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%
114.381240211240941238921238481237421239190.12
214.411244611241811243210.16
单位质量响应值RSD%判断
8617.458627.410.09数据可信
常温25月-供试品溶液-23041801批-左氨氯地平-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%
5min173422-7342253.76354.831.8553.7654.831.85
275723-7572355.44855.45
372881-7288153.36753.37
476070-7607055.70255.70
575967-7596755.62755.63
675228-7522855.08655.09
10min183826-8382661.38262.361.7861.4762.451.78
286856-8685663.60163.69
383184-8318460.91261.00
486703-8670363.48863.58
585702-8570262.75662.85
684722-8472262.03862.13
15min188163-8816364.55865.872.0364.7566.072.03
291374-9137466.90967.11
387175-8717563.83464.02
491318-9131866.86867.07
591145-9114566.74166.94
690558-9055866.31166.51
20min191189-9118966.77367.701.2967.0768.001.29
293708-9370868.61868.93
390980-9098066.62066.92
493674-9367468.59368.90
592857-9285767.99568.30
692294-9229467.58367.89
30min194782-9478269.40470.761.5369.8271.181.53
298419-9841972.06872.49
395433-9543369.88170.29
498223-9822371.92472.35
596852-9685270.92071.34
696122-9612270.38670.80
45min198450-9845072.09073.521.6072.6274.061.60
2102395-10239574.97975.52
398915-9891572.43172.96
4102046-10204674.72375.27
5100576-10057673.64774.19
6100021-10002173.24173.78
60min1101752-10175274.50875.321.2475.1575.981.25
2104757-10475776.70977.38
3101376-10137674.23374.88
4103605-10360575.86576.53
5103354-10335475.68176.34
6102322-10232274.92675.58
90min1105332-10533277.13078.081.5477.9078.861.54
2108587-10858779.51380.31
3104176-10417676.28377.05
4107918-10791879.02379.82
5107142-10714278.45579.24
6106630-10663078.08078.86
120min1107880-10788078.99580.421.2379.8981.331.23
2111632-11163281.74382.67
3109188-10918879.95380.85
4111019-11101981.29482.22
5109442-10944280.13981.06
6109781-10978180.38781.30
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1108605-10860579.52681.351.7980.5682.401.78
2113758-11375883.30084.37
3110599-11059980.98682.02
4113106-11310682.82283.88
5110813-11081381.14382.20
6109685-10968580.31781.36
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%
115.904659132465641146576074658121465858846579720.03
215.934683292468350746834000.01
单位质量响应值RSD%判断
292954.21293998.740.26数据可信
常温25月-供试品溶液-23041801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%
5min1167963-1679633.1903.173.243.193.173.25
2171830-1718303.2643.26
3163768-1637683.1113.11
4164879-1648793.1323.13
5174237-1742373.3103.31
6159627-1596273.0323.03
10min1390018-3900187.4087.522.727.417.532.71
2413872-4138727.8617.87
3398085-3980857.5617.57
4388039-3880397.3717.38
5401610-4016107.6287.63
6384915-3849157.3117.32
15min1590395-59039511.21411.975.5811.2311.985.56
2624031-62403111.85311.87
3631229-63122911.99012.01
4594887-59488711.29911.32
5679309-67930912.90312.92
6660034-66003412.53712.55
20min1774465-77446514.71015.042.1414.7515.082.12
2817951-81795115.53615.57
3794138-79413815.08415.12
4779757-77975714.81114.85
5804851-80485115.28815.33
6780631-78063114.82814.87
30min11072819-107281920.37721.042.0920.4421.102.08
21134602-113460221.55121.62
31113536-111353621.15121.21
41121923-112192321.31021.37
51114963-111496321.17821.24
61087088-108708820.64920.71
45min11429989-142998927.16227.861.8127.2627.961.81
21505458-150545828.59528.70
31475419-147541928.02528.12
41458259-145825927.69927.80
51480867-148086728.12828.23
61449495-144949527.53227.63
60min11701079-170107932.31133.001.6032.4533.141.60
21777971-177797133.77133.92
31754767-175476733.33133.48
41716365-171636532.60132.74
51744561-174456133.13733.28
61728633-172863332.83432.98
90min12102160-210216039.92940.801.4640.1241.001.46
22188120-218812041.56241.77
32135385-213538540.56040.76
42138695-213869540.62340.82
52177838-217783841.36741.57
62146408-214640840.77040.97
120min12403954-240395445.66247.041.6245.9247.301.62
22493681-249368147.36647.64
32487854-248785447.25547.52
42460086-246008646.72846.99
52495733-249573347.40547.68
62517464-251746447.81848.08
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12574524-257452448.90150.241.7649.2450.581.76
22684888-268488850.99851.35
32658214-265821450.49150.84
42645594-264559450.25150.59
52697339-269733951.23451.58
62609093-260909349.55849.90
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%
