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%
114.446614956623436621536622136619906620390.05
214.516595696597306596500.02
单位质量响应值RSD%判断
45847.5845461.750.60数据可信
供试品溶液-2024090521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%
5min1166695-16669521.18827.9929.3921.1927.9929.39
2145229-14522918.45918.46
3290780-29078036.95936.96
4282074-28207435.85335.85
5175612-17561222.32122.32
6260890-26089033.16033.16
10min1388909-38890949.43260.0819.2049.4760.1319.22
2372321-37232147.32347.35
3575149-57514973.10373.17
4558658-55865871.00771.07
5414997-41499752.74852.78
6526269-52626966.89166.95
15min1555015-55501570.54481.2214.0170.6681.3614.02
2539421-53942168.56268.67
3733082-73308293.17793.36
4723624-72362491.97592.15
5582093-58209373.98674.11
6700696-70069689.06189.23
20min1674315-67431585.70892.427.1085.9492.707.13
2669895-66989585.14685.37
3763954-76395497.10197.44
4786447-78644799.960100.29
5700381-70038189.02189.27
6767741-76774197.58397.90
30min1791067-791067100.54798.721.29100.9399.161.23
2777781-77778198.85999.22
3762510-76251096.91897.42
4771161-77116198.01798.52
5783684-78368499.609100.01
6773847-77384798.35998.84
45min1788429-788429100.21299.161.48100.7699.761.43
2794117-794117100.935101.47
3761714-76171496.81697.48
4782349-78234999.439100.10
5781247-78124799.29999.86
6772847-77284798.23298.87
极限1798258-798258101.46199.181.85102.1799.951.79
2793922-793922100.910101.61
3760951-76095196.72097.54
4781343-78134399.311100.14
5779803-77980399.11699.84
6767782-76778297.58898.39
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%
114.446644106640296643416640306640006641620.03
214.516635316631996633650.04
单位质量响应值RSD%判断
45994.6045717.780.43数据可信
供试品溶液-2024090521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%
5min1257088-25708832.53333.329.4532.5333.329.45
2297761-29776137.68037.68
3285605-28560536.14236.14
4228181-22818128.87528.87
5253072-25307232.02532.02
6258080-25808032.65832.66
10min1518602-51860265.62667.916.3965.6867.966.39
2586898-58689874.26874.33
3563232-56323271.27471.33
4489830-48983061.98562.03
5526082-52608266.57266.63
6535208-53520867.72767.78
15min1685793-68579386.78388.874.0786.9589.044.07
2738327-73832793.43193.62
3730506-73050692.44192.62
4661788-66178883.74583.90
5694703-69470387.91088.07
6702606-70260688.91089.08
20min1776028-77602898.20298.651.3598.5198.961.37
2787659-78765999.673100.02
3789901-78990199.957100.29
4760623-76062396.25296.54
5780376-78037698.75299.06
6782625-78262599.03699.35
30min1793245-793245100.38098.762.68100.8599.242.67
2787010-78701099.591100.10
3789580-78958099.916100.42
4786393-78639399.51399.96
5738135-73813593.40693.88
6788170-78817099.738100.22
45min1791147-791147100.11599.650.35100.75100.300.34
2784674-78467499.29699.97
3787168-78716899.611100.28
4784925-78492599.32799.94
5790204-79020499.995100.63
6786716-78671699.554100.20
极限1789949-78994999.96399.420.42100.77100.240.42
2783132-78313299.10099.94
3785544-78554499.406100.24
4781138-78113898.84899.63
5788617-78861799.795100.59
6785749-78574999.432100.24
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%
114.446634506639406636816644446638036638640.06
214.516638876630236634550.10
单位质量响应值RSD%判断
45973.9645723.980.39数据可信
供试品溶液-2024090521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%
5min1237903-23790330.11034.417.5830.1134.417.58
2282506-28250635.75535.75
3290468-29046836.76336.76
4291414-29141436.88236.88
5267871-26787133.90333.90
6261312-26131233.07333.07
10min1477242-47724260.40166.618.1760.4566.668.16
2549334-54933469.52669.59
3559607-55960770.82670.89
4575311-57531172.81372.87
5473759-47375959.96160.02
6522330-52233066.10866.16
15min1643082-64308281.39186.606.6981.5486.776.69
2710875-71087589.97190.15
3716954-71695490.74090.92
4731913-73191392.63392.82
5615668-61566877.92178.08
6687118-68711886.96487.13
20min1739097-73909793.54396.003.6193.8396.313.62
2777212-77721298.36798.69
3777748-77774898.43498.77
4782958-78295899.09499.43
5713294-71329490.27790.56
6760525-76052596.25596.56
30min1766710-76671097.03798.220.7997.4898.690.81
2779836-77983698.69999.19
3779160-77916098.61399.11
4781391-78139198.89699.40
5779267-77926798.62799.06
6769941-76994197.44697.92
45min1765963-76596396.94398.170.7097.5598.810.71
2778054-77805498.47399.13
3776166-77616698.23498.89
4779523-77952398.65999.33
5780819-78081998.82399.42
6773495-77349597.89698.53
极限1766125-76612596.96397.960.8197.7398.760.81
2775678-77567898.17398.99
3773636-77363697.91498.74
4777686-77768698.42799.26
5782962-78296299.09499.86
6768015-76801597.20398.00
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%
114.446651596656506662156666576660326659430.09
214.516659526660636660080.02
单位质量响应值RSD%判断
46117.9445899.930.34数据可信
供试品溶液-2024090521批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1162478-16247820.49229.6116.8920.4929.6116.90
2244280-24428030.80930.81
3267640-26764033.75633.76
4218328-21832827.53627.54
5265688-26568833.50933.51
6250072-25007231.54031.54
10min1369543-36954346.60862.7813.5846.6462.8313.58
2521851-52185165.81865.87
3549271-54927169.27669.33
4477366-47736660.20760.25
5540091-54009168.11868.17
6528550-52855066.66266.71
15min1528084-52808466.60484.8111.1966.7284.9611.20
2693768-69376887.50087.66
3731811-73181192.29892.47
4655931-65593182.72882.87
5710908-71090889.66289.83
6713993-71399390.05190.21
20min1638589-63858980.54196.158.3780.7696.448.38
2775105-77510597.75998.07
3816970-816970103.039103.36
4757973-75797395.59895.88
5791335-79133599.806100.12
6793906-793906100.130100.44
30min1763986-76398696.35699.752.4696.71100.212.49
2779553-77955398.32098.79
3820540-820540103.489103.99
4785033-78503399.01199.45
5796237-796237100.424100.91
6800191-800191100.923101.40
45min1777633-77763398.07899.882.0498.60100.502.06
2777575-77757598.07098.70
3818889-818889103.281103.95
4783360-78336098.80099.41
5792660-79266099.973100.63
6801264-801264101.058101.71
极限1777704-77770498.08799.652.0898.77100.442.10
2775284-77528497.78198.58
3818547-818547103.238104.08
4780195-78019598.40199.17
5791355-79135599.808100.63
6797676-797676100.605101.42
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