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%
112.203840273861483843143868763852983853330.32
212.213822183861363841770.73
单位质量响应值RSD%判断
31584.6731464.130.28数据可信
长期12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%
2min1353612-35361285.02389.437.3485.0289.427.35
2345251-34525183.01383.01
3413369-41336999.39199.39
4390167-39016793.81293.81
5380714-38071491.53991.54
6348439-34843983.77983.78
5min1408316-40831698.176100.912.3098.18100.912.30
2421519-421519101.351101.35
3436588-436588104.974104.97
4421534-421534101.354101.35
5415614-41561499.93199.93
6414473-41447399.65699.66
10min1411675-41167598.984101.322.2498.98101.322.24
2428420-428420103.010103.01
3436470-436470104.945104.95
4420923-420923101.207101.21
5415445-41544599.89099.89
6415475-41547599.89799.90
15min1415445-41544599.890101.821.7299.89101.821.72
2427034-427034102.677102.68
3435968-435968104.825104.82
4422845-422845101.669101.67
5418652-418652100.661100.66
6420861-420861101.192101.19
20min1417734-417734100.440102.392.23100.44102.392.23
2430026-430026103.396103.40
3443247-443247106.575106.57
4422776-422776101.653101.65
5420160-420160101.024101.02
6421200-421200101.274101.27
30min1420398-420398101.081102.541.66101.08102.541.66
2430280-430280103.457103.46
3438466-438466105.425105.43
4423501-423501101.827101.83
5419832-419832100.945100.94
6426437-426437102.533102.53
45min1418154-418154100.541102.481.60100.54102.481.60
2429755-429755103.331103.33
3437036-437036105.081105.08
4423912-423912101.926101.93
5420729-420729101.161101.16
6427760-427760102.851102.85
极限1423490-423490101.824102.741.58101.82102.741.58
2432759-432759104.053104.05
3438119-438119105.342105.34
4423420-423420101.808101.81
5420422-420422101.087101.09
6425563-425563102.323102.32
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%
112.203819623830903842533814313831033827680.29
212.213834763856253845500.40
单位质量响应值RSD%判断
31374.4331494.680.28数据可信
长期12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%
2min1382545-38254592.24293.943.8292.2493.943.82
2394440-39444095.11195.11
3383130-38313092.38492.38
4403112-40311297.20297.20
5367218-36721888.54788.55
6407027-40702798.14698.15
5min1419116-419116101.061100.781.49101.06100.781.49
2414932-414932100.052100.05
3414598-41459899.97199.97
4416878-416878100.521100.52
5412452-41245299.45499.45
6429726-429726103.619103.62
10min1419410-419410101.132101.671.91101.13101.671.91
2414174-41417499.86999.87
3430285-430285103.754103.75
4419730-419730101.209101.21
5413681-41368199.75099.75
6432635-432635104.321104.32
15min1417168-417168100.591101.321.36100.59101.321.36
2417232-417232100.607100.61
3421612-421612101.663101.66
4420219-420219101.327101.33
5414375-41437599.91899.92
6430624-430624103.836103.84
20min1416486-416486100.427100.891.99100.43100.891.99
2414196-41419699.87499.87
3409179-40917998.66598.66
4422250-422250101.816101.82
5415317-415317100.145100.14
6433052-433052104.421104.42
30min1418087-418087100.813102.001.55100.81102.001.55
2418691-418691100.958100.96
3417392-417392100.645100.65
4421912-421912101.735101.73
5428739-428739103.381103.38
6433292-433292104.479104.48
45min1417206-417206100.600101.291.96100.60101.281.96
2412951-41295199.57499.57
3418811-418811100.987100.99
4422149-422149101.792101.79
5413862-41386299.79499.79
6435311-435311104.966104.97
极限1421867-421867101.724101.413.51101.72101.413.51
2419131-419131101.064101.06
3431138-431138103.960103.96
4403777-40377797.36297.36
5405492-40549297.77697.78
