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%
116.063780693782193777713774643775403778130.09
216.073778323779223778770.02
单位质量响应值RSD%判断
23525.0923514.440.04数据可信
供试品溶液-24122001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%
5min1-0.0000.09244.950.000.09244.95
2-0.0000.00
32279-22790.5440.54
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min18043-80431.9201.8518.711.921.8518.72
26961-69611.6611.66
39821-98212.3442.35
48513-85132.0322.03
57496-74961.7891.79
65555-55551.3261.33
15min112165-121652.9043.1413.392.913.1413.38
212314-123142.9392.94
314752-147523.5213.53
415294-152943.6503.65
513670-136703.2633.27
610625-106252.5362.54
20min115601-156013.7243.918.373.733.928.33
215925-159253.8013.81
317019-170194.0624.07
418866-188664.5034.51
515536-155363.7083.72
615258-152583.6423.65
30min118736-187364.4724.838.734.494.858.70
220908-209084.9905.00
320607-206074.9194.94
422034-220345.2595.28
521724-217245.1855.20
617530-175304.1844.20
45min123908-239085.7065.588.245.735.608.21
222657-226575.4085.43
322011-220115.2545.28
426375-263756.2956.32
520935-209354.9975.02
624335-243355.8085.83
60min124356-243565.8135.956.345.845.986.37
226750-267506.3856.42
325298-252986.0386.07
425996-259966.2056.24
525049-250495.9796.01
622185-221855.2955.32
90min126997-269976.4446.303.746.486.343.68
227400-274006.5406.58
326426-264266.3076.35
426424-264246.3076.35
524533-245335.8565.90
626483-264836.3216.36
120min126864-268646.4126.603.846.466.663.82
228093-280936.7056.76
328567-285676.8186.87
428760-287606.8656.92
525995-259956.2056.26
627679-276796.6066.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限128208-282086.7336.463.016.806.532.97
226825-268256.4036.47
325772-257726.1516.22
427589-275896.5856.65
527037-270376.4536.51
627044-270446.4556.51
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%
116.063783883786953784003782823783253784180.05
216.073781033776913778970.08
单位质量响应值RSD%判断
23562.7623515.680.15数据可信
供试品溶液-24122401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%
5min11282-12820.3060.05244.950.310.05244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min18071-80711.9251.3558.721.931.3558.73
21078-10780.2570.26
37982-79821.9041.90
41776-17760.4240.42
56834-68341.6301.63
68235-82351.9641.96
15min113038-130383.1092.8318.573.112.8318.66
29185-91852.1902.19
314727-147273.5123.52
49399-93992.2422.24
513085-130853.1213.12
611825-118252.8202.82
20min115945-159453.8033.9910.263.814.0010.26
215356-153563.6623.67
319081-190814.5514.56
414691-146913.5043.51
516988-169884.0514.06
618296-182964.3634.37
30min123110-231105.5115.026.945.535.036.98
219677-196774.6934.70
322165-221655.2865.30
420503-205034.8904.90
519359-193594.6174.63
621383-213835.1005.11
45min126619-266196.3485.776.586.375.806.58
222287-222875.3155.33
324600-246005.8675.89
424383-243835.8155.83
522580-225805.3855.41
624794-247945.9135.94
60min127062-270626.4546.005.326.496.035.31
223330-233305.5645.59
325206-252066.0116.05
425547-255476.0936.12
525736-257366.1386.17
623953-239535.7125.75
90min129744-297447.0946.535.177.146.575.14
226915-269156.4196.45
325753-257536.1426.19
427163-271636.4786.52
526501-265016.3206.36
628225-282256.7316.77
120min129224-292246.9696.653.627.036.703.61
227958-279586.6686.71
326236-262366.2576.31
427935-279356.6626.71
528511-285116.7996.85
627477-274776.5536.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限129705-297057.0846.684.917.156.744.86
229344-293446.9987.06
326756-267566.3816.45
428183-281836.7216.78
526240-262406.2586.32
627765-277656.6226.69
