替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.011310641311751310541309961311691310920.06
213.991318601317711318160.05
单位质量响应值RSD%判断
9357.039422.160.50数据可信
供试品溶液-F94945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%
5min191235-9123569.75170.811.9069.7570.811.91
295316-9531672.87172.87
393298-9329871.32871.33
493637-9363771.58771.59
591522-9152269.97069.97
690727-9072769.36269.36
10min1110871-11087184.76385.313.2785.1585.703.26
2114007-11400787.16087.56
3112648-11264886.12186.52
4115650-11565088.41688.81
5105078-10507880.33480.72
6111248-11124885.05185.44
15min1118162-11816290.33792.021.2891.2092.881.27
2121805-12180593.12294.01
3120650-12065092.23993.11
4119800-11980091.58992.48
5122281-12228193.48694.32
6119469-11946991.33692.19
20min1123627-12362794.51595.481.8795.8796.861.84
2124407-12440795.11196.52
3123615-12361594.50695.89
4126107-12610796.41197.81
5129000-12900098.62299.98
6122588-12258893.72095.09
30min1126292-12629296.55297.971.1298.4499.881.09
2128539-12853998.270100.20
3128308-12830898.093100.01
4126999-12699997.09399.03
5128285-12828598.07699.98
6130444-13044499.726101.61
45min1131328-131328100.402100.641.59102.82103.101.55
2132102-132102100.994103.47
3133952-133952102.408104.87
4130890-130890100.067102.54
5128147-12814797.970100.42
6133453-133453102.027104.47
60min1126886-12688697.00699.722.7099.99102.732.64
2135590-135590103.661106.70
3130200-13020099.540102.57
4127172-12717297.225100.25
5129097-12909798.697101.69
6133648-133648102.176105.18
极限1128859-12885998.51598.910.76102.03102.470.75
2129571-12957199.059102.68
3128180-12818097.996101.57
4130574-13057499.826103.39
5128635-12863598.343101.88
6130410-13041099.700103.27
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.914340494343544340864341324339754341190.04
210.944389534382354385940.12
单位质量响应值RSD%判断
39790.9340090.860.54数据可信
供试品溶液-F94945批-替米沙坦-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%
5min1150597-15059733.93539.1714.0733.9339.1714.07
2169180-16918038.12238.12
3159083-15908335.84735.85
4219988-21998849.57149.57
5178172-17817240.14940.15
6166050-16605037.41737.42
10min1296599-29659966.83474.5512.3267.0274.7612.32
2325900-32590073.43773.65
3305968-30596868.94669.14
4410215-41021592.43692.71
5317705-31770571.59071.81
6328639-32863974.05474.26
15min1381452-38145285.95593.046.0886.5193.676.11
2400936-40093690.34590.97
3395502-39550289.12189.70
4445816-445816100.458101.25
5437667-43766798.62299.24
6415974-41597493.73494.35
20min1413672-41367293.21598.855.1594.2599.995.16
2419948-41994894.62995.75
3427741-42774196.38697.46
4454876-454876102.500103.85
5472915-472915106.565107.73
6442821-44282199.784100.92
30min1417631-41763194.10799.343.1795.66101.033.18
2432033-43203397.35399.00
3444338-444338100.125101.74
4443475-44347599.931101.85
5454481-454481102.411104.17
6453038-453038102.086103.78
45min1425575-42557595.897100.172.6797.98102.422.66
2437834-43783498.660100.85
3459592-459592103.563105.73
4446554-446554100.625103.10
5444921-444921100.257102.59
6452685-452685102.006104.27
60min1411739-41173992.78098.743.3495.39101.553.29
2447292-447292100.791103.53
3445470-445470100.380103.12
4430675-43067597.047100.08
5444048-444048100.060102.95
6449998-449998101.401104.23
极限1413992-41399293.28797.042.2596.41100.392.29
2423762-42376295.48998.79
3437985-43798598.694102.00
4435726-43572698.185101.75
5437077-43707798.489101.93
