缬沙坦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%
114.112500442499362501442501702498282500240.06
214.042512192516942514560.14
单位质量响应值RSD%判断
17719.6317909.970.76数据可信
供试品溶液-2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%
5min1146674-14667453.37454.041.2253.3754.041.22
2147872-14787253.81053.81
3146517-14651753.31753.32
4148934-14893454.19654.20
5150755-15075554.85954.86
6150296-15029654.69254.69
10min1174020-17402063.32563.700.9563.4163.790.95
2172869-17286962.90663.00
3176220-17622064.12564.21
4177522-17752264.59964.69
5174412-17441263.46763.56
6175275-17527563.78163.87
15min1183135-18313566.64267.911.2266.8468.101.22
2185709-18570967.57867.77
3186959-18695968.03368.23
4190087-19008769.17169.37
5186372-18637267.82068.02
6187410-18741068.19768.39
20min1190532-19053269.33370.321.1169.6470.621.11
2192245-19224569.95770.26
3193893-19389370.55670.87
4196956-19695671.67171.98
5192979-19297970.22470.53
6192787-19278770.15470.47
30min1199386-19938672.55573.511.1472.9873.941.13
2200588-20058872.99373.42
3202205-20220573.58174.01
4206133-20613375.01175.44
5201645-20164573.37773.80
6202090-20209073.53973.97
45min1207611-20761175.54876.891.3776.0977.441.37
2209647-20964776.28976.83
3211649-21164977.01877.57
4216077-21607778.62979.19
5210395-21039576.56177.11
6212471-21247177.31777.87
60min1214557-21455778.07678.311.4278.7478.981.41
2215523-21552378.42779.10
3216145-21614578.65479.33
4219301-21930179.80280.49
5209900-20990076.38177.06
6215729-21572978.50279.18
90min1221298-22129880.52981.541.4881.3382.341.47
2223300-22330081.25782.06
3223061-22306181.17181.98
4230620-23062083.92184.74
5223381-22338181.28782.09
6222728-22272881.04981.86
120min1223576-22357681.35882.661.8782.2983.611.86
2221643-22164380.65581.59
3228532-22853283.16184.11
4233545-23354584.98685.95
5226649-22664982.47683.42
6229060-22906083.35484.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1226434-22643482.39882.662.7983.4783.742.76
2227654-22765482.84283.92
3215910-21591078.56879.65
4234557-23455785.35486.46
5227041-22704182.61983.70
6231331-23133184.18085.26
缬沙坦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100
标示量(mg)160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%
115.509202676920185892014219211513920806592051070.05
215.619226601923941292330060.10
单位质量响应值RSD%判断
593877.87591480.200.29数据可信
供试品溶液-2批-缬沙坦-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%
5min1461886-4618864.3444.422.784.344.422.79
2465923-4659234.3824.38
3450540-4505404.2384.24
4478392-4783924.4994.50
5476312-4763124.4804.48
6486799-4867994.5794.58
10min11007702-10077029.4789.601.749.499.611.73
21010962-10109629.5099.52
3999558-9995589.4019.41
41036790-10367909.7519.76
51027373-10273739.6639.67
61044250-10442509.8229.83
15min11433775-143377513.48513.822.1213.5113.842.12
21466197-146619713.79013.81
31430980-143098013.45913.48
41498438-149843814.09314.12
51484490-148449013.96213.99
61501033-150103314.11814.14
20min11784241-178424116.78217.131.8816.8317.181.88
21815150-181515017.07217.12
31779975-177997516.74116.79
41853599-185359917.43417.48
51836392-183639217.27217.32
61859488-185948817.48917.54
30min12257913-225791321.23721.942.4221.3122.012.42
22320475-232047521.82521.90
32279300-227930021.43821.51
42400250-240025022.57522.65
52357604-235760422.17422.25
62378388-237838822.37022.45
45min12831008-283100826.62727.252.1526.7427.362.14
22879971-287997127.08727.20
32827498-282749826.59426.70
42963901-296390127.87727.99
