左氨氯地平缬沙坦片项目信息
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%
114.392512762510792509452508852507692509910.08
214.362510302508542509420.05
单位质量响应值RSD%判断
17442.0417475.070.14数据可信
长期9月-供试品溶液-2023112221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%
5min187208-8720832.38132.064.2832.3832.064.28
281791-8179130.37030.37
391294-9129433.89833.90
483761-8376131.10131.10
584318-8431831.30831.31
689735-8973533.31933.32
10min1128340-12834047.65449.573.5847.7149.623.57
2128709-12870947.79147.84
3140334-14033452.10752.16
4131451-13145148.80948.86
5136249-13624950.59050.64
6135860-13586050.44650.50
15min1157407-15740758.44762.484.1258.5862.624.11
2166380-16638061.77861.91
3164262-16426260.99261.14
4175460-17546065.15065.28
5174576-17457664.82264.96
6171609-17160963.72063.86
20min1179268-17926866.56470.073.0166.7970.313.01
2189395-18939570.32470.56
3188775-18877570.09470.34
4195987-19598772.77273.01
5192360-19236071.42571.67
6186524-18652469.25869.50
30min1208789-20878977.52579.682.4577.8780.042.44
2218829-21882981.25381.60
3218711-21871181.20981.57
4220413-22041381.84182.20
5210210-21021078.05378.42
6210610-21061078.20178.56
45min1231503-23150385.95987.622.4786.4388.102.46
2239573-23957388.95689.44
3237963-23796388.35888.85
4244835-24483590.90991.41
5229581-22958185.24585.74
6232326-23232686.26586.76
60min1241251-24125189.57990.232.7890.1990.862.77
2246117-24611791.38592.02
3250294-25029492.93693.58
4249633-24963392.69193.34
5234671-23467187.13587.77
6236040-23604087.64488.28
极限1241626-24162689.71892.062.9190.4892.842.90
2257431-25743195.58696.37
3251709-25170993.46294.26
4252555-25255593.77694.58
5238441-23844188.53589.32
6245836-24583691.28192.06
左氨氯地平缬沙坦片项目信息
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%
116.294622826462087346195674619354461697346199190.05
216.294623211462238346227970.02
单位质量响应值RSD%判断
283604.60283781.280.05数据可信
长期9月-供试品溶液-2023112221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%
5min13588409-358840970.51072.382.7070.5172.382.70
23616796-361679671.06871.07
33822151-382215175.10375.10
43587632-358763270.49570.49
53754646-375464673.77673.78
63732911-373291173.34973.35
10min14323592-432359284.95687.201.6485.0787.321.64
24435787-443578787.16087.28
34507288-450728888.56588.69
44383934-438393486.14186.26
54503134-450313488.48488.61
64472821-447282187.88888.01
15min14801812-480181294.35293.781.6194.6194.041.60
24727298-472729892.88893.15
34644965-464496591.27091.54
44803375-480337594.38394.64
54793066-479306694.18194.45
64865362-486536295.60195.87
20min14830179-483017994.91096.661.8395.3397.091.81
24982388-498238897.90198.32
34990794-499079498.06698.49
45022879-502287998.69699.11
54871540-487154095.72296.15
64819092-481909294.69295.12
30min15041699-504169999.06699.941.8199.64100.531.80
25174663-5174663101.679102.26
35147294-5147294101.141101.73
45178799-5178799101.760102.34
55007711-500771198.39898.99
64967947-496794797.61798.20
45min15120694-5120694100.618101.191.72101.36101.941.71
25241097-5241097102.984103.74
35224860-5224860102.665103.42
45211877-5211877102.410103.16
55071911-507191199.660100.41
65029555-502955598.82799.58
60min15097827-5097827100.169101.021.92101.08101.941.91
25243000-5243000103.021103.94
35208250-5208250102.339103.27
45232240-5232240102.810103.73
55040723-504072399.04799.96
65025410-502541098.74699.66
极限15215436-5215436102.480101.901.41103.55102.991.40
25275314-5275314103.656104.75
35200937-5200937102.195103.29
45200748-5200748102.191103.29
55055197-505519799.331100.41
65169250-5169250101.572102.65
左氨氯地平缬沙坦片项目信息
