精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.183282333285953289023288653288593286910.09
210.073271353273243272300.05
单位质量响应值RSD%判断
32287.9232495.530.46数据可信
加速6月-供试品溶液-2023092121批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1252291-25229166.45471.3121.1766.4571.3121.17
2299337-29933778.84678.85
3274478-27447872.29872.30
4243626-24362664.17264.17
5362194-36219495.40395.40
6192373-19237350.67250.67
10min1367477-36747796.79594.715.2496.9194.835.25
2377055-37705599.31899.45
3352757-35275792.91793.04
4366681-36668196.58596.69
5368746-36874697.12997.29
6324645-32464585.51385.60
15min1371044-37104497.73496.223.3598.0196.503.36
2376827-37682799.25799.55
3361627-36162795.25495.53
4371760-37176097.92398.19
5368016-36801696.93797.26
6342513-34251390.21990.45
20min1371156-37115697.76496.522.7998.2096.962.80
2375802-37580298.98799.45
3363139-36313995.65296.09
4373479-37347998.37698.81
5367372-36737296.76797.25
6347767-34776791.60391.98
30min1371861-37186197.94996.952.1898.5597.552.20
2375406-37540698.88399.51
3365609-36560996.30396.90
4374372-37437298.61199.21
5367475-36747596.79497.44
6353706-35370693.16793.70
极限1374684-37468498.69397.991.1199.4598.751.11
2374034-37403498.52299.31
3370715-37071597.64898.40
4377647-37764799.473100.23
5367066-36706696.68697.49
6368011-36801196.93597.62
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.183262143257123261743266363264343262340.11
210.073268943268223268580.02
单位质量响应值RSD%判断
32046.5632458.590.91数据可信
加速6月-供试品溶液-2023092221批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1283462-28346274.98961.6440.5674.9961.6440.56
2171332-17133245.32645.33
3326494-32649486.37386.37
4284029-28402975.13975.14
5261289-26128969.12369.12
671302-7130218.86318.86
10min1377641-37764199.90493.939.24100.0394.039.27
2367905-36790597.32897.40
3363306-36330696.11296.26
4369599-36959997.77797.90
5362860-36286095.99496.11
6289013-28901376.45876.49
15min1378189-378189100.04997.074.09100.3497.334.13
2373934-37393498.92399.16
3368907-36890797.59497.90
4377312-37731299.817100.11
5365254-36525496.62796.90
6338062-33806289.43489.59
20min1377484-37748499.86398.002.48100.3298.422.52
2376970-37697099.727100.13
3369524-36952497.75798.22
4377982-37798299.994100.45
5366030-36603096.83297.27
6354585-35458593.80594.11
30min1378863-378863100.22798.601.56100.8599.181.58
2375561-37556199.35499.92
3369892-36989297.85498.48
4378788-378788100.208100.83
5367123-36712397.12297.72
6365992-36599296.82297.29
极限1378027-378027100.00698.801.29100.8099.551.30
2375531-37553199.346100.08
3368698-36869897.53898.33
4379439-379439100.380101.17
5369014-36901497.62298.38
6370077-37007797.90398.53
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.183282173280263282543281283280933281440.03
210.073265863265793265820.01
单位质量响应值RSD%判断
32234.1832431.180.44数据可信
加速6月-供试品溶液-2023092321批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1306937-30693780.99674.2323.0081.0074.2423.00
2285340-28534075.29775.30
3159525-15952542.09642.10
4337026-33702688.93688.94
5328300-32830086.63386.63
6270713-27071371.43771.44
10min1373942-37394298.67795.554.1898.8195.684.21
2362729-36272995.71895.84
3333387-33338787.97688.05
4374088-37408898.71698.86
5367947-36794797.09597.24
6360503-36050395.13195.25
15min1376794-37679499.43097.222.1599.7397.502.18
2370580-37058097.79098.08
3354566-35456693.56493.78
4373892-37389298.66498.98
5369947-36994797.62397.93
6364691-36469196.23696.51
20min1376360-37636099.31597.681.2499.7898.131.26
2370356-37035697.73198.18
3365217-36521796.37596.75
4373999-37399998.69299.17
5370176-37017697.68498.15
6364970-36497096.31096.75
30min1375768-37576899.15997.741.0299.7998.341.05
2370357-37035797.73198.34
3366751-36675196.78097.31
4372975-37297598.42299.06
5370687-37068797.81898.45
6365712-36571296.50697.10
极限1377660-37766099.65898.041.00100.4598.811.02
2369054-36905497.38798.16
3366868-36686896.81197.51
4372890-37289098.40099.21
5372088-37208898.18898.98
6370605-37060597.79798.56
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.183269553262133264413260233256163262500.16
210.073224043225803224920.04
单位质量响应值RSD%判断
32048.1332025.020.06数据可信
加速6月-供试品溶液-715967批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1153345-15334540.83939.048.8840.8439.048.88
2147996-14799639.41439.41
3161169-16116942.92342.92
4131310-13131034.97134.97
5155621-15562141.44541.45
6130118-13011834.65334.65
10min1304428-30442881.07576.735.5281.1476.795.52
2295745-29574578.76378.83
3298489-29848979.49479.57
4280265-28026574.64074.70
5289280-28928077.04177.11
6260407-26040769.35269.41
15min1377364-377364100.50095.453.28100.7095.643.29
2362350-36235096.50196.70
3358382-35838295.44595.65
4354016-35401694.28294.46
5357073-35707395.09695.29
6341247-34124790.88191.05
20min1381326-381326101.55599.651.64101.93100.001.64
2382160-382160101.777102.13
3371058-37105898.82099.18
4368964-36896498.26398.60
5368408-36840898.11598.47
6373153-37315399.37899.70
30min1380530-380530101.34399.491.75101.88100.001.75
2381534-381534101.610102.14
3369951-36995198.52699.05
4367769-36776997.94498.45
5366376-36637697.57398.09
6375178-37517899.918100.41
极限1379146-379146100.97499.271.86101.6899.961.86
2382761-382761101.937102.63
3368808-36880898.22198.91
4366223-36622397.53398.20
5366413-36641397.58398.27
6373190-37319099.388100.05
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