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%
19.943206073206613204463202363202783204460.06
29.863204383206783205580.06
单位质量响应值RSD%判断
32238.0332510.950.60数据可信
供试品溶液-2023092221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1208573-20857354.96861.0122.2554.9761.0122.25
2277334-27733473.09073.09
3176258-17625846.45246.45
4276445-27644572.85672.86
5277551-27755173.14773.15
6172838-17283845.55145.55
10min1354763-35476393.49695.282.9493.5995.382.96
2359503-35950394.74594.87
3348080-34808091.73591.81
4372539-37253998.18198.30
5375773-37577399.03399.16
6358484-35848494.47794.55
15min1367692-36769296.90498.041.1497.1598.301.14
2366368-36636896.55596.83
3372442-37244298.15598.39
4374609-37460998.72799.01
5377454-37745499.47699.76
6373365-37336598.39998.63
20min1370988-37098897.77298.590.8498.1899.020.83
2370058-37005897.52797.97
3373952-37395298.55398.95
4374959-37495998.81999.27
5376919-37691999.33599.79
6377775-37777599.56199.96
30min1373443-37344398.41998.910.4898.9999.500.48
2373638-37363898.47199.07
3374868-37486898.79599.35
4375005-37500598.83199.45
5377135-37713599.392100.01
6377764-37776499.558100.12
极限1375692-37569299.01299.190.2899.7599.950.27
2376745-37674599.289100.06
3376315-37631599.17699.90
4374971-37497198.82299.60
5376536-37653699.234100.02
6378009-37800999.623100.35
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%
19.943202333200323201543199823199773200760.04
29.863199483196733198100.07
单位质量响应值RSD%判断
32200.8032435.090.52数据可信
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%
5min1275229-27522972.66265.2924.2872.6665.3024.28
2253174-25317466.83966.84
3341239-34123990.08990.09
4161496-16149642.63642.64
5234867-23486762.00662.01
6217927-21792757.53457.53
10min1377934-37793499.77796.854.9499.9096.964.94
2373635-37363598.64298.75
3367033-36703396.89997.05
4367873-36787397.12097.19
5331908-33190887.62587.73
6382685-382685101.031101.13
15min1381178-381178100.63399.442.08100.9299.712.07
2375524-37552499.14099.42
3369631-36963197.58597.90
4377032-37703299.53899.77
5367620-36762097.05497.30
6388984-388984102.694102.96
20min1381043-381043100.59799.991.65101.05100.421.64
2375450-37545099.12199.56
3370745-37074597.87998.35
4379952-379952100.309100.71
5376211-37621199.32299.73
6389081-389081102.719103.15
30min1381805-381805100.799100.341.66101.42100.941.64
2375278-37527899.07599.68
3370953-37095397.93498.57
4379553-379553100.204100.77
5384562-384562101.526102.10
6388347-388347102.526103.13
极限1384192-384192101.429100.621.79102.22101.381.77
2376439-37643999.382100.15
3371018-37101897.95198.75
4379120-379120100.090100.82
5387937-387937102.417103.16
6387978-387978102.428103.21
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%
19.943183553173263177243179143178943178430.12
29.863199063199893199480.02
单位质量响应值RSD%判断
31976.1632449.091.04数据可信
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%
5min1144013-14401338.14656.9136.7538.1556.9136.75
2241788-24178864.04564.04
3307383-30738381.41981.42
4190830-19083050.54750.55
5291930-29193077.32677.33
6113195-11319529.98329.98
10min1340641-34064190.22988.8710.2990.2988.9610.31
2353576-35357693.65593.76
3371520-37152098.40898.54
4323732-32373285.75085.83
5350840-35084092.93093.06
6272803-27280372.26072.31
15min1366667-36666797.12394.795.8797.3495.035.90
2373051-37305198.81499.08
3374244-37424499.13099.43
4356964-35696494.55294.78
5358628-35862894.99395.28
6317534-31753484.10884.28
20min1374029-37402999.07396.504.7499.4596.914.77
2380209-380209100.710101.14
3374931-37493199.31199.78
4363107-36310796.18096.56
5361373-36137395.72096.16
6332360-33236088.03588.35
30min1378978-378978100.38398.113.61100.9298.673.63
2385338-385338102.068102.66
3375812-37581299.545100.18
4370747-37074798.20398.75
5364021-36402196.42297.02
6347500-34750092.04692.50
极限1381044-381044100.931100.072.17101.64100.802.17
2391188-391188103.618104.38
3376754-37675499.794100.59
4378523-378523100.263100.97
5367187-36718797.26098.02
6372159-37215998.57799.19
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%
19.943204583205383206573204223205743205300.03
29.863199033198833198930.01
单位质量响应值RSD%判断
32246.4832443.510.44数据可信
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%
5min1192475-19247550.77255.9121.3150.7755.9121.31
2197849-19784952.18952.19
3286863-28686375.67075.67
4239430-23943063.15863.16
5156525-15652541.28941.29
6198615-19861552.39152.39
10min1354951-35495193.63095.083.4293.7195.173.41
2343398-34339890.58390.67
3353543-35354393.25993.38
4378394-37839499.81499.92
5365729-36572996.47396.54
6366574-36657496.69696.78
15min1376279-37627999.25698.312.2499.5098.562.23
2367636-36763696.97697.21
3358516-35851694.57194.85
4382054-382054100.780101.05
5376485-37648599.31199.54
6375168-37516898.96399.21
20min1376687-37668799.36499.212.0199.7799.622.00
2378269-37826999.781100.18
3361145-36114595.26495.70
4382244-382244100.830101.27
5378869-37886999.939100.33
6379374-379374100.073100.49
30min1375352-37535299.01299.541.8799.58100.121.85
2381726-381726100.693101.26
3363947-36394796.00396.60
4382179-382179100.813101.42
5381164-381164100.545101.11
6379729-379729100.166100.75
极限1373989-37398998.65299.721.5099.39100.471.49
2383236-383236101.091101.83
3368618-36861897.23597.99
4382286-382286100.841101.62
5380756-380756100.437101.17
6379432-379432100.088100.84
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