替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.25357775315785366135367785371405355770.43
2112.45394405405665400030.15
单位质量响应值RSD%判断
4816.344804.300.18数据可信
供试品溶液-25102201批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1472573-47257387.00386.170.7387.0086.170.73
2462142-46214285.08285.08
3469501-46950186.43786.44
4467835-46783586.13186.13
5468677-46867786.28686.29
6467504-46750486.07086.07
10min1486735-48673589.61089.240.6989.7689.380.69
2478926-47892688.17288.31
3487163-48716389.68989.83
4482472-48247288.82588.97
5487002-48700289.65989.80
6486082-48608289.49089.63
15min1489873-48987390.18890.420.4590.4890.710.45
2487712-48771289.79090.08
3492439-49243990.66090.95
4490408-49040890.28690.58
5493093-49309390.78191.07
6493338-49333890.82691.12
20min1498483-49848391.77391.460.2992.2291.900.29
2495294-49529491.18691.62
3496537-49653791.41591.86
4494949-49494991.12291.56
5497450-49745091.58392.03
6497834-49783491.65392.10
30min1501661-50166192.35892.410.3292.9693.010.32
2499308-49930891.92592.52
3503237-50323792.64893.25
4501444-50144492.31892.91
5502335-50233592.48293.08
6503723-50372392.73893.33
45min1506722-50672293.29093.290.4594.0494.040.45
2503929-50392992.77693.52
3507533-50753393.43994.19
4504709-50470992.91993.67
5507186-50718693.37594.13
6510364-51036493.96094.71
60min1506634-50663493.27493.360.5094.1894.260.50
2503693-50369392.73293.63
3508372-50837293.59494.50
4505463-50546393.05893.96
5507260-50726093.38994.30
6511071-51107194.09095.00
极限1506253-50625393.20393.330.4794.2794.390.47
2503725-50372592.73893.79
3508207-50820793.56394.63
4505837-50583793.12794.18
5506956-50695693.33394.40
6510661-51066194.01595.08
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.25409585401605409875400955409905406380.09
2112.45453885454505454190.01
单位质量响应值RSD%判断
4861.854852.480.14数据可信
供试品溶液-25102201批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1452288-45228882.46582.331.8282.4782.331.82
2438012-43801279.86279.86
3451216-45121682.27082.27
4451296-45129682.28482.28
5463774-46377484.55984.56
6452693-45269382.53982.54
10min1465362-46536284.84984.471.5584.9984.611.55
2451715-45171582.36182.49
3462158-46215884.26584.40
4462504-46250484.32884.46
5474057-47405786.43486.58
6463892-46389284.58184.72
15min1468912-46891285.49685.711.5885.7785.981.57
2463377-46337784.48784.76
3464965-46496584.77685.05
4468861-46886185.48785.76
5484169-48416988.27888.56
6470164-47016485.72486.00
20min1477604-47760487.08186.851.3287.5087.271.32
2470140-47014085.72086.13
3472109-47210986.07986.50
4472653-47265386.17886.60
5487415-48741588.87089.30
6478059-47805987.16487.59
30min1484904-48490488.41288.381.1388.9888.951.13
2478771-47877187.29487.85
3482602-48260287.99288.55
4482880-48288088.04388.61
5494988-49498890.25090.83
6484377-48437788.31688.88
45min1491450-49145089.60589.691.2190.3290.401.21
2486932-48693288.78289.48
3491980-49198089.70290.41
4488254-48825489.02389.73
5503362-50336291.77792.51
6489426-48942689.23689.95
60min1495296-49529690.30790.421.2691.1791.281.26
2492155-49215589.73490.58
3494953-49495390.24491.10
4492290-49229089.75990.62
5508268-50826892.67293.56
6492390-49239089.77790.64
极限1500736-50073691.29991.331.1492.3192.341.15
2497458-49745890.70191.70
3501248-50124891.39292.40
4497891-49789190.78091.79
5511878-51187893.33094.37
6496275-49627590.48591.50
