苯磺酸左氨氯地平缬沙坦片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.381208431207891208471206351208881208000.09
214.411202141202441202290.02
单位质量响应值RSD%判断
8400.568343.440.49数据可信
长期24月-供试品溶液-2023051321批-苯磺酸左氨氯地平-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%
5min174888-7488856.47851.0512.6156.4851.0512.61
267274-6727450.73650.74
371023-7102353.56353.56
471318-7131853.78653.79
570666-7066653.29453.29
650983-5098338.45038.45
10min1107301-10730180.92378.811.5581.0278.901.55
2103800-10380078.28278.37
3105001-10500179.18879.28
4102921-10292177.61977.71
5103154-10315477.79577.88
6104847-10484779.07279.14
15min1118740-11874089.55086.812.6589.7887.022.65
2110285-11028583.17383.39
3116822-11682288.10388.32
4112788-11278885.06185.28
5115921-11592187.42487.64
6116086-11608687.54887.74
20min1123194-12319492.90991.101.7293.2991.461.72
2119860-11986090.39490.75
3121158-12115891.37391.74
4117308-11730888.47088.83
5122387-12238792.30092.66
6120866-12086691.15391.49
30min1126493-12649395.39792.682.0195.9393.202.00
2121302-12130291.48291.99
3121493-12149391.62692.15
4119892-11989290.41890.93
5124807-12480794.12594.64
6123361-12336193.03593.53
45min1128458-12845896.87994.862.1097.5795.532.09
2122768-12276892.58793.24
3125445-12544594.60695.28
4122899-12289992.68693.35
5128908-12890897.21897.89
6126235-12623595.20295.85
60min1129822-12982297.90795.652.2598.7696.482.25
2122141-12214192.11492.93
3126319-12631995.26596.10
4126152-12615295.13995.95
5129826-12982697.91098.75
6126700-12670095.55396.36
极限1131493-13149399.16797.391.14100.1898.381.15
2128153-12815396.64997.61
3130105-13010598.12199.11
4128526-12852696.93097.90
5129129-12912997.38598.38
6127433-12743396.10697.07
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.904651188465800646569724656640465962046564850.07
215.934641567464323346424000.03
单位质量响应值RSD%判断
292860.69291424.980.35数据可信
长期24月-供试品溶液-2023051321批-缬沙坦-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%
5min14575655-457565587.30980.737.0687.3180.737.06
24300794-430079482.06482.06
34372112-437211283.42583.42
44257394-425739481.23681.24
54194630-419463080.03880.04
63683516-368351670.28670.29
10min15082212-508221296.97494.242.0597.1294.372.05
24929442-492944294.05994.20
34981541-498154195.05395.19
44775960-477596091.13191.27
54901654-490165493.52993.66
64961885-496188594.67894.80
15min15150121-515012198.27095.781.9998.5896.071.99
24989933-498993395.21395.51
35047646-504764696.31596.61
44847424-484742492.49492.78
55052492-505249296.40796.70
65029891-502989195.97696.25
20min15153891-515389198.34296.041.8998.8196.491.89
24996183-499618395.33395.78
35056646-505664696.48696.94
44873291-487329192.98893.43
55085930-508593097.04597.50
65033678-503367896.04896.48
30min15162330-516233098.50396.361.6999.1496.971.69
25006288-500628895.52696.14
35060874-506087496.56797.19
44913849-491384993.76294.36
55106262-510626297.43398.04
65049803-504980396.35696.95
45min15174378-517437898.73396.581.5099.5397.361.50
25013382-501338295.66196.43
35066162-506616296.66897.45
44954318-495431894.53495.29
55104719-510471997.40498.18
65057165-505716596.49697.25
60min15172702-517270298.70196.691.2899.6697.621.28
25011829-501182995.63196.56
35067088-506708896.68697.63
44996395-499639595.33796.25
55105202-510520297.41398.35
65051444-505144496.38797.30
极限15173743-517374398.72197.281.1199.8598.371.11
25043039-504303996.22797.32
35069242-506924296.72797.83
45160307-516030798.46499.53
55094132-509413297.20298.30
65048311-504831196.32797.40
