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%
110.293320093311123317043316803316943316400.10
210.343316233311353313790.11
单位质量响应值RSD%判断
32229.3532048.260.40数据可信
长期12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%
5min1312939-31293983.07865.2038.0983.0865.2038.09
2277263-27726373.60773.61
3313032-31303283.10283.10
4305419-30541981.08181.08
585087-8508722.58922.59
6179913-17991347.76347.76
10min1376794-376794100.03097.564.77100.1797.674.80
2373489-37348999.15299.27
3378330-378330100.437100.58
4382176-382176101.458101.59
5358275-35827595.11395.15
6335969-33596989.19289.27
15min1383019-383019101.682100.142.76101.99100.412.78
2380197-380197100.933101.22
3380651-380651101.054101.36
4385025-385025102.215102.52
5377671-377671100.262100.46
6356648-35664894.68194.91
20min1384885-384885102.178100.732.27102.65101.172.29
2381152-381152101.187101.64
3379954-379954100.869101.34
4385349-385349102.301102.78
5382915-382915101.655102.02
6362420-36242096.21496.60
30min1385718-385718102.399101.241.75103.04101.841.76
2382131-382131101.446102.07
3380448-380448101.000101.64
4386262-386262102.543103.19
5384908-384908102.184102.72
6368553-36855397.84298.39
极限1386169-386169102.518102.130.83103.33102.900.82
2384314-384314102.026102.82
3380625-380625101.047101.86
4388313-388313103.088103.90
5387376-387376102.839103.54
6381418-381418101.257101.97
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%
110.293316003315563311653318023318243315890.09
210.343315103325753320420.23
单位质量响应值RSD%判断
32224.3932112.380.25数据可信
长期12月-供试品溶液-2023092221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%
5min1295289-29528978.32060.8134.5078.3260.8134.50
2240921-24092163.90063.90
376672-7667220.33620.34
4248837-24883765.99966.00
5228889-22888960.70860.71
6285036-28503675.60075.60
10min1373360-37336099.02690.4714.2499.1690.5814.26
2340652-34065290.35190.46
3251523-25152366.71166.75
4381167-381167101.097101.21
5327986-32798686.99287.09
6371959-37195998.65598.78
15min1375717-37571799.65196.345.4699.9596.605.50
2362121-36212196.04596.30
3329872-32987287.49287.64
4384015-384015101.852102.13
5352387-35238793.46493.71
6375348-37534899.55499.84
20min1375536-37553699.60398.592.29100.0799.012.33
2370995-37099598.39998.82
3361778-36177895.95496.25
4384165-384165101.892102.34
5362742-36274296.21096.61
6375174-37517499.50799.96
30min1376952-37695299.979100.031.02100.61100.611.03
2377330-377330100.079100.66
3377461-377461100.114100.56
4383453-383453101.703102.32
5371432-37143298.51599.08
6376213-37621399.783100.41
极限1376766-37676699.930100.530.74100.72101.270.72
2377682-377682100.173100.92
3381017-381017101.057101.67
4383759-383759101.784102.57
5377455-377455100.112100.84
6377410-377410100.101100.89
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%
110.293316463313513317293317333314563315830.06
210.343313543308743311140.11
单位质量响应值RSD%判断
32223.8132022.630.45数据可信
长期12月-供试品溶液-2023092321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%
5min1290306-29030677.10771.4022.0177.1171.4022.01
2292316-29231677.64177.64
3309594-30959482.23082.23
4313343-31334383.22583.23
5157071-15707141.71941.72
6250222-25022266.46066.46
10min1348905-34890592.67194.167.0192.8094.287.03
2376235-37623599.930100.06
3376050-37605099.881100.02
4370273-37027398.34698.49
5313024-31302483.14183.21
6342486-34248690.96691.08
15min1364081-36408196.70297.983.3696.9898.263.38
2384955-384955102.246102.54
3377839-377839100.356100.66
4373624-37362499.23699.54
5350471-35047193.08793.29
6362428-36242896.26396.53
20min1367261-36726197.54699.111.8697.9999.551.89
2383046-383046101.739102.21
3377725-377725100.326100.80
4374525-37452599.47699.94
5363975-36397596.67497.04
6372398-37239898.91199.33
30min1368410-36841097.85199.941.3298.46100.541.33
2383399-383399101.833102.47
3378867-378867100.629101.27
4374508-37450899.471100.10
5376845-376845100.092100.62
6375611-37561199.764100.35
极限1369157-36915798.050100.201.2198.82100.971.21
2382377-382377101.561102.37
3378666-378666100.576101.38
4375278-37527899.676100.48
5379348-379348100.757101.45
6378664-378664100.575101.33
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%
110.293313113315823316283313303309903313680.08
210.343304913301313303110.08
单位质量响应值RSD%判断
32202.9231944.970.57数据可信
长期12月-供试品溶液-715967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%
5min1125606-12560633.41333.0924.1933.4133.0924.20
2132172-13217235.16035.16
3142195-14219537.82637.83
4144578-14457838.46038.46
564594-6459417.18317.18
6137233-13723336.50636.51
10min1278467-27846774.07669.1117.6974.1369.1717.70
2252736-25273667.23167.29
3296500-29650078.87378.94
4284671-28467175.72775.79
5170716-17071645.41345.44
6275756-27575673.35573.42
15min1352068-35206893.65591.1810.6293.8391.3510.64
2335221-33522189.17489.34
3374608-37460899.65199.85
4363257-36325796.63296.82
5273383-27338372.72472.83
6358070-35807095.25295.43
20min1374062-37406299.50698.733.6599.8499.053.69
2369634-36963498.32898.65
3380075-380075101.106101.47
4381299-381299101.431101.78
5344861-34486191.73891.96
6376858-376858100.250100.59
30min1371657-37165798.86699.561.3499.37100.051.38
2370572-37057298.57899.06
3379557-379557100.968101.50
4380222-380222101.145101.67
5367992-36799297.89198.27
6375641-37564199.926100.43
极限1370421-37042198.53799.432.2099.20100.082.24
2368504-36850498.02798.67
3386781-386781102.889103.59
4377986-377986100.550101.24
5363372-36337296.66297.20
6375588-37558899.912100.59
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