氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.191789551794091786841791431790651790510.15
214.301804341802891803620.06
单位质量响应值RSD%判断
12618.1112612.730.04数据可信
供试品溶液-2816279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%
2min19126-91265.1176.6125.225.126.6125.19
214568-145688.1688.17
38115-81154.5504.55
410782-107826.0456.05
515557-155578.7238.72
612611-126117.0717.07
5min159638-5963833.43827.9322.1833.4427.9222.18
256861-5686131.88131.88
348769-4876927.34427.34
446033-4603325.81025.81
557459-5745932.21632.22
630074-3007416.86216.86
10min167514-6751437.85441.468.4037.8541.468.40
276905-7690543.11943.12
367124-6712437.63537.64
472503-7250340.65140.65
583344-8334446.72946.73
676303-7630342.78242.78
15min179873-7987344.78351.2313.3844.7851.2313.37
298211-9821155.06555.06
376971-7697143.15643.16
489221-8922150.02450.02
593888-9388852.64152.64
6110051-11005161.70361.70
20min184562-8456247.41255.2613.6047.4155.2613.60
2106461-10646159.69159.69
381885-8188545.91145.91
499365-9936555.71255.71
5101856-10185657.10957.11
6117270-11727065.75165.75
30min198544-9854455.25260.7210.3655.2560.7210.36
2113375-11337563.56763.57
394726-9472653.11153.11
4107007-10700759.99760.00
5109907-10990761.62361.62
6126173-12617370.74370.74
45min1107623-10762360.34266.8510.0760.3466.8510.07
2129342-12934272.52072.52
3106319-10631959.61159.61
4114401-11440164.14264.14
5121515-12151568.13168.13
6136195-13619576.36276.36
60min1120047-12004767.30871.716.6767.3171.716.67
2132465-13246574.27174.27
3122100-12210068.45968.46
4123941-12394169.49169.49
5125852-12585270.56370.56
6142992-14299280.17380.17
90min1129303-12930372.49875.685.0072.5075.685.00
2137300-13730076.98176.98
3134328-13432875.31575.32
4129592-12959272.66072.66
5132057-13205774.04274.04
6147283-14728382.57982.58
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1136604-13660476.59177.593.2776.5977.593.27
2135548-13554875.99976.00
3141182-14118279.15879.16
4134678-13467875.51175.51
5135964-13596476.23276.23
6146344-14634482.05282.05
极限1142555-14255579.92881.191.7079.9381.191.70
2145226-14522681.42581.43
3143416-14341680.41180.41
4144749-14474981.15881.16
5143453-14345380.43180.43
6149389-14938983.76083.76
氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.191790721791151791421792961792241791700.06
214.301786831786031786430.04
单位质量响应值RSD%判断
12626.5012492.520.76数据可信
供试品溶液-2816279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%
2min17557-75574.2564.5926.724.264.5926.70
27530-75304.2414.24
38132-81324.5804.58
411965-119656.7396.74
55269-52692.9672.97
68409-84094.7364.74
5min159231-5923133.35829.3613.3833.3629.3613.39
250985-5098528.71428.71
354548-5454830.72130.72
458071-5807132.70532.71
540079-4007922.57222.57
649873-4987328.08828.09
10min183851-8385147.22440.5516.3447.2240.5516.35
278758-7875844.35644.36
384281-8428147.46647.47
466018-6601837.18137.18
557302-5730232.27232.27
661833-6183334.82434.82
15min193589-9358952.70945.5810.8152.7145.5810.81
273233-7323341.24441.24
384885-8488547.80747.81
486068-8606848.47348.47
570561-7056139.73939.74
677296-7729643.53343.53
20min1107798-10779860.71152.6013.0460.7152.6013.04
299720-9972056.16256.16
3103363-10336358.21358.21
490504-9050450.97150.97
578842-7884244.40344.40
680195-8019545.16545.17
30min1118416-11841666.69159.8710.7666.6959.8710.76
2112314-11231463.25463.25
3116880-11688065.82665.83
4103919-10391958.52658.53
591305-9130551.42251.42
694988-9498853.49753.50
45min1124576-12457670.16064.3610.2070.1664.3610.20
2121071-12107168.18668.19
3126642-12664271.32471.32
4109230-10923061.51861.52
597041-9704154.65354.65
6107100-10710060.31860.32
60min1132842-13284274.81669.525.7474.8269.525.74
2126466-12646671.22571.22
3127669-12766971.90271.90
4114849-11484964.68264.68
5123152-12315269.35869.36
6115613-11561365.11265.11
90min1140099-14009978.90372.348.5278.9072.348.52
2132089-13208974.39274.39
3137550-13755077.46777.47
4113208-11320863.75863.76
5130603-13060373.55573.55
6117089-11708965.94465.94
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1144657-14465781.47071.4012.3781.4771.4012.37
2127594-12759471.86071.86
3136499-13649976.87576.88
4101639-10163957.24257.24
5134540-13454075.77275.77
6115752-11575265.19165.19
极限1141161-14116179.50178.833.2179.5078.833.22
2135582-13558276.35976.36
3136222-13622276.71976.72
4139798-13979878.73378.73
5148042-14804283.37683.38
6138998-13899878.28378.28
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