氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
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%
113.989173509147009135509184449145359157160.23
213.999180779159009169880.17
单位质量响应值RSD%判断
65501.8665545.960.05数据可信
长期12月-供试品溶液-2023101921批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1689143-68914375.75585.649.2275.7585.649.22
2846779-84677993.08393.08
3687371-68737175.56075.56
4806785-80678588.68788.69
5812112-81211289.27289.27
6832139-83213991.47491.47
10min1892989-89298998.16399.091.6698.3999.351.68
2922001-922001101.352101.63
3878014-87801496.51796.74
4901366-90136699.08499.35
5909342-90934299.960100.23
6904977-90497799.48199.76
15min1892227-89222798.07999.211.4398.6099.771.45
2923296-923296101.494102.08
3887693-88769397.58198.10
4898023-89802398.71699.28
5909072-90907299.931100.50
6905003-90500399.483100.06
20min1889751-88975197.80798.921.5198.6299.771.53
2920944-920944101.236102.12
3882376-88237696.99697.81
4896401-89640198.53899.40
5903356-90335699.302100.17
6906423-90642399.640100.51
30min1886941-88694197.49898.431.2998.6199.581.31
2911046-911046100.148101.34
3878368-87836896.55697.66
4897033-89703398.60799.76
5902547-90254799.214100.38
6896791-89679198.58199.75
45min1883544-88354497.12597.741.2098.5399.191.22
2907663-90766399.776101.27
3877155-87715596.42297.81
4889974-88997497.83199.28
5893042-89304298.16999.63
6883637-88363797.13598.60
60min1880636-88063696.80597.701.3398.5099.441.35
2904778-90477899.459101.25
3871649-87164995.81797.50
4886986-88698697.50399.25
5891958-89195898.05099.81
6896856-89685698.588100.35
极限1879539-87953996.68497.541.4098.6799.571.41
2905886-90588699.581101.67
3870631-87063195.70597.67
4883318-88331897.10099.14
5889297-88929797.75799.81
6894997-89499798.384100.44
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.948251548227498238138224728252738238920.16
29.968254368251348252850.03
单位质量响应值RSD%判断
82886.5282859.940.03数据可信
长期12月-供试品溶液-2023101921批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154876-548766.56914.61118.996.5714.61118.98
234881-348814.1754.18
33256-32560.3900.39
4215361-21536125.77925.78
547129-471295.6415.64
6376823-37682345.10645.11
10min1841420-841420100.71999.641.18100.7499.681.20
2819162-81916298.05498.07
3820840-82084098.25598.26
4838203-838203100.334100.41
5838378-838378100.355100.37
6836399-836399100.118100.25
15min1844508-844508101.088100.410.95101.41100.760.95
2828506-82850699.17399.48
3833796-83379699.806100.10
4839444-839444100.482100.86
5850689-850689101.828102.15
6836196-836196100.093100.53
20min1840487-840487100.607100.160.88101.23100.810.89
2826083-82608398.88399.49
3830108-83010899.36599.96
4838866-838866100.413101.09
5845949-845949101.261101.88
6839173-839173100.450101.19
30min1839207-839207100.45499.710.97101.38100.650.97
2822687-82268798.47699.38
3827044-82704498.99899.89
4835316-83531699.988100.97
5844207-844207101.052101.98
6829462-82946299.287100.32
45min1836406-836406100.11999.410.90101.35100.660.90
2819939-81993998.14799.34
3825715-82571598.839100.03
4832930-83293099.702100.98
5840258-840258100.580101.81
6827858-82785899.095100.43
60min1832583-83258399.66199.280.91101.19100.820.92
2820012-82001298.15699.65
3822405-82240598.44399.93
4831659-83165999.550101.13
5840826-840826100.648102.18
6828734-82873499.200100.83
极限1830435-83043599.40498.900.81101.23100.740.82
2816797-81679797.77199.56
3821163-82116398.294100.08
4826969-82696998.989100.87
5835700-835700100.034101.87
6826087-82608798.883100.81