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%
116.063787543784593786333786653780263785070.08
216.073783733785473784600.04
单位质量响应值RSD%判断
23568.3123550.720.06数据可信
供试品溶液-24122002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%
5min11663-16630.3960.4023.640.400.4023.52
21558-15580.3710.37
32427-24270.5780.58
41797-17970.4280.43
51382-13820.3290.33
61327-13270.3160.32
10min19765-97652.3272.519.762.332.519.68
29043-90432.1552.16
310658-106582.5402.54
411875-118752.8302.83
511322-113222.6982.70
610434-104342.4862.49
15min118166-181664.3294.068.144.334.068.15
214557-145573.4693.47
317628-176284.2004.21
417054-170544.0644.07
518281-182814.3564.36
616498-164983.9313.94
20min119409-194094.6254.857.344.644.867.31
218933-189334.5114.52
319040-190404.5374.55
422497-224975.3615.37
520441-204414.8714.88
621728-217285.1775.19
30min124174-241745.7605.627.475.785.647.49
220125-201254.7954.81
324056-240565.7325.75
425122-251225.9866.01
523662-236625.6385.66
624357-243575.8045.82
45min126815-268156.3896.306.866.426.336.83
224535-245355.8465.87
325900-259006.1716.20
426891-268916.4086.44
524869-248695.9265.96
629553-295537.0427.07
60min128475-284756.7856.651.626.826.691.58
228041-280416.6826.72
327157-271576.4716.51
427804-278046.6256.67
528210-282106.7226.76
627820-278206.6296.67
90min127264-272646.4966.903.526.556.953.48
230010-300107.1517.20
328848-288486.8746.92
429994-299947.1477.20
529028-290286.9176.97
628645-286456.8266.88
120min127888-278886.6456.972.816.717.042.77
229941-299417.1347.19
328678-286786.8336.90
429890-298907.1227.19
529445-294457.0167.08
629761-297617.0917.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限128099-280996.6957.033.746.777.113.69
229566-295667.0457.12
328648-286486.8266.90
431257-312577.4487.52
530032-300327.1567.23
629463-294637.0207.10
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%
116.063780603781033770853772403769863774950.15
216.073777573774403775980.06
单位质量响应值RSD%判断
23505.2923497.080.03数据可信
供试品溶液-24122402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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min110128-101282.4192.3013.142.422.3013.11
28414-84142.0102.01
310880-108802.5992.60
410625-106252.5382.54
59911-99112.3672.37
67729-77291.8461.85
15min116618-166183.9703.734.553.973.744.55
214739-147393.5213.52
315811-158113.7773.78
415049-150493.5953.60
516179-161793.8653.87
615355-153553.6683.67
20min118972-189724.5324.735.604.544.745.62
218661-186614.4584.47
319550-195504.6704.68
420073-200734.7954.81
521800-218005.2075.22
619652-196524.6944.70
30min122874-228745.4645.511.175.485.531.15
223233-232335.5505.57
323086-230865.5155.53
422812-228125.4495.47
522970-229705.4875.51
623538-235385.6235.64
45min126245-262456.2695.858.246.305.888.23
226509-265096.3326.36
324812-248125.9275.95
424932-249325.9565.98
523485-234855.6105.64
621040-210405.0265.05
60min127421-274216.5506.524.416.596.554.39
227704-277046.6186.65
325462-254626.0826.12
428973-289736.9216.96
527649-276496.6056.64
626451-264516.3186.35
90min129775-297757.1126.862.197.166.912.16
228578-285786.8266.87
328808-288086.8816.93
428498-284986.8076.86
528782-287826.8756.92
627843-278436.6516.70
120min128268-282686.7526.972.326.817.032.30
229919-299197.1477.21
328707-287076.8576.92
429224-292246.9817.04
528996-289966.9266.99
629978-299787.1617.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限128055-280556.7026.692.126.776.762.09
228272-282726.7536.82
328297-282976.7596.83
427383-273836.5416.61
527198-271986.4976.57
628757-287576.8696.94
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