坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数2000系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.962401852398912396712399122399242399170.08
216.112393252394982394120.06
单位质量响应值RSD%判断
15032.3914861.080.82数据可信
供试品溶液-24022702批-坎地沙坦酯-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1133931-133931100607.893103251.5915.26100607.89103251.5915.26
2123070-12307092449.19792449.20
3156630-156630117659.199117659.20
4169373-169373127231.639127231.64
5116247-11624787323.81487323.81
6125451-12545194237.78594237.78
10min1190855-190855143368.745143052.248.16143536.42143224.338.17
2198266-198266148935.828149089.91
3207419-207419155811.489156007.59
4200623-200623150706.388150918.44
5164813-164813123806.203123951.74
6180626-180626135684.802135841.86
15min1207009-207009155503.500154231.867.12155910.13154642.367.12
2219555-219555164927.954165330.26
3220652-220652165752.012166207.80
4208235-208235156424.461156887.69
5184093-184093138289.185138641.07
6192353-192353144494.030144877.23
20min1214754-214754161321.482159776.916.42161987.28160444.466.42
2227614-227614170981.811171659.00
3226840-226840170400.388171132.43
4213240-213240160184.177160908.11
5195586-195586146922.634147505.00
6198153-198153148850.944149474.97
30min1227818-227818171135.054168218.805.35172069.72169152.665.36
2237958-237958178752.140179714.30
3235065-235065176578.942177594.98
4222288-222288166980.962167971.87
5211727-211727159047.624159874.86
6208759-208759156818.086157690.20
45min1238118-238118178872.331176125.224.57180092.23177339.444.57
2247501-247501185920.765187180.84
3243141-243141182645.568183955.91
4232986-232986175017.214176286.43
5226063-226063169816.712170909.03
6218957-218957164478.742165612.22
60min1244356-244356183558.267180944.624.11185076.28182452.384.11
2252598-252598189749.591191319.54
3247707-247707186075.511187690.26
4240696-240696180808.904182369.81
5235095-235095176601.478177976.82
6224808-224808168873.966170281.57
极限1253807-253807190657.782190629.991.21192481.73192439.321.19
2257743-257743193614.474195500.67
3252802-252802189902.834191827.71
4249043-249043187079.103188941.36
5256400-256400192605.623194275.30
6252825-252825189920.112191609.18
坎地沙坦酯氢氯噻嗪片项目信息
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100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)6.25供试品稀释倍数2000系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.181559691553551550371550671551381553130.25
212.301552251544091548170.38
单位质量响应值RSD%判断
12751.4812586.750.92数据可信
供试品溶液-24022702批-氢氯噻嗪-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min155893-55893126682.672128345.9213.41126682.67128345.9213.41
250319-50319114049.083114049.08
363747-63747144483.930144483.93
467895-67895153885.461153885.46
549234-49234111589.907111589.91
652673-52673119384.474119384.47
10min1103455-103455234482.956234353.396.77234694.09234567.306.78
2101465-101465229972.579230162.66
3108472-108472245854.094246094.90
4111037-111037251667.721251924.20
590968-90968206180.905206366.89
6104990-104990237962.067238161.04
15min1127777-127777289609.286289163.164.53290211.23289767.664.54
2130983-130983296875.753297449.12
3131619-131619298317.261298967.82
4130680-130680296188.998296864.92
5116230-116230263437.765263967.38
6128192-128192290549.893291145.47
20min1140874-140874319293.915319357.383.85320378.54320443.823.85
2145214-145214329130.617330198.78
3145429-145429329617.920330765.68
4143120-143120324384.522325554.09
5130811-130811296485.912297454.59
6139964-139964317231.381318311.21
30min1153107-153107347020.270346878.232.73348637.05348496.932.74
2158419-158419359060.031360676.74
3156448-156448354592.717356289.84
4152832-152832346396.976348107.19
5146568-146568332199.487333662.31
6150892-150892341999.925343608.47
45min1157911-157911357908.638357917.702.14360103.79360114.532.14
2162675-162675368706.345370921.49
3160752-160752364347.825366635.93
4157473-157473356915.902359203.44
5154589-154589350379.254352395.74
6154090-154090349248.260351426.81
60min1159124-159124360657.928359704.481.85363449.59362497.841.85
2162352-162352367974.259370803.92
3161115-161115365170.572368065.93
4158807-158807359939.441362821.84
5156327-156327354318.468356918.92
6154495-154495350166.201352926.83
极限1160507-160507363792.527366118.360.92367185.29369511.220.90
2163480-163480370530.895373973.84
3161541-161541366136.110369640.08
4159588-159588361709.594365191.89
5162968-162968369370.436372561.42
6161115-161115365170.572368514.81