52912583-291258327.39427.51
62968245-296824527.91828.03
60min13239702-323970230.47130.971.8630.6231.131.86
23269960-326996030.75530.91
33221832-322183230.30330.46
43383918-338391831.82731.99
53306606-330660631.10031.26
63335268-333526831.37031.53
90min13763829-376382935.40036.021.7035.6036.231.71
23803949-380394935.77835.99
33767392-376739235.43435.64
43935474-393547437.01537.23
53851227-385122736.22236.43
63854556-385455636.25436.47
120min14139893-413989338.93739.531.5239.2039.801.52
24188316-418831639.39339.66
34129607-412960738.84139.10
44296242-429624240.40840.68
54225182-422518239.74040.01
64241105-424110539.88940.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14345398-434539840.87041.231.4941.2041.561.49
24383607-438360741.23041.56
34309241-430924140.53040.86
44484133-448413342.17542.52
54343885-434388540.85641.19
64433558-443355841.69942.04
缬沙坦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%
114.112535532535162535812534062537742535660.06
214.042509322514372511840.15
单位质量响应值RSD%判断
17970.6617890.600.32数据可信
供试品溶液-2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%
5min1151646-15164654.82552.223.2154.8352.223.22
2145617-14561752.64652.65
3140483-14048350.78950.79
4146430-14643052.94052.94
5138597-13859750.10850.11
6143880-14388052.01852.02
10min1174702-17470263.16161.351.8863.2561.431.88
2170456-17045661.62661.71
3168088-16808860.77060.85
4170685-17068561.70961.80
5165107-16510759.69259.78
6169040-16904061.11461.20
15min1184486-18448666.69864.772.0366.8964.962.03
2180495-18049565.25565.45
3177041-17704164.00664.19
4179923-17992365.04865.24
5173623-17362362.77162.95
6179284-17928464.81765.01
20min1191052-19105269.07267.091.8069.3867.391.81
2185675-18567567.12867.43
3183457-18345766.32666.62
4186259-18625967.33967.64
5181048-18104865.45565.74
6185957-18595767.23067.53
30min1198569-19856971.79070.092.6872.2170.502.68
2196426-19642671.01571.43
3192234-19223469.49969.90
4195880-19588070.81771.23
5184149-18414966.57666.97
6195961-19596170.84771.26
45min1209576-20957675.76973.393.0476.3173.923.03
2205010-20501074.11874.65
3192657-19265769.65270.17
4206207-20620774.55175.08
5198828-19882871.88372.39
6205739-20573974.38274.91
60min1216192-21619278.16176.841.5378.8377.491.53
2214304-21430477.47878.13
3210082-21008275.95276.59
4212805-21280576.93677.59
5207426-20742674.99275.62
6214474-21447477.54078.19
90min1225552-22555281.54580.601.2482.3481.371.25
2223287-22328780.72681.51
3220679-22067979.78380.54
4225166-22516681.40582.19
5218579-21857979.02479.78
6224326-22432681.10281.88
120min1232391-23239184.01782.811.2284.9583.721.23
2228893-22889382.75383.67
3227018-22701882.07582.97
4230872-23087283.46884.39
5224730-22473081.24882.13
6230364-23036483.28584.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1237526-23752685.87484.181.5386.9585.221.53
2236233-23623385.40686.46
3229878-22987883.10984.14
4233012-23301284.24285.30
5228384-22838482.56983.59
6231944-23194483.85684.91
缬沙坦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100
标示量(mg)160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%
115.504702964470715947128444715788471666747110840.13
215.614631018463684546339320.09
单位质量响应值RSD%判断
303940.90296856.631.67数据可信
供试品溶液-2批-缬沙坦-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%
5min1217519-2175194.0374.082.864.044.082.83
2223315-2233154.1454.14
3212565-2125653.9453.95
4223619-2236194.1504.15
5213076-2130763.9553.95
6227974-2279744.2314.23
10min1455685-4556858.4578.412.138.468.422.09
