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%
1110.55479145437885448035439965437135448430.33
2111.85454715460245457480.08
单位质量响应值RSD%判断
4930.714881.470.71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%
5min1378598-37859868.34367.331.2768.3467.331.27
2372767-37276767.29067.29
3368124-36812466.45266.45
4367301-36730166.30366.30
5377787-37778768.19668.20
6373492-37349267.42167.42
10min1448689-44868980.99579.711.2481.1179.821.24
2440355-44035579.49179.60
3438449-43844979.14779.26
4433901-43390178.32678.44
5446807-44680780.65580.77
6441192-44119279.64279.75
15min1475938-47593885.91484.841.0886.1685.091.08
2468621-46862184.59384.84
3466635-46663584.23584.48
4462908-46290883.56283.80
5475341-47534185.80686.05
6470573-47057384.94585.19
20min1490769-49076988.59187.600.9788.9887.980.97
2484442-48444287.44987.83
3479994-47999486.64687.03
4480028-48002886.65287.03
5489947-48994788.44388.83
6486415-48641587.80588.19
30min1504810-50481091.12690.131.0191.6790.661.01
2497413-49741389.79190.32
3492542-49254288.91189.44
4496117-49611789.55790.08
5505349-50534991.22391.76
6499632-49963290.19190.72
45min1510948-51094892.23491.410.9592.9392.090.95
2504133-50413391.00491.68
3500229-50022990.29990.97
4504377-50437791.04891.72
5513105-51310592.62393.31
6505373-50537391.22791.91
60min1515254-51525493.01191.991.0293.8692.831.03
2506989-50698991.51992.35
3502682-50268290.74291.57
4507315-50731591.57892.40
5516155-51615593.17494.02
6509287-50928791.93492.77
90min1515386-51538693.03592.270.9694.0493.260.96
2508325-50832591.76092.75
3504576-50457691.08492.06
4510253-51025392.10893.09
5518078-51807893.52194.52
6510340-51034092.12493.11
120min1-0.0000.00-1.161.141.20
2-0.0001.14
3-0.0001.13
4-0.0001.13
5-0.0001.16
6-0.0001.14
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1-0.0000.00-1.161.141.20
2-0.0001.14
3-0.0001.13
4-0.0001.13
5-0.0001.16
6-0.0001.14
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%
1110.55458295446875456775446735454425452620.11
2111.85526225525425525820.02
单位质量响应值RSD%判断
4934.504942.590.12数据可信
供试品溶液-4XG02N批-shui(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%
5min1341499-34149961.23952.269.5361.2452.269.53
2269256-26925648.28448.28
3279205-27920550.06850.07
4268859-26885948.21348.21
5304182-30418254.54754.55
6285688-28568851.23151.23
10min1422777-42277775.81466.009.0375.9266.099.03
2327244-32724458.68358.76
3380243-38024368.18768.27
4374864-37486467.22267.30
5359409-35940964.45164.54
6343746-34374661.64261.73
15min1418699-41869975.08378.7111.1275.3178.9111.09
2383601-38360168.78968.97
3432491-43249177.55677.75
4523514-52351493.87994.07
5412827-41282774.03074.23
6462554-46255482.94783.14
20min1388527-38852769.67269.707.7270.0370.037.70
2354224-35422463.52163.81
3429988-42998877.10777.43
4389234-38923469.79970.15
5356989-35698964.01764.34
6413239-41323974.10474.43
30min1372991-37299166.88666.663.0967.3667.103.10
2354373-35437363.54863.95
3380230-38023068.18468.64
4379779-37977968.10468.57
5361037-36103764.74365.17
6381818-38181868.46968.92
45min1391126-39112670.13869.192.3470.7269.752.34
2375140-37514067.27267.78
3373947-37394767.05867.63
4395489-39548970.92171.50
5389673-38967369.87870.41
6389664-38966469.87670.44
60min1409970-40997073.51873.671.4874.2274.341.49
2404300-40430072.50173.12
3403801-40380172.41173.09
4415197-41519774.45575.15
5412366-41236673.94774.60
6419227-41922775.17875.86
90min1432513-43251377.56078.022.0278.3878.812.03
2428270-42827076.79977.54
3439646-43964678.83979.64
4444032-44403279.62680.45
5422409-42240975.74876.52
6443521-44352179.53480.34
120min1430774-43077477.24878.602.5978.2079.532.59
2427153-42715376.59977.46
3443266-44326679.48880.42
4455933-45593381.76082.71
5428752-42875276.88677.79
6444164-44416479.64980.59
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1425260-42526076.25978.032.9077.3479.092.89
2417870-41787074.93475.93
3436477-43647778.27179.34
4453436-45343681.31282.40
5434965-43496578.00079.03
6442838-44283879.41280.48
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%
1110.55487665475395475125461275461255472140.21
2111.85642135637785639960.06
单位质量响应值RSD%判断
4952.165044.691.31数据可信
供试品溶液-4XG02N批-shui(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%
5min1277765-27776549.21749.4113.9649.2249.4113.96
2304266-30426653.91353.91
3321535-32153556.97356.97
4207460-20746036.76036.76
5281160-28116049.81949.82
6280954-28095449.78349.78
10min1323218-32321857.27157.296.6657.3557.376.67
2329054-32905458.30558.40
3323288-32328857.28457.38
4282710-28271050.09450.15
5344134-34413460.97761.06
6337394-33739459.78359.87
15min1386237-38623768.43862.9612.0368.6263.1412.02
2366583-36658364.95565.14
3393162-39316269.66569.86
4280568-28056849.71449.86
5375144-37514466.47266.66
6330100-33010058.49158.67
20min1349005-34900561.84160.257.9762.1360.547.98
2335082-33508259.37459.67
3356303-35630363.13463.44
4290009-29000951.38751.61
5368229-36822965.24765.54
6341663-34166360.54060.82
30min1351679-35167962.31460.235.1262.7160.625.14
2345478-34547861.21661.61
3357463-35746363.33963.75
4308843-30884354.72455.04
5343595-34359560.88261.29
6332604-33260458.93459.32
45min1370286-37028665.61164.824.9566.1165.304.97
2378185-37818567.01167.51
3384066-38406668.05368.57
4336780-33678059.67460.08
5374307-37430766.32466.83
6351193-35119362.22862.71
60min1403267-40326771.45569.155.3472.0669.745.35
2402033-40203371.23771.84
3408713-40871372.42073.05
4357806-35780663.40063.90
5398963-39896370.69371.31
6370598-37059865.66766.25
90min1437677-43767777.55274.724.4778.2875.424.49
2426933-42693375.64976.38
3440614-44061478.07378.82
4391511-39151169.37269.98
5425865-42586575.45976.19
6407456-40745672.19872.89
120min1448501-44850179.47077.412.4280.3378.242.45
2442985-44298578.49379.35
3441972-44197278.31379.20
4423312-42331275.00775.73
5440237-44023778.00678.87
6424187-42418775.16275.97
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1443081-44308178.51077.081.2879.5078.031.31
2431914-43191476.53177.51
3433782-43378276.86277.87
4426895-42689575.64276.49
5435771-43577177.21578.20
6438471-43847177.69378.63
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