盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303946413947573949043947343948853947840.03
212.273945023942733943880.05
单位质量响应值RSD%判断
32096.2632142.460.11数据可信
加速6月-供试品溶液-2023120221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1363732-36373285.83684.137.5885.8484.137.58
2348964-34896482.35182.35
3333725-33372578.75578.75
4407680-40768096.20796.21
5342317-34231780.78280.78
6342595-34259580.84880.85
5min1400866-40086694.59993.862.3094.6093.862.29
2405696-40569695.73995.74
3385187-38518790.89990.90
4406822-40682296.00596.00
5400034-40003494.40394.40
6387907-38790791.54191.54
10min1401447-40144794.73694.741.9294.7494.741.92
2410027-41002796.76196.76
3389674-38967491.95891.96
4409198-40919896.56596.57
5401873-40187394.83794.84
6396629-39662993.59993.60
15min1402027-40202794.87395.141.5294.8795.141.52
2411049-41104997.00297.00
3394571-39457193.11393.11
4409208-40920896.56896.57
5402394-40239494.96094.96
6399628-39962894.30794.31
20min1402152-40215294.90395.661.3694.9095.661.36
2412485-41248597.34197.34
3398034-39803493.93193.93
4411164-41116497.02997.03
5403987-40398795.33695.34
6404315-40431595.41395.41
30min1402903-40290395.08095.791.1895.0895.791.18
2412649-41264997.38097.38
3399885-39988594.36894.37
4409584-40958496.65696.66
5403121-40312195.13195.13
6407323-40732396.12396.12
45min1401179-40117994.67395.901.2494.6795.901.24
2412738-41273897.40197.40
3400426-40042694.49594.50
4410391-41039196.84796.85
5404849-40484995.53995.54
6408651-40865196.43696.44
60min1399739-39973994.33395.591.1594.3395.591.15
2409622-40962296.66596.67
3400134-40013494.42694.43
4408725-40872596.45496.45
5403055-40305595.11695.12
6409075-40907596.53696.54
极限1399587-39958794.29795.471.2494.3095.471.24
2410557-41055796.88696.89
3399029-39902994.16694.17
4408384-40838496.37396.37
5401849-40184994.83194.83
6408007-40800796.28496.28
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303930043927783928293928903930503929100.03
212.273947373949543948460.04
单位质量响应值RSD%判断
31943.9032179.790.53数据可信
加速6月-供试品溶液-2023120521批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1331991-33199178.48780.334.9678.4980.334.97
2339130-33913080.17580.17
3354233-35423383.74583.75
4364360-36436086.13986.14
5318266-31826675.24275.24
6330694-33069478.18078.18
5min1389090-38909091.98691.612.1691.9991.612.16
2389886-38988692.17492.17
3402068-40206895.05495.05
4381539-38153990.20190.20
5383742-38374290.72290.72
6378673-37867389.52389.52
10min1388429-38842991.83092.552.0191.8392.552.01
2392321-39232192.75092.75
3404561-40456195.64495.64
4384471-38447190.89490.89
5395547-39554793.51293.51
6383596-38359690.68790.69
15min1390608-39060892.34593.041.8292.3493.041.82
2394437-39443793.25093.25
3404537-40453795.63895.64
4385980-38598091.25191.25
5398526-39852694.21794.22
6387107-38710791.51791.52
20min1390890-39089092.41293.211.7292.4193.201.71
2394440-39444093.25193.25
3404937-40493795.73295.73
4387876-38787691.69991.70
5399187-39918794.37394.37
6388175-38817591.77091.77
30min1391211-39121192.48793.521.5092.4993.521.49
2395008-39500893.38593.39
3404183-40418395.55495.55
4391233-39123392.49392.49
5401451-40145194.90894.91
6390362-39036292.28792.29
45min1390971-39097192.43193.581.3292.4393.581.32
2396440-39644093.72493.72
3403411-40341195.37295.37
4391856-39185692.64092.64
5400611-40061194.71094.71
6391803-39180392.62792.63
60min1390504-39050492.32093.501.2592.3293.501.25
2395593-39559393.52393.52
3402631-40263195.18795.19
4391377-39137792.52792.53
5400126-40012694.59594.60
6392805-39280592.86492.86
极限1388118-38811891.75693.071.1891.7693.071.18
2393534-39353493.03793.04
3400021-40002194.57094.57
4390716-39071692.37092.37
5398310-39831094.16694.17
6391364-39136492.52492.52
