氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373370673378093375073361353372563371550.19
214.323364623374063369340.20
单位质量响应值RSD%判断
23462.4223528.910.21数据可信
供试品溶液-2025011321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185733-18573345.87140.1227.9145.8740.1227.91
2148073-14807336.57036.57
3192690-19269047.58947.59
476129-7612918.80218.80
5190806-19080647.12447.12
6181308-18130844.77844.78
10min1330734-33073481.68275.0618.1481.7675.1218.15
2291894-29189472.09072.15
3338517-33851783.60483.68
4196858-19685848.61848.65
5333168-33316882.28382.36
6332317-33231782.07382.15
15min1386643-38664395.49091.7212.2095.7091.9112.22
2367374-36737490.73190.91
3399604-39960498.69198.91
4283237-28323769.95270.06
5384228-38422894.89495.11
6407106-407106100.544100.76
20min1385014-38501495.08895.015.8595.4695.365.88
2392299-39229996.88797.22
3410048-410048101.270101.65
4342743-34274384.64884.88
5385114-38511495.11295.49
6392949-39294997.04797.43
30min1389016-38901696.07696.722.8096.6197.232.82
2395005-39500597.55598.05
3410364-410364101.348101.90
4380881-38088194.06794.44
5381174-38117494.13994.67
6393346-39334697.14597.69
45min1387901-38790195.80196.812.1196.4997.472.14
2392046-39204696.82497.48
3407719-407719100.695101.42
4384866-38486695.05195.58
5387024-38702495.58496.27
6392309-39230996.88997.59
极限1387965-38796595.81796.942.9596.6797.772.95
2406192-406192100.318101.14
3408131-408131100.797101.69
4385807-38580795.28495.97
5381253-38125394.15995.01
6385785-38578595.27896.14
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373367983360313363223371023370933366690.15
214.323405063428073416560.48
单位质量响应值RSD%判断
23428.6023858.661.29数据可信
供试品溶液-2025011321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195153-19515347.90039.6427.8647.9039.6427.86
2168751-16875141.41941.42
3117186-11718628.76328.76
494472-9447223.18823.19
5195520-19552047.99047.99
6197821-19782148.55448.55
10min1351995-35199586.39674.9417.4986.4875.0117.50
2313386-31338676.91976.99
3260387-26038763.91163.96
4220638-22063854.15554.19
5343706-34370684.36184.44
6341936-34193683.92784.01
15min1398062-39806297.70390.2311.0797.9390.4211.09
2387050-38705095.00095.20
3332612-33261281.63881.79
4301450-30145073.99074.12
5388685-38868595.40195.62
6397944-39794497.67497.89
20min1399680-39968098.10095.613.8698.4995.963.90
2398546-39854697.82298.18
3386909-38690994.96595.26
4360759-36075988.54788.80
5391804-39180496.16796.55
6399619-39961998.08598.47
30min1399764-39976498.12197.701.4598.6798.201.44
2397407-39740797.54298.06
3407967-407967100.134100.58
4393584-39358496.60497.00
5391426-39142696.07496.61
6398075-39807597.70698.25
45min1398008-39800897.69097.582.3398.4098.242.29
2396932-39693297.42698.11
3411941-411941101.109101.73
4397601-39760197.59098.15
5382700-38270093.93294.63
6398154-39815497.72598.44
极限1397427-39742797.54797.271.5898.4298.091.54
2395855-39585597.16198.00
3405994-40599499.650100.43
4397034-39703497.45198.17
5386494-38649494.86495.72
6394870-39487096.91997.79
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373450483441553442883444813445313445010.10
214.323366043367133366580.03
单位质量响应值RSD%判断
23973.6323509.641.39数据可信
供试品溶液-2025011421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190770-19077046.63142.4823.3646.6342.4823.37
2186261-18626145.52945.53
3185075-18507545.23945.24
491525-9152522.37222.37
5190305-19030546.51746.52
6198896-19889648.61748.62
10min1342269-34226983.66379.2015.2183.7479.2715.21
2344146-34414684.12284.20
3334480-33448081.75981.83
4224153-22415354.79154.83
5347771-34777185.00885.09
6351290-35129085.86885.95
15min1401432-40143298.12595.4110.0698.3495.6110.08
2425235-425235103.943104.16
3395220-39522096.60696.82
4312957-31295776.49876.63
5401760-40176098.20598.42
6405334-40533499.07899.30
20min1403781-40378198.69997.044.1999.0897.404.23
2407594-40759499.631100.02
3396358-39635896.88497.26
4364204-36420489.02589.28
5402064-40206498.27998.66
6408047-40804799.741100.13
30min1399226-39922697.58598.201.7698.1398.721.78
2412897-412897100.927101.48
3396721-39672196.97397.51
4393729-39372996.24296.65
5400918-40091897.99998.55
6406878-40687899.456100.01
45min1398486-39848697.40497.921.0598.1198.611.08
2405371-40537199.08799.81
3395282-39528296.62197.32
4397207-39720797.09297.66
5402434-40243498.36999.08
6404769-40476998.94099.66
极限1401807-40180798.21697.651.5399.0998.501.56
2405174-40517499.03999.93
3391796-39179695.76996.63
4392130-39213095.85196.58
5400741-40074197.95698.83
6405277-40527799.06499.95
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373365403366863368253370803368633367990.07
214.323364213367493365850.07
单位质量响应值RSD%判断
23437.6523504.540.21数据可信
供试品溶液-2025011421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187915-18791546.45847.467.9546.4647.467.95
2171445-17144542.38642.39
3204619-20461950.58850.59
4208631-20863151.58051.58
5201366-20136649.78449.78
6177835-17783543.96643.97
10min1341153-34115384.34385.055.3084.4285.135.30
2319741-31974179.05079.12
3356840-35684088.22288.31
4359203-35920388.80688.89
5361816-36181689.45289.53
6325263-32526380.41580.49
15min1395309-39530997.73397.932.4697.9598.152.46
2391380-39138096.76196.96
3392365-39236597.00597.24
4411346-411346101.697101.93
5402751-40275199.57299.80
6383490-38349094.81095.02
20min1395938-39593897.88898.332.4098.2798.722.41
2396060-39606097.91898.28
3391378-39137896.76197.15
4411853-411853101.823102.23
5405596-405596100.276100.67
6385587-38558795.32995.69
30min1396551-39655198.04098.281.6998.5898.831.70
2396217-39621797.95798.48
3390981-39098196.66297.22
4407930-407930100.853101.43
5402652-40265299.548100.11
6390867-39086796.63497.16
45min1394783-39478397.60297.762.2998.3198.472.29
2395289-39528997.72898.42
3388809-38880996.12696.84
4409917-409917101.344102.09
5399781-39978198.83899.57
6383832-38383294.89595.58
极限1396185-39618597.94997.472.6798.8298.342.67
2393786-39378697.35698.21
3390395-39039596.51897.39
4404069-40406999.898100.81
5404802-404802100.079100.98
6376253-37625393.02193.86
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