盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
112.303913713923603936063928893931683926790.22
212.273906713907373907040.02
单位质量响应值RSD%判断
31925.1231842.220.19数据可信
长期6月-供试品溶液-2023120221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%
5min1207477-20747749.32452.8010.5149.3252.8010.50
2182793-18279343.45643.46
3241184-24118457.33757.34
4228176-22817654.24554.24
5227877-22787754.17454.17
6245038-24503858.25358.25
10min1253677-25367760.30762.805.0060.4262.925.01
2245542-24554258.37358.47
3271028-27102864.43264.56
4260688-26068861.97462.09
5280571-28057166.70166.82
6273469-27346965.01265.14
15min1284038-28403867.52566.656.6167.7766.906.61
2244454-24445458.11458.34
3288124-28812468.49668.77
4278935-27893566.31266.57
5295992-29599270.36770.64
6290507-29050769.06369.34
20min1297012-29701270.60970.405.4971.0070.815.49
2265397-26539763.09363.45
3304439-30443972.37572.80
4294411-29441169.99170.40
5311606-31160674.07974.50
6303997-30399772.27072.70
30min1318167-31816775.63875.673.9276.1976.233.93
2295986-29598670.36570.86
3324319-32431977.10177.68
4317404-31740475.45776.02
5333663-33366379.32279.91
6320206-32020676.12376.71
45min1337257-33725780.17781.272.9380.9082.002.95
2327017-32701777.74278.39
3344044-34404481.79082.55
4341126-34112681.09681.83
5357640-35764085.02285.79
6344081-34408181.79982.56
60min1351160-35116083.48284.902.5184.3885.812.53
2349433-34943383.07183.90
3357919-35791985.08986.03
4350651-35065183.36184.27
5373020-37302088.67989.63
6360496-36049685.70186.64
90min1367036-36703687.25688.842.4688.3489.932.46
2369964-36996487.95288.96
3376166-37616689.42690.55
4372483-37248388.55189.65
5390732-39073292.88994.04
6365688-36568886.93688.06
120min1375785-37578589.33691.452.4790.6192.742.47
2381634-38163490.72691.93
3389474-38947492.59093.91
4381547-38154790.70692.00
5401561-40156195.46496.82
6378039-37803989.87291.19
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1387133-38713392.03494.382.8593.5195.882.83
2397549-39754994.51095.92
3396372-39637294.23095.76
4396206-39620694.19195.68
5417900-41790099.348100.92
6386932-38693291.98693.51
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
112.303896233894923901443894613898263897090.08
212.273898763903583901170.09
单位质量响应值RSD%判断
31683.6631794.380.25数据可信
长期6月-供试品溶液-2023120521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%
5min1237911-23791156.81758.212.5356.8258.212.52
2242599-24259957.93657.94
3237912-23791256.81756.82
4244889-24488958.48358.48
5254591-25459160.80060.80
6244518-24451858.39558.39
10min1262562-26256262.70463.911.3962.8364.041.38
2267520-26752063.88864.02
3265440-26544063.39163.52
4271495-27149564.83764.97
5266335-26633563.60563.74
6272236-27223665.01465.14
15min1284867-28486768.03168.290.7568.3068.560.75
2286955-28695568.52968.80
3283320-28332067.66167.93
4287010-28701068.54268.82
5284437-28443767.92868.20
6289177-28917769.06069.33
20min1290363-29036369.34371.371.8869.7671.801.87
2298586-29858671.30771.73
3297776-29777671.11371.53
4307634-30763473.46873.89
5301067-30106771.89972.33
6297728-29772871.10271.53
30min1312436-31243674.61476.341.6675.1976.921.65
2327952-32795278.32078.90
3316485-31648575.58176.16
4322379-32237976.98977.58
5318440-31844076.04876.64
6320234-32023476.47777.06
45min1341291-34129181.50580.810.7582.2481.560.74
2338003-33800380.72081.48
3335558-33555880.13680.88
4341515-34151581.55982.32
5336056-33605680.25581.01
6337928-33792880.70281.46
60min1343663-34366382.07283.991.6582.9984.921.64
2351025-35102583.83084.76
3349122-34912283.37684.30
4352452-35245284.17185.11
5352630-35263084.21385.15
6361380-36138086.30387.24
90min1359568-35956885.87087.021.0386.9788.141.03
2366686-36668687.57088.69
3362717-36271786.62287.73
4369592-36959288.26489.39
5361484-36148486.32887.45
6366245-36624587.46588.59
120min1365919-36591987.38789.652.6388.6890.962.60
2391242-39124293.43594.75
3373752-37375289.25890.56
4382522-38252291.35292.68
5372812-37281289.03390.35
6366192-36619287.45288.77
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1379031-37903190.51892.341.3092.0093.851.30
2391279-39127993.44394.97
3384190-38419091.75093.25
4392528-39252893.74295.27
5388122-38812292.68994.20
6384830-38483091.90393.42