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.25443385438125432015437265418875433930.18
2112.45511485506365508920.07
单位质量响应值RSD%判断
4886.634901.170.22数据可信
供试品溶液-25102201批-pH1.2(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1468504-46850484.78184.630.3984.7884.630.39
2467929-46792984.67784.68
3466983-46698384.50584.51
4468280-46828084.74084.74
5464486-46448684.05484.05
6469691-46969184.99585.00
10min1477987-47798786.49786.690.3986.6486.830.39
2477785-47778586.46086.60
3480080-48008086.87587.02
4480475-48047586.94787.09
5476663-47666386.25786.40
6481379-48137987.11187.25
15min1479766-47976686.81986.930.4787.1087.220.47
2478103-47810386.51886.80
3483739-48373987.53887.82
4482177-48217787.25587.54
5478125-47812586.52286.81
6480452-48045286.94387.23
20min1482581-48258187.32887.000.4287.7687.430.42
2479124-47912486.70287.13
3482622-48262287.33587.77
4482087-48208787.23987.67
5477860-47786086.47486.90
6480332-48033286.92187.35
30min1479456-47945686.76386.690.3987.3487.270.39
2477091-47709186.33586.91
3480932-48093287.03087.61
4480648-48064886.97887.56
5476479-47647986.22486.80
6479859-47985986.83587.41
45min1474893-47489385.93785.980.3486.6686.700.34
2473624-47362485.70786.42
3476478-47647886.22486.95
4477633-47763386.43387.15
5474083-47408385.79086.51
6474155-47415585.80386.52
60min1469245-46924584.91584.980.4185.7885.850.41
2466874-46687484.48685.35
3470725-47072585.18386.05
4472531-47253185.50986.38
5468882-46888284.84985.71
6469542-46954284.96885.83
极限1465575-46557584.25183.091.1085.2684.101.09
2465000-46500084.14785.15
3458499-45849982.97083.98
4457059-45705982.71083.72
5453683-45368382.09983.10
6455195-45519582.37283.38
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.25445695453715419385409205469115439420.46
2112.45492085552205522140.77
单位质量响应值RSD%判断
4891.564912.940.31数据可信
供试品溶液-25102301批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1475094-47509485.82786.240.7085.8386.240.69
2479907-47990786.69686.70
3475195-47519585.84585.85
4479975-47997586.70986.71
5480957-48095786.88686.89
6473098-47309885.46685.47
10min1497133-49713389.80889.581.0189.9589.721.01
2500615-50061590.43790.58
3486210-48621087.83587.98
4498220-49822090.00590.15
5495986-49598689.60189.75
6497054-49705489.79489.94
15min1504281-50428191.10090.631.5191.3990.921.51
2507386-50738691.66191.96
3492851-49285189.03589.32
4503594-50359490.97691.27
5510056-51005692.14392.44
6491969-49196988.87589.17
20min1505688-50568891.35491.600.4291.8092.050.42
2508812-50881291.91892.37
3503514-50351490.96191.40
4507680-50768091.71492.16
5509114-50911491.97392.42
6507650-50765091.70892.15
30min1511554-51155492.41493.541.4393.0194.141.43
2525782-52578294.98495.59
3515229-51522993.07793.67
4512885-51288592.65493.25
5528571-52857195.48896.09
6512866-51286692.65193.24
45min1525073-52507394.85694.380.9395.6195.130.92
2529261-52926195.61296.37
3518067-51806793.59094.33
4523645-52364594.59895.35
5522576-52257694.40595.16
6515953-51595393.20893.96
60min1520647-52064794.05693.831.1794.9794.741.16
2526918-52691895.18996.11
3518575-51857593.68294.58
4517140-51714093.42394.33
5523618-52361894.59395.51
6509338-50933892.01392.92
极限1525636-52563694.95894.330.9496.0295.400.93
2517680-51768093.52094.60
3519107-51910793.77894.83
4530016-53001695.74996.82
5522518-52251894.39495.47
6518097-51809793.59694.65
