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%
1 110.55373355361305376595357325350445363800.21
2 111.85387515396105391800.12
单位质量响应值RSD%判断
4854.124822.720.46数据可信
供试品溶液-js1M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%
5min1359781-35978165.85366.071.5565.8566.071.55
2356441-35644165.24265.24
3361539-36153966.17566.17
4353813-35381364.76164.76
5365111-36511166.82966.83
6369034-36903467.54767.55
10min1427189-42718978.19178.831.4378.3078.941.44
2428176-42817678.37278.48
3430687-43068778.83278.94
4422496-42249677.33277.44
5435980-43598079.80079.91
6439390-43939080.42580.54
15min1459937-45993784.18584.721.3384.4384.961.33
2459539-45953984.11384.35
3463329-46332984.80685.05
4455726-45572683.41583.65
5465362-46536285.17885.42
6473391-47339186.64886.89
20min1477144-47714487.33587.570.8987.7287.950.89
2475021-47502186.94687.33
3478892-47889287.65588.04
4473023-47302386.58186.96
5482430-48243088.30388.69
6483957-48395788.58288.97
30min1489242-48924289.54990.270.9090.0890.800.90
2492645-49264590.17290.70
3495189-49518990.63891.17
4487167-48716789.17089.69
5496014-49601490.78991.32
6498969-49896991.33091.87
45min1497838-49783891.12391.880.8991.8092.550.89
2501367-50136791.76992.44
3503254-50325492.11492.79
4496024-49602490.79191.46
5506233-50623392.65993.34
6506983-50698392.79793.49
60min1502706-50270692.01492.400.7992.8493.240.79
2504018-50401892.25493.08
3506490-50649092.70693.54
4498407-49840791.22792.05
5508544-50854493.08293.92
6508809-50880993.13193.98
90min1501626-50162691.81692.590.8392.8093.580.83
2504849-50484992.40693.39
3510265-51026593.39794.39
4500804-50080491.66692.64
5510602-51060293.45994.45
6506980-50698092.79693.80
120min1-0.0000.00-1.131.141.25
2-0.0001.14
3-0.0001.14
4-0.0001.12
5-0.0001.15
6-0.0001.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.131.141.25
2-0.0001.14
3-0.0001.14
4-0.0001.12
5-0.0001.15
6-0.0001.16
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%
1 110.55408585392745373175381035381575387420.26
2 111.85418585384995401780.44
单位质量响应值RSD%判断
4875.494831.650.64数据可信
供试品溶液-4XG02N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%
5min1346765-34676563.27363.781.3263.2763.781.32
2341949-34194962.39562.39
3355211-35521164.81464.81
4350446-35044663.94563.94
5351449-35144964.12864.13
6351368-35136864.11364.11
10min1397310-39731072.49671.750.9672.6071.850.96
2388232-38823270.84070.94
3396903-39690372.42272.53
4392508-39250871.62071.73
5389629-38962971.09571.20
6394680-39468072.01672.12
15min1421357-42135776.88476.440.7177.1176.660.71
2413438-41343875.43975.66
3421572-42157276.92377.15
4419596-41959676.56376.79
5419159-41915976.48376.71
6418390-41839076.34376.57
20min1441561-44156180.57079.791.0380.9280.141.03
2429403-42940378.35278.70
3440701-44070180.41480.77
4439616-43961680.21680.57
5436170-43617079.58779.94
6436105-43610579.57579.93
30min1460818-46081884.08483.890.8984.5784.380.89
2452304-45230482.53183.01
3463815-46381584.63185.12
4462882-46288284.46184.95
5459526-45952683.84984.33
6459227-45922783.79484.28
45min1480746-48074687.72087.590.7788.3588.220.77
2473584-47358486.41487.03
3482999-48299988.13288.76
4483768-48376888.27288.90
5478581-47858187.32587.95
6480571-48057187.68988.31
60min1495607-49560790.43290.090.7591.2190.860.75
2488499-48849989.13589.90
3496521-49652190.59991.38
4498279-49827990.92091.69
5491939-49193989.76390.53
6491445-49144589.67390.45
90min1508204-50820492.73192.400.9093.6693.330.90
2501477-50147791.50392.41
3511190-51119093.27594.21
4511756-51175693.37994.31
5503065-50306591.79392.71
6502773-50277391.74092.66
120min1513810-51381093.75493.780.6494.8394.850.64
2511483-51148393.32994.39
3517530-51753094.43295.52
4518149-51814994.54595.63
5512502-51250293.51594.59
6510163-51016393.08894.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1527977-52797796.33994.860.9797.5896.090.97
2517966-51796694.51295.73
3522156-52215695.27696.52
4520025-52002594.88896.13
5518234-51823494.56195.79
6512872-51287293.58294.81
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%
1 110.55411185407575408555387425377875398520.28
2 111.85459945439515449720.27
单位质量响应值RSD%判断
4885.544874.530.16数据可信
供试品溶液-4XG02N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%
5min1339639-33963961.63661.760.9061.6461.760.89
2337324-33732461.21661.22
3341864-34186462.04062.04
4337245-33724561.20161.20
5345280-34528062.65962.66
6340530-34053061.79761.80
10min1383664-38366469.62569.550.4869.7369.650.48
2382490-38249069.41269.51
3381647-38164769.25969.36
4383372-38337269.57269.67
5386546-38654670.14870.25
6381714-38171469.27169.37
15min1405131-40513173.52174.190.7573.7474.410.75
2408887-40888774.20374.42
3407267-40726773.90974.13
4408035-40803574.04874.27
5414245-41424575.17575.40
6409419-40941974.29974.52
20min1423330-42333076.82477.660.8777.1678.000.87
2425617-42561777.23977.58
3428604-42860477.78178.12
4426451-42645177.39077.73
5433849-43384978.73379.08
6429884-42988478.01378.36
30min1447991-44799181.29981.940.7281.7782.410.72
2448883-44888381.46181.93
3450624-45062481.77782.25
4451052-45105281.85482.32
5456612-45661282.86383.34
6453966-45396682.38382.86
45min1468181-46818184.96385.830.9485.5786.440.94
2470778-47077885.43486.04
3472772-47277285.79686.40
4471325-47132585.53386.14
5481184-48118487.32387.94
6473378-47337885.90686.52
60min1484840-48484087.98688.490.6388.7389.240.63
2485886-48588688.17688.92
3488103-48810388.57889.33
4485307-48530788.07188.82
5493030-49303089.47290.23
6488652-48865288.67889.43
90min1501690-50169091.04491.350.5591.9492.250.55
2500615-50061590.84991.74
3504065-50406591.47592.37
4501280-50128090.97091.87
5507875-50787592.16693.08
6504757-50475791.60092.50
120min1507017-50701792.01192.470.4793.0693.530.47
2509381-50938192.44093.49
3510854-51085492.70793.76
4508028-50802892.19493.24
5513635-51363593.21294.28
6508506-50850692.28193.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1514872-51487293.43693.610.4394.6394.820.43
2514597-51459793.38694.59
3516918-51691893.80795.01
4514919-51491993.44594.65
5519880-51988094.34595.56
6513911-51391193.26294.47
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