氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566509264970650446499665186650580.14
212.556501665015650160.01
单位质量响应值RSD%判断
5179.785180.560.02数据可信
供试品溶液-2025020311批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125613-2561332.05744.4518.0132.0644.4618.00
239126-3912648.96948.97
344882-4488256.17456.17
435212-3521244.07144.07
535072-3507243.89643.90
633202-3320241.55541.56
10min153925-5392567.49274.026.7167.8574.516.78
261645-6164577.15477.70
364793-6479381.09481.72
459523-5952374.49874.99
559417-5941774.36574.85
655534-5553469.50569.97
15min157057-5705771.41277.965.1072.5279.285.20
263632-6363279.64181.04
366396-6639683.10084.63
463374-6337479.31880.64
562718-6271878.49779.81
660546-6054675.77877.01
20min160558-6055875.79381.564.7377.6983.754.82
265818-6581882.37784.66
369492-6949286.97589.42
467100-6710083.98186.18
564638-6463880.90083.09
663408-6340879.36081.44
30min167239-6723984.15587.955.3186.9091.045.35
271020-7102088.88792.09
376255-7625595.43998.85
471139-7113989.03692.17
570500-7050088.23791.32
665470-6547081.94184.90
45min169503-6950386.98988.957.0190.6793.016.94
272674-7267490.95895.15
377812-7781297.388101.86
472687-7268790.97495.09
571071-7107188.95193.02
662654-6265478.41782.28
60min169457-6945786.93191.434.0291.5796.484.15
274743-7474393.54798.75
377713-7771397.264102.82
472466-7246690.69795.83
573130-7313091.52896.58
670780-7078088.58793.33
极限169738-6973887.28390.474.1392.8996.544.21
272292-7229290.47996.72
376821-7682196.148102.79
474857-7485793.69099.83
570269-7026987.94794.02
669714-6971487.25392.98
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305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200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011347643134772213476361348039134766713477410.02
29.051346648134537413460110.07
单位质量响应值RSD%判断
149582.80148730.500.41数据可信
供试品溶液-2025020311批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163496-634963.8315.6216.883.835.6216.88
291123-911235.4985.50
3109527-1095276.6096.61
496803-968035.8415.84
5100344-1003446.0556.05
697200-972005.8655.87
10min1164383-1643839.91911.918.579.9611.978.61
2194821-19482111.75511.82
3209047-20904712.61412.69
4206477-20647712.45912.52
5206205-20620512.44212.51
6203440-20344012.27612.34
15min1204275-20427512.32614.036.4912.4814.236.55
2227618-22761813.73413.93
3241384-24138414.56514.78
4242910-24291014.65714.86
5243495-24349514.69214.90
6235448-23544814.20714.41
20min1223675-22367513.49615.125.6313.7915.475.69
2247296-24729614.92215.27
3256895-25689515.50115.88
4258259-25825915.58315.95
5262365-26236515.83116.20
6255044-25504415.38915.75
30min1249062-24906215.02816.344.4315.4716.864.52
2266795-26679516.09816.61
3280755-28075516.94117.49
4270853-27085316.34316.88
5280575-28057516.93017.47
6276529-27652916.68617.22
45min1261051-26105115.75216.533.1416.3617.233.24
2275077-27507716.59817.29
3283076-28307617.08117.82
4274572-27457216.56817.29
5282426-28242617.04217.77
6267195-26719516.12216.84
60min1259532-25953215.66016.874.1716.4417.754.23
2279024-27902416.83617.71
3284525-28452517.16818.09
4275924-27592416.64917.55
5294160-29416017.75018.67
6284444-28444417.16318.06
极限1264151-26415115.93917.033.5616.8918.103.69
2277735-27773516.75817.82
3288547-28854717.41118.53
4285739-28573917.24118.33
5292088-29208817.62518.74
6284942-28494217.19318.28
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566521264869651336514765013650750.21
212.556559765650656240.06
单位质量响应值RSD%判断
5181.135229.000.66数据可信
供试品溶液-2025020311批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137315-3731546.48043.8616.3946.4843.8616.38
235483-3548344.19844.20
335114-3511443.73943.74
433684-3368441.95841.96
525920-2592032.28732.29
643773-4377354.52554.52
10min158203-5820372.49972.645.1173.0273.135.18
258557-5855772.94073.43
357327-5732771.40871.89
457210-5721071.26271.73
554823-5482368.28968.65
663775-6377579.44080.05
15min159837-5983774.53476.844.8675.8678.144.90
262465-6246577.80879.11
362165-6216577.43478.71
463519-6351979.12180.38
556805-5680570.75871.88
665345-6534581.39582.88
20min165518-6551881.61180.624.0983.7682.774.16
264725-6472580.62382.79
364350-6435080.15682.30
465889-6588982.07384.21
559959-5995974.68676.59
667908-6790884.58886.98
30min165356-6535681.40984.324.4284.4787.364.45
269493-6949386.56289.62
365965-6596582.16785.20
467285-6728583.81286.86
565186-6518681.19783.93
672852-7285290.74694.08
45min166508-6650882.84486.824.9286.8190.814.84
270299-7029987.56691.59