2452044-4520448.3908.40
3437995-4379958.1298.14
4462706-4627068.5878.59
5447524-4475248.3068.31
6463255-4632558.5988.60
15min1644310-64431011.95811.942.7011.9811.962.70
2641508-64150811.90611.93
3614361-61436111.40211.42
4658606-65860612.22312.24
5637769-63776911.83611.86
6663215-66321512.30912.33
20min1811296-81129615.05714.983.0515.1015.023.06
2801584-80158414.87714.92
3761446-76144614.13214.17
4827417-82741715.35615.40
5811594-81159415.06315.10
6828509-82850915.37615.42
30min11073771-107377119.92819.952.6519.9920.022.64
21069778-106977819.85419.92
31022846-102284618.98319.05
41101127-110112720.43620.50
51084105-108410520.12020.19
61098012-109801220.37820.45
45min11412701-141270126.21926.302.2826.3226.402.28
21406956-140695626.11226.21
31361649-136164925.27125.37
41450237-145023726.91527.02
51423336-142333626.41626.51
61446461-144646126.84526.95
60min11698751-169875131.52731.352.2331.6731.492.24
21672874-167287431.04731.19
31621661-162166130.09730.23
41715729-171572931.84231.99
51699144-169914431.53531.68
61725850-172585032.03032.18
90min12100251-210025138.97939.132.1539.1739.322.16
22092794-209279438.84139.03
32030674-203067437.68837.87
42158505-215850540.06040.26
52126229-212622939.46139.66
62140920-214092039.73439.93
120min12403019-240301944.59844.961.8844.8645.221.89
22401845-240184544.57644.83
32353068-235306843.67143.92
42477336-247733645.97746.24
52437986-243798645.24745.51
62460768-246076845.67045.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12659953-265995349.36749.121.7249.7049.451.72
22652050-265205049.22049.55
32558604-255860447.48647.81
42691853-269185349.95950.30
52660198-266019849.37149.71
62656745-265674549.30749.65
缬沙坦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%
114.112511812511992513352512622511822512320.03
214.042518582521332519960.08
单位质量响应值RSD%判断
17805.2417948.430.57数据可信
供试品溶液-2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%
5min139213-3921314.22014.343.8014.2214.343.79
238787-3878714.06514.07
337229-3722913.50013.50
439859-3985914.45414.45
540874-4087414.82214.82
641376-4137615.00415.00
10min182056-8205629.75629.471.7529.7829.491.75
280902-8090229.33729.36
379626-7962628.87428.90
483313-8331330.21130.24
581830-8183029.67429.70
679828-7982828.94828.97
15min1113103-11310341.01440.911.3941.0940.981.39
2112151-11215140.66940.74
3111334-11133440.37340.44
4115676-11567641.94742.02
5112841-11284140.91940.99
6111711-11171140.50940.58
20min1139381-13938150.54349.861.6650.6850.001.65
2138425-13842550.19750.34
3138906-13890650.37150.51
4138887-13888750.36450.51
5133759-13375948.50548.65
6135613-13561349.17749.32
30min1170211-17021161.72362.321.1961.9562.551.18
2174444-17444463.25863.48
3172411-17241162.52162.74
4173984-17398463.09163.32
5170153-17015361.70261.93
6169992-16999261.64461.87
45min1204299-20429974.08473.121.4774.4173.451.46
2204661-20466174.21574.54
3202027-20202773.26073.59
4202525-20252573.44173.77
5199314-19931472.27772.60
6197056-19705671.45871.78
60min1218785-21878579.33778.992.0179.7979.442.00
2221772-22177280.42080.87
3223635-22363581.09681.54
4216337-21633778.45078.91
5212767-21276777.15577.60
6213635-21363577.47077.91
90min1231146-23114683.82083.091.5684.4083.671.55
2234684-23468485.10385.69
3229263-22926383.13783.72
4228357-22835782.80883.39
5227045-22704582.33382.91
6224294-22429481.33581.91
120min1234095-23409584.88984.541.9985.6185.271.98
2238063-23806386.32887.06
3238082-23808286.33587.06
4233024-23302484.50185.23