苯磺酸左氨氯地平缬沙坦片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.381205921204111202031199211199881202230.24
214.411213821215641214730.11
单位质量响应值RSD%判断
8360.438429.770.59数据可信
长期24月-供试品溶液-2023051321批-苯磺酸左氨氯地平-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%
5min176540-7654057.56556.014.6757.5756.024.67
275496-7549656.78056.78
367581-6758150.82750.83
476877-7687757.81957.82
575826-7582657.02857.03
674545-7454556.06556.06
10min1108361-10836181.49879.023.2881.5979.123.28
2107667-10766780.97681.07
399415-9941574.76974.85
4105599-10559979.42079.52
5106824-10682480.34280.44
6102547-10254777.12577.22
15min1117952-11795288.71187.641.9688.9487.861.96
2119481-11948189.86190.09
3114555-11455586.15686.37
4113440-11344085.31885.55
5117721-11772188.53788.77
6115980-11598087.22887.45
20min1127014-12701495.52691.673.2895.9192.043.27
2124442-12444293.59293.97
3123122-12312292.59992.95
4115362-11536286.76387.13
5120689-12068990.76991.15
6120664-12066490.75191.12
30min1129970-12997097.75094.072.5398.2994.602.52
2126076-12607694.82195.36
3126750-12675095.32895.84
4121365-12136591.27891.79
5123832-12383293.13393.66
6122474-12247492.11292.63
45min1132366-13236699.55295.834.13100.2596.514.11
2131676-13167699.03399.73
3130982-13098298.51199.18
4119247-11924789.68590.35
5123494-12349492.87993.56
6126708-12670895.29695.97
60min1131806-13180699.13096.602.89100.0097.442.88
2129837-12983797.65098.51
3132493-13249399.647100.48
4123250-12325092.69693.51
5124976-12497693.99494.83
6128294-12829496.48997.32
极限1133284-133284100.24297.752.61101.2798.752.61
2133166-133166100.153101.17
3131067-13106798.57599.57
4125023-12502394.02995.00
5126755-12675595.33296.33
6130537-13053798.17699.17
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.904666609466325546587854656120465498246599500.11
215.934690481469446346924720.07
单位质量响应值RSD%判断
293078.62294568.240.36数据可信
长期24月-供试品溶液-2023051321批-缬沙坦-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%
5min14430017-443001784.04682.793.8884.0582.793.88
24515617-451561785.67085.67
34031055-403105576.47776.48
44412293-441229383.71083.71
54409309-440930983.65383.65
64383940-438394083.17283.17
10min15018312-501831295.20794.022.8195.3594.162.81
25121818-512181897.17197.31
34714666-471466689.44789.57
44891006-489100692.79292.93
54993706-499370694.74094.88
64994232-499423294.75094.89
15min15176161-517616198.20296.032.3498.5096.322.34
25218824-521882499.01199.32
34932765-493276593.58493.86
44938372-493837293.69193.98
55060661-506066196.01196.31
65043259-504325995.68195.98
20min15309659-5309659100.73597.202.63101.2097.662.62
25256308-525630899.723100.19
35089717-508971796.56296.99
44948340-494834093.88094.33
55073224-507322496.24996.71
65063501-506350196.06596.52
30min15219989-521998999.03497.412.4599.6698.032.44
25296049-5296049100.477101.11
35191023-519102398.48499.08
44945364-494536493.82394.43
55073605-507360596.25696.87
65081746-508174696.41197.03
45min15207987-520798798.80697.562.5099.6098.342.49
25312381-5312381100.786101.59
35214477-521447798.92999.69
44948647-494864793.88694.65
55075896-507589696.30097.08
65095353-509535396.66997.45
60min15192518-519251898.51297.472.4699.4798.412.45
25304651-5304651100.640101.61
35205542-520554298.75999.68
44937660-493766093.67794.60
55080944-508094496.39697.33
65105098-510509896.85497.79
极限15186175-518617598.39297.432.4299.5298.532.41
25302527-5302527100.599101.74
35200986-520098698.67399.76
44940115-494011593.72494.80
55083452-508345296.44397.54
65099242-509924296.74397.84
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