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%
1113.65489645478015476495459945451405471100.28
2114.35520425519205519810.02
单位质量响应值RSD%判断
4816.114829.230.20数据可信
供试品溶液-25090101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%
5min1474653-47465387.16284.672.2387.1684.662.23
2458638-45863884.22184.22
3455994-45599483.73683.74
4448855-44885582.42582.42
5455638-45563883.67083.67
6472596-47259686.78486.78
10min1499076-49907691.64789.911.6491.7990.051.64
2486148-48614889.27389.41
3483757-48375788.83488.97
4486246-48624689.29189.43
5482039-48203988.51888.66
6500347-50034791.88092.02
15min1506360-50636092.98490.891.7593.2891.191.75
2491276-49127690.21590.50
3486993-48699389.42889.72
4493657-49365790.65290.94
5486788-48678889.39089.68
6504806-50480692.69993.00
20min1507844-50784493.25791.201.6593.7191.641.66
2492415-49241590.42490.86
3489573-48957389.90290.34
4494742-49474290.85191.29
5489418-48941889.87390.31
6505920-50592092.90493.36
30min1508295-50829593.34091.051.7293.9591.651.71
2491913-49191390.33190.92
3488850-48885089.76990.36
4495513-49551390.99391.58
5486893-48689389.41090.00
6503594-50359492.47793.08
45min1502129-50212992.20790.491.4492.9791.241.44
2487968-48796889.60790.35
3486609-48660989.35890.09
4492855-49285590.50491.24
5486484-48648489.33590.07
6500588-50058891.92592.69
60min1497538-49753891.36489.721.5792.2890.621.57
2482519-48251988.60689.50
3483151-48315188.72389.61
4491218-49121890.20491.10
5480167-48016788.17589.06
6496779-49677991.22592.14
极限1488725-48872589.74687.981.6790.8289.031.67
2471231-47123186.53487.57
3473373-47337386.92787.96
4480989-48098988.32589.37
5472229-47222986.71787.75
6488043-48804389.62190.69
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%
1113.65532455541055529015530815526725532010.10
2114.35576675570195573430.09
单位质量响应值RSD%判断
4869.734876.140.10数据可信
供试品溶液-25090101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%
5min1449493-44949381.69079.353.1181.6979.353.11
2415702-41570275.54975.55
3449237-44923781.64481.64
4425300-42530077.29377.29
5438547-43854779.70179.70
6441358-44135880.21280.21
10min1472506-47250685.87383.492.9786.0183.622.97
2439963-43996379.95880.08
3470919-47091985.58485.72
4452825-45282582.29682.42
5450112-45011281.80381.94
6470071-47007185.43085.56
15min1483973-48397387.95786.461.8788.2486.731.88
2462747-46274784.09984.36
3480680-48068087.35887.64
4470247-47024785.46285.73
5471647-47164785.71685.99
6485038-48503888.15088.43
20min1493013-49301389.60087.871.8890.0388.291.89
2470633-47063385.53285.93
3492140-49214089.44189.87
4477571-47757186.79387.20
5479066-47906687.06587.48
6488669-48866988.81089.23
30min1495809-49580990.10889.121.9890.6889.681.98
2477546-47754686.78987.33
3497939-49793990.49591.07
4484125-48412587.98488.54
5484444-48444488.04288.60
6502355-50235591.29791.87
45min1504501-50450191.68789.992.2292.4190.702.22
2482006-48200687.59988.29
3500345-50034590.93291.66
4486403-48640388.39889.10
5488576-48857688.79389.50
6509100-50910092.52393.25
60min1518062-51806294.15291.162.8495.0392.022.83
2484480-48448088.04988.88
3503666-50366691.53692.41
4494000-49400089.77990.63
5491140-49114089.25990.11
6518165-51816594.17195.05
极限1523841-52384195.20292.202.7896.2493.212.78
2492575-49257589.52090.50
3508586-50858692.43093.46
4497906-49790690.48991.49
5496444-49644490.22391.22
6524449-52444995.31396.35
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%
1113.65504345509495504785499965506235504960.07
2114.35615065616475615760.02
单位质量响应值RSD%判断
4845.924913.180.98数据可信
供试品溶液-25090101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%
5min1481300-48130087.35687.521.0287.3687.521.02
2480966-48096687.29687.30
3487423-48742388.46888.47
4486032-48603288.21588.22
5483762-48376287.80387.80
6473611-47361185.96185.96
10min1497412-49741290.28191.190.9390.4391.340.93
2498225-49822590.42890.57
3509277-50927792.43492.58
4505224-50522491.69991.85
5504562-50456291.57891.72
6499880-49988090.72990.87
15min1504022-50402291.48092.500.8891.7892.800.88
2507709-50770992.15092.45
3515853-51585393.62893.93
4513149-51314993.13793.44
5510845-51084592.71993.02
6506186-50618691.87392.17
20min1508312-50831292.25993.150.9992.7193.600.99
2510716-51071692.69593.15
3518923-51892394.18594.64
4519488-51948894.28894.74
5513698-51369893.23793.69
6508124-50812492.22592.67
30min1511189-51118992.78193.820.9393.3894.420.92
2515568-51556893.57694.18
3521649-52164994.68095.29
4523367-52336794.99295.60
5516484-51648493.74294.35
6513126-51312693.13393.73
45min1513490-51349093.19994.280.9093.9695.050.90
2517164-51716493.86694.63
3525473-52547395.37496.15
4523993-52399395.10595.88
5520064-52006494.39295.16
6516469-51646993.74094.50
60min1513480-51348093.19794.540.9194.1195.460.91
2520884-52088494.54195.46
3525741-52574195.42296.35
4525009-52500995.29096.22
5522749-52274994.87995.80
6517288-51728893.88894.80
极限1515321-51532193.53194.920.9794.6096.000.97
2521910-52191094.72795.80
3529353-52935396.07897.17
4527320-52732095.70996.80
5523714-52371495.05596.14
6520051-52005194.39095.46
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