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%
1 110.55474525472435488525478505469975476790.14
2 111.85512695493655503170.25
单位质量响应值RSD%判断
4956.374922.330.49数据可信
供试品溶液-25101701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%
5min1472746-47274684.76284.290.5884.7684.280.58
2470553-47055384.36984.37
3472811-47281184.77484.77
4466114-46611483.57383.57
5470682-47068284.39284.39
6467675-46767583.85383.85
10min1492617-49261788.32588.420.7988.4788.560.80
2494114-49411488.59388.73
3495067-49506788.76488.91
4485807-48580787.10487.24
5497195-49719589.14689.29
6493975-49397588.56888.71
15min1499639-49963989.58489.690.5689.8789.980.56
2500838-50083889.79990.09
3502747-50274790.14190.43
4495728-49572888.88289.17
5503357-50335790.25090.54
6499230-49923089.51089.80
20min1500919-50091989.81389.920.7190.2590.360.71
2503810-50381090.33290.77
3502392-50239290.07790.52
4494708-49470888.70089.13
5504324-50432490.42490.86
6502846-50284690.15990.60
30min1500294-50029489.70189.970.8090.2990.560.80
2506838-50683890.87491.46
3503871-50387190.34290.93
4495255-49525588.79889.38
5503773-50377390.32590.92
6500888-50088889.80890.39
45min1497338-49733889.17189.350.7189.9190.090.71
2502391-50239190.07790.82
3499716-49971689.59890.34
4492117-49211788.23588.96
5498531-49853189.38590.13
6500042-50004289.65690.39
60min1495072-49507288.76588.750.6589.6589.630.65
2498858-49885889.44490.33
3496691-49669189.05589.94
4489228-48922887.71788.59
5494768-49476888.71089.60
6495156-49515688.78089.67
90min1490163-49016387.88587.890.7888.9288.920.77
2496674-49667489.05290.09
3488587-48858787.60288.64
4485056-48505686.96987.99
5490916-49091688.02089.06
6489612-48961287.78688.82
120min1-0.0000.00-1.181.180.54
2-0.0001.19
3-0.0001.18
4-0.0001.17
5-0.0001.18
6-0.0001.18
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1-0.0000.00-1.181.180.54
2-0.0001.19
3-0.0001.18
4-0.0001.17
5-0.0001.18
6-0.0001.18
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%
1 110.55482525500625479295504585506035494610.24
2 111.85535345552955544140.23
单位质量响应值RSD%判断
4972.504958.980.20数据可信
供试品溶液-25101701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%
5min1462971-46297182.56782.341.0082.5782.341.00
2462286-46228682.44582.45
3469109-46910983.66283.66
4462045-46204582.40282.40
5458155-45815581.70881.71
6455748-45574881.27981.28
10min1490843-49084387.53887.601.1087.6887.741.10
2493551-49355188.02188.16
3499126-49912689.01589.15
4491987-49198787.74287.88
5488736-48873687.16287.30
6482840-48284086.11186.25
15min1508503-50850390.68889.531.3590.9789.811.35
2506119-50611990.26290.55
3508883-50888390.75591.04
4499043-49904389.00189.28
5496957-49695788.62888.91
6492622-49262287.85588.13
20min1508372-50837290.66490.451.1691.1090.881.16
2508349-50834990.66091.09
3514960-51496091.83992.28
4509194-50919490.81191.24
5504784-50478490.02490.45
6497300-49730088.69089.12
30min1516522-51652292.11891.911.4392.7092.491.43
2518567-51856792.48293.07
3523932-52393293.43994.03
4519831-51983192.70893.29
5509318-50931890.83391.41
6504023-50402389.88990.46
45min1524903-52490393.61293.401.5194.3594.141.51
2528755-52875594.29995.04
3531549-53154994.79895.55
4528429-52842994.24194.98
5517863-51786392.35793.09
6510856-51085691.10791.83
60min1528023-52802394.16993.921.5095.0694.811.50
2529078-52907894.35795.25
3533923-53392395.22196.13
4533072-53307295.06995.96
5522860-52286093.24894.13
6512767-51276791.44892.32
90min1532943-53294395.04694.801.3796.1095.851.37
2534776-53477695.37396.43
3536597-53659795.69896.76
4539313-53931396.18297.24
5525345-52534593.69194.73
6520308-52030892.79393.82
120min1-0.0000.00-1.211.201.15
2-0.0001.21
3-0.0001.22
4-0.0001.21
5-0.0001.20
6-0.0001.18
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1-0.0000.00-1.211.201.15
2-0.0001.21
3-0.0001.22
4-0.0001.21
5-0.0001.20
6-0.0001.18
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%
1 110.55705245692925684875691605711155697160.19
2 111.85572595581815577200.12
单位质量响应值RSD%判断
5155.804988.552.34数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25101701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%
5min1406831-40683171.05270.301.9471.0570.311.94
2401088-40108870.04970.05
3416196-41619672.68772.69
4398893-39889369.66669.67
5396611-39661169.26769.27
6395688-39568869.10669.11
10min1438511-43851176.58574.641.9676.7074.751.96
2427065-42706574.58674.70
3436619-43661976.25476.38
4421700-42170073.64973.76
5420992-42099273.52573.64
6419289-41928973.22873.34
15min1465289-46528981.26177.812.5181.5178.052.51
2438298-43829876.54776.79
3452621-45262179.04979.30
4439628-43962876.78077.02
5439531-43953176.76377.00
6437722-43772276.44776.68
20min1475172-47517282.98779.192.4783.3779.562.47
2446320-44632077.94878.32
3455312-45531279.51979.90
4448575-44857578.34278.71
5449342-44934278.47678.84
6445802-44580277.85878.22
30min1479604-47960483.76180.752.0984.2881.262.09
2459571-45957180.26380.76
3466365-46636581.44981.96
4460728-46072880.46580.96
5454345-45434579.35079.85
6453614-45361479.22279.72
45min1485969-48596984.87383.011.8285.5383.651.82
2470655-47065582.19982.83
3480591-48059183.93484.58
4480825-48082583.97584.61
5462541-46254180.78181.41
6471378-47137882.32582.95
60min1492783-49278386.06384.462.0786.8685.232.07
2484293-48429384.58085.35
3492457-49245786.00686.79
4488063-48806385.23986.01
5467203-46720381.59682.36
6476655-47665583.24684.01
90min1500071-50007187.33686.052.5788.2886.972.56
2500388-50038887.39188.30
3508117-50811788.74189.67
4492159-49215985.95486.87
5476929-47692983.29484.19
6478595-47859583.58584.49
120min1505745-50574588.32787.202.3689.4288.262.35
2509852-50985289.04490.10
3511693-51169389.36690.45
4497338-49733886.85987.92
5485938-48593884.86885.91
6485010-48501084.70685.75
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1514798-51479889.90888.251.5891.1589.451.59
2509094-50909488.91290.12
3511710-51171089.36990.60
4503481-50348187.93189.13
5497964-49796486.96888.15
6494641-49464186.38887.57
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