依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606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500
标示量(mg)10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%
110.103433633435933425103435613434333432920.14
210.013428163431023429590.06
单位质量响应值RSD%判断
33989.3134261.640.57数据可信
长期12月-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1200086-20008658.48746.4317.2058.4946.4317.20
2137022-13702240.05340.05
3134312-13431239.26139.26
4144966-14496642.37542.37
5185354-18535454.18154.18
6151351-15135144.24144.24
10min1313484-31348491.63485.225.3091.8185.365.32
2279959-27995981.83481.95
3274126-27412680.12980.25
4286697-28669783.80483.93
5306910-30691089.71289.87
6288139-28813984.22584.36
15min1320000-32000093.53993.881.3193.9994.281.31
2325734-32573495.21595.58
3314734-31473491.99992.36
4321336-32133693.92994.31
5325772-32577295.22695.66
6319520-31952093.39893.78
20min1320362-32036293.64495.491.2694.3896.161.22
2333207-33320797.39998.05
3327024-32702495.59296.23
4325582-32558295.17095.83
5326735-32673595.50796.22
6327073-32707395.60696.27
30min1320006-32000693.54096.191.7694.5597.161.72
2336972-33697298.50099.44
3331403-33140396.87297.79
4328563-32856396.04296.99
5325876-32587695.25696.26
6331697-33169796.95897.91
45min1319304-31930493.33596.312.0794.6397.562.02
2339357-33935799.197100.44
3331737-33173796.96998.18
4329292-32929296.25597.49
5325216-32521695.06396.35
6331937-33193797.02898.27
60min1319251-31925193.32096.382.2694.8997.922.21
2341304-34130499.766101.30
3331372-33137296.86398.37
4329462-32946296.30497.83
5324808-32480894.94496.52
6332137-33213797.08698.62
极限1340066-34006699.40498.700.79101.26100.530.80
2339711-33971199.300101.14
3334574-33457497.79999.59
4338215-33821598.863100.67
5339361-33936199.198101.06
6334090-33409097.65799.48
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606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500
标示量(mg)10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%
110.103431283427923427763426443429993428680.06
210.013428923427763428340.03
单位质量响应值RSD%判断
33947.3334249.150.63数据可信
长期12月-供试品溶液-2024012421批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1136136-13613639.82646.529.4239.8346.529.42
2151459-15145944.30844.31
3162585-16258547.56347.56
4176411-17641151.60851.61
5154261-15426145.12845.13
6173252-17325250.68450.68
10min1278889-27888981.58784.804.3481.7184.944.34
2272973-27297379.85679.99
3304017-30401788.93889.08
4293061-29306185.73385.89
5287515-28751584.11084.25
6302784-30278488.57788.73
15min1313988-31398891.85594.672.1192.2295.062.12
2316675-31667592.64193.01
3330978-33097896.82597.23
4328301-32830196.04296.45
5324363-32436394.89095.28
6327317-32731795.75496.17
20min1316792-31679292.67596.782.1893.3297.462.19
2331740-33174097.04897.70
3335339-33533998.10198.80
4336021-33602198.30199.00
5334625-33462597.89298.56
6330434-33043496.66697.37
30min1316133-31613392.48297.572.7293.4098.542.71
2336293-33629398.38099.32
3338974-33897499.164100.16
4338567-33856799.045100.04
5339780-33978099.400100.37
6331312-33131296.92397.92
45min1315990-31599092.44197.882.8593.6499.142.85
2336683-33668398.49499.73
3340568-34056899.631100.92
4339433-33943399.299100.59
5341180-34118099.810101.07
6333634-33363497.60298.89
60min1316961-31696192.72597.862.6594.2099.422.65
2336476-33647698.43499.97
3339152-33915299.216100.81
4339055-33905599.188100.78
5340644-34064499.653101.22
6334904-33490497.97499.55
极限1331896-33189697.09499.011.1698.84100.861.18
2336080-33608098.318100.15
3342109-342109100.082101.97
4339733-33973399.386101.27
5341909-341909100.023101.89
6338943-33894399.155101.03
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606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500
标示量(mg)10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%
110.103429123421923425953425043434653427340.15
210.013429163425273427220.09
单位质量响应值RSD%判断
33934.0634237.960.64数据可信
长期12月-供试品溶液-2025012521批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1107926-10792631.58439.9812.9231.5839.9812.92
2156498-15649845.79945.80
3150993-15099344.18844.19
4143423-14342341.97241.97
5132383-13238338.74238.74
6128481-12848137.60037.60
10min1261606-26160676.55877.271.8676.6577.391.86
2263401-26340177.08477.22
3271466-27146679.44479.58
4257388-25738875.32475.45
5267562-26756278.30178.42
6262729-26272976.88777.00
15min1316920-31692092.74692.121.5593.0792.471.55
2320825-32082593.88994.26
3316492-31649292.62192.99
4307769-30776990.06890.42
5316532-31653292.63292.98
6310097-31009790.74991.09
20min1336049-33604998.34496.881.3698.9597.501.35
2336322-33632298.42499.07
3329794-32979496.51497.16
4327864-32786495.94996.57
5324996-32499695.10995.74
6331191-33119196.92297.54
30min1341626-34162699.97698.551.62100.8799.461.61
2343724-343724100.590101.54
3332600-33260097.33598.27
4335959-33595998.31899.23
5329139-32913996.32297.24
6337371-33737198.73199.64
45min1342911-342911100.35299.101.46101.55100.311.45
2344330-344330100.767102.01
3338086-33808698.940100.17
4338083-33808398.939100.14
5330258-33025896.64997.85
6338110-33811098.947100.15
60min1342339-342339100.18598.641.55101.68100.151.54
2343337-343337100.477102.03
3332028-33202897.16798.69
4336791-33679198.561100.06
5330516-33051696.72598.22
6337378-33737898.733100.23
极限1342583-342583100.25699.081.06102.06100.891.06
2342922-342922100.355102.21
3334874-33487498.00099.82
4337596-33759698.797100.59
5334787-33478797.97599.76
6338667-33866799.110100.91
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