368542-6854285.37789.32
466726-6672683.11587.10
570320-7032087.59291.23
675826-7582694.45198.79
60min168939-6893985.87288.974.6590.7593.924.66
273275-7327591.27396.27
370285-7028587.54992.44
470172-7017287.40892.31
568595-6859585.44390.05
677299-7729996.285101.68
极限166258-6625882.53288.115.7088.3794.055.58
274111-7411192.31498.33
369418-6941886.46992.33
467761-6776184.40590.28
569956-6995687.13992.70
676933-7693395.829102.29
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305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200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011348566134882513480451346073134565813474330.11
29.051361044135931213601780.10
单位质量响应值RSD%判断
149548.61150295.910.36数据可信
供试品溶液-2025020311批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193417-934175.6085.5415.535.615.5415.53
291888-918885.5165.52
3100835-1008356.0536.05
497177-971775.8345.83
564826-648263.8923.89
6105467-1054676.3316.33
10min1195604-19560411.74211.737.4111.8011.797.45
2197407-19740711.85111.91
3199742-19974211.99112.06
4204148-20414812.25512.32
5167359-16735910.04710.09
6208097-20809712.49212.56
15min1229280-22928013.76413.815.4813.9614.005.53
2234644-23464414.08614.28
3238641-23864114.32614.53
4239433-23943314.37414.57
5205469-20546912.33512.49
6232504-23250413.95814.17
20min1251964-25196415.12614.954.7515.4715.294.81
2249305-24930514.96615.32
3254134-25413415.25615.62
4260096-26009615.61415.97
5226004-22600413.56713.86
6252258-25225815.14315.51
30min1263253-26325315.80315.943.8516.3216.453.93
2268110-26811016.09516.61
3267370-26737016.05116.58
4276136-27613616.57717.11
5246585-24658514.80315.25
6271466-27146616.29716.83
45min1268350-26835016.10916.452.6516.8017.142.73
2272257-27225716.34417.04
3283693-28369317.03117.74
4279279-27927916.76617.48
5264000-26400015.84816.46
6276503-27650316.59917.31
60min1272714-27271416.37116.713.7317.2417.583.79
2277215-27721516.64217.52
3286351-28635117.19018.09
4288244-28824417.30418.21
5260921-26092115.66316.45
6284566-28456617.08317.98
极限1276394-27639416.59216.822.5417.6417.882.65
2284685-28468517.09018.15
3284549-28454917.08218.17
4283260-28326017.00518.10
5267325-26732516.04817.01
6285111-28511117.11618.20
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566446164691644656458964577645570.15
212.556568565733657090.06
单位质量响应值RSD%判断
5139.895235.781.31数据可信
供试品溶液-2025020411批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115225-1522519.02940.4726.0619.0340.4626.06
234597-3459743.24143.24
336966-3696646.20246.20
435692-3569244.60944.61
535709-3570944.63144.63
636068-3606845.07945.08
10min150910-5091063.62972.936.7663.8473.386.87
259641-5964174.54275.02
362240-6224077.79078.30
460720-6072075.89076.39
558371-5837172.95473.45
658215-5821572.75973.26
15min164449-6444980.55178.333.6981.4779.593.55
266036-6603682.53483.84
361484-6148476.84578.22
462714-6271478.38379.72
561840-6184077.29078.60
659495-5949574.35975.67
20min169499-6949986.86382.584.4588.6884.714.27
268757-6875785.93588.16
367513-6751384.38086.61
465010-6501081.25283.46
562696-6269678.36080.53
662968-6296878.70080.84
30min172507-7250790.62286.625.8293.4089.675.63
274439-7443993.03796.22
371285-7128589.09592.26
467455-6745584.30887.42
564263-6426380.31983.35
665880-6588082.33985.35
45min174319-7431992.88791.381.9596.6795.391.91
274488-7448893.09897.31
372821-7282191.01595.17
474167-7416792.69796.75
571409-7140989.25093.18
671495-7149589.35793.28
60min169891-6989187.35391.233.2892.1796.253.26
275143-7514393.91799.17
375985-7598594.969100.14
472754-7275490.93196.01
570723-7072388.39293.31
673446-7344691.79696.71
极限170826-7082688.52189.853.6294.3195.893.56
276100-7610095.113101.41
373037-7303791.28597.51
472443-7244390.54296.63
570308-7030887.87493.78
668617-6861785.76091.70
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305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200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011340803133936013395491339847133940713397930.05
29.051364663136655413656080.10
单位质量响应值RSD%判断
148700.67150895.911.04数据可信
供试品溶液-2025020411批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148003-480032.8845.3225.802.885.3225.82
277371-773714.6494.65
3111857-1118576.7216.72
4100926-1009266.0646.06
594285-942855.6655.67
699228-992285.9625.96
10min1214117-21411712.86512.436.2412.9012.496.24
2189945-18994511.41311.46
3225822-22582213.56813.64
4211788-21178812.72512.79
5197152-19715211.84611.91
6202862-20286212.18912.26