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.25481065556235560175563075555395543180.63
2112.45528125554955541540.35
单位质量响应值RSD%判断
4984.874930.200.78数据可信
供试品溶液-25102301批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1469055-46905583.79383.412.0483.7983.412.04
2452862-45286280.90080.90
3469431-46943183.86083.86
4472336-47233684.37984.38
5458697-45869781.94381.94
6479030-47903085.57585.58
10min1483824-48382486.43286.032.1786.5786.162.17
2470934-47093484.12984.26
3480844-48084485.89986.04
4496040-49604088.61488.75
5468784-46878483.74583.88
6488863-48886387.33287.47
15min1491143-49114387.73987.281.3388.0287.571.32
2486734-48673486.95187.23
3487640-48764087.11387.40
4496503-49650388.69788.98
5477505-47750585.30385.58
6492061-49206187.90388.19
20min1507934-50793490.73988.372.0291.1788.802.01
2486278-48627886.87087.29
3491553-49155387.81288.24
4502006-50200689.68090.12
5481693-48169386.05186.47
6498681-49868189.08689.52
30min1515275-51527592.05090.192.0692.6390.772.06
2503868-50386890.01290.58
3505012-50501290.21790.79
4516730-51673092.31092.90
5488590-48859087.28387.84
6499838-49983889.29289.88
45min1525231-52523193.82991.212.0794.5691.932.06
2499402-49940289.21489.93
3512239-51223991.50892.23
4518793-51879392.67993.42
5498699-49869989.08989.80
6508937-50893790.91891.65
60min1521681-52168193.19491.381.8294.0992.261.81
2511738-51173891.41892.28
3507698-50769890.69691.57
4521194-52119493.10794.00
5496812-49681288.75289.61
6510140-51014091.13392.02
极限1527068-52706894.15792.081.6595.2093.111.65
2509232-50923290.97191.99
3519152-51915292.74393.77
4521216-52121693.11194.16
5504274-50427490.08591.09
6511754-51175491.42192.46
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.25519785552215593125568005531975553020.53
2112.45476755520355498550.57
单位质量响应值RSD%判断
4993.724891.951.46数据可信
供试品溶液-25102301批-pH1.2(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1483766-48376686.68586.710.9386.6886.720.93
2477579-47757985.57685.58
3488186-48818687.47787.48
4479919-47991985.99586.00
5485339-48533986.96786.97
6488757-48875787.57987.58
10min1490457-49045787.88488.691.0988.0388.831.09
2487009-48700987.26687.41
3500109-50010989.61389.76
4494150-49415088.54588.69
5498073-49807389.24889.39
6499818-49981889.56189.71
15min1500167-50016789.62489.360.8689.9189.660.86
2490358-49035887.86688.15
3502468-50246890.03690.33
4499062-49906289.42689.72
5500478-50047889.67989.97
6499756-49975689.55089.85
20min1505030-50503090.49589.531.2890.9489.971.28
2492133-49213388.18488.62
3509293-50929391.25991.70
4497067-49706789.06889.51
5495412-49541288.77289.21
6498913-49891389.39989.84
30min1497106-49710689.07589.081.1289.6789.671.11
2486892-48689287.24587.83
3501651-50165189.89090.49
4495821-49582188.84589.43
5500158-50015889.62290.21
6501199-50119989.80990.40
45min1475629-47562985.22787.621.8085.9788.361.78
2485558-48555887.00687.73
3498640-49864089.35090.10
4498785-49878589.37690.11
5488451-48845187.52488.26
6486927-48692787.25187.99
60min1479242-47924285.87486.640.8386.7687.530.83
2478202-47820285.68886.56
3487083-48708387.27988.18
4486321-48632187.14388.03
5483128-48312886.57087.46
6487142-48714287.29088.18
极限1457365-45736581.95482.701.4382.9883.731.41
2458225-45822582.10883.12
3464497-46449783.23284.27
4457123-45712381.91182.94
5473718-47371884.88485.91
6458384-45838482.13783.17
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