阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.231057331054891057801053621055301055790.17
210.191053601054661054130.08
单位质量响应值RSD%判断
10320.5310344.750.17数据可信
长期9月-供试品溶液-2023111721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%
5min156851-5685149.37045.9910.2249.3745.9910.23
252540-5254045.62645.63
343706-4370637.95537.95
455433-5543348.13948.14
550488-5048843.84543.84
658726-5872650.99951.00
10min188897-8889777.19977.2310.8477.4777.4810.83
296622-9662283.90884.16
373385-7338563.72963.94
484691-8469173.54773.81
589003-8900377.29177.54
6100995-10099587.70687.99
15min198403-9840385.45586.207.1586.1686.887.16
2103758-10375890.10590.82
387203-8720375.72876.29
496730-9673084.00284.68
5101654-10165488.27888.95
6107786-10778693.60394.37
20min1104777-10477790.99091.454.9192.1792.624.95
2110345-11034595.82597.05
395891-9589183.27384.26
4104244-10424490.52791.67
5108007-10800793.79594.96
6108598-10859894.30895.60
30min1107346-10734693.22195.442.6394.9097.122.69
2113834-11383498.855100.61
3105976-10597692.03193.48
4110998-11099896.39298.04
5109658-10965895.22996.91
6111619-11161996.93298.75
45min1111423-11142396.76197.180.9698.9699.381.04
2113061-11306198.184100.49
3110495-11049595.95597.91
4111357-11135796.70498.89
5113276-11327698.371100.58
6111787-11178797.07799.43
60min1110767-11076796.19296.930.8398.9399.670.79
2112395-11239597.605100.45
3112459-11245997.661100.15
4111936-11193697.20799.93
5110209-11020995.70798.47
6111935-11193597.206100.10
极限1109920-10992095.45696.591.2598.7399.871.21
2111349-11134996.697100.09
3112824-11282497.978101.01
4110354-11035495.83399.09
5109937-10993795.47198.76
6112946-11294698.084101.52
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.231054081052771052761053331051211052830.11
210.191043461048381045920.34
单位质量响应值RSD%判断
10291.5910264.180.19数据可信
长期9月-供试品溶液-2023111721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%
5min154868-5486847.90245.954.6447.9045.964.64
254187-5418747.30747.31
349882-4988243.54943.55
451298-5129844.78544.79
550244-5024443.86543.87
655343-5534348.31748.32
10min190164-9016478.71776.676.5578.9876.926.54
290147-9014778.70278.96
383656-8365673.03573.28
482846-8284672.32872.58
582886-8288672.36372.61
697193-9719384.85385.12
15min199961-9996187.27085.663.8587.9786.343.86
299656-9965687.00487.70
395230-9523083.14083.79
496011-9601183.82284.47
593879-9387981.96082.61
6103990-10399090.78891.53
20min1105165-10516591.81390.222.3693.0091.382.39
2104576-10457691.29992.48
3100063-10006387.35988.47
4100888-10088888.07989.20
5103168-10316890.07091.17
6106178-10617892.69893.94
30min1112295-11229598.03896.091.7199.7497.751.74
2111966-11196697.75199.44
3108644-10864494.85196.45
4107839-10783994.14895.75
5108825-10882595.00996.61
6110799-11079996.73298.49
45min1109901-10990195.94896.071.4398.1998.261.43
2111026-11102696.93099.16
3112031-11203197.80899.93
4108525-10852594.74796.88
5107939-10793994.23596.36
6110850-11085096.77799.07
60min1108480-10848094.70794.521.3597.4897.241.29
2106765-10676593.21095.98
3106490-10649092.97095.64
4109431-10943195.53898.19
5110209-11020996.21798.87
6108189-10818994.45397.29
极限1107058-10705893.46695.431.5096.7798.681.48
2109998-10999896.03399.32
3108574-10857494.79097.97
4110095-11009596.11799.30
5108414-10841494.65097.84
6111739-11173997.553100.91
