盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.093845183846753847453847243845503846420.03
212.183944993952353948670.14
单位质量响应值RSD%判断
31814.8932419.291.34数据可信
供试品溶液-1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%
5min1185631-18563143.81337.7221.6043.8137.7221.60
2143457-14345733.85933.86
3190251-19025144.90444.90
4175310-17531041.37741.38
5166272-16627239.24439.24
698052-9805223.14323.14
10min1231536-23153654.64847.8817.0554.7247.9517.05
2185723-18572343.83543.89
3229188-22918854.09454.17
4219712-21971251.85751.93
5210109-21010949.59149.66
6140969-14096933.27233.31
15min1256903-25690360.63553.6915.0660.8053.8315.07
2210038-21003849.57449.70
3252127-25212759.50859.67
4243199-24319957.40157.56
5236422-23642255.80155.95
6166185-16618539.22439.32
20min1277061-27706165.39358.4213.3565.6658.6513.37
2233025-23302555.00055.21
3270480-27048063.84064.10
4259146-25914661.16561.42
5257916-25791660.87461.12
6187485-18748544.25144.41
30min1302211-30221171.32964.9810.8871.7065.3110.91
2268471-26847163.36663.67
3292542-29254269.04769.42
4283370-28337066.88267.24
5286683-28668367.66468.01
6218556-21855651.58451.82
45min1325571-32557176.84371.519.4677.3471.959.49
2309727-30972773.10373.51
3316067-31606774.59975.09
4305377-30537772.07672.54
5314888-31488874.32174.78
6246175-24617558.10358.42
60min1338055-33805579.78974.678.1580.4175.238.19
2319973-31997375.52176.05
3325992-32599276.94277.55
4319562-31956275.42476.01
5329002-32900277.65278.23
6265614-26561462.69163.11
极限1356774-35677484.20778.997.4384.9679.687.47
2338550-33855079.90680.56
3343822-34382281.15081.89
4335952-33595279.29380.00
5346870-34687081.87082.58
6286166-28616667.54268.06
盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.093837403838323836913841403842323839270.07
212.183836463839143837800.05
单位质量响应值RSD%判断
31755.7531509.030.56数据可信
供试品溶液-1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%
5min1186973-18697344.80347.6711.8344.8047.6611.83
2210816-21081650.51650.52
3158558-15855837.99437.99
4223566-22356653.57253.57
5199071-19907147.70247.70
6214527-21452751.40651.41
10min1236525-23652556.67757.907.3556.7557.987.35
2250790-25079060.09560.18
3208754-20875450.02250.09
4255670-25567061.26461.35
5242794-24279458.17958.26
6255216-25521661.15661.24
15min1261170-26117062.58262.665.3262.7562.845.32
2266670-26667063.90064.08
3234202-23420256.12056.27
4271963-27196365.16965.36
5265270-26527063.56563.74
6269814-26981464.65464.84
20min1277469-27746966.48866.554.4066.7666.834.42
2282160-28216067.61267.90
3253741-25374160.80261.04
4286691-28669168.69869.00
5280742-28074267.27267.55
6285543-28554368.42368.72
30min1299094-29909471.67071.523.5472.0571.913.56
2301999-30199972.36672.77
3277614-27761466.52366.86
4306674-30667473.48673.90
5300899-30089972.10272.50
6304502-30450272.96673.38
45min1322845-32284577.36176.653.1077.8677.163.11
2320873-32087376.88977.41
3300292-30029271.95772.41
4327608-32760878.50279.04
5325222-32522277.93178.45
6322503-32250377.27977.81
60min1333235-33323579.85179.463.0680.4880.103.07
2334034-33403480.04280.69
3311396-31139674.61875.19
4337906-33790680.97081.64
5338389-33838981.08681.73
6334710-33471080.20480.86
极限1352686-35268684.51283.292.5285.2884.062.53
2349129-34912983.65984.45
3330263-33026379.13979.84
4354052-35405284.83985.64
5350620-35062084.01784.80
6348683-34868383.55384.35
盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.093856933859403849583843183847273851270.18
212.183846463850943848700.09
单位质量响应值RSD%判断
31855.0031598.520.58数据可信
供试品溶液-1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%
5min1378394-37839490.40287.0314.0490.4087.0314.04
2408694-40869497.64197.64
3268203-26820364.07764.08
4398642-39864295.24095.24
5381346-38134691.10891.11
6350444-35044483.72583.72
10min1398235-39823595.14393.999.0595.2994.149.06
2424396-424396101.393101.56
3323861-32386177.37477.48
4410705-41070598.12298.28
5407710-40771097.40697.56
6395641-39564194.52394.66
15min1406418-40641897.09895.896.9697.4196.196.98
2426195-426195101.823102.15
3346750-34675082.84283.08
4412630-41263098.58298.90
5413511-41351198.79299.11
6402559-40255996.17696.47
20min1412050-41205098.44396.845.8298.9197.305.84
2426833-426833101.975102.48
3359552-35955285.90186.27
4412457-41245798.54099.03
5416489-41648999.50499.98
6404690-40469096.68597.14
30min1414609-41460999.05497.864.0299.6998.484.05
2426248-426248101.835102.51
3378355-37835590.39390.91
4411415-41141598.29198.94
5417936-41793699.849100.49
6409125-40912597.74498.36
45min1416986-41698699.62299.022.42100.4299.802.46
2427245-427245102.073102.91
3397516-39751694.97195.64
4412023-41202398.43799.25
5420335-420335100.422101.23
6412561-41256198.56599.35
60min1416777-41677799.57299.281.84100.54100.231.88
2426474-426474101.889102.90
3404708-40470896.68997.51
4411474-41147498.30699.28
5421056-421056100.595101.57
6412949-41294998.65899.60
极限1416498-41649899.50699.301.57100.64100.421.60
2425772-425772101.721102.90
3408287-40828797.54498.53
4410613-41061398.10099.24
5420067-420067100.358101.50
6412568-41256898.56799.68
盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.093840603841253841133836963838593839710.05
212.183863193865653864420.05
单位质量响应值RSD%判断
31759.3931727.590.08数据可信
供试品溶液-1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%
5min1394299-39429994.15192.127.4794.1592.127.47
2400344-40034495.59595.59
3350522-35052283.69883.70
4402683-40268396.15396.15
5417513-41751399.69499.69
6349377-34937783.42583.42
10min1408753-40875397.60297.174.5797.7697.324.57
2411298-41129898.21098.37
3380414-38041490.83690.98
4421021-421021100.532100.69
5429859-429859102.642102.81
6390286-39028693.19393.33
15min1408981-40898197.65798.333.8397.9898.653.83
2413610-41361098.76299.09
3387343-38734392.49092.78
4424403-424403101.339101.67
5432142-432142103.187103.52
6404324-40432496.54596.84
20min1409370-40937097.75098.873.2898.2399.343.28
2413334-41333498.69699.18
3394622-39462294.22894.67
4426187-426187101.765102.26
5432414-432414103.252103.76
6408322-40832297.50097.95
30min1409484-40948497.77799.292.7798.4299.942.77
2412584-41258498.51799.17
3402005-40200595.99196.59
4427279-427279102.026102.69
5432167-432167103.193103.87
6411482-41148298.25498.87
45min1409519-40951997.78599.802.3298.59100.602.33
2414599-41459998.99899.81
3408163-40816397.46298.22
4428520-428520102.322103.16
5431138-431138102.948103.80
6415679-41567999.256100.04
60min1409792-40979297.85199.952.0898.82100.932.09
2413372-41337298.70599.69
3413084-41308498.63799.56
4426759-426759101.902102.91
5431662-431662103.073104.10
6416842-41684299.534100.48
极限1406874-40687497.15499.462.3498.29100.602.35
2411820-41182098.33599.48
3408300-40830097.49498.58
4427481-427481102.074103.25
5429521-429521102.561103.76
6415233-41523399.150100.26
盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.093870543865893865213868843867773867650.06
212.183861453864453862950.06
单位质量响应值RSD%判断
31990.4931715.520.62数据可信
供试品溶液-1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%
5min1355071-35507184.49487.103.5284.4987.103.52
2346578-34657882.47382.47
3365307-36530786.93086.93
4375155-37515589.27489.27
5378327-37832790.02890.03
6375730-37573089.41089.41
10min1385831-38583191.81494.192.0291.9594.342.02
2389145-38914592.60392.74
3391599-39159993.18793.33
4400301-40030195.25795.41
5404300-40430096.20996.36
6403793-40379396.08896.24
15min1392408-39240893.37996.502.0593.6796.802.05
2400916-40091695.40495.70
3415310-41531098.82999.13
4412335-41233598.12198.43
5404051-40405196.15096.46
6408047-40804797.10197.41
20min1397128-39712894.50296.511.7594.9596.971.74
2404996-40499696.37596.83
3417553-41755399.36399.83
4403926-40392696.12096.59
5400960-40096095.41495.88
6408816-40881697.28497.75
30min1386507-38650791.97597.263.0292.5897.883.01
2403969-40396996.13096.74
3420868-420868100.152100.78
4416675-41667599.15499.79
5409907-40990797.54398.17
6414393-41439398.61199.24
45min1400309-40030995.25997.571.4896.0298.361.48
2407526-40752696.97797.75
3416582-41658299.13299.93
4415733-41573398.93099.73
5408106-40810697.11597.91
6411825-41182598.00098.80
60min1404679-40467996.29998.501.4997.2299.451.49
2412473-41247398.15499.09
3420734-420734100.120101.08
4418970-41897099.700100.66
5409577-40957797.46598.42
6417224-41722499.284100.25
极限1406372-40637296.70297.361.0697.7898.471.06
2406479-40647996.72897.82
3409698-40969897.49498.62
4412663-41266398.19999.33
5404112-40411296.16497.28
6415500-41550098.874100.00
盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.093864943865953867393863463868423866030.06
212.183865353869883867620.09
单位质量响应值RSD%判断
31977.0931753.860.50数据可信
供试品溶液-1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%
5min1356209-35620984.73187.812.7784.7387.812.77
2381197-38119790.67590.68
3357899-35789985.13385.13
4368708-36870887.70487.70
5376735-37673589.61489.61
6374174-37417489.00589.00
10min1387155-38715592.09293.062.2992.2393.212.29
2378838-37883890.11490.27
3386298-38629891.88992.03
4400138-40013895.18195.33
5392591-39259193.38593.53
6402412-40241295.72295.87
15min1396963-39696394.42595.541.2894.7295.841.28
2398621-39862194.82095.12
3405689-40568996.50196.80
4407193-40719396.85997.16
5395678-39567894.12094.42
6405820-40582096.53296.84
20min1396322-39632294.27396.041.1194.7396.501.11
2405499-40549996.45696.92
3401845-40184595.58796.04
4407677-40767796.97497.44
5402742-40274295.80096.26
6408404-40840497.14797.62
30min1404191-40419196.14596.761.3596.7597.381.34
2402211-40221195.67496.29
3400992-40099295.38496.00
4412476-41247698.11698.74
5406573-40657396.71197.33
6414199-41419998.52599.16
45min1404680-40468096.26197.681.3197.0398.461.31
2408249-40824997.11097.89
3414688-41468898.64299.42
4408095-40809597.07397.86
5408813-40881397.24498.03
6419386-41938699.759100.55
60min1401236-40123695.44296.452.6496.3797.402.62
2386392-38639291.91192.85
3407814-40781497.00797.95
4409376-40937697.37898.33
5410753-41075397.70698.65
6417349-41734999.275100.24
极限1401621-40162195.53397.201.4796.6298.301.47
2404289-40428996.16897.26
3409012-40901297.29298.39
4413530-41353098.36699.48
5405654-40565496.49397.60
6417539-41753999.320100.45
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