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%
1 110.55506525510755517535536395510175516270.22
2 111.85605335617535611430.16
单位质量响应值RSD%判断
4992.105019.170.39数据可信
供试品溶液-4XG02N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%
5min1411495-41149572.80272.390.7072.8072.390.70
2409537-40953772.45672.46
3412944-41294473.05973.06
4409035-40903572.36772.37
5405901-40590171.81371.81
6406103-40610371.84971.85
10min1469843-46984383.12682.820.8083.2582.940.80
2473104-47310483.70283.82
3470884-47088483.31083.43
4466187-46618782.47982.60
5465042-46504282.27682.40
6463586-46358682.01982.14
15min1493479-49347987.30787.250.5987.5787.510.59
2496708-49670887.87988.14
3495644-49564487.69087.95
4492482-49248287.13187.39
5492200-49220087.08187.34
6488485-48848586.42486.68
20min1506992-50699289.69889.330.5890.1089.730.58
2506123-50612389.54489.95
3508103-50810389.89590.30
4504186-50418689.20289.60
5504067-50406789.18189.58
6499912-49991288.44588.85
30min1516127-51612791.31491.370.6991.8791.920.69
2518153-51815391.67392.23
3520280-52028092.04992.61
4517912-51791291.63092.18
5516076-51607691.30591.86
6509942-50994290.22090.77
45min1518984-51898491.82091.650.5992.5392.360.59
2519914-51991491.98492.69
3520712-52071292.12592.84
4519099-51909991.84092.54
5517192-51719291.50392.21
6512315-51231590.64091.34
60min1517631-51763191.58090.980.7892.4491.840.77
2515215-51521591.15392.01
3517718-51771891.59692.46
4515376-51537691.18192.04
5512447-51244790.66391.52
6507214-50721489.73790.59
极限1511874-51187490.56290.530.6291.5791.540.62
2513297-51329790.81491.83
3514964-51496491.10892.12
4513370-51337090.82691.84
5510742-51074290.36191.37
6505961-50596189.51690.51
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%
1 110.55525305535495525485533275501845524280.25
2 111.85511825509955510880.03
单位质量响应值RSD%判断
4999.354929.231.00数据可信
供试品溶液-4XG02N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%
5min1404821-40482172.22170.870.9672.2270.870.96
2396120-39612070.66970.67
3394690-39469070.41470.41
4397046-39704670.83470.83
5395931-39593170.63570.64
6394881-39488170.44870.45
10min1457959-45795981.70181.500.4981.8281.620.50
2457194-45719481.56581.68
3456144-45614481.37781.49
4459454-45945481.96882.09
5452863-45286380.79280.91
6457495-45749581.61881.74
15min1479906-47990685.61786.020.5485.8786.270.54
2482389-48238986.06086.31
3485091-48509186.54286.79
4484218-48421886.38686.64
5478352-47835285.33985.59
6483059-48305986.17986.43
20min1492501-49250187.86488.150.2488.2688.540.24
2493620-49362088.06388.46
3495575-49557588.41288.81
4495319-49531988.36688.77
5493838-49383888.10288.50
6493643-49364388.06788.46
30min1501436-50143689.45890.040.4090.0090.580.40
2506215-50621590.31090.85
3505353-50535390.15690.70
4506590-50659090.37790.92
5503084-50308489.75290.29
6505457-50545790.17590.72
45min1505190-50519090.12790.470.2290.8291.170.22
2507233-50723390.49291.19
3507446-50744690.53091.22
4507645-50764590.56591.26
5506905-50690590.43391.12
6508357-50835790.69291.39
60min1504073-50407389.92889.940.3690.7790.780.36
2504986-50498690.09190.94
3504927-50492790.08090.93
4505505-50550590.18491.03
5500610-50061089.31090.15
6504575-50457590.01890.86
极限1502574-50257489.66189.670.2390.6690.660.23
2504579-50457990.01891.01
3501701-50170189.50590.50
4502942-50294289.72690.72
5501303-50130389.43490.42
6502647-50264789.67490.67
