缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.771166001168041169021168071167171167660.10
213.791168731167321168020.09
单位质量响应值RSD%判断
8479.748470.050.09数据可信
供试品溶液-1批-左氨氯地平-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%
15min18853-88536.5958.0529.896.608.0529.86
28560-85606.3776.38
310841-108418.0778.08
48202-82026.1106.11
516797-1679712.51412.51
611598-115988.6418.64
5min118022-1802213.42614.648.3913.4414.668.39
221382-2138215.93015.94
318461-1846113.75313.77
418321-1832113.64913.66
521814-2181416.25116.27
619908-1990814.83114.85
10min125765-2576519.19519.877.3919.2319.907.39
223529-2352917.52917.57
326843-2684319.99820.03
426650-2665019.85419.89
529376-2937621.88521.93
627834-2783420.73620.78
20min132912-3291224.51925.564.1524.5825.644.17
232778-3277824.42024.49
334481-3448125.68825.76
434037-3403725.35825.42
536555-3655527.23327.32
635117-3511726.16226.24
30min146523-4652334.66036.354.4634.7736.474.46
250096-5009637.32237.43
347186-4718635.15435.27
447316-4731635.25035.36
552188-5218838.88039.01
649462-4946236.84936.97
45min164275-6427547.88551.014.1148.0551.184.11
271152-7115253.00853.18
367893-6789350.58050.75
466443-6644349.50049.67
571481-7148153.25353.45
669557-6955751.82052.00
60min179504-7950459.23163.824.1659.4764.084.16
288291-8829165.77766.03
384589-8458963.01963.27
484680-8468063.08763.34
587949-8794965.52265.81
689009-8900966.31266.58
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.734783115478131847808674781869477977747813890.03
215.704792771479446247936160.03
单位质量响应值RSD%判断
303966.24305325.860.32数据可信
供试品溶液-1批-缬沙坦-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%
15min1596008-59600810.90610.9215.1210.9110.9215.11
2513069-5130699.3889.39
3568893-56889310.41010.41
4544670-5446709.9669.97
5770084-77008414.09114.09
6586552-58655210.73310.73
5min11198015-119801521.92121.733.9721.9421.753.97
21109122-110912220.29520.31
31186050-118605021.70221.72
41165181-116518121.32021.34
51237116-123711622.63722.66
61230495-123049522.51622.53
10min11653395-165339530.25430.435.0130.3130.485.02
21510150-151015027.63327.68
31726655-172665531.59431.65
41647280-164728030.14230.19
51733783-173378331.72531.79
61707173-170717331.23831.29
20min12056584-205658437.63138.512.4137.7438.622.42
22048166-204816637.47737.57
32116790-211679038.73338.84
42082892-208289238.11338.22
52155432-215543239.44039.55
62169053-216905339.68939.80
30min12745808-274580850.24351.811.7350.4151.981.73
22878436-287843652.67052.83
32822987-282298751.65551.83
42816637-281663751.53951.70
52871880-287188052.55052.73
62854038-285403852.22352.40
45min13535335-353533564.68966.981.9364.9467.241.92
23739510-373951068.42568.67
33657920-365792066.93267.19
43648325-364832566.75767.01
53672046-367204667.19167.46
63710841-371084167.90168.16
60min14076682-407668274.59576.961.8374.9577.321.82
24289789-428978978.49478.85
34186121-418612176.59776.97
44184145-418414576.56176.92
54225601-422560177.32077.70
64271850-427185078.16678.54
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.771168381165921166641166301164021166250.14
213.791172171170671171420.10
单位质量响应值RSD%判断
8469.508494.710.22数据可信
供试品溶液-2批-左氨氯地平-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%
15min115961-1596111.88112.348.5911.8812.348.57
216876-1687612.56212.56
314355-1435510.68510.69
416367-1636712.18312.18
517345-1734512.91112.91
618599-1859913.84513.84
5min126515-2651519.73720.748.7919.7620.768.79
228869-2886921.48921.51
325494-2549418.97718.99
428199-2819920.99021.01
526024-2602419.37119.39
632109-3210923.90123.92
10min134909-3490925.98526.946.8226.0427.006.83
237414-3741427.85027.91
335527-3552726.44526.49
436170-3617026.92426.98
532937-3293724.51724.57
640228-4022829.94430.01
20min143094-4309432.07833.276.8832.1733.376.88
246007-4600734.24634.35
346931-4693134.93435.03
443835-4383532.62932.73
539878-3987829.68429.78
648442-4844236.05936.17
