4713005-713005100.164102.99
5679600-67960095.47198.28
6701509-70150998.549101.33
厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167222267220477222177213087214257218450.07
212.167204957207227206080.03
单位质量响应值RSD%判断
59362.2559260.530.13数据可信
长期36月-供试品溶液-20210301批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min178067-7806710.96915.7732.0310.9715.7732.03
2148128-14812820.81220.81
383845-8384511.78011.78
4141451-14145119.87419.87
576813-7681310.79210.79
6145304-14530420.41520.42
10min1289242-28924240.63954.0020.4140.6954.0820.43
2461002-46100264.77164.88
3354876-35487649.86149.92
4438277-43827761.57961.68
5303778-30377842.68142.74
6458895-45889564.47564.58
15min1502039-50203970.53781.138.7570.8081.488.80
2619446-61944687.03387.46
3578585-57858581.29281.60
4618760-61876086.93787.34
5530831-53083174.58374.85
6614979-61497986.40586.83
20min1628456-62845688.29990.311.8988.9191.071.95
2638928-63892889.77090.63
3629917-62991788.50489.22
4655379-65537992.08292.92
5648884-64888491.16991.81
6655149-65514992.04992.91
30min1669652-66965294.08795.011.0095.1496.220.97
2677454-67745495.18396.50
3678988-67898895.39996.56
4678457-67845795.32496.63
5685492-68549296.31397.41
6667227-66722793.74695.06
45min1694069-69406997.51896.791.2299.0498.471.15
2695153-69515397.67099.46
3680431-68043195.60297.24
4685674-68567496.33898.12
5698898-69889898.19699.77
6678901-67890195.38797.17
60min1688599-68859996.74996.191.8498.7698.351.75
2690824-69082497.06299.34
3682767-68276795.93098.04
4687215-68721596.55598.82
5697292-69729297.971100.04
6660891-66089192.85695.12
极限1685917-68591796.37296.320.7198.8798.970.63
2683960-68396096.09798.86
3693006-69300697.36899.96
4681043-68104395.68898.43
5689145-68914596.82699.38
6680357-68035795.59198.32
厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167239147240537243047233397226347236490.10
212.167254787253407254090.02
单位质量响应值RSD%判断
59510.6159655.350.18数据可信
长期36月-供试品溶液-20210302批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1144934-14493420.27120.5015.5120.2720.5015.52
2143742-14374220.10420.10
3116573-11657316.30416.30
4146355-14635520.46920.47
5187039-18703926.15926.16
6140700-14070019.67819.68
10min1487960-48796068.24766.045.8068.3566.145.82
2474447-47444766.35766.46
3426272-42627259.61959.70
4466544-46654465.25165.35
5508857-50885771.16971.30
6468885-46888565.57965.68
15min1592532-59253282.87285.712.1983.3186.152.17
2620540-62054086.78987.22
3610220-61022085.34685.73
4609880-60988085.29985.73
5610958-61095885.44985.94
6632975-63297588.52988.95
20min1668106-66810693.44292.162.7494.3093.022.69
2647998-64799890.63091.50
3657230-65723091.92192.73
4670726-67072693.80994.66
5629870-62987088.09489.01
6679706-67970695.06495.93
30min1672278-67227894.02696.042.0195.3597.371.98
2688167-68816796.24897.57
3687559-68755996.16397.43
4705307-70530798.64599.97
5669925-66992593.69795.05
6697046-69704697.49098.83
45min1658125-65812592.04697.733.0693.8499.533.01
2702607-70260798.267100.07
3707945-70794599.014100.76
4721448-721448100.903102.72
5700171-70017197.92799.75
6702189-70218998.209100.04
60min1663107-66310792.74394.831.9995.0097.121.93
2676309-67630994.58996.88
3700154-70015497.924100.17
4683662-68366295.61897.94
5665575-66557593.08895.40
6679336-67933695.01397.34
极限1676207-67620794.57596.122.5397.2998.882.47
2688098-68809896.23899.00
3699627-69962797.851100.58
4714477-71447799.928102.73
5667381-66738193.34196.12
6677553-67755394.76397.56
厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167240647225737241717236077237217236270.09
212.167200507201437200960.01
单位质量响应值RSD%判断
59508.8059218.420.35数据可信
长期36月-供试品溶液-AA366批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1134476-13447618.87819.5918.3618.8819.5918.37
2114077-11407716.01416.01
3108941-10894115.29315.29
4144612-14461220.30020.30
5173753-17375324.39124.39
6161331-16133122.64722.65
10min1454375-45437563.78563.915.2463.8864.005.26
2415399-41539958.31358.39
3448510-44851062.96163.04
4453627-45362763.68063.78
5480199-48019967.41067.53
6479419-47941967.30067.41
15min1559187-55918778.49879.582.5678.9180.002.57
2565344-56534479.36279.73
3561686-56168678.84979.24
4547532-54753276.86277.28
5582079-58207981.71182.17
6585719-58571982.22282.67
20min1625435-62543587.79886.042.3588.6086.852.31
2634194-63419489.02789.80
3595349-59534983.57484.36
4609349-60934985.54086.34
5609924-60992485.62086.49
6603178-60317884.67385.53
30min1651412-65141291.44489.732.4692.6990.982.46
2611017-61101785.77486.99
3631373-63137388.63189.83
4642536-64253690.19891.43
5651426-65142691.44692.74
6647469-64746990.89192.18
45min1668631-66863193.86293.801.1095.5695.491.07
2668644-66864493.86395.51
3674775-67477594.72496.37
4667188-66718893.65995.34
5674907-67490794.74396.50
6654862-65486291.92993.67
60min1682522-68252295.81294.351.5597.9896.521.52
2677569-67756995.11697.23
3664591-66459193.29495.41
4669306-66930693.95696.11
5682037-68203795.74397.97
6656727-65672792.19094.39
极限1686859-68685996.42095.941.4599.0798.581.40
2686891-68689196.42599.01
3694642-69464297.513100.10
4682338-68233895.78698.41
5684920-68492096.14898.85
6665094-66509493.36596.02
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