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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.121019131020641018681015951020591019000.19
210.161016681014511015600.16
单位质量响应值RSD%判断
10069.179996.060.52数据可信
供试品溶液-2023111921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%
5min150611-5061145.28939.8318.2745.2939.8318.27
244891-4489140.17040.17
339434-3943435.28735.29
452542-5254247.01747.02
530898-3089827.64927.65
648704-4870443.58243.58
10min195450-9545085.41382.618.8985.6682.838.91
288797-8879779.45979.68
386028-8602876.98277.18
4100895-10089590.28590.55
581390-8139072.83172.98
6101348-10134890.69190.93
15min1104979-10497993.94090.846.6394.6791.526.66
2103950-10395093.01993.68
398375-9837588.03088.65
4105077-10507794.02794.79
589250-8925079.86580.42
6107431-10743196.13496.88
20min1102843-10284392.02891.586.1693.2892.776.18
2108128-10812896.75897.94
3100182-10018289.64790.76
4104609-10460993.60994.89
590951-9095181.38782.39
6107351-10735196.06297.34
30min1101569-10156990.88891.795.5492.6593.495.56
2108662-10866297.23598.95
3102888-10288892.06993.68
4104062-10406293.11994.92
592177-9217782.48483.94
6106121-10612194.96296.78
45min1106100-10610094.94395.573.9297.2197.773.98
2111040-11104099.363101.62
3106653-10665395.43897.56
4109456-10945697.946100.27
599102-9910288.68190.59
6108457-10845797.05299.39
60min1105066-10506694.01893.744.0696.8196.474.10
2110559-11055998.933101.74
3104328-10432893.35796.01
4104869-10486993.84196.71
597406-9740687.16389.57
6106286-10628695.10997.99
极限1110895-11089599.23497.271.64102.55100.521.58
2108641-10864197.217100.58
3107914-10791496.56699.74
4105727-10572794.60998.00
5109135-10913597.659100.55
6109872-10987298.318101.73
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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.121013141018521019071018621017491017370.24
210.161011931013521012720.12
单位质量响应值RSD%判断
10053.069967.720.61数据可信
供试品溶液-2023111921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%
5min145062-4506240.41338.916.8540.4138.916.85
247712-4771242.79042.79
343906-4390639.37639.38
440309-4030936.15136.15
539806-3980635.69935.70
643499-4349939.01139.01
10min182138-8213873.66476.444.2473.8976.654.23
285104-8510476.32476.56
383930-8393075.27175.49
483596-8359674.97275.17
584299-8429975.60275.80
692320-9232082.79683.01
15min190642-9064281.29187.695.8481.9288.335.82
2105050-10505094.21294.87
396556-9655686.59587.23
497990-9799087.88188.50
592882-9288283.30083.92
6103562-10356292.87893.55
20min196813-9681386.82590.515.5087.9191.635.49
2109094-10909497.83999.02
399099-9909988.87589.99
497906-9790687.80588.91
595928-9592886.03287.11
6106664-10666495.66096.85
30min1102299-10229991.74595.233.4393.3196.863.46
2110007-11000798.658100.39
3104857-10485794.03995.65
4105932-10593295.00396.60
5102923-10292392.30593.86
6111095-11109599.634101.36
45min1104743-10474393.93797.022.5496.0199.182.55
2108954-10895497.71499.99
3107347-10734796.27298.41
4106055-10605595.11497.23
5109554-10955498.252100.32
6112427-112427100.828103.11
60min1106677-10667795.67297.311.6998.27100.011.71
2109006-10900697.760100.58
3107659-10765996.55299.22
4106597-10659795.60098.25
5110114-11011498.754101.37
6111000-11100099.549102.39
极限1106334-10633495.36497.221.4798.49100.461.47
2107413-10741396.33299.69
3107754-10775496.63899.84
4108426-10842697.240100.42
5110045-11004598.692101.86
6110473-11047399.076102.47