5228049-22804982.69783.41
6227554-22755482.51783.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1252230-25223091.46590.981.3292.3391.841.31
2252401-25240191.52792.40
3255534-25553492.66393.53
4247064-24706489.59290.46
5247164-24716489.62890.48
6251004-25100491.02191.87
缬沙坦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100
标示量(mg)160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%
115.509229549922754192249709227977922629792272670.02
215.619217287923141792243520.11
单位质量响应值RSD%判断
595307.55590925.820.53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%
5min13337278-333727831.36630.951.7731.3730.951.77
23289542-328954230.91730.92
33180383-318038329.89129.89
43331516-333151631.31131.31
53301678-330167831.03131.03
63317374-331737431.17931.18
10min15189332-518933248.77248.201.1048.8248.251.10
25117475-511747548.09748.15
35045386-504538647.41947.47
45191203-519120348.79048.84
55095328-509532847.88947.94
65131149-513114948.22548.28
15min16227048-622704858.52558.260.7658.6658.390.76
26201192-620119258.28258.41
36163017-616301757.92458.05
46264548-626454858.87859.01
56131830-613183057.63057.76
66205242-620524258.32058.45
20min16945507-694550765.27865.000.8165.5165.230.81
26944547-694454765.26965.50
36930232-693023265.13465.36
46971385-697138565.52165.75
56816185-681618564.06264.29
66888544-688854464.74264.97
30min17835559-783555973.64373.260.8773.9873.600.87
27848135-784813573.76174.10
37809211-780921173.39573.73
47836538-783653873.65273.99
57670330-767033072.09072.42
67770156-777015673.02873.37
45min18537620-853762080.24179.810.9380.7080.270.93
28563805-856380580.48880.95
38539947-853994780.26380.72
48516927-851692780.04780.51
58360224-836022478.57479.03
68431691-843169179.24679.71
60min18852494-885249483.20182.861.0783.8083.451.07
28888480-888848083.53984.13
38907816-890781683.72184.31
48828429-882842982.97583.57
58652767-865276781.32481.91
68768133-876813382.40883.00
90min19106485-910648585.58885.120.8286.3285.850.81
29135324-913532485.85986.59
39108331-910833185.60586.33
49052164-905216485.07785.81
58949744-894974484.11584.84
68990295-899029584.49685.22
120min19133869-913386985.84585.581.0686.7286.461.05
29190562-919056286.37887.26
39195646-919564686.42687.30
49120860-912086085.72386.60
58942150-894215084.04384.90
69053395-905339585.08985.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限19754099-975409991.67591.030.7592.7092.040.75
29676716-967671690.94791.97
39756175-975617591.69492.71
49692140-969214091.09292.11
59559158-955915889.84290.84
69674939-967493990.93191.94
缬沙坦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%
114.112501702502912502972502252503022502570.03
214.042527742522872525300.14
单位质量响应值RSD%判断
17736.1417986.471.00数据可信
供试品溶液-2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%
5min138426-3842613.94713.275.5413.9513.275.55
234441-3444112.50012.50
335834-3583413.00613.01
435583-3558312.91512.91
539666-3966614.39714.40
635391-3539112.84512.85
10min180057-8005729.05727.833.4329.0827.863.43
272962-7296226.48226.50
375721-7572127.48327.50
475993-7599327.58227.60
579389-7938928.81528.84
676000-7600027.58427.61
15min1110531-11053140.11839.232.6640.1939.292.66
2103913-10391337.71637.78
3108211-10821139.27639.34
4105476-10547638.28338.35
5111254-11125440.38040.45
6109059-10905939.58339.65
20min1135583-13558349.21048.272.1949.3548.412.19
2129410-12941046.97047.10
3130662-13066247.42447.56
4131555-13155547.74847.88
5136762-13676249.63849.78