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%
114.392487102484482484872482402480062483780.11
214.362481432481182481300.01
单位质量响应值RSD%判断
17260.4617279.250.08数据可信
长期9月-供试品溶液-2023112221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%
5min179226-7922629.73931.624.5629.7431.624.55
281683-8168330.66130.66
385554-8555432.11432.11
487472-8747232.83432.83
589284-8928433.51433.51
682152-8215230.83730.84
10min1126248-12624847.38949.353.7647.4449.403.77
2129156-12915648.48148.53
3126462-12646247.47047.52
4134498-13449850.48650.54
5138450-13845051.96952.03
6134028-13402850.31050.36
15min1156679-15667958.81262.814.2258.9462.954.22
2164710-16471061.82761.96
3163269-16326961.28661.42
4174890-17489065.64865.79
5174074-17407465.34165.48
6170430-17043063.97464.11
20min1187969-18796970.55772.532.7570.7872.772.75
2192590-19259072.29272.53
3186274-18627469.92170.16
4199904-19990475.03775.29
5196685-19668573.82974.08
6195975-19597573.56273.80
30min1218228-21822881.91581.702.4682.2682.062.46
2210968-21096879.19079.55
3211352-21135279.33479.69
4223872-22387284.03484.41
5221369-22136983.09483.47
6220124-22012482.62782.99
45min1238462-23846289.51089.212.5489.9989.702.54
2230053-23005386.35486.84
3232700-23270087.34887.83
4243769-24376991.50392.02
5235719-23571988.48188.99
6245255-24525592.06092.56
60min1250726-25072694.11492.072.8094.7492.722.79
2235870-23587088.53889.17
3238109-23810989.37890.01
4252320-25232094.71295.38
5245458-24545892.13792.80
6249243-24924393.55794.21
极限1252251-25225194.68693.823.2495.4794.623.23
2239354-23935489.84590.62
3242117-24211790.88291.66
4261368-26136898.10998.93
5250409-25040993.99594.81
6254205-25420595.42096.23
左氨氯地平缬沙坦片项目信息
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%
116.294622153462182246194784615596461246746183030.10
216.294623263462391946235910.02
单位质量响应值RSD%判断
283505.40283830.020.09数据可信
长期9月-供试品溶液-2023112221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%
5min13625086-362508671.23772.602.6971.2472.602.70
23590622-359062270.56070.56
33607100-360710070.88370.88
43746750-374675073.62873.63
53827089-382708975.20675.21
63770788-377078874.10074.10
10min14437637-443763787.20487.311.6287.3287.431.62
24384223-438422386.15586.27
34333704-433370485.16285.28
44486279-448627988.16088.28
54510707-451070788.64088.77
64505275-450527588.53488.66
15min14804711-480471194.41893.841.4994.6894.111.49
24731093-473109392.97193.23
34656127-465612791.49891.76
44803820-480382094.40094.67
54798544-479854494.29794.57
64857731-485773195.46095.73
20min14997271-499727198.20297.111.5798.6297.541.57
24888154-488815496.05896.47
34823567-482356794.78895.20
44977258-497725897.80898.24
54930968-493096896.89997.33
65034532-503453298.93499.36
30min15155159-5155159101.30499.911.62101.89100.501.62
25016744-501674498.58499.16
34978812-497881297.83998.41
45119252-5119252100.599101.19
55048758-504875899.21499.81
65187795-5187795101.946102.54
45min15223000-5223000102.638100.971.60103.39101.721.60
25074452-507445299.718100.46
35044277-504427799.12599.86
45174824-5174824101.691102.45
55079709-507970999.822100.58
65232759-5232759102.829103.59
60min15221306-5221306102.604100.971.58103.53101.901.58
25073328-507332899.696100.60
35054282-505428299.322100.22
45175188-5175188101.698102.63
55072810-507281099.686100.61
65233279-5233279102.840103.78
极限15210005-5210005102.382101.391.46103.48102.471.45
25067506-506750699.582100.65
35168621-5168621101.569102.63
45222495-5222495102.628103.72
55064538-506453899.524100.61
65223006-5223006102.638103.75
左氨氯地平缬沙坦片项目信息
