盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.071998311994742000821996971992451996660.17
216.052003022008612005820.20
单位质量响应值RSD%判断
12424.7712497.320.42数据可信
供试品溶液-2024042721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%
5min150206-5020626.94325.7113.0426.9425.7113.05
249613-4961326.62526.62
346276-4627624.83424.83
446435-4643524.91924.92
537924-3792420.35220.35
656977-5697730.57630.58
10min1119593-11959364.17962.434.8164.3362.574.81
2119284-11928464.01364.16
3106876-10687657.35457.49
4112920-11292060.59860.74
5117052-11705262.81562.93
6122274-12227465.61865.79
15min1135338-13533872.62871.831.2373.1372.321.24
2132168-13216870.92771.43
3133822-13382271.81572.27
4132425-13242571.06571.54
5133119-13311971.43871.90
6136249-13624973.11773.65
20min1142705-14270576.58276.301.2477.4977.191.27
2142248-14224876.33777.23
3141312-14131275.83476.69
4141837-14183776.11676.99
5139840-13984075.04475.90
6145155-14515577.89778.84
30min1145167-14516777.90377.581.2879.2478.891.29
2144198-14419877.38378.70
3142185-14218576.30377.58
4146029-14602978.36679.66
5142861-14286176.66677.94
6146951-14695178.86180.23
45min1146230-14623078.47478.191.1280.2479.941.13
2145399-14539978.02879.78
3145245-14524577.94579.65
4143615-14361577.07078.80
5145244-14524477.94479.65
6148530-14853079.70881.52
极限1152599-15259981.89179.162.2384.1081.342.19
2143361-14336176.93479.12
3148180-14818079.52081.65
4146493-14649378.61580.77
5145094-14509477.86480.00
6149325-14932580.13582.39
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.071999692001752003681996982001932000810.13
216.052004801998042001420.24
单位质量响应值RSD%判断
12450.5912469.910.11数据可信
供试品溶液-2024042721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%
5min153336-5333628.62426.268.2728.6226.268.27
251634-5163427.71127.71
345281-4528124.30124.30
449277-4927726.44626.45
551159-5115927.45627.46
642872-4287223.00823.01
10min1123796-12379666.43863.825.5166.6063.965.51
2122270-12227065.61965.77
3113522-11352260.92461.06
4122021-12202165.48665.63
5123779-12377966.42966.58
6108115-10811558.02358.15
15min1140686-14068675.50373.881.9476.0374.381.97
2138434-13843474.29474.81
3134229-13422972.03772.51
4138415-13841574.28474.79
5139614-13961474.92775.45
6134563-13456372.21772.67
20min1147531-14753179.17677.331.7580.1278.241.77
2142526-14252676.49077.42
3142658-14265876.56177.43
4145471-14547178.07178.99
5145578-14557878.12879.07
6140729-14072975.52676.38
30min1150754-15075480.90679.412.4382.2980.752.43
2152363-15236381.76983.13
3142918-14291876.70178.00
4147320-14732079.06380.42
5149448-14944880.20581.58
6144977-14497777.80679.08
45min1153315-15331582.28079.212.5484.1280.992.55
2149000-14900079.96581.78
3143135-14313576.81778.54
4149511-14951180.23982.04
5146058-14605878.38680.20
6144497-14449777.54879.25
极限1154949-15494983.15781.102.6385.4583.322.64
2154907-15490783.13585.39
3145436-14543678.05280.20
4152803-15280382.00684.25
5151317-15131781.20883.46
6147289-14728979.04681.18
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.071998522001901997732000992000041999840.09
216.052019922016522018220.12
单位质量响应值RSD%判断
12444.5612574.580.74数据可信
供试品溶液-18016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%
5min162124-6212433.21034.164.8733.2134.164.88
261662-6166232.96332.96
364467-6446734.46234.46
466535-6653535.56835.57
560280-6028032.22432.22
668355-6835536.54136.54
10min1126033-12603367.37467.633.6967.5667.823.68
2125835-12583567.26867.45
3123333-12333365.93166.12
4124500-12450066.55466.75
5123643-12364366.09666.28
6135755-13575572.57172.77
15min1151174-15117480.81478.332.0681.3778.902.05
2144263-14426377.11977.68
3145202-14520277.62178.18
4148655-14865579.46780.03
5143043-14304376.46777.01
6146831-14683178.49279.10
20min1159283-15928385.14882.122.0086.1683.121.97
2151984-15198481.24782.23
3154919-15491982.81683.80
4152054-15205481.28482.29
5152282-15228281.40682.38
6151145-15114580.79881.84
30min1159995-15999585.52983.901.2387.0185.361.23
2155529-15552983.14284.58
3156856-15685683.85185.30
4157282-15728284.07985.54
5154382-15438282.52883.95
6157628-15762884.26485.75
45min1159135-15913585.06982.621.9287.0384.541.90
2152631-15263181.59283.49
3156161-15616183.47985.39
4154932-15493282.82284.75
5150574-15057480.49382.37
6153872-15387282.25684.22
极限1160699-16069985.90583.622.0588.3386.002.02
2152809-15280981.68884.04
3159970-15997085.51687.89
4155821-15582183.29885.69
5154066-15406682.36084.69
6155177-15517782.95385.37
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.071999091993852002692000611997521998750.17
216.052023782026832025300.11
单位质量响应值RSD%判断
12437.7712618.691.03数据可信
供试品溶液-18016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%
5min166293-6629335.38735.338.5035.3935.348.49
261870-6187033.02633.03
360729-6072932.41732.42
463635-6363533.96833.97
568573-6857336.60436.60
676065-7606540.60340.60
10min1140635-14063575.07072.664.0275.2772.854.02
2132660-13266070.81371.00
3127264-12726467.93268.11
4139691-13969174.56674.75
5135318-13531872.23172.43
6141100-14110075.31875.54
15min1158527-15852784.62081.692.7585.2382.292.74
2148539-14853979.28979.87
3148781-14878179.41879.98
4157348-15734883.99184.59
5152082-15208281.18081.78
6152921-15292181.62882.27
20min1162862-16286286.93484.801.3988.0285.861.40
2157077-15707783.84684.86
3158123-15812384.40585.40
4159970-15997085.39086.46
5157428-15742884.03485.09
6157767-15776784.21485.31
30min1163498-16349887.27485.462.0488.8486.982.03
2159612-15961285.19986.68
3158695-15869584.71086.18
4163248-16324887.14088.68
5154715-15471582.58584.11
6160801-16080185.83487.40
45min1162581-16258186.78485.351.5588.8487.351.56
2156762-15676283.67885.63
3157769-15776984.21686.15
4162788-16278886.89588.92
5159289-15928985.02787.01
6160224-16022485.52687.57
极限1162781-16278186.89186.661.4289.4289.141.41
2158658-15865884.69087.11
3164229-16422987.66490.07
4162585-16258586.78689.30
5160905-16090585.89088.34
6164988-16498888.06990.59
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