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.231054651057171051681051451051491053290.25
210.191047081049091048080.14
单位质量响应值RSD%判断
10296.0910285.380.08数据可信
中间条件9月-供试品溶液-2023111721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%
5min143192-4319237.66144.2012.6137.6644.2012.61
252087-5208745.41745.42
360832-6083253.04253.04
448154-4815441.98841.99
554182-5418247.24447.24
645727-4572739.87239.87
10min177820-7782067.85574.146.9768.0674.396.98
290613-9061379.01079.26
386385-8638575.32375.62
484221-8422173.43673.67
592262-9226280.44880.71
678896-7889668.79369.01
15min194599-9459982.48684.722.3383.0785.382.34
299403-9940386.67487.37
394737-9473782.60683.32
496469-9646984.11684.76
599803-9980387.02387.73
697936-9793685.39586.00
20min1101465-10146588.47289.501.3089.5290.631.34
2103921-10392190.61491.79
3103033-10303389.84091.01
4102748-10274889.59190.70
5104000-10400090.68391.88
6100696-10069687.80288.88
30min1106646-10664692.99094.621.8394.5396.241.83
2107463-10746393.70295.38
3107649-10764993.86595.54
4110766-11076696.58298.19
5111271-11127197.02398.72
6107267-10726793.53195.10
45min1111744-11174497.43596.460.9199.4998.610.90
2110400-11040096.26398.46
3110030-11003095.94198.13
4110564-11056496.40698.55
5111787-11178797.47399.71
6109218-10921895.23397.32
60min1108616-10861694.70895.770.9197.3098.460.89
2110498-11049896.34999.08
3109188-10918895.20697.93
4111282-11128297.03299.71
5109231-10923195.24498.02
6110198-11019896.08798.70
极限1113263-11326398.76095.922.36101.8899.142.23
2108051-10805194.21597.48
3107028-10702893.32396.58
4108780-10878094.85198.07
5109934-10993495.85799.16
6112976-11297698.509101.66
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.231060191053331053531046671046941052130.54
210.191045381044271044820.08
单位质量响应值RSD%判断
10284.7510253.390.22数据可信
中间条件9月-供试品溶液-2023111721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%
5min132450-3245028.35545.6322.6928.3545.6322.69
259180-5918051.71151.71
356877-5687749.69949.70
465421-6542157.16457.16
554868-5486847.94347.94
644528-4452838.90838.91
10min164898-6489856.70770.0010.4956.8670.2610.54
284223-8422373.59373.88
380643-8064370.46570.74
488624-8862477.43977.76
585011-8501174.28274.55
677291-7729167.53667.75
15min183224-8322472.72080.505.6573.1981.145.73
297613-9761385.29385.99
391492-9149279.94580.61
496703-9670384.49885.25
593380-9338081.59582.27
690343-9034378.94179.53
20min196756-9675684.54588.243.0685.4289.333.15
2104525-10452591.33392.50
399880-9988087.27488.39
4104137-10413790.99492.21
5101908-10190889.04690.18
698714-9871486.25587.29
30min1109793-10979395.93695.471.2597.2897.051.28
2110556-11055696.60398.28
3108093-10809394.45196.05
4110280-11028096.36298.08
5109745-10974595.89497.52
6107111-10711193.59395.10
45min1111988-11198897.85497.441.8199.7399.551.83
2113602-11360299.264101.48
3112530-11253098.328100.45
4112224-11222498.060100.32
5110950-11095096.94799.11
6107783-10778394.18096.21
60min1110204-11020496.29597.070.5898.7299.720.64
2111584-11158497.501100.27
3110669-11066996.70299.37
4110712-11071296.73999.54
5111785-11178597.677100.38
6111574-11157497.492100.04
极限1109410-10941095.60197.491.3398.56100.681.38
2111625-11162597.537100.84
3110440-11044096.50199.71
4113316-11331699.015102.35
5111693-11169397.596100.84
6112961-11296198.704101.80
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