氢氯噻嗪沙库巴曲缬沙坦片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373608573610033610483608383606663608820.05
214.463625523626873626200.03
单位质量响应值RSD%判断
25113.5725077.460.11数据可信
供试品溶液-25080101批-氢氯噻嗪-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%
5min171400-7140020.48519.279.5620.4819.279.55
269268-6926819.87319.87
367421-6742119.34319.34
454646-5464615.67815.68
572252-7225220.72920.73
668054-6805419.52519.52
10min1179791-17979151.58350.605.9751.6250.635.98
2182956-18295652.49152.52
3177418-17741850.90250.93
4156865-15686545.00545.03
5186987-18698753.64753.68
6174163-17416349.96850.00
15min1252513-25251372.44772.974.3872.5773.094.38
2267609-26760976.77876.90
3253077-25307772.60972.73
4236874-23687467.96068.06
5265293-26529376.11476.24
6250698-25069871.92672.04
20min1292477-29247783.91385.013.7384.1585.243.73
2309762-30976288.87289.12
3292227-29222783.84184.08
4282335-28233581.00381.22
5309599-30959988.82589.08
6291314-29131483.57983.81
30min1301311-30131186.44787.543.3586.8387.923.35
2315375-31537590.48290.88
3300792-30079286.29886.68
4296224-29622484.98885.34
5320350-32035091.91092.31
6296714-29671485.12885.50
45min1302611-30261186.82087.773.1987.3588.303.20
2315922-31592290.63991.19
3301996-30199686.64487.17
4296863-29686385.17185.66
5320228-32022891.87592.43
6297999-29799985.49786.01
60min1301704-30170486.56087.793.1387.2388.463.14
2316153-31615390.70691.40
3300880-30088086.32486.99
4299329-29932985.87986.51
5320095-32009591.83792.54
6297784-29778485.43586.09
极限1301613-30161386.53487.693.3087.3588.503.30
2316535-31653590.81591.66
3301189-30118986.41287.22
4296472-29647285.05985.84
5320049-32004991.82392.68
6297923-29792385.47586.28
氢氯噻嗪沙库巴曲缬沙坦片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.545914305918165918165917255916965916970.03
222.586012136014066013100.03
单位质量响应值RSD%判断
26250.9826630.201.02数据可信
供试品溶液-25080101批-沙库巴-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%
5min1156727-15672711.98611.547.9511.9911.547.96
2153447-15344711.73511.74
3159522-15952212.20012.20
4126860-1268609.7029.70
5155368-15536811.88211.88
6153459-15345911.73611.74
10min1400718-40071830.64630.333.9930.6730.354.00
2403751-40375130.87830.90
3410898-41089831.42431.44
4365568-36556827.95827.97
5398919-39891930.50830.53
6399457-39945730.54930.57
15min1566525-56652543.32643.622.3543.4043.682.35
2582800-58280044.57144.64
3583816-58381644.64944.72
4549518-54951842.02642.09
5562314-56231443.00443.07
6576914-57691444.12144.19
20min1653985-65398550.01550.431.1250.1650.571.12
2664170-66417050.79450.94
3668064-66806451.09251.24
4650725-65072549.76649.90
5653914-65391450.01050.15
6665417-66541750.88951.03
30min1669044-66904451.16751.330.6451.3951.560.63
2667584-66758451.05551.29
3677832-67783251.83952.07
4675253-67525351.64251.86
5668975-66897551.16151.39
6668518-66851851.12751.36
45min1668971-66897151.16151.320.6451.4751.640.64
2667815-66781551.07351.39
3677853-67785351.84052.16
4674732-67473251.60251.90
5667028-66702851.01351.32
6670241-67024151.25851.57
60min1666285-66628550.95651.300.9251.3551.700.90
2667274-66727451.03151.43
3675593-67559351.66852.07
4681044-68104452.08452.47
5666423-66642350.96651.36
6668175-66817551.10051.50
极限1665396-66539650.88851.060.5451.3751.550.54
2665217-66521750.87451.36
3673430-67343051.50251.99
4670403-67040351.27151.75
5664114-66411450.79051.27
6667563-66756351.05351.54
氢氯噻嗪沙库巴曲缬沙坦片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.541102551110320611030331102441110242211027310.04
