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%
114.613375873375223371943377303373743374810.07
214.603373353373353373350.00
单位质量响应值RSD%判断
23099.3223105.140.02数据可信
供试品溶液-2025011321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%
5min1155643-15564339.09442.107.2439.0942.107.25
2185276-18527646.53746.54
3152301-15230138.25538.25
4173556-17355643.59343.59
5167997-16799742.19742.20
6170934-17093442.93542.93
10min1315111-31511179.14983.494.7079.2183.564.71
2347084-34708487.18087.26
3313363-31336378.71078.77
4339721-33972185.33085.40
5329881-32988182.85982.93
6349181-34918187.70687.78
15min1381481-38148195.81998.352.0296.0298.562.03
2391274-39127498.27998.50
3385635-38563596.86397.06
4401978-401978100.968101.18
5389464-38946497.82598.03
6399498-399498100.345100.56
20min1383041-38304196.21199.022.2296.5799.402.21
2387829-38782997.41497.80
3395317-39531799.29599.65
4407173-407173102.273102.66
5391660-39166098.37698.75
6400396-400396100.571100.96
30min1383464-38346496.31898.692.3496.8399.232.34
2384621-38462196.60897.16
3393019-39301998.71899.24
4407381-407381102.325102.88
5389513-38951397.83798.37
6399435-399435100.329100.88
45min1383097-38309796.22598.532.0796.9099.242.07
2387008-38700897.20897.92
3392877-39287798.68299.37
4405301-405301101.803102.53
5387881-38788197.42798.13
6397568-39756899.860100.58
极限1383804-38380496.40398.232.1297.2499.102.12
2382799-38279996.15197.02
3391416-39141698.31599.17
4403735-403735101.409102.30
5386964-38696497.19798.06
6397767-39776799.910100.80
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%
114.613372163369933370583370223370713370720.03
214.603372673370893371780.04
单位质量响应值RSD%判断
23071.3223094.380.08数据可信
供试品溶液-2025011321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%
5min1161115-16111540.50239.665.7840.5039.665.78
2158423-15842339.82639.83
3147341-14734137.04037.04
4153683-15368338.63438.63
5173585-17358543.63743.64
6152538-15253838.34638.35
10min1324519-32451981.58081.593.7381.6581.663.73
2325373-32537381.79581.86
3311449-31144978.29578.36
4320839-32083980.65580.72
5347007-34700787.23487.31
6318132-31813279.97580.04
15min1395140-39514099.33497.542.5899.5497.752.58
2378007-37800795.02795.23
3383012-38301296.28596.48
4390339-39033998.12798.33
5403088-403088101.332101.55
6378525-37852595.15795.35
20min1397069-39706999.81997.903.35100.1998.263.35
2378503-37850395.15195.51
3384790-38479096.73297.08
4390812-39081298.24698.61
5410381-410381103.165103.55
6374946-37494694.25794.61
30min1396330-39633099.63397.813.29100.1798.333.29
2375740-37574094.45794.98
3385730-38573096.96897.48
4389330-38933097.87398.40
5409979-409979103.064103.62
6377259-37725994.83995.35
45min1395965-39596599.54197.723.11100.2498.413.11
2375988-37598894.51995.20
3385021-38502196.79097.47
4388301-38830197.61498.30
5408618-408618102.722103.45
6378413-37841395.12995.80
极限1397837-397837100.01297.872.95100.8898.722.95
2377784-37778494.97195.81
3386735-38673597.22198.06
4388825-38882597.74698.60
5406988-406988102.312103.21
6377735-37773594.95895.79
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%
114.616731366730646729506733406732966731570.03
214.606738526740666739590.03
单位质量响应值RSD%判断
46075.0946161.580.14数据可信
供试品溶液-2025011221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%
5min1254531-25453132.02629.239.5732.0329.249.57
2220445-22044527.73727.74
3253928-25392831.95031.95
4228171-22817128.70928.71
5196469-19646924.72024.72
6240476-24047630.25830.26
10min1558641-55864170.29066.196.1470.3466.246.14
2490447-49044761.71061.76
3557381-55738170.13270.18
4519341-51934165.34565.39
5486756-48675661.24561.29
6543765-54376568.41868.47
15min1733195-73319592.25389.893.6792.4290.043.68
2670949-67094984.42184.57
3741507-74150793.29993.47
4721379-72137990.76690.92
5696202-69620287.59987.74
6723096-72309690.98291.15
20min1791098-79109899.53998.711.1899.8699.021.19
2769194-76919496.78397.07
3796154-796154100.175100.50
4783442-78344298.57598.88
5781521-78152198.33498.62
6785851-78585198.87899.19
30min1790947-79094799.52099.240.79100.0199.710.79
2787710-78771099.11299.56
3796911-796911100.270100.76
4780852-78085298.24998.72
5782703-78270398.48298.94
6793071-79307199.787100.27
45min1790188-79018899.42499.120.61100.0899.760.62
2787244-78724499.05499.67
3795227-795227100.058100.72
4782294-78229498.43199.07
5783049-78304998.52699.14
6788473-78847399.20899.86
极限1789172-78917299.29698.880.79100.1299.680.80
2787122-78712299.03899.82
3794614-79461499.981100.81
4778085-77808597.90198.70
5779400-77940098.06798.85
6786642-78664298.97899.79
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%
114.616714306715426707646711166711446711990.05
214.606694136697466695800.04
单位质量响应值RSD%判断
45941.0745861.640.13数据可信
供试品溶液-2025011221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%
5min1244333-24433330.88830.844.5830.8930.844.58
2258581-25858132.68932.69
3243846-24384630.82730.83
4227395-22739528.74728.75
5236714-23671429.92529.92
6253048-25304831.99031.99
10min1538855-53885568.12167.802.7268.1767.862.72
2554530-55453070.10370.16
3521557-52155765.93465.99
4517616-51761665.43665.48
5536857-53685767.86867.92
6548593-54859369.35269.41
15min1735741-73574193.01192.131.8893.1892.301.88
2748143-74814394.57994.75
3712931-71293190.12790.29
4716707-71670790.60590.76
5722250-72225091.30691.47
6736890-73689093.15693.33
20min1794515-794515100.441100.100.99100.76100.420.99
2801620-801620101.339101.67
3783091-78309198.99799.31
4783262-78326299.01999.33
5789834-78983499.849100.16
6798531-798531100.949101.27
30min1797686-797686100.842100.330.70101.33100.810.71
2801048-801048101.267101.76
3787043-78704399.49799.97
4787778-78777899.589100.06
5792939-792939100.242100.72
6795286-795286100.539101.03
45min1797752-797752100.850100.240.70101.51100.890.70
2800192-800192101.159101.83
3788384-78838499.666100.31
4786226-78622699.393100.03
5790493-79049399.933100.58
6794471-794471100.436101.10
极限1796472-796472100.689100.000.66101.51100.820.66
2797182-797182100.778101.61
3783340-78334099.02899.84
4788784-78878499.717100.52
5790694-79069499.958100.77
6789858-78985899.852100.68
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