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%
114.392478942478812476302477582473382477000.10
214.362486242484012485120.07
单位质量响应值RSD%判断
17213.3417305.850.38数据可信
长期9月-供试品溶液-2023112421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%
5min173083-7308327.44928.5810.0827.4528.5810.09
280874-8087430.37630.38
383289-8328931.28331.28
462652-6265223.53223.53
575245-7524528.26128.26
681487-8148730.60630.61
10min1112841-11284142.38244.726.1042.4344.776.10
2123223-12322346.28246.33
3124559-12455946.78346.84
4107306-10730640.30340.34
5121981-12198145.81545.86
6124544-12454446.77846.83
15min1143430-14343053.87156.684.7353.9956.814.73
2161061-16106160.49360.62
3157532-15753259.16859.30
4144269-14426954.18654.29
5150949-15094956.69556.82
6148267-14826755.68855.82
20min1170955-17095564.20967.523.4164.4267.743.41
2184868-18486869.43569.66
3182612-18261268.58868.82
4174297-17429765.46465.66
5179451-17945167.40067.62
6186516-18651670.05470.28
30min1200697-20069775.38078.872.4875.6979.202.49
2214868-21486880.70381.05
3210919-21091979.21979.56
4208427-20842778.28378.59
5210403-21040379.02679.36
6214610-21461080.60680.94
45min1218547-21854782.08487.083.3982.5287.543.38
2237173-23717389.08089.56
3226858-22685885.20685.68
4238550-23855089.59790.03
5232289-23228987.24687.71
6237640-23764089.25689.73
60min1228062-22806285.65891.393.8886.2391.993.86
2246002-24600292.39693.02
3237510-23751089.20789.82
4254408-25440895.55396.14
5243759-24375991.55492.16
6250187-25018793.96894.59
极限1237211-23721189.09494.903.5489.8195.663.52
2254855-25485595.72196.50
3249192-24919293.59494.36
4263952-26395299.13899.88
5254970-25497095.76596.52
6255901-25590196.11496.89
左氨氯地平缬沙坦片项目信息
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%
116.294617518461811946166074616558461403846165680.04
216.294637392463722446373080.01
单位质量响应值RSD%判断
283398.90284672.070.32数据可信
长期9月-供试品溶液-2023112421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%
5min13525673-352567369.19468.638.2569.1968.638.25
23534952-353495269.37669.38
33677897-367789772.18172.18
42932417-293241757.55157.55
53577564-357756470.21270.21
63733459-373345973.27273.27
10min14299589-429958984.38384.274.9084.5084.394.90
24319957-431995784.78284.90
34403980-440398086.43186.55
43889061-388906176.32676.42
54358026-435802685.52985.65
64493829-449382988.19588.32
15min14660960-466096091.47592.192.4091.7392.442.41
24701960-470196092.27992.54
34737275-473727592.97293.24
44517161-451716188.65388.88
54701768-470176892.27692.54
64864302-486430295.46595.73
20min14844720-484472095.08196.301.6195.4996.711.61
24881146-488114695.79696.21
34914395-491439596.44996.87
44851525-485152595.21595.59
54890437-489043795.97896.39
65058742-505874299.28199.71
30min15004732-500473298.22299.981.6598.79100.551.64
25040819-504081998.93099.50
35055310-505531099.21499.79
45165533-5165533101.377101.91
55075412-507541299.609100.18
65225014-5225014102.545103.14
45min15063061-506306199.366101.812.10100.10102.542.08
25120266-5120266100.489101.22
35124212-5124212100.566101.31
45327343-5327343104.553105.25
55178930-5178930101.640102.38
65310901-5310901104.230104.99
60min15061498-506149899.336101.962.30100.23102.872.28
25117702-5117702100.439101.34
35125461-5125461100.591101.50
45352454-5352454105.046105.92
55187034-5187034101.799102.71
65327945-5327945104.565105.50
极限15062247-506224799.350101.922.24100.41102.992.22
25115272-5115272100.391101.46
35109106-5109106100.270101.35
45341053-5341053104.822105.87
55215116-5215116102.350103.43
65315251-5315251104.316105.43
左氨氯地平缬沙坦片项目信息