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
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%
113.989150329154649154099149079156719152970.04
213.999129109154819141960.20
单位质量响应值RSD%判断
65471.8965346.390.14数据可信
长期12月-供试品溶液-2023102021批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1862706-86270695.00079.8710.8595.0079.8710.84
2656616-65661672.30672.31
3670553-67055373.84173.84
4672907-67290774.10074.10
5724146-72414679.74279.74
6764912-76491284.23184.23
10min1922020-922020101.53296.292.73101.8296.532.74
2873663-87366396.20796.42
3864313-86431395.17795.40
4858731-85873194.56394.78
5863870-86387095.12995.37
6864154-86415495.16095.41
15min1923846-923846101.73396.582.67102.3297.112.69
2875556-87555696.41596.92
3866097-86609795.37495.88
4861299-86129994.84595.35
5865757-86575795.33695.86
6869869-86986995.78996.33
20min1920469-920469101.36196.272.70102.2697.092.72
2873943-87394396.23897.03
3865203-86520395.27596.07
4854007-85400794.04294.83
5863820-86382095.12395.93
6868191-86819195.60496.43
30min1918987-918987101.19895.742.93102.4096.842.95
2867475-86747595.52696.61
3852192-85219293.84394.92
4850173-85017393.62094.69
5859060-85906094.59995.69
6868442-86844295.63296.74
45min1913700-913700100.61695.672.65102.1297.072.67
2868360-86836095.62396.99
3857071-85707194.38095.74
4850293-85029393.63494.99
5857293-85729394.40495.78
6866209-86620995.38696.79
60min1910083-910083100.21895.392.58102.0297.072.59
2862141-86214194.93896.60
3854948-85494894.14695.79
4849982-84998293.59995.23
5854037-85403794.04695.71
6866185-86618595.38497.07
极限1910088-910088100.21895.492.50102.3297.452.52
2864356-86435695.18297.12
3860516-86051694.75996.69
4850999-85099993.71195.63
5853946-85394694.03695.98
6862822-86282295.01396.98
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.948252358237678241068250368241248244540.08
29.968226378221228223800.05
单位质量响应值RSD%判断
82943.0682568.270.33数据可信
长期12月-供试品溶液-2023102021批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1777817-77781793.23862.6474.3793.2462.6474.37
2-0.0000.00
3670344-67034480.35580.36
4785150-78515094.11794.12
5848341-848341101.692101.69
653641-536416.4306.43
10min1869607-869607104.241100.662.82104.52100.842.92
2817350-81735097.97797.98
3854700-854700102.454102.70
4824543-82454398.83999.12
5857472-857472102.787103.09
6814566-81456697.64397.66
15min1868396-868396104.096101.092.19104.69101.582.27
2829265-82926599.40599.70
3854573-854573102.439102.99
4824790-82479098.86999.45
5855423-855423102.541103.15
6827502-82750299.19499.51
20min1865932-865932103.801100.642.30104.71101.442.38
2825773-82577398.98799.58
3850832-850832101.991102.85
4819051-81905198.18199.06
5852419-852419102.181103.10
6823391-82339198.70199.31
30min1863307-863307103.48699.652.38104.70100.742.43
2821754-82175498.50599.39
3818028-81802898.05899.22
4815622-81562297.77098.94
5848358-848358101.694102.92
6820623-82062398.36999.28
45min1860947-860947103.203100.072.21104.73101.462.29
2821218-82121898.44199.63
3845602-845602101.364102.82
4815128-81512897.71199.17
5845465-845465101.347102.88
6820419-82041998.34599.55
60min1857102-857102102.74299.762.18104.58101.462.27
2817552-81755298.00199.48
3842600-842600101.004102.76
4813549-81354997.52199.28
5844505-844505101.232103.07
6818058-81805898.06299.56
极限1856568-856568102.67899.482.28104.82101.472.36
2817161-81716197.95499.73
3840861-840861100.795102.86
4809062-80906296.98499.03
5841082-841082100.822102.96
6814652-81465297.65499.44
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
