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%
114.613364153366803368183367753364853366350.06
214.603358933363093361010.09
单位质量响应值RSD%判断
23041.4123020.620.07数据可信
供试品溶液-2025011421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%
5min1173778-17377843.78440.8512.4543.7840.8512.45
2183235-18323546.16746.17
3178315-17831544.92744.93
4140185-14018535.32035.32
5135454-13545434.12834.13
6161893-16189340.79040.79
10min1326338-32633882.22281.316.7282.3081.386.72
2344958-34495886.91486.99
3337551-33755185.04785.12
4288314-28831472.64272.70
5305157-30515776.88676.94
6334030-33403084.16084.23
15min1382484-38248496.36897.182.7696.5897.382.76
2401551-401551101.173101.39
3380922-38092295.97596.19
4370220-37022093.27993.46
5391837-39183798.72598.91
6387207-38720797.55897.77
20min1382939-38293996.48398.512.8396.8598.882.82
2402256-402256101.350101.74
3380978-38097895.98996.37
4384306-38430696.82897.16
5407311-407311102.624102.97
6388141-38814197.79498.16
30min1382879-38287996.46898.052.1497.0098.582.14
2401703-401703101.211101.77
3381041-38104196.00596.54
4384679-38467996.92297.42
5396957-396957100.015100.54
6387584-38758497.65398.19
45min1381272-38127296.06397.812.2096.7698.502.20
2400171-400171100.825101.55
3379366-37936695.58396.28
4383869-38386996.71797.38
5396874-39687499.994100.68
6387651-38765197.67098.37
极限1381641-38164196.15697.662.2197.0198.522.20
2399781-399781100.727101.62
3379101-37910195.51696.37
4383505-38350596.62697.45
5396765-39676599.967100.82
6384856-38485696.96697.83
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%
114.613361303356083357153361093358443358810.07
214.603361043363843362440.06
单位质量响应值RSD%判断
22989.8023030.410.13数据可信
供试品溶液-2025011421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%
5min1161808-16180840.80541.621.4840.8141.621.48
2163070-16307041.12441.12
3168516-16851642.49742.50
4164557-16455741.49941.50
5166698-16669842.03842.04
6165521-16552141.74241.74
10min1332966-33296683.96883.351.8384.0483.421.83
2323195-32319581.50481.57
3337781-33778185.18385.25
4331220-33122083.52883.60
5323254-32325481.51981.59
6334614-33461484.38484.45
15min1382564-38256496.47697.701.0896.6897.901.08
2392440-39244098.96799.17
3388074-38807497.86698.08
4392054-39205498.87099.08
5385041-38504197.10197.31
6384242-38424296.89997.11
20min1383751-38375196.77697.911.0297.1498.281.02
2393449-39344999.22199.59
3387374-38737497.68998.07
4392188-39218898.90399.28
5388152-38815297.88598.25
6384534-38453496.97397.34
30min1382719-38271996.51597.711.1497.0598.241.13
2392692-39269299.03099.57
3387283-38728397.66698.21
4392190-39219098.90499.44
5387247-38724797.65798.19
6382552-38255296.47397.01
45min1382171-38217196.37797.601.2997.0798.301.28
2393674-39367499.27899.98
3387949-38794997.83498.54
4390892-39089298.57699.28
5386787-38678797.54198.23
6380733-38073396.01596.71
极限1383051-38305196.59997.511.0097.4598.380.99
2391421-39142198.71099.58
3386847-38684797.55698.42
4390955-39095598.59299.46
5385312-38531297.16998.03
6382491-38249196.45897.31
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%
114.613369093368153369543370263367333368870.04
214.603344033340223342120.09
单位质量响应值RSD%判断
23058.6622891.230.52数据可信
供试品溶液-2025011521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%
5min1187075-18707547.25043.675.0047.2543.675.00
2162712-16271241.09741.10
3165972-16597241.92041.92
4170500-17050043.06443.06
5175683-17568344.37344.37
6175391-17539144.29944.30
10min1346494-34649487.51585.122.0987.5985.192.09
2332080-33208083.87483.94
3328189-32818982.89282.96
4341000-34100086.12786.20
5341494-34149486.25286.33
6332781-33278184.05184.13
15min1407483-407483102.91999.781.97103.1499.991.97
2398914-398914100.755100.96
3387883-38788397.96998.18
4397025-397025100.278100.49
5386722-38672297.67597.89
6392222-39222299.06499.28
20min1410301-410301103.631100.212.15104.03100.592.15
2402161-402161101.575101.95
3391830-39183098.96599.34
4397311-397311100.350100.73
5386376-38637697.58897.97
6392466-39246699.12699.51
30min1409796-409796103.50399.972.16104.07100.522.16
2400524-400524101.161101.71
3391370-39137098.84999.39
4395875-39587599.987100.54
5385189-38518997.28897.83
6392153-39215399.04799.59
45min1413128-413128104.345100.242.67105.09100.962.67
2401023-401023101.287102.00
3388609-38860998.15298.85
4402673-402673101.704102.42
5384957-38495797.23097.93
6390985-39098598.75299.46
极限1407404-407404102.89999.442.25103.81100.322.24
2399522-399522100.908101.79
3390078-39007898.52399.39
4393881-39388199.484100.37
5382031-38203196.49197.36
6389294-38929498.32599.20
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%
114.613354713354493353153349773351623352750.07
214.603361423358083359750.08
单位质量响应值RSD%判断
22948.3223011.990.20数据可信
供试品溶液-2025011521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%
5min1156176-15617639.43640.424.2139.4440.424.20
2159227-15922740.20740.21
3159766-15976640.34340.34
4173313-17331343.76443.76
5155271-15527139.20839.21
6156652-15665239.55739.56
10min1337735-33773585.28282.534.5485.3582.604.53
2334579-33457984.48584.55
3333873-33387384.30784.37
4332139-33213983.86983.94
5297886-29788675.22075.29
6324815-32481582.02082.09
15min1398417-398417100.60598.812.74100.8199.022.74
2389784-38978498.42598.63
3404553-404553102.155102.36
4392576-39257699.13099.34
5372838-37283894.14694.34
6389743-38974398.41598.62
20min1399921-399921100.985100.171.34101.36100.541.34
2390245-39024598.54298.91
3405205-405205102.319102.70
4395586-39558699.890100.27
5396237-396237100.055100.40
6392860-39286099.20299.57
30min1394967-39496799.73499.811.06100.28100.351.06
2390198-39019898.53099.07
3402500-402500101.636102.18
4393923-39392399.470100.01
5397002-397002100.248100.76
6393081-39308199.25899.79
45min1397369-397369100.34199.911.18101.05100.611.18
2390401-39040198.58199.28
3402847-402847101.724102.44
4394063-39406399.506100.22
5397936-397936100.484101.17
6391316-39131698.81299.51
极限1397643-397643100.41099.641.13101.29100.511.13
2388519-38851998.10698.97
3400989-400989101.255102.14
4393352-39335299.326100.20
5395562-39556299.884100.73
6391495-39149598.85799.72
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