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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.121014861014921013591011111015491013990.18
210.161012041013451012740.10
单位质量响应值RSD%判断
10019.669967.910.37数据可信
供试品溶液-54916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%
5min128180-2818025.31424.3613.4025.3124.3613.40
220159-2015918.10918.11
329333-2933326.35026.35
429363-2936326.37726.38
526200-2620023.53623.54
629504-2950426.50426.50
10min156090-5609050.38653.249.6950.5353.389.69
249506-4950644.47244.57
365179-6517958.55158.70
461570-6157055.30955.46
563610-6361057.14257.27
659661-5966153.59453.74
15min180408-8040872.23270.326.2172.6570.756.23
269029-6902962.01062.36
383249-8324974.78475.26
480059-8005971.91872.37
578438-7843870.46270.91
678505-7850570.52270.97
20min197834-9783487.88687.651.6188.7188.471.59
297338-9733887.44088.13
396804-9680486.96087.85
495740-9574086.00586.86
5100414-10041490.20391.04
697291-9729187.39888.23
30min1107474-10747496.54596.322.3197.8697.632.24
2109044-10904497.95699.13
3104409-10440993.79295.16
4104105-10410593.51994.85
5108152-10815297.15498.50
6110148-11014898.947100.27
45min1107478-10747896.54997.451.6498.4099.291.63
2107548-10754896.61298.33
3106203-10620395.40497.29
4109064-10906497.97499.82
5109338-10933898.220100.10
6111243-11124399.931101.80
60min1105997-10599795.21997.832.4697.60100.212.43
2108480-10848097.44999.71
3107292-10729296.38298.80
4107361-10736196.44498.84
5112966-112966101.479103.91
6111295-11129599.978102.41
极限1106908-10690896.03796.241.5198.9599.171.49
2105975-10597595.19998.00
3105121-10512194.43297.39
4108300-10830097.287100.22
5109608-10960898.462101.45
6106897-10689796.02799.01
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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.121015191011591015011012561015571013980.18
210.161009931010641010280.05
单位质量响应值RSD%判断
10019.579943.700.54数据可信
供试品溶液-54916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%
5min120315-2031518.27222.5415.8518.2722.5415.85
222168-2216819.93819.94
327964-2796425.15125.15
429443-2944326.48126.48
528430-2843025.57025.57
622063-2206319.84419.84
10min157169-5716951.41954.245.1551.5254.375.15
258580-5858052.68852.80
364291-6429157.82457.96
457387-5738751.61551.76
563552-6355257.16057.30
660886-6088654.76254.87
15min177459-7745969.66872.564.0070.0572.994.02
279305-7930571.32871.73
385128-8512876.56577.03
481362-8136273.17873.61
583505-8350575.10675.57
677300-7730069.52569.94
20min197496-9749687.68988.942.4588.4689.762.46
299578-9957889.56290.36
3102928-10292892.57593.46
497128-9712887.35888.20
599829-9982989.78890.66
696330-9633086.64187.44
30min1106793-10679396.05197.421.2897.3198.741.26
2109716-10971698.68099.98
3106837-10683796.09197.49
4110082-11008299.009100.34
5108153-10815397.27498.65
6108314-10831497.41998.70
45min1107489-10748996.67798.251.5998.47100.111.61
2109585-10958598.562100.41
3112360-112360101.058102.99
4108776-10877697.83599.71
5109345-10934598.347100.26
6107861-10786197.01298.84
60min1109278-10927898.28697.521.25100.6299.931.19
2110651-11065199.521101.91
3107784-10778496.94399.44
4108130-10813097.25499.67
5106767-10676796.02898.49
6107951-10795197.09399.45
极限1106829-10682996.08497.751.2398.96100.701.21
2108436-10843697.529100.47
3108659-10865997.730100.76
4107796-10779696.95399.91
5110062-11006298.991101.99
6110316-11031699.220102.12
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