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%
1112.55477885467915459605477305479775472490.16
2112.55486165471615478880.19
单位质量响应值RSD%判断
4864.444870.120.09数据可信
供试品溶液-49G03N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%
5min1357855-35785565.11264.461.0965.1164.461.09
2355862-35586264.74964.75
3349359-34935963.56663.57
4349565-34956563.60363.60
5357362-35736265.02265.02
6355788-35578864.73664.74
10min1388352-38835270.66171.330.8370.7771.440.82
2397554-39755472.33572.44
3393067-39306771.51971.62
4389663-38966370.89971.01
5392648-39264871.44271.55
6391046-39104671.15171.26
15min1419184-41918476.27076.430.7876.5076.650.77
2421752-42175276.73876.97
3425297-42529777.38377.61
4418877-41887776.21576.44
5419497-41949776.32776.55
6415608-41560875.62075.85
20min1431381-43138178.49078.910.8778.8479.270.87
2433858-43385878.94079.30
3440628-44062880.17280.53
4430565-43056578.34178.69
5434549-43454979.06679.42
6431313-43131378.47778.83
30min1462229-46222984.10383.770.7484.5984.260.74
2462150-46215084.08884.58
3464966-46496684.60185.09
4459731-45973183.64884.13
5457683-45768383.27583.76
6455665-45566582.90883.39
45min1489782-48978289.11688.380.7489.7489.010.74
2488956-48895688.96589.59
3488191-48819188.82689.46
4482520-48252087.79488.42
5481935-48193587.68888.31
6483129-48312987.90588.53
60min1508451-50845192.51391.320.7793.2992.100.76
2502889-50288991.50192.28
3502507-50250791.43192.21
4498466-49846690.69691.46
5501289-50128991.20991.98
6497840-49784090.58291.35
极限1521939-52193994.96794.160.8095.8995.080.79
2517850-51785094.22395.15
3519418-51941894.50895.44
4513852-51385293.49594.41
5520614-52061494.72695.65
6511354-51135493.04193.96
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%
1112.55504695485225500915484985476375490430.22
2112.55582985581385582180.03
单位质量响应值RSD%判断
4880.384961.941.18数据可信
供试品溶液-25052801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%
5min1440806-44080679.33278.711.8279.3378.711.82
2435557-43555778.38778.39
3429297-42929777.26177.26
4451667-45166781.28681.29
5433164-43316477.95677.96
6433688-43368878.05178.05
10min1470489-47048984.67483.871.8084.8184.001.80
2456266-45626682.11482.24
3467538-46753884.14384.27
4478410-47841086.09986.23
5457097-45709782.26482.39
6466368-46636883.93284.06
15min1475952-47595285.65785.271.7185.9385.541.71
2466251-46625183.91184.18
3475400-47540085.55885.83
4482778-48277886.88687.16
5462021-46202183.15083.42
6480410-48041086.45986.73
20min1482401-48240186.81885.942.1587.2386.352.15
2465824-46582483.83484.24
3478133-47813386.05086.46
4489987-48998788.18388.61
5464673-46467383.62784.03
6484084-48408487.12187.53
30min1493915-49391588.89087.132.3989.4587.692.39
2473213-47321385.16485.71
3483738-48373887.05887.61
4495781-49578189.22689.80
5467616-46761684.15784.70
6490713-49071388.31488.87
45min1493390-49339088.79587.732.4789.5088.432.46
2477431-47743185.92386.61
3485702-48570287.41288.11
4502403-50240390.41791.14
5470350-47035084.64985.33
6495532-49553289.18189.89
60min1500410-50041090.05988.422.3590.9289.262.35
2480036-48003686.39287.22
3489039-48903988.01288.86
4503033-50303390.53191.40
5475656-47565685.60486.43
6499554-49955489.90590.76
极限1504243-50424390.74989.052.4991.7690.042.48
2480465-48046586.46987.45
3493411-49341188.79989.79
4504986-50498690.88291.90
5479666-47966686.32587.29
6506022-50602291.06992.07
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%
1112.55566085555905560535545945567355559160.16
2112.55621285615305618290.08
单位质量响应值RSD%判断
4941.484994.040.75数据可信
供试品溶液-25061601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%
5min1486730-48673086.77282.714.1086.7782.714.11
2477290-47729085.08985.09
3475608-47560884.78984.79
4439395-43939578.33378.33
5459482-45948281.91481.91
6445160-44516079.36179.36
10min1518197-51819792.38188.352.5192.5388.492.51
2495389-49538988.31588.46
3495162-49516288.27588.42
4493573-49357387.99288.12
5490753-49075387.48987.63
6480405-48040585.64485.78
15min1525911-52591193.75789.802.4294.0690.092.42
2501374-50137489.38289.67
3502186-50218689.52789.82
4504463-50446389.93390.21
5499579-49957989.06289.34
6488925-48892587.16387.44
20min1530647-53064794.60190.672.2395.0691.102.23
2503850-50385089.82490.26
3505967-50596790.20190.64
4508894-50889490.72391.15
5503717-50371789.80090.23
6498515-49851588.87389.29
30min1535809-53580995.52191.622.2196.1392.202.21
2508302-50830290.61791.21
3512256-51225691.32291.91
4513453-51345391.53692.11
5510604-51060491.02891.61
6503109-50310989.69290.26
45min1540370-54037096.33492.342.2497.1193.082.24
2509673-50967390.86291.60
3514663-51466391.75192.49
4519261-51926192.57193.30
5514540-51454091.72992.46
6509387-50938790.81191.53
60min1541366-54136696.51292.542.1997.4493.432.19
2510530-51053091.01591.90
3515140-51514091.83692.73
4519441-51944192.60393.49
5515469-51546991.89592.78
6512459-51245991.35892.23
极限1543889-54388996.96293.152.1598.0594.192.15
2512115-51211591.29792.34
3519570-51957092.62693.67
4524076-52407693.42994.47
5518843-51884392.49793.53
6516406-51640692.06293.08
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