氢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250
标示量(mg)40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%
114.593358993355963354983354573360453356990.08
214.563348963348353348660.02
单位质量响应值RSD%判断
23008.8422999.040.04数据可信
供试品溶液-H322批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102658-10265825.89628.3316.6325.9028.3316.63
2132062-13206233.31333.31
3105985-10598526.73526.73
482686-8268620.85820.86
5123124-12312431.05831.06
6127333-12733332.12032.12
10min1251130-25113063.34863.484.7163.3963.534.71
2272292-27229268.68668.74
3250940-25094063.30063.34
4237693-23769359.95859.99
5254654-25465464.23764.29
6243327-24332761.37961.43
15min1352998-35299889.04487.662.5489.1987.812.55
2361982-36198291.31091.48
3344037-34403786.78486.93
4337874-33787485.22985.36
5347109-34710987.55987.72
6340960-34096086.00786.16
20min1398080-398080100.41699.831.15100.71100.131.16
2401985-401985101.401101.72
3395729-39572999.823100.12
4388337-38833797.95898.24
5394069-39406999.40499.71
6396329-39632999.974100.27
30min1401244-401244101.214101.380.76101.68101.850.76
2404421-404421102.016102.51
3403348-403348101.745102.21
4399824-399824100.856101.30
5397259-397259100.209100.68
6405281-405281102.232102.70
45min1399250-399250100.711100.980.81101.34101.620.82
2403015-403015101.661102.32
3402181-402181101.450102.08
4397438-397438100.254100.86
5396055-39605599.905100.54
6404011-404011101.912102.55
极限1399164-399164100.689100.820.78101.49101.620.78
2402226-402226101.462102.29
3401307-401307101.230102.03
4396790-396790100.091100.87
5395383-39538399.736100.54
6403143-403143101.693102.50
氢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250
标示量(mg)40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%
114.593355323355373355793356843356013355870.02
214.563347683347943347810.01
单位质量响应值RSD%判断
23001.1722993.200.03数据可信
供试品溶液-H322批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1138511-13851134.95033.864.0034.9533.864.01
2130831-13083133.01233.01
3125044-12504431.55231.55
4139063-13906335.08935.09
5135088-13508834.08634.09
6136554-13655434.45634.46
10min1278944-27894470.38569.211.1770.4469.261.16
2272841-27284168.84568.90
3276313-27631369.72169.77
4269940-26994068.11368.17
5275182-27518269.43569.49
6272473-27247368.75268.81
15min1370382-37038293.45790.801.5393.6390.981.52
2360304-36030490.91491.08
3355789-35578989.77489.94
4356233-35623389.88690.06
5359679-35967990.75690.93
6356837-35683790.03990.21
20min1409403-409403103.303101.491.06103.63101.811.06
2401615-401615101.337101.66
3397119-397119100.203100.52
4399381-399381100.774101.10
5404000-404000101.939102.26
6401812-401812101.387101.71
30min1408022-408022102.954102.080.87103.46102.580.87
2404280-404280102.010102.50
3398940-398940100.663101.15
4403302-403302101.763102.25
5408564-408564103.091103.58
6404314-404314102.018102.51
45min1408154-408154102.987101.700.95103.66102.360.96
2402384-402384101.532102.19
3397553-397553100.313100.97
4401678-401678101.353102.01
5406698-406698102.620103.29
6401863-401863101.400102.06
极限1406607-406607102.597101.300.94103.44102.130.94
2400515-400515101.060101.89
3395905-39590599.897100.72
4399831-399831100.887101.72
5404617-404617102.095102.93
6401327-401327101.265102.09
氢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250
标示量(mg)40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%
114.593357593362913357823359363361033359740.07
214.563364343360583362460.08
单位质量响应值RSD%判断
23027.6923093.820.21数据可信
供试品溶液-H322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%
5min1148003-14800337.24228.5728.3437.2428.5728.33
268944-6894417.34817.35
3117926-11792629.67429.67
480830-8083020.33920.34
5123702-12370231.12731.13
6141923-14192335.71235.71
10min1275052-27505269.21163.289.2369.2763.339.24
2236599-23659959.53559.56
3256253-25625364.48164.53
4212212-21221253.39953.43
5261883-26188365.89865.95
6266924-26692467.16667.23
15min1359858-35985890.55186.643.7090.7386.793.71
2332086-33208683.56383.69
3346692-34669287.23887.39
4326369-32636982.12482.25
5347835-34783587.52687.69
6353025-35302588.83289.00
20min1403128-403128101.43999.641.31101.7799.941.33
2396679-39667999.816100.08
3393660-39366099.05799.36
4388200-38820097.68397.94
5394537-39453799.27799.58
6399772-399772100.595100.91
30min1405703-405703102.087101.471.24102.58101.931.22
2407163-407163102.454102.89
3397269-39726999.965100.43
4409665-409665103.084103.51
5398587-398587100.296100.77
6401022-401022100.909101.40
45min1402379-402379101.251100.920.94101.92101.560.92
2403591-403591101.556102.16
3394893-39489399.367100.00
4404411-404411101.762102.36
5398152-398152100.187100.83
6402998-402998101.406102.06
极限1398054-398054100.162100.891.23101.00101.691.21
2404089-404089101.681102.45
3392337-39233798.72499.52
4405539-405539102.046102.81
5402498-402498101.281102.09
6403158-403158101.447102.27
氢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250
标示量(mg)40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%
114.593371983371743370983370853373303371770.03
214.563369263368863369060.01
单位质量响应值RSD%判断
23110.1423139.150.09数据可信
供试品溶液-H322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%
5min1116824-11682429.31533.568.1829.3233.568.18
2145799-14579936.58636.59
3143526-14352636.01636.02
4130258-13025832.68632.69
5138354-13835434.71834.72
6127675-12767532.03832.04
10min1253086-25308663.50866.203.6063.5666.263.60
2271442-27144268.11468.18
3272538-27253868.38968.45
4271703-27170368.18068.23
5261917-26191765.72465.78
6252203-25220363.28663.34
15min1350593-35059387.97688.331.5888.1388.501.58
2356617-35661789.48789.66
3355378-35537889.17689.35
4355813-35581389.28689.45
5351861-35186188.29488.46
6341765-34176585.76185.92
20min1395362-39536299.21099.101.0399.5199.411.04
2398754-398754100.061100.38
3394443-39444398.97999.30
4398554-398554100.011100.33
5394870-39487099.08699.40
6387560-38756097.25297.55
30min1397512-39751299.74999.880.71100.22100.360.72
2401865-401865100.842101.33
3399545-399545100.260100.75
4398590-398590100.020100.50
5397226-39722699.678100.16
6393415-39341598.72199.19
45min1390750-39075098.05399.690.9498.69100.340.94
2401011-401011100.627101.29
3399245-399245100.184100.84
4399765-399765100.315100.97
5396014-39601499.373100.02
6396809-39680999.573100.20
极限1398501-39850199.99899.500.69100.79100.310.69
2400886-400886100.596101.42
3394709-39470999.04699.87
4394320-39432098.94899.77
5394018-39401898.87399.68
6396754-39675499.559100.35
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