非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.163092413090503089853090253086833089970.07
2 11.243090043091483090760.04
单位质量响应值RSD%判断
27687.9027497.860.49数据可信
供试品溶液-25090401批-恩格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180938-18093858.01459.402.4358.0159.402.43
2189904-18990460.88960.89
3184960-18496059.30459.30
10min1132935-13293542.62340.8944.9642.7240.9944.86
2181982-18198258.34958.45
367688-6768821.70321.80
15min1250049-25004980.17384.824.7580.3484.984.74
2271266-27126686.97687.17
3272303-27230387.30887.44
20min1249038-24903879.84968.0730.2580.1568.3830.15
2249714-24971480.06680.41
3138168-13816844.30144.58
30min1268302-26830286.02690.574.9186.4690.994.84
2283149-28314990.78691.26
3295968-29596894.89695.25
45min1285944-28594491.68279.1421.8292.2679.7121.72
2269109-26910986.28486.91
3185413-18541359.44959.96
60min1275955-27595588.47992.714.6289.2193.414.52
2288825-28882592.60693.38
3302660-30266097.04297.65
极限1293223-29322394.01685.3913.0694.8986.2513.00
2278645-27864589.34290.27
3227061-22706172.80373.58
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
1 22.207909187911207912597906467912697910420.04
2 22.277913327913947913630.01
单位质量响应值RSD%判断
35632.5235534.930.20数据可信
供试品溶液-25090401批-非奈利酮-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1284899-28489936.02936.546.4136.0336.546.41
2309126-30912639.09339.09
3272751-27275134.49334.49
10min1189905-18990524.01623.8552.6924.0823.9152.57
2287342-28734236.33836.40
388622-8862211.20711.26
15min1492817-49281762.32364.034.7462.4264.134.76
2533958-53395867.52667.65
3492118-49211862.23462.31
20min1420070-42007053.12347.4335.2653.3347.6335.17
2478812-47881260.55260.79
3226166-22616628.60228.78
30min1593736-59373675.08577.452.8375.3877.742.84
2627834-62783479.39779.74
3615811-61581177.87778.10
45min1563937-56393771.31762.3027.2971.7362.7127.19
2576358-57635872.88873.36
3337576-33757642.69143.05
60min1648664-64866482.03284.532.5782.5785.052.55
2680015-68001585.99686.59
3676510-67651085.55385.98
极限1634878-63487880.28871.8519.7480.9672.5119.67
2630865-63086579.78180.52
3438686-43868655.47756.05
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.163080943080033081253082743083103081610.05
2 11.243094433092223093320.06
单位质量响应值RSD%判断
27612.9927520.640.24数据可信
供试品溶液-25090402批-恩格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1230763-23076374.05966.1011.3674.0666.1011.36
2202841-20284165.09865.10
3184314-18431459.15259.15
10min1238570-23857076.56457.6659.0176.6957.7758.92
2243139-24313978.03178.14
357284-5728418.38418.48
15min1285719-28571991.69690.543.8891.9590.753.95
2290803-29080393.32793.57
3269822-26982286.59486.72
20min1288398-28839892.55675.3836.6192.9675.7336.54
2280518-28051890.02790.42
3135691-13569143.54743.82
30min1293471-29347194.18493.552.6494.7494.032.74
2298004-29800495.63896.18
3283019-28301990.82991.18
45min1299069-29906995.98085.9716.3996.7086.6116.41
2286892-28689292.07292.78
3217691-21769169.86470.36
60min1297214-29721495.38594.462.8696.2695.252.99
2300951-30095196.58497.44
3284874-28487491.42592.04
极限1302204-30220496.98690.907.9998.0291.848.06
2289257-28925792.83193.85
3258218-25821882.87083.64
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
1 22.207889817887357887037888207890127888500.02
2 22.277911137915237913180.04
单位质量响应值RSD%判断
35533.7835532.910.01数据可信
供试品溶液-25090402批-非奈利酮-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186881-18688123.66716.3547.8123.6716.3547.80
2136258-13625817.25617.26
364093-640938.1178.12
10min1209242-20924226.49917.4545.4226.5417.4845.43
2111453-11145314.11514.14
392684-9268411.73811.75
15min1386305-38630548.92242.9012.8049.0142.9612.85
2328519-32851941.60441.66
3301442-30144238.17538.21
20min1355953-35595345.07843.2311.5745.2443.3611.59
2371528-37152847.05147.17
3296693-29669337.57437.67
30min1494768-49476862.65859.525.4062.9059.725.42
2444070-44407056.23856.44
3471176-47117659.67059.83
45min1444269-44426956.26358.478.0656.6158.778.02
2504458-50445863.88564.18
3436445-43644555.27255.53
60min1566384-56638471.72868.744.7572.1769.144.75
2515281-51528165.25665.66
3546631-54663169.22669.58
极限1506748-50674864.17567.846.6264.7368.366.55
2575239-57523972.84973.36
3525176-52517666.50966.98
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.163084013083533086413084043081163083830.07