6435301-43530198.089101.48
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.011307451304761306201306561305751306140.08
213.991319021318011318520.06
单位质量响应值RSD%判断
9322.919424.730.77数据可信
供试品溶液-F57850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%
5min190063-9006368.97269.706.7868.9769.706.77
293042-9304271.25371.25
391164-9116469.81569.81
4100989-10098977.33977.34
588724-8872467.94667.95
682066-8206662.84762.85
10min1108019-10801982.72383.271.4183.1183.661.40
2109774-10977484.06784.46
3109076-10907683.53283.92
4109114-10911483.56183.99
5106063-10606381.22581.60
6110382-11038284.53284.88
15min1115541-11554188.48388.741.5389.3389.591.52
2117801-11780190.21491.08
3116262-11626289.03589.89
4116283-11628389.05189.95
5112618-11261886.24587.07
6116753-11675389.41190.23
20min1120352-12035292.16791.441.7593.5092.791.74
2119192-11919291.27992.64
3119583-11958391.57892.92
4121409-12140992.97794.37
5115455-11545588.41789.73
6120453-12045392.24593.56
30min1122633-12263393.91494.521.4795.7696.381.48
2124292-12429295.18597.06
3122505-12250593.81695.67
4126066-12606696.54398.45
5120857-12085792.55494.35
6124224-12422495.13396.96
45min1124586-12458695.41096.282.2197.7898.662.18
2125862-12586296.38798.79
3125252-12525295.92098.30
4127841-12784197.903100.34
5121384-12138492.95895.27
6129412-12941299.106101.46
60min1127858-12785897.91697.932.01100.81100.841.99
2126340-12634096.75399.69
3130566-13056699.989102.90
4130819-130819100.183103.17
5124053-12405395.00297.83
6127649-12764997.755100.66
极限1126595-12659596.94897.401.61100.39100.851.60
2127039-12703997.288100.76
3128483-12848398.394101.86
4128894-12889498.709102.25
5123469-12346994.55497.91
6128597-12859798.481101.93
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.914337704331294332984333824331674333490.06
210.944376494373714375100.05
单位质量响应值RSD%判断
39720.3539991.770.49数据可信
供试品溶液-F57850批-替米沙坦-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%
5min1145588-14558832.87631.7414.9432.8831.7414.94
2124426-12442628.09728.10
3119680-11968027.02627.03
4135493-13549330.59630.60
5178726-17872640.35940.36
6139500-13950031.50131.50
10min1272471-27247161.52861.189.6461.7161.369.65
2246446-24644655.65155.81
3255573-25557357.71257.86
4248214-24821456.05056.22
5311139-31113970.26070.48
6291843-29184365.90366.08
15min1354643-35464380.08480.136.4580.6180.656.47
2336090-33609075.89476.36
3346283-34628378.19678.67
4329530-32953074.41374.89
5389810-38981088.02588.64
6372848-37284884.19584.74
20min1402738-40273890.94490.423.8491.9191.383.89
2384033-38403386.72087.61
3402212-40221290.82691.73
4384043-38404386.72387.62
5425345-42534596.04997.15
6404224-40422491.28092.29
30min1411296-41129692.87795.532.0994.3596.992.11
2419976-41997694.83796.21
3429542-42954296.99798.41
4420647-42064794.98896.37
5436622-43662298.596100.23
6420088-42008894.86296.38
45min1408339-40833992.20996.012.2094.2098.012.17
2421193-42119395.11297.01
3431623-43162397.46799.42
4428336-42833696.72598.63
5427567-42756796.55198.74
6433991-43399198.002100.04
60min1415294-41529493.78097.232.7096.2899.762.64
2421450-42145095.17097.59
3445066-445066100.503102.99
4440187-44018799.401101.84
5435889-43588998.430101.15
6425586-42558696.10498.69
极限1407961-40796192.12495.962.2695.1599.032.22
2420901-42090195.04698.00
3433083-43308397.797100.85
4433543-43354397.901100.89
5428572-42857296.778100.05
6425736-42573696.13899.26