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%
114.392467832468652468502466282466312467510.05
214.362487542488022487780.02
单位质量响应值RSD%判断
17147.3917324.370.73数据可信
长期9月-供试品溶液-2023112421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%
5min186496-8649632.53231.123.4332.5331.123.43
279705-7970529.97829.98
382296-8229630.95330.95
485735-8573532.24632.25
582127-8212730.88930.89
680042-8004230.10530.11
10min1134445-13444550.56747.324.5650.6247.374.56
2119343-11934344.88744.94
3119862-11986245.08245.13
4125010-12501047.01847.07
5129008-12900848.52248.57
6127132-12713247.81647.87
15min1170824-17082464.25060.134.6864.3960.264.68
2151511-15151156.98657.11
3152718-15271857.44057.57
4156995-15699559.04859.18
5164707-16470761.94962.08
6162474-16247461.10961.24
20min1196800-19680074.02069.244.3474.2769.474.34
2176955-17695566.55666.78
3175068-17506865.84666.07
4183090-18309068.86369.09
5188895-18889571.04671.28
6183680-18368069.08569.32
30min1225720-22572084.89780.653.3985.2781.003.39
2204105-20410576.76777.10
3209940-20994078.96279.29
4216110-21611081.28281.63
5216799-21679981.54181.90
6213969-21396980.47780.82
45min1247326-24732693.02388.963.0493.5389.443.04
2228147-22814785.81086.27
3234816-23481688.31888.78
4238112-23811289.55890.04
5241022-24102290.65291.14
6229759-22975986.41686.90
60min1257762-25776296.94892.652.8497.6193.282.85
2236310-23631088.88089.48
3245260-24526092.24692.86
4248736-24873693.55394.18
5246176-24617692.59193.23
6243799-24379991.69792.32
极限1268223-268223100.88395.812.92101.7196.592.92
2247356-24735693.03493.78
3250357-25035794.16394.93
4254705-25470595.79896.58
5256886-25688696.61997.41
6250869-25086994.35695.13
左氨氯地平缬沙坦片项目信息
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%
116.294612013461186246145164612920461154646125710.03
216.294655149465735146562500.04
单位质量响应值RSD%判断
283153.53285834.870.67数据可信
长期9月-供试品溶液-2023112421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%
5min13676142-367614272.03270.751.5172.0370.751.51
23535817-353581769.28269.28
33604886-360488670.63670.64
43667067-366706771.85471.85
53609337-360933770.72370.72
63570537-357053769.96369.96
10min14536140-453614088.88385.762.0689.0085.882.06
24264709-426470983.56483.68
34340993-434099385.05985.18
44389596-438959686.01286.13
54384195-438419585.90686.02
64345629-434562985.15085.27
15min14909397-490939796.19792.712.0396.4692.972.02
24630422-463042290.73090.99
34691843-469184391.93492.19
44741032-474103292.89893.16
54732161-473216192.72492.98
64683712-468371291.77592.03
20min15089682-508968299.72996.221.96100.1696.641.96
24815060-481506094.34894.75
34878070-487807095.58396.00
44917323-491732396.35296.77
54913702-491370296.28196.70
64849642-484964295.02695.44
30min15258565-5258565103.03999.362.00103.6399.932.00
24970500-497050097.39497.96
35058264-505826499.11499.69
45076719-507671999.475100.05
55065907-506590799.26499.84
64994406-499440697.86298.43
45min15348594-5348594104.803100.992.06105.57101.732.06
25051859-505185998.98899.71
35164400-5164400101.193101.93
45143211-5143211100.778101.52
55147525-5147525100.863101.60
65068430-506843099.313100.05
60min15350793-5350793104.846101.172.02105.79102.082.02
25056957-505695799.08899.98
35180484-5180484101.509102.41
45154577-5154577101.001101.91
55158628-5158628101.080101.99
65077889-507788999.498100.40
极限15340254-5340254104.639101.051.97105.76102.121.97
25056110-505611099.072100.13
35168887-5168887101.281102.36
45145178-5145178100.817101.90
55158392-5158392101.076102.15
65072215-507221599.387100.45
左氨氯地平缬沙坦片项目信息
