缬沙坦氨氯地平口崩片项目信息
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22AD221对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.722384182383232383442382692383932383490.03
213.732369662371422370540.06
单位质量响应值RSD%判断
17372.3817265.400.44数据可信
供试品溶液-24022901批-氨氯地平-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%
5min151262-5126219.28418.562.9819.2818.562.98
250230-5023018.89618.90
350010-5001018.81318.81
447128-4712817.72917.73
548551-4855118.26418.26
648775-4877518.34818.35
10min1121720-12172045.78946.041.0545.8246.081.05
2121159-12115945.57845.61
3124345-12434546.77646.81
4121514-12151445.71145.74
5122041-12204145.90945.94
6123623-12362346.50446.54
15min1168622-16862263.43264.531.7863.5464.631.78
2172357-17235764.83764.94
3172398-17239864.85364.96
4167280-16728062.92763.03
5175592-17559266.05466.16
6172967-17296765.06765.17
20min1203983-20398376.73476.561.0976.9576.781.09
2204030-20403076.75276.97
3201478-20147875.79276.01
4203448-20344876.53376.74
5207212-20721277.94978.17
6201039-20103975.62775.84
30min1237077-23707789.18487.432.4989.5387.782.48
2224272-22427284.36784.71
3227392-22739285.54085.88
4231095-23109586.93387.27
5236029-23602988.78989.14
6238647-23864789.77490.12
45min1249643-24964393.91194.230.7994.4094.720.79
2246991-24699192.91393.40
3251692-25169294.68195.17
4252475-25247594.97695.46
5251430-25143094.58395.08
6250747-25074794.32694.82
60min1246937-24693792.89395.472.2793.5496.122.25
2251879-25187994.75295.39
3252134-25213494.84895.49
4263589-26358999.15799.80
5251345-25134594.55195.20
6256892-25689296.63897.29
极限1253480-25348095.35496.590.9896.1697.400.98
2257897-25789797.01697.81
3254181-25418195.61896.42
4258467-25846797.23098.04
5259897-25989797.76898.58
6256670-25667096.55497.36
缬沙坦氨氯地平口崩片项目信息
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22AD221对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.722369122369452369932370252370702369890.03
213.732367472367302367380.01
单位质量响应值RSD%判断
17273.2517242.390.13数据可信
供试品溶液-24022902批-氨氯地平-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%
5min143468-4346816.41017.125.1116.4117.125.10
242649-4264916.10016.10
344105-4410516.65016.65
447865-4786518.06918.07
545880-4588017.32017.32
648141-4814118.17418.17
10min1120911-12091145.64546.061.3545.6746.091.35
2123695-12369546.69646.72
3120459-12045945.47445.50
4122765-12276546.34546.37
5120353-12035345.43445.46
6123956-12395646.79446.82
15min1169762-16976264.08664.401.8064.1964.511.80
2169325-16932563.92264.03
3171044-17104464.57064.67
4172792-17279265.23065.34
5165914-16591462.63462.74
6174793-17479365.98666.09
20min1199293-19929375.23577.301.8975.4477.511.89
2206097-20609777.80378.01
3202018-20201876.26376.47
4207892-20789278.48178.70
5203617-20361776.86777.08
6209690-20969079.16079.38
30min1233134-23313488.01088.661.4588.3589.001.45
2237048-23704889.48789.83
3230805-23080587.13187.47
4235453-23545388.88589.23
5232599-23259987.80888.15
6240130-24013090.65191.00
45min1247802-24780293.54794.581.6794.0395.071.67
2253012-25301295.51496.00
3245621-24562192.72493.21
4249616-24961694.23294.73
5249670-24967094.25294.74
6257453-25745397.19197.69
60min1249126-24912694.04796.291.4694.6996.931.46
2254522-25452296.08496.73
3253218-25321895.59296.23
4257350-25735097.15297.80
5256198-25619896.71797.36
6259939-25993998.12998.79
极限1253750-25375095.79396.351.6296.5997.161.62
2255416-25541696.42297.23
3248125-24812593.66994.47
4257564-25756497.23298.05
5256200-25620096.71797.52
6260325-26032598.27599.10
缬沙坦氨氯地平口崩片项目信息