6442067-442067106.595106.59
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%
112.203829013833013848363827493862223840020.39
212.213857143855003856070.04
单位质量响应值RSD%判断
31475.5731581.240.24数据可信
长期12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%
2min1365545-36554587.88185.319.7287.8885.319.72
2318550-31855076.58376.58
3328836-32883679.05679.06
4407198-40719897.89597.89
5377921-37792190.85690.86
6331159-33115979.61479.61
5min1409002-40900298.32899.592.6298.3399.592.62
2407378-40737897.93897.94
3414854-41485499.73599.74
4435535-435535104.707104.71
5411862-41186299.01699.02
6406877-40687797.81797.82
10min1409992-40999298.566100.262.2398.57100.262.23
2416655-416655100.168100.17
3419469-419469100.845100.84
4433640-433640104.252104.25
5415202-41520299.81999.82
6407266-40726697.91197.91
15min1410217-41021798.620100.282.1698.62100.282.16
2414290-41429099.60099.60
3418933-418933100.716100.72
4434149-434149104.374104.37
5415380-41538099.86299.86
6409795-40979598.51998.52
20min1410470-41047098.681100.612.3398.68100.612.32
2417626-417626100.402100.40
3423023-423023101.699101.70
4435148-435148104.614104.61
5416524-416524100.137100.14
6408264-40826498.15198.15
30min1411072-41107298.826100.932.2498.83100.932.24
2419785-419785100.921100.92
3424958-424958102.164102.16
4435838-435838104.780104.78
5415212-41521299.82199.82
6412053-41205399.06299.06
45min1409830-40983098.527100.472.6198.53100.472.61
2417693-417693100.418100.42
3422161-422161101.492101.49
4437075-437075105.077105.08
5413792-41379299.48099.48
6406798-40679897.79897.80
极限1414362-41436299.617100.892.4399.62100.882.43
2419257-419257100.794100.79
3424275-424275102.000102.00
4436724-436724104.993104.99
5416599-416599100.155100.15
6406632-40663297.75997.76
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%
112.203837383869483874403847683847643855320.42
212.213851843855663853750.08
单位质量响应值RSD%判断
31600.9831562.240.09数据可信
长期12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%
2min1384601-38460192.30687.233.7592.3187.233.75
2347540-34754083.41183.41
3372362-37236289.36989.37
4353614-35361484.86984.87
5356813-35681385.63785.64
6365784-36578487.79087.79
5min1422078-422078101.30199.352.17101.3099.352.18
2401334-40133496.32296.32
3424391-424391101.856101.86
4415069-41506999.61999.62
5414931-41493199.58599.59
6405783-40578397.39097.39
10min1422026-422026101.28899.662.06101.2999.662.06
2401449-40144996.35096.35
3425470-425470102.115102.11
4414867-41486799.57099.57
5416989-416989100.079100.08
6410663-41066398.56198.56
15min1424701-424701101.93099.841.88101.9399.841.88
2402789-40278996.67196.67
3422627-422627101.433101.43
4416426-41642699.94499.94
5416587-41658799.98399.98
6412789-41278999.07199.07
20min1418376-418376100.412100.372.48100.41100.372.48
2402621-40262196.63196.63
3425226-425226102.056102.06
4413125-41312599.15299.15
5416949-416949100.070100.07
6432941-432941103.908103.91
30min1421357-421357101.12899.462.24101.1399.462.24
2400140-40014096.03696.04
3426652-426652102.399102.40
4413250-41325099.18299.18
5415457-41545799.71299.71
6409525-40952598.28898.29
45min1423150-423150101.55899.651.98101.5699.651.98
2403237-40323796.77996.78
3424950-424950101.990101.99
4414499-41449999.48299.48
5415872-41587299.81199.81
6409468-40946898.27498.27
极限1420303-420303100.875100.252.34100.87100.252.34
2401873-40187396.45196.45
3424535-424535101.890101.89
4413749-41374999.30299.30
5415705-41570599.77199.77
6429986-429986103.199103.20