30min156992-5699242.42343.276.3242.5743.436.33
262060-6206046.19646.36
354265-5426540.39340.54
460099-6009944.73644.89
553724-5372439.99040.13
661655-6165545.89446.07
45min174346-7434655.34157.825.2855.5658.055.28
282161-8216161.15861.40
379193-7919358.94959.17
479579-7957959.23659.47
571131-7113152.94853.16
679635-7963559.27859.53
60min188957-8895766.21766.598.2266.5366.928.19
297080-9708072.26372.60
378228-7822858.23058.55
495102-9510270.79171.12
583584-8358462.21762.52
693816-9381669.83470.18
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.734786496478458447860004782694478476347849070.04
215.704811040481301248120260.03
单位质量响应值RSD%判断
304189.89306498.470.54数据可信
供试品溶液-2批-缬沙坦-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%
15min1759017-75901713.85714.995.5013.8614.995.49
2810067-81006714.78914.79
3848734-84873415.49515.49
4789483-78948314.41314.41
5886800-88680016.19016.19
6831808-83180815.18615.19
5min11347313-134731324.59726.183.8524.6226.203.85
21441273-144127326.31226.34
31487537-148753727.15727.18
41402109-140210925.59725.62
51430769-143076926.12126.15
61494811-149481127.29027.32
10min11837046-183704633.53835.324.6633.6035.394.67
21938408-193840835.38835.46
32086654-208665438.09538.17
41864413-186441334.03734.10
51902246-190224634.72834.80
61979224-197922436.13336.20
20min12264610-226461041.34343.905.6941.4644.025.69
22390121-239012143.63543.76
32660121-266012148.56448.70
42317489-231748942.30942.43
52380826-238082643.46543.59
62413905-241390544.06944.20
30min13006526-300652654.88856.893.4655.0857.103.46
23132296-313229657.18457.38
33315859-331585960.53560.75
43104249-310424956.67256.87
53043316-304331655.56055.76
63096254-309625456.52656.73
45min13772568-377256868.87371.252.7369.1571.542.73
23934499-393449971.82972.12
34078817-407881774.46474.78
43932630-393263071.79572.08
53869255-386925570.63870.93
63829046-382904669.90470.20
60min14274266-427426678.03279.751.8678.4380.171.87
24428914-442891480.85681.27
34464558-446455881.50681.95
44428549-442854980.84981.26
54301862-430186278.53678.95
64312555-431255578.73179.15
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.771157041159901157101157781156851157730.11
213.791166801163811165300.19
单位质量响应值RSD%判断
8407.638450.330.36数据可信
供试品溶液-1批-左氨氯地平-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%
15min1387134-387134289.988306.164.63289.99306.164.63
2394720-394720295.670295.67
3402833-402833301.747301.75
4438506-438506328.469328.47
5406417-406417304.432304.43
6422702-422702316.631316.63
5min1104395-10439578.19876.711.6578.6877.211.63
2100900-10090075.58076.07
3102170-10217076.53277.03
4100639-10063975.38575.93
5104520-10452078.29278.80
6101790-10179076.24776.77
10min1114052-11405285.43283.593.5086.0584.223.46
2108170-10817081.02681.64
3114819-11481986.00786.64
4107796-10779680.74681.42
5116354-11635487.15787.79
6108327-10832781.14481.80
20min1118912-11891289.07386.053.6789.8386.833.63
2113100-11310084.71985.47
3112978-11297884.62885.40
4111140-11114083.25184.06
5121365-12136590.91091.69
6111775-11177583.72784.52
30min1118267-11826788.58987.643.3689.4988.563.32
2113975-11397585.37586.27
3120071-12007189.94190.86
4112019-11201983.90984.86
5122373-12237391.66592.60
6115277-11527786.35087.28
45min1118718-11871888.92787.762.4789.9888.832.44
2115060-11506086.18787.22
3119718-11971889.67690.74
4113716-11371685.18086.27
5120654-12065490.37791.46
6115116-11511686.22987.30
60min1119719-11971989.67788.543.5790.8889.753.53
2116289-11628987.10888.29
3121012-12101290.64691.86
4112420-11242084.21085.44
5124120-12412092.97494.21
6115616-11561686.60487.82
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.734774936477630547756484776434477520847757060.02
215.704799575480027147999230.02
单位质量响应值RSD%判断
303604.96305727.580.50数据可信
供试品溶液-1批-缬沙坦-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%
15min12136975-213697539.10053.6523.1939.1053.6523.19
22901484-290148453.08853.09
