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%
1111.65300345298235298045334665298725306000.31
2113.35431295432155431720.02
单位质量响应值RSD%判断
4754.484794.100.59数据可信
供试品溶液-25091201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%
5min1407632-40763275.61478.914.1975.6178.914.19
2399407-39940774.08974.09
3428882-42888279.55679.56
4434274-43427480.55680.56
5442559-44255982.09382.09
6439714-43971481.56581.57
10min1466521-46652186.53887.301.2386.6687.431.24
2463183-46318385.91986.04
3470166-47016687.21487.35
4479964-47996489.03289.17
5473249-47324987.78687.92
6470566-47056687.28887.42
15min1478308-47830888.72589.361.4388.9989.631.43
2474861-47486188.08588.35
3479753-47975388.99389.27
4494563-49456391.74092.02
5483505-48350589.68989.97
6479362-47936288.92089.20
20min1484869-48486989.94290.581.2290.3691.011.21
2488444-48844490.60591.02
3485945-48594590.14190.57
4499570-49957092.66993.10
5488403-48840390.59791.03
6482788-48278889.55689.99
30min1491375-49137591.14891.571.4891.7292.141.48
2488173-48817390.55491.12
3490912-49091291.06391.64
4507797-50779794.19594.78
5494595-49459591.74692.33
6488935-48893590.69691.27
45min1500064-50006492.76093.131.4593.4893.861.45
2498306-49830692.43493.15
3499217-49921792.60393.33
4515906-51590695.69996.45
5503420-50342093.38394.12
6495411-49541191.89792.63
60min1503455-50345593.38993.881.5994.2694.761.59
2502168-50216893.15094.02
3504207-50420793.52994.41
4521401-52140196.71897.62
5507121-50712194.06994.96
6498248-49824892.42393.31
极限1506142-50614293.88894.601.4394.9295.641.43
2507429-50742994.12695.15
3509766-50976694.56095.60
4523783-52378397.16098.23
5509863-50986394.57895.63
6502785-50278593.26594.30
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%
1111.65345745324825337795334655352875339170.21
2113.35470945472925471930.03
单位质量响应值RSD%判断
4784.204829.590.67数据可信
供试品溶液-25091501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%
5min1432465-43246579.67779.252.9079.6879.262.90
2409638-40963875.47175.47
3443208-44320881.65681.66
4438059-43805980.70880.71
5436246-43624680.37480.37
6421398-42139877.63877.64
10min1471957-47195786.95386.601.8387.0986.731.84
2458576-45857684.48884.61
3479990-47999088.43388.57
4475067-47506787.52687.66
5474256-47425687.37787.51
6460446-46044684.83284.96
15min1484413-48441389.24888.671.8489.5388.951.84
2468755-46875586.36386.63
3491739-49173990.59890.88
4483777-48377789.13189.41
5486639-48663989.65889.94
6472411-47241187.03787.31
20min1489134-48913490.11889.821.8990.5490.241.88
2475387-47538787.58588.00
3499157-49915791.96492.40
4491049-49104990.47190.90
5492612-49261290.75991.19
6477690-47769088.00988.43
30min1498936-49893691.92490.942.0392.5091.512.03
2480337-48033788.49789.05
3504372-50437292.92593.51
4497846-49784691.72392.30
5498216-49821691.79192.37
6481767-48176788.76089.32
45min1504353-50435392.92292.051.8593.6592.771.86
2487978-48797889.90590.61
3510403-51040394.03694.78
4503122-50312292.69593.43
5503352-50335292.73793.47
6488369-48836989.97790.69
60min1505940-50594093.21492.631.8894.1093.511.88
2490406-49040690.35291.21
3513373-51337394.58495.48
4506897-50689793.39094.28
5508336-50833693.65594.54
6491810-49181090.61191.47
极限1506661-50666193.34792.931.8394.3993.961.83
2492442-49244290.72791.73
3514909-51490994.86695.92
4508764-50876493.73494.78
5509858-50985893.93694.98
6493671-49367190.95491.97
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%
1111.65358265344895356335355035365325355970.14
2113.35425115424315424710.02
单位质量响应值RSD%判断
4799.264787.920.17数据可信
供试品溶液-1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%
5min1384246-38424670.98871.591.6170.9971.591.61
2388113-38811371.70371.70
3378883-37888369.99870.00
4397758-39775873.48573.48
5386639-38663971.43071.43
6389319-38931971.92671.93
10min1426755-42675578.84278.991.0878.9679.111.08
2431463-43146379.71279.83
3422623-42262378.07878.20
4433805-43380580.14480.27
5422402-42240278.03878.16
6428208-42820879.11079.23
15min1441943-44194381.64881.781.3481.9082.021.34
2447672-44767282.70682.96
3436146-43614680.57780.82
4450706-45070683.26783.52
5436230-43623080.59280.84
6443102-44310281.86282.11
20min1449469-44946983.03883.361.2883.4283.751.28
2456388-45638884.31684.71
3445668-44566882.33682.72
4459621-45962184.91485.31
5445344-44534482.27682.66
6450905-45090583.30383.69
30min1458940-45894084.78885.341.3385.3185.861.33
2470931-47093187.00387.53
3458727-45872784.74885.27
4467517-46751786.37286.91
5454508-45450883.96984.49
6460929-46092985.15585.68
45min1477013-47701388.12787.821.5488.7988.491.53
2485850-48585089.75990.44
3476938-47693888.11388.77
4477973-47797388.30488.98
5465041-46504185.91586.58
6469267-46926786.69687.36
60min1487421-48742190.05089.361.3890.8690.181.37
2492119-49211990.91891.74
3485907-48590789.77090.58
4485400-48540089.67690.50
5476387-47638788.01188.81
6475016-47501687.75888.57
极限1494702-49470291.39591.041.1092.3692.001.10
2499908-49990892.35793.33
3489905-48990590.50991.46
4497585-49758591.92792.90
5487213-48721390.01190.96
6487353-48735390.03791.00
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