114.381249691251651249511250711252971250910.12
214.411230351230891230620.04
单位质量响应值RSD%判断
8698.968540.041.31数据可信
常温25月-供试品溶液-23050401批-左氨氯地平-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%
5min174540-7454054.60551.6721.3654.6151.6821.36
276660-7666056.15856.16
340171-4017129.42829.43
473994-7399454.20554.21
577121-7712156.49656.50
680733-8073359.14259.14
10min188053-8805364.50465.312.9364.6065.402.94
288773-8877365.03265.13
388032-8803264.48964.54
486327-8632763.24063.33
589759-8975965.75465.85
693961-9396168.83268.93
15min193011-9301168.13668.811.9968.3469.002.00
294743-9474369.40569.61
393055-9305568.16968.33
491126-9112666.75666.95
595446-9544669.92070.12
696166-9616670.44870.66
20min195039-9503969.62270.822.4069.9371.132.41
297278-9727871.26271.58
394864-9486469.49469.76
494250-9425069.04469.35
598716-9871672.31672.64
699898-9989873.18273.51
30min199097-9909772.59573.622.0073.0274.052.01
2101045-10104574.02274.46
399525-9952572.90873.29
497920-9792071.73372.15
5102196-10219674.86575.31
6103197-10319775.59876.05
45min1101954-10195474.68875.982.3175.2476.532.31
2104145-10414576.29376.85
3103169-10316975.57876.09
4100379-10037973.53474.08
5106056-10605677.69378.26
6106604-10660478.09478.67
60min1104414-10441476.49077.591.7777.1678.261.78
2106645-10664578.12478.81
3105537-10553777.31377.95
4103244-10324475.63376.30
5107469-10746978.72879.42
6108156-10815679.23179.94
90min1108863-10886379.74980.472.2880.5581.272.28
2110692-11069281.08981.91
3108938-10893879.80480.57
4105832-10583277.52978.32
5112340-11234082.29683.12
6112386-11238682.33083.17
120min1110979-11097981.29982.281.7082.2383.221.71
2112049-11204982.08383.04
3111478-11147881.66582.56
4110116-11011680.66781.59
5114528-11452883.89984.86
6114744-11474484.05785.04
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1112830-11283082.65583.431.7883.7284.511.79
2114839-11483984.12785.22
3112703-11270382.56283.59
4111014-11101481.32582.38
5115915-11591584.91586.02
6116035-11603585.00386.12
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%
115.904698677470149347057134710459470931147051310.11
215.934659145465837146587580.02
单位质量响应值RSD%判断
295920.19292451.850.84数据可信
常温25月-供试品溶液-23050401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%
5min1172105-1721053.2613.483.913.263.483.90
2186261-1862613.5293.53
3190026-1900263.6013.60
4179260-1792603.3973.40
5182719-1827193.4623.46
6191099-1910993.6213.62
10min1406558-4065587.7048.227.017.718.227.02
2439597-4395978.3308.34
3415796-4157967.8797.88
4425213-4252138.0578.06
5423282-4232828.0218.03
6491526-4915269.3149.32
15min1631902-63190211.97412.322.1311.9912.342.14
2670737-67073712.71012.73
3637772-63777212.08512.10
4650223-65022312.32112.34
5655636-65563612.42412.44
6653661-65366112.38612.41
20min1823733-82373315.60916.101.9915.6516.141.98
2873572-87357216.55316.59
3839799-83979915.91315.95
4850643-85064316.11916.16
5854621-85462116.19416.23
6856879-85687916.23716.28
30min11150727-115072721.80522.301.6321.8722.371.63
21207389-120738922.87922.95
31164016-116401622.05722.12
41178082-117808222.32422.39
51180888-118088822.37722.44
61181300-118130022.38522.45
45min11508600-150860028.58729.301.5828.6929.411.58
21582545-158254529.98830.09
31534954-153495429.08629.19
41545424-154542429.28429.39
51556011-155601129.48529.59
61550807-155080729.38629.49
60min11793533-179353333.98634.581.0834.1334.721.08
21844164-184416434.94535.10
31807667-180766734.25434.40
41832654-183265434.72734.88
51836533-183653334.80134.95
61833287-183328734.73934.89
90min12207540-220754041.83142.411.3442.0442.621.35
22286761-228676143.33243.55
32211296-221129641.90242.11
42225377-222537742.16942.38
52255373-225537342.73742.95
62241112-224111242.46742.68
120min12506126-250612647.48948.190.9847.7648.470.98
22576221-257622148.81749.10
32524139-252413947.83048.11
42550658-255065848.33348.61
52556194-255619448.43848.72
62545032-254503248.22648.51
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12689699-268969950.96751.540.8451.3251.900.85
22753123-275312352.16952.54
32701280-270128051.18751.54
42715564-271556451.45851.82
52733655-273365551.80052.16
62725823-272582351.65252.02
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%