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数2000系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.964801274799514800954799124793464798860.07
216.114789694789654789670.01
单位质量响应值RSD%判断
30068.0529731.040.80数据可信
供试品溶液-24022701批-坎地沙坦酯
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1250012-25001293884.348101192.149.1393884.35101192.149.13
2272137-272137102192.713102192.71
3277747-277747104299.377104299.38
4231183-23118386813.69386813.69
5291227-291227109361.378109361.38
6294529-294529110601.343110601.34
10min1361431-361431135724.340149272.587.67135880.81149441.237.67
2406160-406160152520.945152691.27
3390014-390014146457.810146631.64
4366034-366034137452.855137597.54
5432728-432728162497.744162680.01
6428691-428691160981.772161166.11
15min1411341-411341154466.511161624.104.10154849.19162041.544.10
2430882-430882161804.535162229.06
3415443-415443156006.892156424.82
4421864-421864158418.101158791.88
5449880-449880168938.652169391.75
6452999-452999170109.897170562.54
20min1430050-430050161492.103166268.773.25162132.23166955.593.26
2437496-437496164288.220164982.42
3426274-426274160074.142160752.08
4443629-443629166591.280167229.09
5457985-457985171982.236172716.90
6461187-461187173184.649173920.80
30min1450861-450861169307.037171925.102.65170216.32172889.022.66
2449527-449527168806.094169774.10
3442727-442727166252.562167197.29
4461072-461072173141.465174056.92
5469255-469255176214.340177235.64
6473555-473555177829.073178853.87
45min1471882-471882177200.829177809.302.43178392.29179059.772.43
2461456-461456173285.664174535.02
3459072-459072172390.426173612.24
4478630-478630179734.834180938.86
5482406-482406181152.795182467.79
6487568-487568183091.226184412.40
60min1487810-487810183182.102181668.262.18184668.89183215.082.17
2470526-470526176691.625178229.79
3470269-470269176595.116178104.25
4490231-490231184091.234185594.82
5490531-490531184203.890185820.80
6493305-493305185245.580186871.91
极限1530462-530462199198.754198644.860.40200990.85200494.460.40
2526335-526335197648.985199481.63
3527427-527427198059.052199862.51
4530732-530732199300.144201110.55
5531309-531309199516.818201440.74
6527657-527657198145.422200080.49
坎地沙坦酯氢氯噻嗪片项目信息
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100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)6.25供试品稀释倍数2000系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.183074913078283087703083593075003079900.19
212.303082493081323081900.03
单位质量响应值RSD%判断
25286.5425056.100.65数据可信
供试品溶液-24022701批-氢氯噻嗪
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min195039-95039108415.824116841.228.53108415.82116841.228.53
2103048-103048117552.098117552.10
3106241-106241121194.515121194.52
489129-89129101673.986101673.99
5109332-109332124720.576124720.58
6111760-111760127490.320127490.32
10min1183790-183790209658.606230189.087.55209839.30230383.827.55
2204826-204826233655.442233851.36
3206189-206189235210.285235412.28
4182649-182649208357.009208526.47
5216131-216131246551.631246759.50
6217139-217139247701.508247913.99
15min1244124-244124278484.670292656.034.44279014.79293234.414.45
2256647-256647292770.294293355.64
3253450-253450289123.313289717.32
4245247-245247279765.734280282.45
5269809-269809307784.857308403.64
6270004-270004308007.303308632.62
20min1276720-276720315668.586326820.952.98316662.85327887.092.99
2284406-284406324436.398325509.69
3280525-280525320009.144321085.02
4283437-283437323331.010324314.00
5297614-297614339503.436340635.20
6296276-296276337977.111339115.78
30min1310738-310738354474.650359046.592.34355995.03360657.442.34
2309582-309582353155.942354769.97
3305295-305295348265.543349874.77
4317311-317311361972.806363494.69
5321940-321940367253.342368950.94
6323609-323609369157.255370859.22
45min1326677-326677372657.079372282.721.97374768.25374491.981.97
2321023-321023366207.273368409.89
3316292-316292360810.381363000.05
4330437-330437376946.302379071.47
5331805-331805378506.849380816.54
6331859-331859378568.450380885.67
60min1332138-332138378886.719375368.641.91381618.98378198.371.90
2323267-323267368767.118371580.08
3319059-319059363966.838366757.86
4333697-333697380665.150383418.56
5333192-333192380089.071383029.61
6332971-332971379836.965382785.13
极限1340251-340251388141.631386721.590.69391505.37390176.930.69
2335404-335404382612.412386039.99
3336835-336835384244.826387642.46
4341051-341051389054.232392442.09
5339769-339769387591.789391165.81
6340727-340727388684.629392265.86
