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%
1111.25397655395705428125391245399625402470.28
2111.85399285403825401550.06
单位质量响应值RSD%判断
4858.344831.440.40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%
5min1435200-43520079.55180.100.6479.5580.100.64
2440800-44080080.57580.57
3441558-44155880.71380.71
4435752-43575279.65279.65
5439698-43969880.37380.37
6436245-43624579.74279.74
10min1462142-46214284.47685.450.6084.6185.580.60
2467933-46793385.53485.67
3467959-46795985.53985.67
4467786-46778685.50885.64
5470452-47045285.99586.13
6468546-46854685.64685.78
15min1475310-47531086.88387.690.6087.1687.970.60
2477642-47764287.30987.59
3482170-48217088.13788.41
4479602-47960287.66787.94
5482799-48279988.25288.53
6480954-48095487.91588.19
20min1483063-48306388.30088.980.6188.7289.400.60
2483533-48353388.38688.81
3488378-48837889.27289.70
4488279-48827989.25389.67
5490475-49047589.65590.08
6486882-48688288.99889.42
30min1492468-49246890.01990.750.8490.5891.320.84
2491746-49174689.88790.46
3501750-50175091.71692.29
4500159-50015991.42592.00
5497972-49797291.02591.60
6494631-49463190.41590.99
45min1498310-49831091.08792.230.9091.8092.950.90
2501966-50196691.75592.47
3509701-50970193.16993.89
4507180-50718092.70893.43
5508506-50850692.95193.68
6501763-50176391.71892.44
60min1502940-50294091.93393.140.8592.8094.020.85
2507508-50750892.76893.64
3512636-51263693.70694.59
4511261-51126193.45494.33
5515050-51505094.14795.03
6508010-50801092.86093.73
极限1505643-50564392.42793.620.7093.4594.650.70
2511361-51136193.47394.50
3514642-51464294.07295.11
4512827-51282793.74194.77
5515721-51572194.27095.31
6512705-51270593.71894.75
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%
1111.25420655421585413915414005405435415110.13
2111.85434465428655431560.08
单位质量响应值RSD%判断
4869.704858.280.17数据可信
供试品溶液-2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%
5min1423797-42379777.16277.970.9977.1677.970.99
2422735-42273576.96976.97
3429644-42964478.22778.23
4433906-43390679.00379.00
5428874-42887478.08678.09
6430464-43046478.37678.38
10min1450503-45050382.02483.331.1482.1583.461.14
2453758-45375882.61782.75
3461641-46164184.05284.18
4458123-45812383.41283.54
5464900-46490084.64684.78
6457091-45709183.22483.35
15min1460910-46091083.91985.281.0984.1885.551.09
2463408-46340884.37484.64
3473442-47344286.20186.47
4470353-47035385.63985.91
5472721-47272186.07086.34
6469488-46948885.48185.75
20min1468173-46817385.24286.411.0685.6586.821.06
2469578-46957885.49785.90
3479345-47934587.27687.69
4477274-47727486.89987.31
5479910-47991087.37987.79
6473179-47317986.15386.56
30min1477219-47721986.88987.981.0987.4488.541.08
2478807-47880787.17887.73
3487677-48767788.79389.35
4483315-48331587.99988.56
5490860-49086089.37289.93
6481499-48149987.66888.22
45min1487250-48725088.71589.730.9789.4190.430.96
2488155-48815588.88089.57
3496532-49653290.40591.11
4492893-49289389.74290.45
5499556-49955690.95691.66
6492582-49258289.68690.39
60min1493330-49333089.82290.771.0690.6691.621.06
2491479-49147989.48590.33
3503248-50324891.62892.49
4499698-49969890.98191.84
5504571-50457191.86992.73
6498979-49897990.85191.70
极限1498639-49863990.78991.280.5891.7892.290.58
2497780-49778090.63291.62
3504940-50494091.93692.95
4502221-50222191.44192.45
5503937-50393791.75392.77
6500657-50065791.15692.16
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%
1111.25524285526575555785549985579245547170.41
2111.85542335529725536020.17
单位质量响应值RSD%判断
4988.464951.720.53数据可信
供试品溶液-3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%
5min1458491-45849181.69881.581.0881.7081.581.08
2454121-45412180.91980.92
3451964-45196480.53580.53
4455405-45540581.14881.15
5464561-46456182.77982.78
6462443-46244382.40282.40
10min1478147-47814785.20085.150.7985.3485.280.79
2482145-48214585.91386.05
3471623-47162384.03884.17
4476300-47630084.87185.01
5481190-48119085.74285.88
6477646-47764685.11185.25
15min1485648-48564886.53786.800.6386.8187.080.63
2489057-48905787.14487.42
3481567-48156785.81086.08
4488738-48873887.08787.36
5489647-48964787.24987.53
6488057-48805786.96687.25
20min1490807-49080787.45687.590.6487.8888.010.64
2493659-49365987.96488.39
3485619-48561986.53286.95
4493053-49305387.85688.28
5492089-49208987.68588.11
6494058-49405888.03588.46
30min1497312-49731288.61588.930.6689.1889.500.66
2503414-50341489.70390.27
3494986-49498688.20188.76
4498341-49834188.79989.37
5497906-49790688.72189.29
6502629-50262989.56390.13
45min1507287-50728790.39390.460.8291.1191.180.82
2512482-51248291.31892.04
3501151-50115189.29990.01
4505186-50518690.01890.73
5508429-50842990.59691.32
6511418-51141891.12991.85
60min1513613-51361391.52091.320.7992.3992.190.79
2516086-51608691.96192.83
3506318-50631890.22091.08
4508865-50886590.67491.54
5513875-51387591.56792.44
6516295-51629591.99892.87
极限1515128-51512891.79091.750.9992.8192.780.99
2520212-52021292.69693.72
3507678-50767890.46291.47
4510017-51001790.87991.90
5517359-51735992.18793.21
6519191-51919192.51493.54
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