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%
114.392472962472582472782471562472442472460.03
214.362469792470682470240.03
单位质量响应值RSD%判断
17181.7917202.230.09数据可信
长期9月-供试品溶液-2023112521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%
5min169545-6954526.22325.498.7026.2225.488.70
273149-7314927.58227.58
369199-6919926.09326.09
468363-6836325.77725.78
556091-5609121.15021.15
669190-6919026.08926.09
10min1120816-12081645.55644.215.7945.6044.265.79
2120935-12093545.60045.65
3119033-11903344.88344.93
4119974-11997445.23845.28
5103494-10349439.02439.06
6119258-11925844.96845.01
15min1157464-15746459.37457.853.5859.4957.963.59
2156464-15646458.99759.12
3153962-15396258.05458.17
4154718-15471858.33958.46
5142506-14250653.73453.83
6155389-15538958.59258.71
20min1179163-17916367.55666.662.1767.7766.872.18
2176559-17655966.57466.79
3179785-17978567.79168.01
4176193-17619366.43666.65
5169600-16960063.95064.14
6179374-17937467.63667.85
30min1205968-20596877.66378.901.5477.9979.231.55
2209887-20988779.14179.47
3212115-21211579.98180.31
4207964-20796478.41678.74
5205929-20592977.64977.95
6213698-21369880.57880.91
45min1231457-23145787.27488.162.2387.7488.612.22
2235389-23538988.75789.22
3240705-24070590.76291.22
4226338-22633885.34485.80
5231048-23104887.12087.55
6237820-23782089.67490.14
60min1244078-24407892.03392.611.9392.6493.211.93
2246038-24603892.77293.38
3253000-25300095.39896.01
4239696-23969690.38190.98
5242218-24221891.33291.90
6248539-24853993.71594.33
极限1248009-24800993.51694.692.3894.2895.452.37
2250613-25061394.49895.26
3258426-25842697.44498.22
4249444-24944494.05794.81
5242726-24272691.52492.25
6257516-25751697.10097.87
左氨氯地平缬沙坦片项目信息
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%
116.294620546462159846202024620070461976646204360.02
216.294625048462759646263220.04
单位质量响应值RSD%判断
283636.34283997.670.10数据可信
长期9月-供试品溶液-2023112521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%
5min13652309-365230971.73470.336.5071.7370.336.50
23707931-370793172.82772.83
33696743-369674372.60772.61
43645955-364595571.60971.61
53108466-310846661.05361.05
63672446-367244672.13072.13
10min14376586-437658685.95985.064.1986.0885.184.20
24427643-442764386.96287.08
34465448-446544887.70587.83
44334009-433400985.12385.24
53972040-397204078.01478.12
64410336-441033686.62286.74
15min14713658-471365892.58092.482.7092.8492.742.71
24774317-477431793.77194.04
34837517-483751795.01295.28
44688510-468851092.08692.35
54471771-447177187.82988.06
64764823-476482393.58593.85
20min14889322-488932296.03096.361.9596.4596.781.96
24947131-494713197.16597.59
35029775-502977598.78999.21
44883235-488323595.91096.33
54743615-474361593.16893.55
64943617-494361797.09697.52
30min15057763-505776399.33899.901.4099.92100.471.42
25105066-5105066100.267100.85
35202200-5202200102.175102.77
45059042-505904299.36399.94
54988046-498804697.96998.50
65104817-5104817100.262100.84
45min15138618-5138618100.926101.401.23101.67102.141.24
25168754-5168754101.518102.27
35277247-5277247103.649104.41
45135117-5135117100.858101.60
55088101-508810199.934100.63
65169731-5169731101.537102.29
60min15144441-5144441101.041101.661.24101.95102.561.25
25179322-5179322101.726102.65
35291121-5291121103.922104.85
45148132-5148132101.113102.02
55102937-5102937100.225101.09
65188838-5188838101.913102.83
极限15145951-5145951101.070101.501.23102.15102.581.23
25168796-5168796101.519102.61
35281592-5281592103.734104.84
45136066-5136066100.876101.95
55094975-5094975100.069101.10
65181105-5181105101.761102.85
左氨氯地平缬沙坦片项目信息
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%