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数2000系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.964820154819484822214811374814624817570.10
216.114789984798964794470.14
单位质量响应值RSD%判断
30185.2829760.831.01数据可信
供试品溶液-505806批-坎地沙坦酯
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1428762-428762160616.491100703.5031.49160616.49100703.5031.49
2207281-20728177648.54877648.55
3196275-19627573525.64373525.64
4243932-24393291378.20591378.20
5251576-25157694241.68794241.69
6285128-285128106810.442106810.44
10min1523455-523455196088.984160168.5913.33196356.68160336.4313.35
2409984-409984153582.153153711.57
3358974-358974134473.540134596.08
4409095-409095153249.129153401.43
5403294-403294151076.044151233.11
6460596-460596172541.674172719.69
15min1527027-527027197427.074178848.967.24198021.58179283.757.27
2485496-485496181869.344182254.73
3434019-434019162585.790162932.46
4470039-470039176079.071176486.78
5446759-446759167358.261167767.12
6501259-501259187774.246188239.83
20min1527202-527202197492.630187001.003.99198416.18187733.874.03
2513709-513709192438.082193126.58
3475567-475567178149.889178767.53
4490113-490113183598.896184300.07
5482067-482067180584.823181272.62
6506511-506511189741.673190520.22
30min1527558-527558197625.989193567.391.34198878.70194611.931.38
2521378-521378195310.929196320.16
3508107-508107190339.543191254.10
4512711-512711192064.226193071.40
5516759-516759193580.628194569.40
6513829-513829192483.034193577.81
45min1526482-526482197222.914195586.950.72198805.00196954.100.74
2522137-522137195595.254196930.00
3519170-519170194483.801195715.59
4520179-520179194861.777196189.06
5526733-526733197316.940198628.34
6517988-517988194041.017195456.60
60min1526589-526589197262.997195678.290.78199173.79197371.420.79
2522123-522123195590.010197250.75
3519620-519620194652.373196208.30
4522547-522547195748.843197400.89
5526879-526879197371.633199011.90
6516394-516394193443.897195182.88
极限1528059-528059197813.667195202.481.07200053.23197221.741.09
2520398-520398194943.816196930.54
3517590-517590193891.924195772.28
4522151-522151195600.499197578.80
5525677-525677196921.357198890.57
6512656-512656192043.622194105.02
坎地沙坦酯氢氯噻嗪片项目信息
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100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)6.25供试品稀释倍数2000系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.183096183099803101753098033098113098770.07
212.303070723077133073920.15
单位质量响应值RSD%判断
25441.4624991.221.27数据可信
供试品溶液-505806批-氢氯噻嗪
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1134679-134679153369.88393541.1833.21153369.8893541.1833.21
263522-6352272337.64572337.64
359622-5962267896.39967896.40
473088-7308883231.22483231.22
577802-7780288599.43788599.44
684136-8413695812.47695812.48
10min1244449-244449278373.870215603.1216.74278629.49215759.0316.75
2172729-172729196700.499196821.06
3154951-154951176455.250176568.41
4175486-175486199840.118199978.84
5182262-182262207556.498207704.16
6206091-206091234692.509234852.20
15min1296243-296243337355.892289298.9610.12338075.46289814.1910.14
2247480-247480281825.515282273.91
3223728-223728254777.189255184.44
4244975-244975278972.869279444.65
5240545-240545273928.069274421.66
6271285-271285308934.196309485.04
20min1318552-318552362760.956330937.156.38364042.79331934.566.40
2292678-292678333296.137334214.24
3267267-267267304358.574305190.46
4282932-282932322197.578323134.32
5278351-278351316980.822317930.96
6303859-303859346028.847347094.58
30min1335264-335264381792.264368877.542.34383678.70370426.512.38
2327135-327135372535.113374008.71
3314061-314061357646.691358985.84
4319422-319422363751.696365225.43
5319922-319922364321.086365799.53
6327735-327735373218.382374860.83
45min1339301-339301386389.523380533.340.89388912.28382697.110.92
2334699-334699381148.853383243.34
3332419-332419378552.432380487.66
4332026-332026378104.891380184.88
5335241-335241381766.072383851.72
6331265-331265377238.279379502.76
60min1336856-336856383605.203380170.830.79386771.94382968.810.80
2334191-334191380570.352383300.09
3333096-333096379323.387381889.53
4331924-331924377988.735380698.90
5336691-336691383417.304386139.22
6330283-330283376119.996379013.20
极限1336111-336111382756.811377021.341.10386562.89380452.941.11
2332477-332477378618.481381982.50
3331274-331274377248.528380446.88
4329468-329468375191.889378532.03
5331980-331980378052.507381413.46
6325137-325137370259.829373779.90
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