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.011312351310541310221311031309931310810.08
213.991313481313921313700.03
单位质量响应值RSD%判断
9356.259390.280.26数据可信
供试品溶液-24110501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%
5min1111308-11130885.24482.033.3285.2482.033.32
2108178-10817882.84782.85
3105501-10550180.79780.80
4100947-10094777.30977.31
5107862-10786282.60582.61
6108887-10888783.39083.39
10min1122591-12259193.88591.402.3194.3691.852.31
2121679-12167993.18793.65
3120490-12049092.27692.72
4115356-11535688.34488.77
5117291-11729189.82690.29
6118645-11864590.86391.33
15min1121661-12166193.17394.063.6894.1795.033.65
2131026-131026100.345101.32
3124478-12447895.33096.29
4118075-11807590.42791.35
5120961-12096192.63793.59
6120747-12074792.47393.44
20min1129401-12940199.10195.284.85100.6196.774.81
2133936-133936102.574104.11
3123159-12315994.32095.81
4119726-11972691.69193.11
5118396-11839690.67292.15
6121894-12189493.35194.83
30min1123867-12386794.86293.731.8896.9395.751.89
2125072-12507295.78597.89
3121131-12113192.76794.78
4119765-11976591.72193.65
5120207-12020792.05994.04
6124304-12430495.19797.20
45min1123880-12388094.87293.062.2097.4695.602.21
2124223-12422395.13597.77
3120449-12044992.24594.78
4118970-11897091.11293.55
5118123-11812390.46392.95
6123429-12342994.52797.06
60min1118787-11878790.97291.861.5894.0994.911.56
2122386-12238693.72896.89
3117763-11776390.18893.23
4119806-11980691.75294.70
5118852-11885291.02294.01
6122060-12206093.47896.53
极限1121160-12116092.78993.601.4996.4197.171.49
2124964-12496495.70299.39
3120511-12051192.29295.84
4121610-12161093.13496.59
5121083-12108392.73096.23
6124014-12401494.97598.55
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.914333404328154331984332044329664331050.05
210.944347104347174347140.01
单位质量响应值RSD%判断
39697.9839736.200.07数据可信
供试品溶液-24110501批-替米沙坦-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%
5min1123952-12395228.08826.858.2828.0926.858.28
2101268-10126822.94822.95
3112040-11204025.38925.39
4124266-12426628.15928.16
5125961-12596128.54328.54
6123393-12339327.96127.96
10min1232702-23270252.73151.585.7552.8951.735.75
2208826-20882647.32147.45
3221162-22116250.11650.26
4240979-24097954.60754.76
5241813-24181354.79554.95
6220277-22027749.91550.07
15min1281696-28169663.83368.325.1864.2868.765.16
2301210-30121068.25568.65
3296727-29672767.23967.66
4325257-32525773.70474.16
5313018-31301870.93171.39
6291197-29119765.98666.42
20min1344655-34465578.10079.774.6178.9080.594.59
2363119-36311982.28483.05
3339423-33942376.91477.71
4379437-37943785.98186.85
5348177-34817778.89879.75
6337406-33740676.45777.26
30min1361365-36136581.88688.805.5583.1290.065.52
2389830-38983088.33789.56
3381205-38120586.38287.60
4425767-42576796.48097.83
5404311-40431191.61892.91
6388721-38872188.08589.31
45min1385857-38585787.43692.613.9089.1394.363.90
2413601-41360193.72395.44
3398254-39825490.24591.95
4427359-42735996.84198.72
5423949-42394996.06897.87
6403028-40302891.32793.04
60min1376615-37661585.34291.774.6087.5294.034.58
2407831-40783192.41694.65
3395580-39558089.64091.84
4426664-42666496.68399.10
5423290-42329095.91998.26
6399784-39978490.59292.81
极限1384826-38482687.20393.193.8489.8595.963.83
2415225-41522594.09196.84
3411468-41146893.24095.94
4424677-42467796.23399.19
5428106-42810697.01099.88
6403074-40307491.33894.06