32431226-243122644.48444.48
43772259-377225969.02169.02
52626955-262695548.06548.07
63723890-372389068.13668.14
5min14389130-438913080.30772.3711.4680.3772.4611.41
23909604-390960471.53471.62
34315112-431511278.95379.03
43382948-338294861.89762.01
54294083-429408378.56878.65
63441818-344181862.97563.09
10min15037788-503778892.17684.4110.9492.3784.6210.91
24588860-458886083.96284.17
35056115-505611592.51192.72
43936499-393649972.02672.24
54990079-499007991.30391.51
64069739-406973974.46474.68
20min15248927-524892796.03987.9810.8996.3988.3310.86
24777429-477742987.41287.76
35254484-525448496.14196.50
44093112-409311274.89175.23
55215991-521599195.43695.80
64261469-426146977.97278.31
30min15299983-529998396.97388.7310.8197.4989.2210.78
24805555-480555587.92788.42
35303712-530371297.04197.56
44131288-413128875.59076.05
55244008-524400895.94996.47
64311593-431159378.88979.36
45min15309891-530989197.15488.8510.8497.8389.5010.81
24807713-480771387.96688.61
35314935-531493597.24797.93
44131466-413146675.59376.18
55251302-525130296.08296.76
64322415-432241579.08779.69
60min15307732-530773297.11588.9911.0597.9589.7811.02
24803556-480355687.89088.68
35311721-531172197.18898.03
44127195-412719575.51576.23
55313472-531347297.22098.06
64318557-431855779.01679.75
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.771158941156831157281157761156261157410.09
213.791164691162331163510.15
单位质量响应值RSD%判断
8405.308437.350.27数据可信
供试品溶液-2批-左氨氯地平-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%
15min1415889-415889311.809311.043.46311.81311.043.46
2397306-397306297.877297.88
3401809-401809301.253301.25
4436853-436853327.527327.53
5422698-422698316.914316.91
6414659-414659310.887310.89
5min1105386-10538679.01275.618.0179.5376.137.97
2100820-10082075.58976.09
384823-8482363.59564.10
4105909-10590979.40479.95
5105047-10504778.75879.29
6103080-10308077.28377.80
10min1115946-11594686.93086.247.2187.5886.887.18
2113092-11309284.79085.41
399642-9964274.70675.31
4121130-12113090.81691.49
5122580-12258091.90392.56
6117793-11779388.31488.96
20min1121341-12134190.97489.317.8091.7790.107.77
2116052-11605287.00987.77
3102289-10228976.69077.42
4127731-12773195.76596.59
5126661-12666194.96395.78
6120677-12067790.47791.27
30min1122589-12258991.91090.767.9192.8691.697.88
2117841-11784188.35089.26
3103557-10355777.64178.50
4129404-12940497.02098.01
5128811-12881196.57597.55
6124092-12409293.03793.98
45min1122023-12202391.48690.957.5092.5992.047.47
2119026-11902689.23990.29
3104893-10489378.64379.63
4129238-12923896.89598.05
5129823-12982397.33498.47
6122822-12282292.08593.18
60min1123213-12321392.37891.965.1693.6393.205.16
2119877-11987789.87791.08
3112358-11235884.24085.36
4127159-12715995.33696.65
5130733-13073398.01699.31
6122591-12259191.91293.17
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.734772275477196347729084771734477350647724770.02
215.704797872479852047981960.01
单位质量响应值RSD%判断
303399.68305617.580.52数据可信
供试品溶液-2批-缬沙坦-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%
15min12292336-229233641.96440.514.8041.9640.514.80
22247375-224737541.14141.14
32213798-221379840.52740.53
42315874-231587442.39542.40
52019183-201918336.96436.96
62188006-218800640.05440.05
5min14257358-425735877.93777.681.0478.0177.751.05
24254569-425456977.88677.95
34299635-429963578.71178.78
44260799-426079978.00078.07
54215723-421572377.17577.24
64171607-417160776.36776.43
10min14986687-498668791.28892.461.0691.4992.661.06
24998493-499849391.50491.70
35078765-507876592.97493.17
45096898-509689893.30693.51
55113879-511387993.61793.81
65029572-502957292.07392.27
20min15179676-517967694.82196.051.0895.1796.401.08
25177805-517780594.78795.14
35272957-527295796.52996.88
45312018-531201897.24497.60
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30min15200261-520026195.19896.641.2395.7197.151.23
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