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%
1 110.55523015544825513625501575501265516860.33
2 111.85546095541645543860.06
单位质量响应值RSD%判断
4992.634958.730.49数据可信
供试品溶液-4XG02N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%
5min1405303-40530372.13971.451.3472.1471.451.33
2407130-40713072.46472.46
3399763-39976371.15371.15
4392136-39213669.79569.80
5403697-40369771.85371.85
6400463-40046371.27771.28
10min1453096-45309680.64680.460.6580.7780.580.65
2455308-45530881.03981.16
3449188-44918879.95080.07
4448166-44816679.76879.88
5451930-45193080.43880.56
6454703-45470380.93281.05
15min1481254-48125485.65785.360.5185.9185.610.51
2481614-48161485.72185.98
3476518-47651884.81485.07
4476464-47646484.80585.05
5480179-48017985.46685.72
6481414-48141485.68685.94
20min1498600-49860088.74588.260.4389.1488.650.43
2493593-49359387.85388.25
3493028-49302887.75388.15
4496563-49656388.38288.77
5496870-49687088.43788.83
6496436-49643688.36088.76
30min1518903-51890392.35891.890.4692.9092.440.46
2516998-51699892.01992.56
3512192-51219291.16491.70
4516875-51687591.99792.54
5517754-51775492.15492.70
6515027-51502791.66892.21
45min1529107-52910794.17593.850.3394.8794.550.33
2526310-52631093.67794.38
3525964-52596493.61594.31
4529153-52915394.18394.87
5528162-52816294.00694.70
6525145-52514593.46994.17
60min1533195-53319594.90294.360.4995.7695.210.49
2530582-53058294.43795.29
3528638-52863894.09194.94
4530244-53024494.37795.23
5532174-53217494.72095.57
6525944-52594493.61294.46
极限1532081-53208194.70494.940.5295.7295.950.52
2534172-53417295.07696.09
3533208-53320894.90495.91
4536442-53644295.48096.49
5535620-53562095.33496.35
6528813-52881394.12295.13
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%
1 110.55608565590845599035596195590115596950.14
2 111.85588215569055578630.25
单位质量响应值RSD%判断
5065.114989.831.06数据可信
供试品溶液-4XG02N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%
5min1407591-40759171.80271.191.0271.8071.191.02
2407753-40775371.83171.83
3405655-40565571.46171.46
4401463-40146370.72370.72
5397157-39715769.96469.96
6405016-40501671.34871.35
10min1460166-46016681.06480.040.7881.1880.160.78
2455429-45542980.22980.35
3450976-45097679.44579.56
4451483-45148379.53479.65
5452249-45224979.66979.79
6455870-45587080.30780.43
15min1487836-48783685.93885.060.7886.1985.310.78
2483972-48397285.25785.51
3478520-47852084.29784.55
4482162-48216284.93985.19
5478798-47879884.34684.60
6485690-48569085.56085.81
20min1505685-50568589.08387.981.0189.4888.371.00
2502298-50229888.48688.88
3492098-49209886.68987.08
4497301-49730187.60688.00
5496419-49641987.45087.84
6502636-50263688.54588.94
30min1520171-52017191.63491.130.6492.1891.670.64
2521074-52107491.79392.34
3513248-51324890.41590.95
4514597-51459790.65291.19
5515504-51550490.81291.35
6519350-51935091.49092.03
45min1533324-53332493.95193.260.5994.6593.950.59
2533255-53325593.93994.64
3527518-52751892.92993.62
4527176-52717692.86893.56
5528511-52851193.10493.79
6526488-52648892.74793.44
60min1536983-53698394.59694.050.6195.4594.900.61
2538671-53867194.89395.75
3531251-53125193.58694.43
4530691-53069193.48894.33
5532210-53221093.75594.60
6533389-53338993.96394.81
极限1537018-53701894.60294.420.4295.6295.420.41
2539969-53996995.12296.13
3535076-53507694.26095.26
4535073-53507394.26095.26
5534093-53409394.08795.09
6534562-53456294.17095.18
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