托伐普坦口崩片项目信息
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101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.453906863944353903773936323934273925110.48
216.523951313926983939140.44
单位质量响应值RSD%判断
23860.8523844.670.05数据可信
供试品溶液-24102501批-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%
5min137202-372029.3589.285.959.369.285.95
234098-340988.5778.58
336670-366709.2249.22
437248-372489.3699.37
535467-354678.9218.92
640623-4062310.21810.22
10min186932-8693221.86722.231.7621.8822.251.76
287284-8728421.95621.97
388466-8846622.25322.27
488983-8898322.38322.40
591132-9113222.92422.94
687494-8749422.00922.03
15min1132498-13249833.32934.171.7133.3834.221.71
2136893-13689334.43534.49
3134066-13406633.72333.78
4136145-13614534.24634.30
5139205-13920535.01635.07
6136153-13615334.24834.30
20min1167874-16787442.22843.101.5542.3443.211.55
2170732-17073242.94643.05
3169438-16943842.62142.73
4171325-17132543.09643.21
5175138-17513844.05544.17
6173534-17353443.65143.76
30min1213540-21354053.71554.421.1853.8954.601.19
2217098-21709854.61054.79
3213775-21377553.77453.95
4215462-21546254.19854.38
5220052-22005255.35355.54
6218026-21802654.84355.03
45min1249302-24930262.71064.491.7362.9864.771.72
2258353-25835364.98765.26
3252873-25287363.60863.88
4258343-25834364.98465.26
5261276-26127665.72266.00
6258226-25822664.95565.23
60min1279919-27991970.41271.601.7070.7871.981.70
2284480-28448071.55971.94
3282262-28226271.00171.38
4280445-28044570.54470.92
5291967-29196773.44273.83
6288851-28885172.65973.04
90min1315686-31568679.40979.851.0579.9080.351.05
2318237-31823780.05080.55
3312290-31229078.55479.05
4316648-31664879.65180.15
5321655-32165580.91081.42
6320028-32002880.50181.01
120min1331851-33185183.47584.471.2784.1085.101.27
2336913-33691384.74885.38
3330085-33008583.03183.66
4338308-33830885.09985.73
5341686-34168685.94986.59
6336057-33605784.53385.17
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1352880-35288088.76590.081.4689.5390.851.45
2358279-35827990.12390.90
3350675-35067588.21088.97
4361625-36162590.96491.74
5362827-36282791.26792.05
6362339-36233991.14491.92
240min1364812-36481291.76692.781.3192.6793.701.31
2369761-36976193.01193.93
3361150-36115090.84591.75
4372488-37248893.69794.62
5372195-37219593.62394.56
6372746-37274693.76294.69
极限1366808-36680892.26893.301.3293.3394.371.32
2367724-36772492.49893.58
3365148-36514891.85192.91
4374734-37473494.26295.34
5376660-37666094.74695.84
6374273-37427394.14695.23
托伐普坦口崩片项目信息
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101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.453939703921353957563909073938713933280.48
216.524021144002304011720.34
单位质量响应值RSD%判断
23910.5224284.021.10数据可信
供试品溶液-24102501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%
5min178145-7814519.45917.996.4119.4617.996.42
273293-7329318.25018.25
370930-7093017.66217.66
464105-6410515.96315.96
573608-7360818.32918.33
673446-7344618.28818.29
10min1137648-13764834.27533.054.4834.3133.084.48
2139296-13929634.68634.72
3128728-12872832.05432.08
4123587-12358730.77430.80
5131633-13163332.77732.81
6135552-13555233.75333.78
15min1174874-17487443.54542.343.7743.6342.423.77
2177606-17760644.22544.31
3166111-16611141.36341.45
4160514-16051439.96940.05
5167526-16752641.71541.80
6173502-17350243.20343.29
20min1203117-20311750.57749.043.3750.7449.193.37
2206046-20604651.30751.47
3192710-19271047.98648.14
4188678-18867846.98247.13
5193448-19344848.17048.32
6197576-19757649.19849.36
30min1237747-23774759.20058.002.8659.4558.242.87
2241407-24140760.11260.36
3227551-22755156.66256.89
4224759-22475955.96656.19
5229118-22911857.05257.29
6236969-23696959.00759.25
45min1274460-27446068.34266.762.6368.6967.102.63
2275619-27561968.63168.98
3263093-26309365.51265.84
4260377-26037764.83565.15
5261909-26190965.21765.55
6273280-27328068.04868.39
60min1297373-29737374.04872.502.4274.5172.942.42
2298413-29841374.30774.77
3286802-28680271.41571.85
4283636-28363670.62771.05
5284080-28408070.73871.18
6296571-29657173.84874.30
90min1324140-32414080.71379.202.3381.3079.762.34
2326369-32636981.26881.85
3312324-31232477.77078.32
4311745-31174577.62678.17
5310104-31010477.21877.77
6323691-32369180.60181.18
120min1341473-34147385.02984.052.4685.7584.752.47
2348050-34805086.66687.39
3333721-33372183.09883.78
4329720-32972082.10282.77
5327836-32783681.63382.32
6344489-34448985.78086.49
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1363919-36391990.61888.782.4691.4889.622.47
2365945-36594591.12291.99
3350858-35085887.36688.19
4348203-34820386.70587.51
5346937-34693786.38987.21
6363353-36335390.47791.33
240min1376195-37619593.67590.952.6494.6891.932.64
2376785-37678593.82294.84
3357925-35792589.12590.09
4358549-35854989.28190.23
5354810-35481088.35089.32
6367221-36722191.44092.44
极限1371961-37196192.62091.052.3893.7992.192.38
2375874-37587493.59594.77
3357385-35738588.99190.11
4359097-35909789.41790.52
5357046-35704688.90790.02
6372513-37251392.75893.91
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