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%
113.989142379154539163609155519144399152080.10
213.999139009148989143990.08
单位质量响应值RSD%判断
65465.5265360.900.12数据可信
长期12月-供试品溶液-2023102121批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1555222-55522261.13780.2913.0661.1480.2913.06
2721379-72137979.43379.43
3801489-80148988.25488.25
4723880-72388079.70879.71
5746947-74694782.24882.25
6826159-82615990.97090.97
10min1813411-81341189.56695.315.5389.7595.555.54
2909758-909758100.175100.41
3873679-87367996.20396.47
4811177-81117789.32189.56
5858857-85885794.57194.82
6926364-926364102.004102.28
15min1817498-81749890.01795.655.5390.4796.175.54
2915665-915665100.826101.36
3875912-87591296.44997.00
4814204-81420489.65490.16
5859939-85993994.69095.22
6928638-928638102.254102.83
20min1815258-81525889.77095.405.4990.4996.225.50
2914201-914201100.665101.51
3874525-87452596.29697.14
4811819-81181989.39190.17
5858835-85883594.56895.38
6923889-923889101.731102.62
30min1814424-81442489.67895.115.5290.6796.215.52
2910710-910710100.280101.42
3871161-87116195.92597.06
4808195-80819588.99290.04
5855378-85537894.18895.29
6922784-922784101.610102.80
45min1811397-81139789.34594.695.5490.6196.075.54
2906704-90670499.839101.28
3866456-86645695.40796.83
4803102-80310288.43189.74
5853109-85310993.93895.32
6918752-918752101.166102.66
60min1807392-80739288.90494.235.3490.4395.905.35
2900157-90015799.118100.86
3863002-86300295.02796.73
4802780-80278088.39689.97
5848921-84892193.47795.14
6912439-912439100.471102.27
极限1806509-80650988.80794.325.5490.6096.275.55
2900985-90098599.209101.25
3861402-86140294.85196.84
4801371-80137188.24190.08
5851991-85199193.81595.76
6917316-917316101.008103.11
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.948243558222998234578229778218648229900.12
29.968218688216548217610.02
单位质量响应值RSD%判断
82795.7782506.120.25数据可信
长期12月-供试品溶液-2023102121批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124804-12480414.97943.8684.2314.9843.8684.24
2205432-20543224.65724.66
3140510-14051016.86416.86
4206660-20666024.80424.80
5815915-81591597.92997.93
6699340-69934083.93783.94
10min1841035-841035100.944101.570.97100.99101.701.01
2831869-83186999.84499.92
3852250-852250102.290102.34
4851543-851543102.205102.28
5850079-850079102.029102.32
6850832-850832102.120102.37
15min1847265-847265101.691102.251.00102.04102.690.98
2840716-840716100.905101.28
3864591-864591103.771104.13
4858431-858431103.032103.41
5848902-848902101.888102.49
6851561-851561102.207102.77
20min1844959-844959101.415101.850.97102.07102.600.95
2838104-838104100.592101.27
3861329-861329103.379104.05
4854903-854903102.608103.30
5846541-846541101.605102.51
6845781-845781101.513102.38
30min1845071-845071101.428101.610.96102.39102.660.93
2835434-835434100.271101.25
3858243-858243103.009103.99
4853101-853101102.392103.39
5841887-841887101.046102.26
6845727-845727101.507102.68
45min1839669-839669100.780101.310.99102.04102.660.98
2832569-83256999.928101.21
3855680-855680102.701103.99
4851059-851059102.147103.45
5840886-840886100.926102.44
6844532-844532101.363102.84
60min1835609-835609100.292100.791.00101.86102.450.98
2828588-82858899.450101.03
3852699-852699102.344103.94
4845552-845552101.486103.10
5838025-838025100.582102.40
6838196-838196100.603102.38
极限1834873-834873100.204100.520.90102.07102.480.88
2826556-82655699.206101.08
3848126-848126101.795103.70
4843253-843253101.210103.13
5835284-835284100.253102.37
6836731-836731100.427102.51