114.392476302476932476802475902475972476380.02
214.362484002480532482260.10
单位质量响应值RSD%判断
17209.0317285.930.32数据可信
长期9月-供试品溶液-2023112521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%
5min173938-7393827.79027.212.7527.7927.212.75
274354-7435427.94627.95
372986-7298627.43227.43
468959-6895925.91925.92
572803-7280327.36327.36
671272-7127226.78826.79
10min1122615-12261546.08545.251.4946.1345.291.50
2121350-12135045.61045.66
3120655-12065545.34945.39
4118704-11870444.61544.66
5121187-12118745.54945.59
6117808-11780844.27944.32
15min1159724-15972460.03358.032.1260.1658.152.12
2152968-15296857.49457.62
3156649-15664958.87759.00
4150579-15057956.59656.71
5153704-15370457.77057.89
6152786-15278657.42557.54
20min1185839-18583969.84867.292.0570.0767.512.05
2177285-17728566.63366.85
3180298-18029867.76667.99
4178272-17827267.00467.22
5176177-17617766.21766.43
6176330-17633066.27466.49
30min1211446-21144679.47377.751.6779.8178.081.67
2208714-20871478.44678.78
3207029-20702977.81378.15
4205318-20531877.17077.49
5207470-20747077.97978.31
6201208-20120875.62575.95
45min1228383-22838385.83984.663.0686.3185.123.05
2212595-21259579.90580.36
3230815-23081586.75387.21
4222548-22254883.64684.10
5230468-23046886.62287.08
6226636-22663685.18285.63
60min1246979-24697992.82890.641.8693.4491.241.85
2242937-24293791.30991.90
3238522-23852289.65090.26
4238146-23814689.50890.10
5244971-24497192.07392.68
6235452-23545288.49689.09
极限1246322-24632292.58193.301.8093.3594.051.79
2249838-24983893.90394.65
3244062-24406291.73292.49
4246734-24673492.73693.48
5256486-25648696.40197.16
6245902-24590292.42393.16
左氨氯地平缬沙坦片项目信息
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%
116.294637571463932346366444637567463634946374910.03
216.294652460465126346518620.02
单位质量响应值RSD%判断
284683.30285565.500.22数据可信
长期9月-供试品溶液-2023112521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%
5min13746569-374656973.24872.531.5973.2572.541.59
23657421-365742171.50571.51
33769347-376934773.69373.69
43618794-361879470.75070.75
53722706-372270672.78272.78
63745614-374561473.22973.23
10min14452266-445226687.04586.630.6187.1786.750.61
24444514-444451486.89387.01
34457941-445794187.15687.28
44386953-438695385.76885.89
54429091-442909186.59286.71
64414063-441406386.29886.42
15min14784045-478404593.53292.790.9093.8093.050.90
24673472-467347291.37091.63
34779334-477933493.43993.71
44729564-472956492.46692.73
54773390-477339093.32393.59
64735817-473581792.58992.85
20min14955381-495538196.88196.180.8297.3096.600.82
24850640-485064094.83495.25
34931521-493152196.41596.84
44912194-491219496.03796.45
54961028-496102896.99297.41
64906812-490681295.93296.35
30min15114167-511416799.98699.410.82100.57100.000.81
25027623-502762398.29498.87
35079147-507914799.30199.89
45087804-508780499.470100.05
55144283-5144283100.574101.16
65056473-505647398.85899.44
45min15172558-5172558101.127100.740.87101.88101.490.87
25090658-509065899.526100.26
35137207-5137207100.436101.19
45169438-5169438101.066101.81
55220200-5220200102.059102.81
65127559-5127559100.247100.99
60min15184642-5184642101.364100.990.93102.28101.900.92
25099190-509919099.693100.60
35144778-5144778100.584101.50
45184727-5184727101.365102.27
55237625-5237625102.399103.32
65141369-5141369100.517101.43
极限15167615-5167615101.031100.890.84102.12101.970.84
25101127-510112799.731100.80
35138981-5138981100.471101.56
45178862-5178862101.250102.33
55228770-5228770102.226103.32
65145796-5145796100.604101.68
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