6133997-13399748.63548.77
30min1172835-17283562.73161.961.3962.9562.171.39
2167356-16735660.74360.95
3171192-17119262.13562.35
4168552-16855261.17761.39
5170887-17088762.02462.25
6173393-17339362.93463.15
45min1208047-20804775.51175.571.2175.8475.891.22
2203846-20384673.98774.29
3208070-20807075.52075.84
4208363-20836375.62675.94
5211491-21149176.76177.09
6209486-20948676.03476.35
60min1230948-23094883.82383.310.9284.2783.760.92
2229098-22909883.15283.58
3228708-22870883.01083.45
4226804-22680482.31982.76
5232891-23289184.52984.98
6228803-22880383.04583.49
90min1253055-25305591.84790.640.9792.4491.220.97
2248358-24835890.14290.71
3249397-24939790.52091.10
4248940-24894090.35490.93
5252029-25202991.47592.07
6246586-24658689.49990.08
120min1255268-25526892.65093.160.4293.3993.900.42
2257051-25705193.29894.02
3257041-25704193.29494.02
4256312-25631293.02993.76
5258393-25839393.78594.53
6256031-25603192.92793.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1265732-26573296.44895.881.0497.3596.771.03
2261635-26163594.96195.84
3261034-26103494.74395.63
4265604-26560496.40297.28
5268051-26805197.29098.19
6262982-26298295.45096.34
缬沙坦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100
标示量(mg)160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%
115.504633989463951846423614642733464034046397880.08
215.614644727465107546479010.10
单位质量响应值RSD%判断
299341.16297751.510.38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%
5min11609482-160948230.05229.523.7130.0529.533.70
21532166-153216628.60828.61
31567398-156739829.26629.27
41536503-153650328.68928.69
51686433-168643331.48931.49
61555622-155562229.04629.05
10min12569127-256912747.97046.542.0748.0246.592.08
22436531-243653145.49545.54
32464301-246430146.01346.06
42457776-245777645.89145.94
52540153-254015347.42947.48
62486599-248659946.42946.48
15min13078738-307873857.48657.031.2457.6257.161.24
23006454-300645456.13656.26
33038660-303866056.73756.86
43029743-302974356.57156.70
53111838-311183858.10458.24
63059476-305947657.12657.25
20min13482330-348233065.02264.611.1365.2564.831.14
23412387-341238763.71663.93
33434310-343431064.12564.34
43446085-344608564.34564.56
53523289-352328965.78666.01
63462239-346223964.64664.87
30min14019885-401988575.05974.830.9975.3975.160.99
23952964-395296473.80974.13
33986178-398617874.42974.76
43984687-398468774.40274.73
54056196-405619675.73776.07
64044749-404474975.52375.85
45min14498139-449813983.98983.900.8384.4584.350.83
24443888-444388882.97683.42
34471814-447181483.49783.95
44487095-448709583.78284.23
54554644-455464485.04485.51
64503171-450317184.08384.54
60min14771214-477121489.08788.750.7689.6989.350.76
24713330-471333088.00788.59
34720829-472082988.14788.74
44750313-475031388.69789.29
54812420-481242089.85790.46
64751311-475131188.71689.31
90min15007713-500771393.50393.050.6494.2593.790.64
24958869-495886992.59193.32
34943747-494374792.30993.05
44990236-499023693.17793.91
55028823-502882393.89794.65
64970455-497045592.80893.55
120min15082252-508225294.89594.440.5995.8095.340.59
25050289-505028994.29895.18
35015923-501592393.65794.55
45058486-505848694.45195.34
55099573-509957395.21896.13
65042216-504221694.14895.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15157750-515775096.30596.020.9697.3797.080.96
25099226-509922695.21296.25
35092715-509271595.09096.14
45159440-515944096.33697.39
55224285-522428597.54798.62
65121885-512188595.63596.69
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