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
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%
113.989117239120979120909125749115019119970.05
213.999052039058359055190.05
单位质量响应值RSD%判断
65235.8464726.160.56数据可信
中间条件12月-供试品溶液-2023101921批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1698454-69845477.42179.329.6977.4279.329.69
2691653-69165376.66776.67
3627548-62754869.56169.56
4838160-83816092.90792.91
5705442-70544278.19678.20
6732495-73249581.19481.19
10min1854378-85437894.70596.553.3994.9496.783.39
2845148-84514893.68193.91
3888220-88822098.45698.66
4897481-89748199.48299.76
5835746-83574692.63992.87
6904925-904925100.308100.55
15min1857913-85791395.09696.903.4195.6197.433.41
2850389-85038994.26294.77
3893171-89317199.00599.51
4897904-89790499.529100.11
5836355-83635592.70793.22
6909380-909380100.801101.35
20min1857269-85726995.02596.913.2995.8397.733.29
2851068-85106894.33895.13
3890739-89073998.73599.54
4897837-89783799.522100.40
5839262-83926293.02993.82
6909678-909678100.834101.68
30min1854538-85453894.72296.573.2895.8197.683.27
2850779-85077994.30695.38
3890603-89060398.72099.82
4888551-88855198.49399.67
5834822-83482292.53793.61
6908146-908146100.665101.81
45min1850818-85081894.31096.253.2695.6897.653.26
2847627-84762793.95695.32
3885147-88514798.11599.51
4884696-88469698.06599.54
5834111-83411192.45893.81
6907587-907587100.603102.05
60min1846465-84646593.82795.823.2795.4897.513.27
2842289-84228993.36595.01
3881526-88152697.71499.40
4886378-88637898.252100.02
5830412-83041292.04893.67
6899728-89972899.731101.48
极限1849098-84909894.11995.943.2896.0597.913.28
2844751-84475193.63795.56
3880918-88091897.64699.63
4887931-88793198.424100.48
5829315-82931591.92693.83
6901036-90103699.876101.93
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.948207568210108207458198378201378204970.06
29.968143308157158150220.13
单位质量响应值RSD%判断
82544.9781829.520.62数据可信
中间条件12月-供试品溶液-2023101921批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1292477-29247735.30368.0544.6835.3068.0544.68
2304117-30411736.70836.71
3724517-72451787.45187.45
4812784-81278498.10598.10
5423297-42329751.09351.09
6825635-82563599.65699.66
10min1807003-80700397.40798.561.1997.5198.761.23
2824839-82483999.56099.67
3809378-80937897.69497.96
4819480-81948098.91399.21
5808428-80842897.57997.73
6830092-830092100.194100.49
15min1814597-81459798.32499.011.0998.7299.501.10
2830719-830719100.270100.68
3810559-81055997.83698.39
4821762-82176299.18999.78
5813271-81327198.16498.61
6830551-830551100.249100.85
20min1814864-81486498.35698.881.0999.0599.681.10
2827761-82776199.913100.62
3808092-80809297.53998.39
4820516-82051699.03899.93
5813109-81310998.14498.88
6830950-830950100.298101.20
30min1810596-81059697.84198.361.0298.8399.461.02
2824392-82439299.506100.52
3805087-80508797.17698.32
4812735-81273598.09999.28
5810978-81097897.88798.92
6825688-82568899.662100.86
45min1806450-80645097.34098.031.1898.6299.421.19
2823123-82312399.353100.66
3801007-80100796.68398.12
4811651-81165197.96899.45
5806369-80636997.33198.66
6824292-82429299.494100.99
60min1804480-80448097.10397.671.0798.6899.351.08
2818540-81854098.800100.41
3798641-79864196.39898.12
4809660-80966097.72899.50
5803741-80374197.01398.63
6820020-82002098.978100.78
极限1802580-80258096.87397.461.1898.7499.441.18
2817972-81797298.731100.63
3795220-79522095.98598.00
4808154-80815497.54699.61
5801732-80173296.77198.68
6819022-81902298.858100.95
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