坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.943836138441384623836838501384270.16
215.973834138531384360.35
单位质量响应值RSD%判断
2410.732406.760.12数据可信
供试品溶液-2025011621批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15923-592313.80415.8311.8713.8015.8311.88
28244-824419.21319.21
36846-684615.95515.96
46841-684115.94315.94
56176-617614.39414.39
66732-673215.68915.69
10min114134-1413432.94042.4315.0132.9642.4615.01
221344-2134449.74449.78
317642-1764241.11641.14
418607-1860743.36543.39
520972-2097248.87748.90
616547-1654738.56438.59
15min122433-2243352.28265.8811.4852.3665.9811.49
231053-3105372.37172.49
328189-2818965.69665.79
429326-2932668.34668.45
531252-3125272.83572.94
627361-2736163.76763.86
20min129677-2967769.16480.707.3369.3380.917.34
235836-3583683.51883.75
334849-3484981.21881.42
436054-3605484.02684.24
536663-3666385.44685.67
634688-3468880.84381.04
30min138134-3813488.87494.243.2389.1594.583.24
239867-3986792.91393.29
340584-4058494.58494.92
441819-4181997.46297.81
541236-4123696.10396.47
640968-4096895.47995.81
45min141159-4115995.92498.442.4496.3598.942.44
240876-4087695.26495.79
342586-4258699.25099.75
443236-43236100.765101.28
542251-4225198.46999.00
643316-43316100.951101.44
60min141522-4152296.77098.492.6297.3699.162.60
240890-4089095.29795.99
342218-4221898.39299.06
443443-43443101.247101.93
541793-4179397.40298.10
643693-43693101.830102.49
极限142571-4257199.21598.822.2799.9699.642.24
240866-4086695.24196.09
342361-4236198.72599.55
443072-43072100.382101.23
541902-4190297.65698.51
643630-43630101.683102.51
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.943856038466383083843538353384240.26
215.973865638606386310.10
单位质量响应值RSD%判断
2410.542418.970.25数据可信
供试品溶液-24121702批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16428-642814.94416.9035.6214.9416.9035.64
26445-644514.98314.98
37475-747517.37817.38
412240-1224028.45528.46
54741-474111.02211.02
66281-628114.60214.60
10min116068-1606837.35438.8915.1537.3838.9215.16
216119-1611937.47337.50
316076-1607637.37337.40
421487-2148749.95250.00
513864-1386432.23132.25
616767-1676738.98039.00
15min124645-2464557.29460.338.7157.3860.428.72
225995-2599560.43360.52
325778-2577859.92860.02
429560-2956068.72068.85
522817-2281753.04453.12
626909-2690962.55762.65
20min131221-3122172.58275.426.1972.7675.616.21
232624-3262475.84376.03
332529-3252975.62375.81
435980-3598083.64583.89
529980-2998069.69769.86
632319-3231975.13475.33
30min137799-3779987.87490.224.0088.1890.534.03
238729-3872990.03690.35
338798-3879890.19790.51
441660-4166096.85097.23
537114-3711486.28286.56
638737-3873790.05590.37
45min141035-4103595.39797.773.5195.8598.243.54
241480-4148096.43296.90
342219-4221998.15098.62
444809-44809104.171104.72
540681-4068194.57494.99
642103-4210397.88098.35
60min141549-4154996.59298.833.1897.2099.463.21
242189-4218998.08098.71
342188-4218898.07898.71
445154-45154104.973105.69
541512-4151296.50697.08
642465-4246598.72299.35
极限142163-4216398.02099.542.7798.79100.342.80
242104-4210497.88298.67
342713-4271399.298100.09
445195-45195105.068105.96
542314-4231498.37199.11
642413-4241398.60199.40
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.943852738352386313824838573384660.42
215.973835338260383060.18
单位质量响应值RSD%判断
2413.172398.620.43数据可信
供试品溶液-24122002批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13400-34007.9339.2718.007.939.2718.02
23096-30967.2247.22
33525-35258.2258.23
44410-441010.29010.29
54646-464610.84110.84
64755-475511.09511.10
10min110932-1093225.50828.249.9725.5228.259.98
211482-1148226.79226.80
310842-1084225.29825.31
412456-1245629.06429.08
513743-1374332.06732.09
613154-1315430.69330.71
15min119184-1918444.76348.176.9344.8248.246.94
220905-2090548.77948.84
318636-1863643.48443.54
421271-2127149.63349.70
522299-2229952.03152.10
621575-2157550.34250.41
20min126697-2669762.29364.975.2162.4265.115.22
228006-2800665.34865.49
325615-2561559.76959.90
428224-2822465.85666.00
529409-2940968.62168.78
629114-2911467.93368.09
30min135548-3554882.94684.333.2683.1884.583.27
236224-3622484.52384.77
334074-3407479.50779.73
436816-3681685.90586.16
537121-3712186.61686.89
637066-3706686.48886.75
45min140805-4080595.21294.701.6395.5895.091.64
240555-4055594.62995.02
339389-3938991.90892.27
440451-4045194.38694.79
541020-4102095.71496.13
641280-4128096.32196.73
60min142082-4208298.19297.251.0298.7297.801.03
241388-4138896.57397.12
341023-4102395.72196.23
441610-4161097.09197.65
541832-4183297.60998.19
642124-4212498.29098.86
极限142490-4249099.14498.050.8799.8498.760.88
241958-4195897.90398.61
341505-4150596.84697.52
441882-4188297.72598.45
542399-4239998.93299.67
641901-4190197.77098.50
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.943882138864386003837838324385970.64
215.973869738872387840.32
单位质量响应值RSD%判断
2421.392428.550.21数据可信
供试品溶液-24122402批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15293-529312.25311.4723.2512.2511.4723.25
25471-547112.66512.67
34617-461710.68810.69
45552-555212.85312.85
52791-27916.4616.46
66001-600113.89213.89
10min115665-1566536.26435.7918.9236.2835.8118.92
217415-1741540.31540.34
314903-1490334.50034.52
417012-1701239.38239.40
59934-993422.99723.01
617830-1783041.27641.30
15min125815-2581559.76157.7013.9759.8457.7813.97
226880-2688062.22762.31
324736-2473657.26357.34
426360-2636061.02361.11
518109-1810941.92241.97
627641-2764163.98864.08
20min132565-3256575.38772.9210.3575.5773.1010.36
232620-3262075.51575.71
331074-3107471.93672.11
432286-3228674.74174.93
525395-2539558.78958.91
635049-3504981.13881.34
30min139539-3953991.53288.465.4391.8488.765.46
238482-3848289.08589.40
337811-3781187.53287.82
437983-3798387.93088.24
534651-3465180.21680.43
640813-4081394.48194.82
45min143010-4301099.56796.993.67100.0397.443.70
241890-4189096.97497.44
341390-4139095.81796.25
441598-4159896.29996.76
539499-3949991.43991.79
644003-44003101.866102.36
60min143990-43990101.83698.512.69102.4699.122.71
242312-4231297.95198.58
342029-4202997.29697.89
441804-4180496.77597.40
541266-4126695.53096.03
643930-43930101.697102.36
极限143899-43899101.62599.061.83102.4299.831.85
242319-4231997.96898.76
342520-4252098.43399.19
442089-4208997.43598.22
542261-4226197.83398.50
643659-43659101.070101.90
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