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%
112.203868003870483877263863043875643870880.15
212.213818673832663825660.26
单位质量响应值RSD%判断
31728.5231332.190.89数据可信
长期12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%
2min1342168-34216882.25987.469.0382.2687.469.03
2407311-40731197.91997.92
3377927-37792790.85590.86
4345635-34563583.09283.09
5389039-38903993.52793.53
6320659-32065977.08877.09
5min1403461-40346196.99499.042.6096.9999.042.60
2419746-419746100.909100.91
3411651-41165198.96398.96
4407770-40777098.03098.03
5428953-428953103.122103.12
6400377-40037796.25296.25
10min1406676-40667697.76799.782.5097.7799.782.50
2423928-423928101.914101.91
3419601-419601100.874100.87
4411439-41143998.91298.91
5427676-427676102.815102.82
6401067-40106796.41896.42
15min1408127-40812798.116100.803.8198.12100.803.81
2443611-443611106.646106.65
3425840-425840102.374102.37
4414558-41455899.66299.66
5425710-425710102.343102.34
6398026-39802695.68795.69
20min1410881-41088198.77899.822.3898.7899.822.38
2422491-422491101.569101.57
3417614-417614100.396100.40
4413015-41301599.29199.29
5427738-427738102.830102.83
6399488-39948896.03996.04
30min1405018-40501897.36899.682.4997.3799.682.49
2422777-422777101.637101.64
3417362-417362100.336100.34
4414127-41412799.55899.56
5427757-427757102.835102.83
6400705-40070596.33196.33
45min1407916-40791698.06599.532.4098.0699.532.40
2419557-419557100.863100.86
3415061-41506199.78299.78
4414289-41428999.59799.60
5428169-428169102.934102.93
6399069-39906995.93895.94
极限1407623-40762397.99499.512.5197.9999.512.51
2421192-421192101.256101.26
3415895-41589599.98399.98
4413191-41319199.33399.33
5427669-427669102.814102.81
6398116-39811695.70995.71
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%
112.203838273834353853303844043837223841440.20
212.213839493847863843680.16
单位质量响应值RSD%判断
31487.2131479.770.02数据可信
长期12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%
2min1370305-37030589.15286.273.2089.1586.273.19
2361469-36146987.02587.02
3359935-35993586.65586.66
4338024-33802481.38081.38
5353907-35390785.20485.20
6366454-36645488.22588.22
5min1423348-423348101.92299.832.19101.9299.832.19
2420334-420334101.197101.20
3415403-415403100.009100.01
4400746-40074696.48196.48
5406704-40670497.91597.92
6421379-421379101.448101.45
10min1418899-418899100.851100.171.88100.85100.171.88
2421325-421325101.435101.44
3418742-418742100.813100.81
4405161-40516197.54497.54
5407665-40766598.14698.15
6424537-424537102.208102.21
15min1420453-420453101.225100.232.39101.23100.232.39
2418775-418775100.821100.82
3420244-420244101.175101.17
4402343-40234396.86596.87
5406735-40673597.92397.92
6429290-429290103.353103.35
20min1419179-419179100.918100.071.84100.92100.071.85
2418512-418512100.758100.76
3417988-417988100.632100.63
4404325-40432597.34297.34
5408797-40879798.41998.42
6425188-425188102.365102.37
30min1417773-417773100.58099.822.44100.5899.822.44
2420003-420003101.117101.12
3418286-418286100.704100.70
4397688-39768895.74495.74
5407969-40796998.22098.22
6425858-425858102.526102.53
45min1418477-418477100.749100.052.01100.75100.052.01
2420517-420517101.241101.24
3420152-420152101.153101.15
4404592-40459297.40797.41
5405581-40558197.64597.64
6424188-424188102.124102.12
极限1419822-419822101.073101.193.63101.07101.193.64
2418118-418118100.663100.66
3431840-431840103.967103.97
4402409-40240996.88196.88
5406549-40654997.87897.88
6443023-443023106.659106.66
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