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.011319531319811321781318831319461319880.09
213.991315891314871315380.06
单位质量响应值RSD%判断
9420.999402.290.15数据可信
供试品溶液-24110701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%
5min1107469-10746981.96881.903.6081.9781.903.60
2102427-10242778.12378.12
3105829-10582980.71780.72
4105357-10535780.35780.36
5113545-11354586.60386.60
6109687-10968783.66083.66
10min1117548-11754889.65689.261.5490.1189.711.55
2113579-11357986.62987.06
3117942-11794289.95690.40
4117308-11730889.47389.92
5118776-11877690.59291.07
6117012-11701289.24789.71
15min1115615-11561588.18190.192.8789.1391.142.86
2112672-11267285.93786.85
3121584-12158492.73493.68
4120307-12030791.76092.70
5119708-11970891.30392.29
6119622-11962291.23892.20
20min1117393-11739389.53893.213.2190.9894.663.19
2117788-11778889.83991.23
3127197-12719797.01598.48
4124003-12400394.57996.03
5122173-12217393.18394.67
6124669-12466995.08796.55
30min1118757-11875790.57893.094.4892.5295.064.42
2115972-11597288.45490.35
3122372-12237293.33595.34
4123118-12311893.90495.88
5131892-131892100.596102.61
6120220-12022091.69493.69
45min1118530-11853090.40591.983.8092.8594.473.75
2116196-11619688.62591.01
3122873-12287393.71796.24
4118236-11823690.18192.68
5128807-12880798.243100.81
6118947-11894790.72393.23
60min1113299-11329986.41591.082.6889.3694.082.64
2118890-11889090.67993.55
3119813-11981391.38394.42
4121090-12109092.35795.36
5121616-12161692.75895.87
6121774-12177492.87995.89
极限1116999-11699989.23790.632.5392.6694.132.52
2113538-11353886.59789.98
3120152-12015291.64295.19
4121499-12149992.66996.18
5120608-12060891.99095.62
6120144-12014491.63695.16
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.914376314376574378074375554377324376760.03
210.944367984369494368740.03
单位质量响应值RSD%判断
40116.9639933.640.33数据可信
供试品溶液-24110701批-替米沙坦-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%
5min196293-9629321.65220.3312.3621.6520.3312.36
282094-8209418.46018.46
383382-8338218.74918.75
478730-7873017.70317.70
5108419-10841924.37924.38
693622-9362221.05221.05
10min1176582-17658239.70637.876.5739.8337.986.59
2158671-15867135.67935.78
3159027-15902735.75935.86
4159095-15909535.77435.87
5184423-18442341.46941.60
6172701-17270138.83338.95
15min1229194-22919451.53651.274.5551.8851.604.57
2214917-21491748.32648.63
3223799-22379950.32350.63
4222466-22246650.02350.32
5245195-24519555.13455.50
6232588-23258852.29952.63
20min1282492-28249263.52163.803.2564.1564.413.28
2273981-27398161.60762.18
3280638-28063863.10463.69
4277051-27705162.29762.87
5299503-29950367.34668.02
6288754-28875464.92965.55
30min1358767-35876780.67280.116.9181.6581.086.88
2340781-34078176.62877.54
3336418-33641875.64776.58
4344828-34482877.53878.46
5403638-40363890.76291.81
6353272-35327279.43680.42
45min1418276-41827694.05392.295.6795.4893.705.66
2410324-41032492.26593.60
3390980-39098087.91589.27
4387796-38779687.19988.55
5451695-451695101.568103.12
6403459-40345990.72192.15
60min1409422-40942292.06294.783.8394.0196.703.81
2437648-43764898.409100.26
3398892-39889289.69491.54
4419757-41975794.38696.22
5440883-44088399.136101.25
6422582-42258295.02196.95
极限1417972-41797293.98595.851.6796.4598.301.71
2425612-42561295.70398.10
3421607-42160794.80297.14
4430214-43021496.73799.10
5438159-43815998.524101.19
6424064-42406495.35597.81
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