2 11.243118873120973119920.05
单位质量响应值RSD%判断
27632.8927757.300.32数据可信
供试品溶液-25090403批-恩格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1166307-16630753.12640.2756.4653.1340.2756.46
2167991-16799153.66453.66
343893-4389314.02114.02
10min1165315-16531552.80950.773.6852.9050.843.74
2157608-15760850.34750.44
3153846-15384649.14549.17
15min1277634-27763488.68975.7933.8188.8775.9533.80
2289261-28926192.40392.58
3144901-14490146.28846.39
20min1279113-27911389.16185.524.4289.4985.794.41
2255497-25549781.61781.94
3268492-26849285.76885.95
30min1294603-29460394.10984.6521.1094.5885.0721.09
2299825-29982595.77796.24
3200516-20051664.05464.38
45min1294328-29432894.02194.111.2894.6594.671.37
2298490-29849095.35195.97
3290998-29099892.95893.39
60min1298973-29897395.50588.9014.1096.2989.6214.11
2302850-30285096.74497.53
3233055-23305574.44875.04
极限1298310-29831095.29396.191.0696.2497.061.08
2304567-30456797.29298.24
3300499-30049995.99396.70
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
1 22.207893217892047901587886637883047891300.09
2 22.277971477972807972140.02
单位质量响应值RSD%判断
35546.4035797.670.50数据可信
供试品溶液-25090403批-非奈利酮-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1218061-21806127.50920.4755.4227.5120.4755.44
2210269-21026926.52626.53
358537-585377.3847.38
10min1214513-21451327.06126.203.0627.1126.243.12
2206622-20662226.06626.11
3201971-20197125.47925.49
15min1454819-45481957.37646.7442.0757.4746.8242.04
2466107-46610758.80058.89
3190668-19066824.05324.11
20min1450328-45032856.80954.174.3557.0054.324.37
2414561-41456152.29752.48
3423263-42326353.39553.49
30min1554276-55427669.92261.4126.3070.2061.6526.28
2566879-56687971.51271.79
3339165-33916542.78642.97
45min1550694-55069469.47068.301.5669.8768.651.65
2539282-53928268.03168.42
3534237-53423767.39467.65
60min1602704-60270476.03268.8019.3076.5569.2719.29
2609572-60957276.89877.40
3423941-42394153.48153.85
极限1601353-60135375.86175.300.7276.5075.880.84
2596619-59661975.26475.90
3592789-59278974.78175.24
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.163105013106443108053111313107843107730.08
2 11.243163133165683164400.06
单位质量响应值RSD%判断
27847.0428153.020.78数据可信
供试品溶液批-恩格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1220931-22093169.80867.143.4569.8167.143.45
2208811-20881165.97965.98
3207753-20775365.64465.64
10min1283871-28387189.69685.524.3089.8185.634.30
2262029-26202982.79482.90
3266022-26602284.05684.17
15min1295615-29561593.40689.523.9793.6789.783.96
2273623-27362386.45886.71
3280738-28073888.70688.96
20min1297426-29742693.97990.054.0194.4090.454.01
2274959-27495986.88087.27
3282561-28256189.28289.68
30min1305930-30593096.66691.704.7897.2492.254.77
2279857-27985788.42788.96
3284818-28481889.99590.54
45min1300719-30071995.01992.222.6495.7692.932.65
2286939-28693990.66591.35
3287955-28795590.98691.68
60min1300661-30066195.00193.771.9195.9094.631.92
2299364-29936494.59195.43
3290262-29026291.71592.56
极限1300902-30090295.07794.551.7096.1395.561.70
2293528-29352892.74793.74
3303241-30324195.81696.82
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)1.5补液体积(ml)1.5
对照品批号250201对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
1 22.207920457937857927197936917923557929190.10
2 22.278081578082618082090.01
单位质量响应值RSD%判断
35717.0736291.381.13数据可信
供试品溶液批-非奈利酮-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182076-8207610.25914.4731.3110.2614.4831.31
2154129-15412919.26519.27
3111189-11118913.89813.90
10min1257364-25736432.16931.944.8932.1931.974.91
2267003-26700333.37433.41
3242241-24224130.27830.30
15min1347584-34758443.44645.264.4743.5245.344.46
2359129-35912944.88944.98
3379530-37953047.43947.51
20min1410330-41033051.28854.286.3251.4354.446.30
2428374-42837453.54453.71
3464201-46420158.02258.17
30min1512044-51204464.00266.225.2164.2366.475.20
2515862-51586264.47964.73
3561574-56157470.19370.44
45min1622161-62216177.76675.895.0678.1076.245.02
2571840-57184071.47671.84
3627348-62734878.41478.78
60min1678133-67813384.76280.656.5985.2381.136.54
2597315-59731574.66075.14
3660331-66033182.53783.03
极限1731751-73175191.46490.331.7492.0790.951.74
2708391-70839188.54489.15
3727969-72796990.99191.63
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