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
112.303919063918293919613918523918743918840.02
212.273918313916943917620.03
单位质量响应值RSD%判断
31860.4931928.440.16数据可信
长期6月-供试品溶液-2023120621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%
5min1176727-17672741.99951.8115.4042.0051.8115.40
2227110-22711053.97353.97
3237013-23701356.32656.33
4255379-25537960.69160.69
5175913-17591341.80641.81
6235837-23583756.04756.05
10min1260122-26012261.81860.809.4361.9160.929.44
2256223-25622360.89261.01
3257970-25797061.30761.43
4284789-28478967.68067.82
5211414-21141450.24350.34
6264532-26453262.86662.99
15min1276943-27694365.81665.308.2766.0565.558.28
2275886-27588665.56565.82
3275823-27582365.55065.81
4302766-30276671.95372.24
5233427-23342755.47455.68
6283757-28375767.43567.70
20min1292461-29246169.50468.887.0669.8869.277.07
2289337-28933768.76169.16
3290650-29065069.07369.48
4316584-31658475.23675.68
5253487-25348760.24160.57
6296467-29646770.45670.87
30min1313570-31357074.52073.986.0375.0574.536.05
2312485-31248574.26274.82
3308464-30846473.30773.87
4337585-33758580.22780.84
5279223-27922366.35866.82
6316447-31644775.20475.77
45min1327895-32789577.92578.984.8078.6279.694.83
2333798-33379879.32780.05
3329877-32987778.39679.12
4357375-35737584.93085.72
5307990-30799073.19473.80
6337080-33708080.10780.85
60min1344509-34450981.87382.413.7382.7483.303.76
2348744-34874482.87983.77
3343450-34345081.62182.52
4368168-36816887.49588.47
5327973-32797377.94378.71
6347800-34780082.65583.57
90min1362236-36223686.08686.722.9787.1487.793.01
2366105-36610587.00588.08
3357903-35790385.05686.14
4383745-38374591.19792.37
5352031-35203183.66084.61
6367400-36740087.31388.41
120min1369549-36954987.82488.333.1989.0789.593.23
2373478-37347888.75790.03
3366634-36663487.13188.40
4392113-39211393.18694.56
5355904-35590484.58185.71
6372276-37227688.47289.77
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1381299-38129990.61691.622.0292.0593.082.06
2383602-38360291.16392.63
3382015-38201590.78692.25
4401285-40128595.36696.95
5382390-38239090.87592.19
6382438-38243890.88792.38
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
112.303926653945653928683928503923893930670.22
212.273923723926633925180.06
单位质量响应值RSD%判断
31956.6731990.060.08数据可信
长期6月-供试品溶液-2205008609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%
5min1292752-29275269.40164.198.8669.4064.208.86
2228407-22840754.14754.15
3294804-29480469.88769.89
4268279-26827963.59963.60
5267850-26785063.49863.50
6272658-27265864.63764.64
10min1325562-32556277.17973.144.8277.3373.294.82
2283445-28344567.19567.31
3320052-32005275.87376.03
4311285-31128573.79573.94
5302073-30207371.61171.75
6308850-30885073.21773.36
15min1339959-33995980.59276.374.4180.9276.674.41
2297971-29797170.63870.91
3331724-33172478.64078.96
4323390-32339076.66476.97
5319846-31984675.82476.12
6319948-31994875.84876.15
20min1346802-34680282.21478.314.1382.7278.794.14
2306477-30647772.65573.08
3339121-33912180.39380.89
4332662-33266278.86279.34
5328203-32820377.80578.27
6328794-32879477.94578.42
30min1351524-35152483.33480.753.3684.0281.403.38
2319476-31947675.73676.32
3349541-34954182.86483.54
4342933-34293381.29781.95
5339208-33920880.41481.06
6341135-34113580.87181.52
45min1367705-36770587.17083.783.1188.0484.613.13
2334364-33436479.26680.02
3358002-35800284.86985.73
4356129-35612984.42585.26
5350776-35077683.15683.98
6353448-35344883.79084.62
60min1374764-37476488.84385.453.0389.9186.463.04
2342198-34219881.12382.06
3365065-36506586.54487.59
4363229-36322986.10987.13
5355567-35556784.29285.30
6361832-36183285.77786.79
90min1385848-38584891.47188.442.3892.7389.642.40
2358978-35897885.10186.21
3378021-37802189.61590.86
4372770-37277088.37089.58
5371147-37114787.98689.18
6371586-37158688.09089.29
120min1390996-39099692.69190.281.9594.1691.681.98
2368708-36870887.40788.71
3383723-38372390.96792.41
4379521-37952189.97191.38
5378274-37827489.67591.06
6383784-38378490.98192.38
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1398126-39812694.38192.281.6096.0593.881.63
2382125-38212590.58892.08
3393022-39302293.17194.82
4390787-39078792.64294.25
5382355-38235590.64392.23
6389244-38924492.27693.88
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