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303950613948793946373946353946833947790.05
212.273924773927553926160.06
单位质量响应值RSD%判断
32095.8531998.040.22数据可信
加速6月-供试品溶液-2023120621批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1359642-35964285.06385.445.8985.0685.445.89
2379166-37916689.68089.68
3348345-34834582.39182.39
4387444-38744491.63891.64
5364301-36430186.16586.16
6328454-32845477.68677.69
5min1412155-41215597.48394.092.6697.4894.102.66
2398010-39801094.13794.14
3390522-39052292.36692.37
4408759-40875996.68096.68
5386046-38604691.30891.31
6391459-39145992.58892.59
10min1414552-41455298.05094.392.7898.0594.392.78
2398368-39836894.22294.22
3391704-39170492.64692.65
4410315-41031597.04897.05
5386675-38667591.45691.46
6392882-39288292.92592.92
15min1413437-41343797.78694.772.4497.7994.772.44
2398739-39873994.31094.31
3396037-39603793.67193.67
4412020-41202097.45197.45
5389895-38989592.21892.22
6393988-39398893.18693.19
20min1412710-41271097.61494.552.6197.6194.552.61
2397868-39786894.10494.10
3392419-39241992.81592.82
4412556-41255697.57897.58
5388619-38861991.91691.92
6394326-39432693.26693.27
30min1410470-41047097.08494.372.4897.0894.372.48
2396736-39673693.83693.84
3392201-39220192.76492.76
4411971-41197197.44097.44
5388212-38821291.82091.82
6394375-39437593.27893.28
45min1414051-41405197.93194.412.8597.9394.412.84
2396404-39640493.75893.76
3391072-39107292.49692.50
4412426-41242697.54797.55
5387225-38722591.58791.59
6393729-39372993.12593.12
60min1410079-41007996.99294.372.3896.9994.372.38
2395527-39552793.55093.55
3390509-39050992.36392.36
4411957-41195797.43697.44
5392184-39218492.75992.76
6393756-39375693.13193.13
极限1407693-40769396.42893.832.4396.4393.832.43
2394443-39444393.29493.29
3389696-38969692.17192.17
4409621-40962196.88496.88
5386837-38683791.49591.49
6391936-39193692.70192.70
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303951783952153953023952023953563952510.02
212.273938833939383939100.01
单位质量响应值RSD%判断
32134.2332103.500.07数据可信
加速6月-供试品溶液-2205008609批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1165233-16523338.99349.3328.4838.9949.3328.48
2265449-26544962.64362.64
3126404-12640429.83029.83
4213483-21348350.38050.38
5284335-28433567.10067.10
6199237-19923747.01847.02
5min1365945-36594586.35990.713.3686.3690.713.36
2384168-38416890.66090.66
3371765-37176587.73387.73
4392334-39233492.58792.59
5396322-39632293.52893.53
6395646-39564693.36993.37
10min1404802-40480295.52996.681.8695.5396.681.87
2399443-39944394.26594.26
3411850-41185097.19397.19
4407113-40711396.07596.07
5413570-41357097.59897.60
6421310-42131099.42599.43
15min1405728-40572895.74896.991.9495.7597.001.94
2401013-40101394.63594.64
3413560-41356097.59697.60
4407144-40714496.08296.08
5415401-41540198.03198.03
6423182-42318299.86799.87
20min1405041-40504195.58696.682.0195.5996.682.01
2398825-39882594.11994.12
3412919-41291997.44597.44
4406563-40656395.94595.94
5411918-41191897.20997.21
6422884-42288499.79699.80
30min1403940-40394095.32696.921.9195.3396.921.91
2402648-40264895.02195.02
3417524-41752498.53298.53
4405142-40514295.61095.61
5413635-41363597.61497.61
6421217-42121799.40399.40
45min1403970-40397095.33396.391.9895.3396.391.98
2397556-39755693.81993.82
3414076-41407697.71897.72
4403881-40388195.31295.31
5411636-41163697.14297.14
6419639-41963999.03199.03
60min1401203-40120394.68096.042.0094.6896.042.00
2396876-39687693.65993.66
3409987-40998796.75396.75
4403244-40324495.16295.16
5411008-41100896.99496.99
6419445-41944598.98598.98
极限1399846-39984694.36095.292.0594.3695.292.05
2396622-39662293.59993.60
3396910-39691093.66793.67
4402186-40218694.91294.91
5409473-40947396.63296.63
6417611-41761198.55298.55
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