15min1298498-29849817.93515.249.6718.1115.449.53
2229587-22958713.79513.97
3260657-26065715.66115.89
4253031-25303115.20315.41
5242637-24263714.57914.77
6237937-23793714.29614.50
20min1333288-33328820.02516.9010.2220.4017.2710.09
2248678-24867814.94215.27
3288678-28867817.34517.74
4279100-27910016.76917.15
5268595-26859516.13816.49
6269528-26952816.19416.55
30min1364808-36480821.91918.4310.1022.5218.989.96
2273094-27309416.40916.91
3305845-30584518.37618.97
4305928-30592818.38118.95
5292011-29201117.54518.08
6298504-29850417.93518.48
45min1392304-39230423.57119.2312.0624.4119.9911.86
2275860-27586016.57517.25
3313906-31390618.86119.66
4318931-31893119.16319.93
5307147-30714718.45519.19
6311889-31188918.74019.48
60min1383365-38336523.03419.499.9924.1420.469.90
2287241-28724117.25918.12
3329660-32966019.80720.81
4320630-32063019.26520.25
5306985-30698518.44519.38
6318010-31801019.10720.06
极限1392652-39265223.59219.4510.9624.9520.6410.80
2290104-29010417.43118.49
3322588-32258819.38220.61
4316505-31650519.01720.21
5310240-31024018.64019.78
6310374-31037418.64919.81
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566445864316643916465164396644420.20
212.556486564836648500.04
单位质量响应值RSD%判断
5130.735167.330.51数据可信
供试品溶液-2025020411批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133876-3387642.65640.8214.0342.6640.8214.03
233604-3360442.31342.31
337047-3704746.64846.65
424834-2483431.27031.27
535787-3578745.06245.06
629340-2934036.94436.94
10min157087-5708771.88272.184.9172.3672.634.96
257683-5768372.63373.10
361013-6101376.82677.34
452817-5281766.50566.85
559268-5926874.62875.13
656065-5606570.59571.01
15min161517-6151777.46079.692.4178.7380.952.38
265362-6536282.30283.58
363380-6338079.80681.18
462470-6247078.66079.75
562195-6219578.31479.64
664806-6480681.60282.80
20min165860-6586082.92982.542.6485.0684.682.55
265860-6586082.92985.12
365345-6534582.28084.54
464929-6492981.75683.72
562996-6299679.32381.52
668340-6834086.05188.15
30min173326-7332692.33087.155.0595.3890.214.91
271340-7134089.82992.94
368665-6866586.46189.63
466637-6663783.90786.78
563928-6392880.49683.58
671389-7138989.89192.95
45min173605-7360592.68189.422.3496.7693.442.26
268746-6874686.56390.67
371718-7171890.30594.44
470891-7089189.26493.06
569860-6986087.96591.94
671256-7125689.72393.78
60min175285-7528594.79692.142.2199.9197.162.20
274751-7475194.12499.20
372967-7296791.87897.01
471047-7104789.46094.25
571981-7198190.63695.59
673002-7300291.92296.98
极限173201-7320192.17291.353.1598.3497.393.07
274465-7446593.76499.88
375483-7548395.046101.20
470520-7052088.79694.58
569562-6956287.59093.55
672062-7206290.73896.81
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305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200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011336022133687313356741337536133560913363430.07
29.051341452134437413429130.16
单位质量响应值RSD%判断
148317.76148388.180.04数据可信
供试品溶液-2025020411批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193144-931445.6515.4910.875.655.4910.85
286726-867265.2615.26
3104863-1048636.3626.36
474963-749634.5484.55
594161-941615.7125.71
689250-892505.4145.41
10min1205022-20502212.43812.534.5412.5012.594.53
2192609-19260911.68511.74
3212634-21263412.90012.97
4209590-20959012.71512.77
5200310-20031012.15212.22
6219031-21903113.28813.35
15min1244179-24417914.81315.747.9215.0115.947.83
2241948-24194814.67814.87
3256397-25639715.55515.77
4277510-27751016.83517.03
5245428-24542814.88915.09
6291634-29163417.69217.90
20min1265640-26564016.11517.097.7116.4817.477.64
2257974-25797415.65016.00
3281418-28141817.07317.46
4303172-30317218.39218.77
5269908-26990816.37416.74
6312233-31223318.94219.35
30min1296597-29659717.99318.666.5018.5419.226.48
2286124-28612417.35817.88
3306183-30618318.57519.15
4324837-32483719.70720.29
5293698-29369817.81818.36
6337918-33791820.50021.12
45min1299589-29958918.17519.296.5418.9220.066.49
2303317-30331718.40119.12
3312288-31228818.94519.73
4345392-34539220.95421.76
5304130-30413018.45019.19
6343061-34306120.81221.65
60min1312582-31258218.96319.797.1019.9120.777.01
2302885-30288518.37519.30
3315710-31571019.15320.15
4353405-35340521.44022.47
5315101-31510119.11620.06
6357380-35738021.68122.75
极限1307246-30724618.63919.967.9819.8021.177.87
2302736-30273618.36619.49
3335294-33529420.34121.55
4360212-36021221.85323.13
5309945-30994518.80319.96
6359103-35910321.78523.10
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