222.581113267111376211135140.04
单位质量响应值RSD%判断
48923.2949314.170.57数据可信
供试品溶液-25080101批-曲缬沙坦-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%
5min1283255-28325511.02510.648.3011.0210.638.30
2278088-27808810.82410.82
3290678-29067811.31411.31
4227931-2279318.8728.87
5280980-28098010.93610.94
6278493-27849310.84010.84
10min1735058-73505828.61028.324.0028.6328.344.00
2741863-74186328.87528.89
3754955-75495529.38529.40
4671101-67110126.12126.14
5732120-73212028.49628.51
6731227-73122728.46128.48
15min11046176-104617640.72040.972.3840.7941.042.38
21075891-107589141.87641.94
31074522-107452241.82341.89
41013587-101358739.45139.51
51036543-103654340.34540.41
61069262-106926241.61841.68
20min11210973-121097347.13447.521.2347.2747.661.23
21229603-122960347.85948.00
31237826-123782648.17948.32
41202302-120230246.79646.92
51210474-121047447.11547.25
61234845-123484548.06348.20
30min11241051-124105148.30548.510.6648.5248.720.65
21237673-123767348.17348.39
31258648-125864848.99049.21
41253844-125384448.80349.00
51242186-124218648.34948.56
61243852-124385248.41448.63
45min11239524-123952448.24548.460.6848.5448.760.68
21239483-123948348.24448.54
31259141-125914149.00949.31
41251228-125122848.70148.98
51237814-123781448.17948.47
61243643-124364348.40648.70
60min11234836-123483648.06348.430.8148.4448.800.80
21240630-124063048.28848.66
31255194-125519448.85549.24
41258257-125825748.97449.34
51236791-123679148.13948.51
61239443-123944348.24248.62
极限11236709-123670948.13648.250.5748.5948.710.57
21233552-123355248.01348.47
31251446-125144648.70949.17
41244007-124400748.42048.87
51233459-123345948.00948.46
61239044-123904448.22748.68
氢氯噻嗪沙库巴曲缬沙坦片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373656923656033659013661603662403659190.08
214.463688543688243688390.01
单位质量响应值RSD%判断
25464.0925507.540.13数据可信
供试品溶液-25080101批-氢氯噻嗪-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%
5min166536-6653618.79719.2312.5818.8019.2312.58
267745-6774519.13919.14
370884-7088420.02520.03
457976-5797616.37916.38
582946-8294623.43323.43
662321-6232117.60617.61
10min1171287-17128748.39050.936.3148.4250.966.31
2177478-17747850.13950.17
3189355-18935553.49553.53
4177116-17711650.03750.06
5198169-19816955.98556.02
6168240-16824047.53047.56
15min1240568-24056867.96372.765.8768.0772.885.88
2254875-25487572.00572.12
3272533-27253376.99377.12
4259944-25994473.43773.55
5276217-27621778.03478.17
6241198-24119868.14168.25
20min1280227-28022779.16785.675.7479.3985.915.74
2296098-29609883.65183.89
3322371-32237191.07391.32
4310468-31046887.71087.94
5321060-32106090.70390.97
6289232-28923281.71181.93
30min1288997-28899781.64588.806.0382.0089.186.04
2302883-30288385.56885.94
3335471-33547194.77495.18
4324873-32487391.78092.16
5331893-33189393.76394.18
6301814-30181485.26685.62
45min1289514-28951481.79188.745.8882.2889.275.88
2303215-30321585.66186.18
3334084-33408494.38294.94
4324346-32434691.63192.16
5331991-33199193.79194.36
6301534-30153485.18685.69
60min1289076-28907681.66788.595.9082.3089.275.90
2302393-30239385.42986.09
3333157-33315794.12094.84
4324635-32463591.71392.40
5331373-33137393.61694.34
6300843-30084384.99185.63
极限1289052-28905281.66088.925.8382.4389.755.82
2305239-30523986.23387.04
3333712-33371294.27795.15
4327321-32732192.47293.31
5330813-33081393.45894.34
6302413-30241385.43586.22
氢氯噻嗪沙库巴曲缬沙坦片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.546091066083706086416083576086296086210.05