114.381245771242891245231243801246401244820.12
214.411257981257421257700.04
单位质量响应值RSD%判断
8656.618727.970.59数据可信
-供试品溶液-23050401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%
5min134274-3427424.89621.3311.5324.9021.3311.54
225868-2586818.79018.79
328384-2838420.61820.62
432347-3234723.49623.50
529298-2929821.28121.28
626040-2604018.91518.91
10min150851-5085136.93732.248.2536.9832.288.25
240568-4056829.46829.50
342750-4275031.05331.09
446150-4615033.52233.56
543674-4367431.72431.76
642313-4231330.73530.77
15min162969-6296945.73941.007.2645.8441.097.26
252196-5219637.91437.99
354815-5481539.81739.90
458998-5899842.85542.95
556986-5698641.39341.48
652731-5273138.30338.39
20min172939-7293952.98148.675.3453.1648.825.35
262940-6294045.71845.86
365186-6518647.35047.50
468717-6871749.91550.08
567564-6756449.07749.23
664652-6465246.96247.11
30min188912-8891264.58459.945.2064.8560.185.21
277799-7779956.51256.73
379815-7981557.97658.21
486138-8613862.56962.82
582794-8279460.14060.38
679619-7961957.83458.06
45min1106323-10632377.23172.284.2177.6172.624.22
294626-9462668.73469.05
397325-9732570.69571.02
4101828-10182873.96674.32
5100061-10006172.68273.02
696883-9688370.37470.70
60min1117101-11710185.06081.463.1985.5681.923.21
2108340-10834078.69679.12
3109674-10967479.66580.11
4115808-11580884.12184.60
5112150-11215081.46481.92
6109820-10982079.77180.21
90min1131241-13124195.33190.763.1995.9891.363.21
2119790-11979087.01387.57
3122132-12213288.71489.29
4126015-12601591.53592.15
5126667-12666792.00892.60
6123865-12386589.97390.54
120min1136734-13673499.32194.432.95100.1395.182.96
2126009-12600991.53092.24
3126590-12659091.95292.68
4130334-13033494.67295.44
5130112-13011294.51195.26
6130257-13025794.61695.34
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1138643-138643100.70895.393.18101.6896.293.19
2126095-12609591.59392.45
3129331-12933193.94394.82
4131972-13197295.86296.79
5131718-13171895.67796.58
6130173-13017394.55595.43
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%
115.904693722468502046902884689100469091946898100.07
215.934751720475225047519850.01
单位质量响应值RSD%判断
294956.60298304.140.80数据可信
-供试品溶液-23050401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%
5min11050412-105041219.74019.085.9419.7419.085.94
2947452-94745217.80517.81
31010850-101085018.99719.00
41115221-111522120.95820.96
5993888-99388818.67818.68
6972289-97228918.27218.27
10min11900549-190054935.71735.192.9735.7535.222.98
21779542-177954233.44333.47
31901934-190193435.74335.77
41935740-193574036.37836.41
51838916-183891634.55934.59
61878138-187813835.29635.33
15min12516308-251630847.28946.662.2747.3846.762.27
22385031-238503144.82244.91
32496160-249616046.91047.00
42550351-255035147.92948.02
52462508-246250846.27846.37
62488134-248813446.75946.85
20min12977494-297749455.95655.542.1256.1355.702.12
22853475-285347553.62553.79
32951636-295163655.47055.64
43043417-304341757.19557.37
52930968-293096855.08155.25
62973736-297373655.88556.05
30min13649024-364902468.57668.141.4868.8468.401.49
23527904-352790466.30066.55
33660887-366088768.79969.06
43662385-366238568.82769.10
53598769-359876967.63167.89
63656685-365668568.72068.98
45min14270295-427029580.25179.701.5880.6380.071.58
24139644-413964477.79678.16
34235499-423549979.59779.97
44236989-423698979.62580.01
54217527-421752779.26079.63
64344360-434436081.64382.02
60min14605618-460561886.55386.301.0087.0786.811.00
24577513-457751386.02586.51
34579535-457953586.06386.57
44549936-454993685.50786.02
54563651-456365185.76486.27
64677967-467796787.91388.42
90min14969321-496932193.38892.521.7094.0493.181.69
24862812-486281291.38692.02
34954157-495415793.10393.76
44813256-481325690.45591.12
54893965-489396591.97292.62
65046695-504669594.84295.50
120min15084088-508408895.54594.691.9396.3695.491.92
24996552-499655293.90094.69
35025784-502578494.44995.26
44910282-491028292.27993.09
55014387-501438794.23595.03
65199293-519929397.71098.53
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15125699-512569996.32795.301.9197.3096.261.89
25053771-505377194.97595.92
35051212-505121294.92795.89
44920573-492057392.47293.44
55062361-506236195.13796.09
65212794-521279497.96498.94
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