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%
1120.76015136024316006466023455988006011470.25
2121.86048956040976044960.10
单位质量响应值RSD%判断
4980.514963.020.25数据可信
供试品溶液-25092801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%
5min1406792-40679272.46074.512.1772.4674.512.17
2421539-42153975.08775.09
3419376-41937674.70274.70
4409027-40902772.85972.86
5431317-43131776.82976.83
6421773-42177375.12975.13
10min1447583-44758379.72681.161.9379.8581.281.93
2461698-46169882.24182.37
3451623-45162380.44680.57
4444806-44480679.23279.35
5466249-46624983.05183.18
6461659-46165982.23482.36
15min1460408-46040882.01183.231.9782.2683.481.97
2470387-47038783.78884.05
3466435-46643583.08483.34
4453300-45330080.74581.00
5476528-47652884.88285.15
6476344-47634484.84985.11
20min1468435-46843583.44184.432.0383.8384.832.03
2476073-47607384.80185.20
3472577-47257784.17884.58
4458963-45896381.75382.14
5484184-48418486.24686.65
6483717-48371786.16386.57
30min1475100-47510084.62886.162.0385.1686.702.03
2486685-48668586.69187.23
3479684-47968485.44485.98
4471683-47168384.01984.54
5493285-49328587.86788.42
6495811-49581188.31788.86
45min1486138-48613886.59488.211.9487.2688.891.93
2499450-49945088.96589.65
3492712-49271287.76588.44
4482751-48275185.99186.66
5504955-50495589.94690.64
6505224-50522489.99490.69
60min1493630-49363087.92989.601.9588.7490.431.95
2507204-50720490.34691.18
3500502-50050289.15389.98
4490511-49051187.37388.18
5514587-51458791.66292.51
6511661-51166191.14091.98
90min1500949-50094989.23290.541.7290.1991.521.72
2513130-51313091.40292.39
3505964-50596490.12691.10
4496050-49605088.36089.31
5517213-51721392.12993.13
6516465-51646591.99692.99
120min1-0.0000.00-1.111.131.90
2-0.0001.14
3-0.0001.12
4-0.0001.10
5-0.0001.15
6-0.0001.15
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1-0.0000.00-1.111.131.90
2-0.0001.14
3-0.0001.12
4-0.0001.10
5-0.0001.15
6-0.0001.15
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%
1120.76043176029766022996036506053026037090.20
2121.86114246079966097100.40
单位质量响应值RSD%判断
5001.735005.830.06数据可信
供试品溶液-25092801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%
5min1439837-43983777.84575.691.8077.8575.691.81
2434871-43487176.96676.97
3422856-42285674.84074.84
4422573-42257374.79074.79
5422956-42295674.85774.86
6422734-42273474.81874.82
10min1465930-46593082.46381.161.4282.5981.291.42
2466300-46630082.52982.66
3458641-45864181.17381.30
4450144-45014479.66979.79
5453744-45374480.30680.43
6456769-45676980.84280.97
15min1474919-47491984.05482.451.4984.3282.711.49
2471297-47129783.41383.68
3464868-46486882.27582.54
4454790-45479080.49280.75
5464587-46458782.22582.48
6464628-46462882.23382.49
20min1476738-47673884.37682.881.3684.7883.281.36
2474470-47447083.97584.38
3467970-46797082.82483.22
4459698-45969881.36081.75
5464853-46485382.27382.67
6465954-46595482.46782.86
30min1477390-47739084.49183.101.3185.0483.641.31
2474801-47480184.03384.58
3468590-46859082.93483.47
4459891-45989181.39481.92
5468113-46811382.85083.38
6468343-46834382.89083.42
45min1473004-47300483.71582.771.1484.4083.451.14
2472941-47294183.70484.39
3467192-46719282.68783.36
4458478-45847881.14481.81
5466959-46695982.64583.32
6467542-46754282.74883.42
60min1469915-46991583.16882.021.2384.0082.831.23
2467429-46742982.72883.55
3463543-46354382.04182.85
4453279-45327980.22481.02
5463354-46335482.00782.82
6463003-46300381.94582.76
90min1462193-46219381.80280.511.2782.7781.461.27
2459745-45974581.36982.33
3454654-45465480.46781.42
4445655-44565578.87579.81
5453870-45387080.32981.27
6453353-45335380.23781.18
120min1452805-45280580.14078.931.3481.2480.011.33
2451039-45103979.82880.93
3447043-44704379.12080.20
4436262-43626277.21278.28
5443143-44314378.43079.51
6445369-44536978.82479.90
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1449029-44902979.47278.231.1880.7179.451.18
2445668-44566878.87780.11
3442539-44253978.32379.54
4433731-43373176.76477.96
5440351-44035177.93679.15
6440924-44092478.03779.25
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%
1120.76103306080366078566063766060066077210.29
2121.86255456248146251800.09
单位质量响应值RSD%判断
5034.975132.841.37数据可信
供试品溶液-25092801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%
5min1378855-37885566.00167.773.4766.0067.773.47
2378801-37880165.99265.99
3394158-39415868.66768.67
4394740-39474068.76968.77
5376517-37651765.59465.59
6411011-41101171.60371.60
10min1409619-40961971.36173.352.4071.4773.462.41
2415598-41559872.40372.51
3428364-42836474.62774.74
4424375-42437573.93274.05
5412615-41261571.88371.99
6435684-43568475.90276.02
15min1418180-41818072.85275.292.1473.0875.532.15
2426636-42663674.32674.56
3439415-43941576.55276.79
4438762-43876276.43876.68
5428389-42838974.63174.86
6441715-44171576.95277.20
20min1429261-42926174.78376.762.0275.1377.122.02
2432907-43290775.41875.77
3450564-45056478.49478.86
4448510-44851078.13678.50
5436403-43640376.02776.38
6445870-44587077.67678.05
30min1431320-43132075.14278.072.4275.6278.562.42
2439790-43979076.61777.10
3461608-46160880.41880.92
4453879-45387979.07279.57
5450828-45082878.54079.02
6451463-45146378.65179.15
45min1442301-44230177.05580.692.9677.6581.312.95
2452780-45278078.88079.49
3480625-48062583.73184.36
4463925-46392580.82281.45
5470831-47083182.02582.64
6468688-46868881.65282.29
60min1460627-46062780.24783.592.3780.9884.352.36
2475483-47548382.83583.57
3493995-49399586.06086.83
4482226-48222684.01084.77
5479974-47997483.61884.37
6486744-48674484.79785.57
90min1479041-47904183.45586.191.9384.3287.081.93
2490872-49087285.51686.39
3505396-50539688.04788.96
4500657-50065787.22188.12
5491965-49196585.70786.59
6500557-50055787.20388.12
120min1486291-48629184.71886.981.7785.7288.011.78
2492508-49250885.80186.82
3507685-50768588.44589.51
4505724-50572488.10489.15
5496644-49664486.52287.55
6506675-50667588.26989.33
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1490375-49037585.43087.021.3086.5788.201.31
2495535-49553586.32987.49
3504598-50459887.90789.12
4506818-50681888.29489.49
5495857-49585786.38587.56
6503679-50367987.74788.95
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