222.586221956214966218460.08
单位质量响应值RSD%判断
27001.8227539.681.40数据可信
供试品溶液-25080101批-沙库巴-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%
5min1155268-15526811.51410.8611.4211.5110.8611.41
2149902-14990211.11611.12
3144325-14432510.70210.70
4122521-1225219.0859.09
5171264-17126412.70012.70
6135726-13572610.06410.06
10min1404975-40497530.03029.123.2830.0529.143.29
2396082-39608229.37129.39
3394287-39428729.23729.26
4375718-37571827.86127.88
5406265-40626530.12630.15
6378911-37891128.09728.11
15min1568985-56898542.19241.582.2542.2641.652.25
2569318-56931842.21642.28
3572643-57264342.46342.53
4547365-54736540.58940.65
5563690-56369041.79941.87
6542776-54277640.24840.31
20min1658350-65835048.81848.791.4848.9648.931.48
2660899-66089949.00749.15
3675535-67553550.09350.23
4648037-64803748.05448.18
5652020-65202048.34948.49
6653323-65332348.44648.58
30min1670983-67098349.75550.001.6849.9850.221.68
2670921-67092149.75149.97
3696862-69686251.67451.90
4669083-66908349.61449.82
5665381-66538149.34049.56
6672824-67282449.89250.10
45min1669974-66997449.68049.841.2449.9850.141.24
2670728-67072849.73650.04
3688426-68842651.04951.36
4667337-66733749.48549.78
5665017-66501749.31349.62
6671116-67111649.76550.06
60min1669154-66915449.62049.761.2350.0150.141.23
2668479-66847949.57049.95
3687095-68709550.95051.34
4666865-66686549.45049.82
5663871-66387149.22849.61
6670888-67088849.74850.13
极限1666532-66653249.42549.631.3249.8950.091.32
2670722-67072249.73650.20
3685975-68597550.86751.34
4663801-66380149.22349.68
5661005-66100549.01549.48
6667532-66753249.49949.96
氢氯噻嗪沙库巴曲缬沙坦片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.541126444112551811264701126232112725411263840.06
222.581143790114390011438450.01
单位质量响应值RSD%判断
49972.6750657.440.97数据可信
供试品溶液-25080101批-曲缬沙坦-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%
5min1286577-28657710.88910.2311.7310.8910.2311.74
2274403-27440310.42710.43
3264935-26493510.06710.07
4223803-2238038.5048.50
5315735-31573511.99712.00
6249152-2491529.4679.47
10min1750506-75050628.51827.643.3628.5427.663.36
2732831-73283127.84627.86
3730829-73082927.77027.79
4694544-69454426.39126.41
5753410-75341028.62828.65
6702125-70212526.67926.70
15min11055535-105553540.10839.522.2440.1739.582.25
21055048-105504840.09040.15
31062219-106221940.36240.43
41015012-101501238.56938.63
51046014-104601439.74739.81
61006961-100696138.26338.32
20min11220966-122096646.39446.351.4946.5346.481.50
21225651-122565146.57246.70
31252357-125235747.58747.72
41201949-120194945.67245.79
51209459-120945945.95746.09
61208673-120867345.92746.05
30min11245533-124553347.32847.501.4747.5447.701.46
21246241-124624147.35547.56
31285547-128554748.84849.06
41241100-124110047.15947.36
51233034-123303446.85347.06
61248622-124862247.44547.65
45min11243468-124346847.24947.401.2347.5447.681.23
21245049-124504947.31047.60
31277303-127730348.53548.83
41239239-123923947.08947.37
51233690-123369046.87847.17
61245401-124540147.32347.60
60min11240175-124017547.12447.321.2147.4947.691.21
21242495-124249547.21247.58
31274815-127481548.44148.81
41238170-123817047.04847.40
51232159-123215946.82047.19
61244549-124454947.29147.65
极限11237793-123779347.03447.211.3347.4847.651.33
21243118-124311847.23647.68
31274103-127410348.41448.87
41232985-123298546.85147.29
51227176-122717646.63047.08
61238794-123879447.07247.51
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