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22AD221对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.722361462362102362592362312362022362100.02
213.732350042348932349480.04
单位质量响应值RSD%判断
17216.4717112.020.44数据可信
供试品溶液-P0133批-氨氯地平-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%
5min1199139-19913975.58777.122.4975.5977.122.49
2200034-20003475.92775.93
3205094-20509477.84777.85
4197920-19792075.12475.12
5211122-21112280.13580.14
6205769-20576978.10478.10
10min1213558-21355881.06080.770.9981.1980.900.99
2211869-21186980.41980.55
3216312-21631282.10582.24
4210350-21035079.84279.97
5211424-21142480.25080.38
6213231-21323180.93681.07
15min1210384-21038479.85582.651.9780.1282.921.97
2218875-21887583.07883.34
3222763-22276384.55484.82
4216092-21609282.02282.28
5220651-22065183.75284.02
6217785-21778582.66482.93
20min1223615-22361584.87784.331.4185.2784.731.40
2220662-22066283.75684.16
3227215-22721586.24486.65
4218512-21851282.94083.34
5222980-22298084.63685.04
6220011-22001183.50983.91
30min1228256-22825686.63986.380.8787.1786.920.87
2226887-22688786.11986.66
3231004-23100487.68288.23
4226162-22616285.84486.38
5227726-22772686.43886.99
6225374-22537485.54586.09
45min1232113-23211388.10387.931.1588.7888.621.15
2229869-22986987.25187.93
3236704-23670489.84690.54
4230658-23065887.55188.23
5231320-23132087.80288.49
6229315-22931587.04187.73
60min1235481-23548189.38189.101.3590.2189.931.34
2232804-23280488.36589.19
3240661-24066191.34792.19
4232858-23285888.38689.21
5234466-23446688.99689.83
6232126-23212688.10888.94
极限1230758-23075887.58989.271.7888.5690.241.78
2231512-23151287.87588.85
3242474-24247492.03693.04
4234962-23496289.18490.15
5236283-23628389.68690.67
6235066-23506689.22490.20
缬沙坦氨氯地平口崩片项目信息
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22AD221对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.722351512351372351212350962350442351100.02
213.732349292348232348760.04
单位质量响应值RSD%判断
17136.3017106.770.13数据可信
供试品溶液-P0133批-氨氯地平-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%
5min1198889-19888975.68074.381.5875.6874.381.58
2196557-19655774.79274.79
3195095-19509574.23674.24
4195955-19595574.56374.56
5189727-18972772.19472.19
6196591-19659174.80574.81
10min1247818-24781894.29892.741.3594.4292.861.35
2240829-24082991.63891.76
3245007-24500793.22893.35
4240118-24011891.36891.49
5241690-24169091.96692.09
6246861-24686193.93494.06
15min1254314-25431496.77095.972.3897.0596.252.38
2248736-24873694.64794.92
3251072-25107295.53695.82
4249565-24956594.96395.24
5246410-24641093.76294.04
6263216-263216100.157100.44
20min1262134-26213499.74597.631.91100.1998.071.91
2250671-25067195.38395.82
3255536-25553697.23597.67
4256051-25605197.43197.87
5252478-25247896.07196.50
6262535-26253599.898100.35
30min1255931-25593197.38597.191.5998.0097.791.59
2250087-25008795.16195.76
3255063-25506397.05597.66
4255233-25523397.11997.72
5253677-25367796.52797.12
6262512-26251299.889100.50
45min1256955-25695597.77597.501.7998.5598.261.78
2249161-24916194.80995.56
3258514-25851498.36899.13
4254794-25479496.95297.71
5255020-25502097.03897.79
6262928-262928100.047100.83
60min1259738-25973898.83496.101.4999.7797.031.48
2249415-24941594.90695.82
3250548-25054895.33796.26
4250778-25077895.42496.34
5253250-25325096.36597.28
6251607-25160795.74096.69
极限1258615-25861598.40696.871.6799.5197.961.67
2247328-24732894.11195.18
3253816-25381696.58097.67
4254408-25440896.80597.89
5254164-25416496.71397.79
6259109-25910998.59499.70
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