沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
114.033491893489353491033487043488523489570.06
214.013487453492873490160.11
单位质量响应值RSD%判断
24872.2024911.920.12数据可信
供试品溶液-24FA489批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108844-10884431.38935.299.4531.3935.299.46
2114481-11448133.01433.01
3137594-13759439.68039.68
4134495-13449538.78638.79
5123026-12302635.47835.48
6115760-11576033.38333.38
10min1180616-18061652.08653.633.7252.1453.693.72
2175794-17579450.69650.75
3193000-19300055.65855.72
4190394-19039454.90654.97
5191853-19185355.32755.39
6184247-18424753.13353.19
15min1213537-21353761.58061.513.5161.7261.663.51
2198873-19887357.35157.49
3215127-21512762.03962.20
4217817-21781762.81462.97
5220112-22011263.47663.63
6214260-21426061.78961.93
20min1230887-23088766.58366.223.4966.8366.483.49
2214541-21454161.87062.10
3229121-22912166.07466.34
4234367-23436767.58767.85
5237749-23774968.56268.82
6231177-23117766.66766.91
30min1248752-24875271.73572.353.6272.0972.713.61
2236137-23613768.09768.44
3247339-24733971.32871.70
4260174-26017475.02975.40
5260152-26015275.02375.39
6252760-25276072.89173.25
45min1268175-26817577.33779.003.5577.8179.483.54
2267957-26795777.27477.73
3264837-26483776.37476.87
4290240-29024083.70084.20
5280870-28087080.99881.49
6271636-27163678.33578.81
60min1286720-28672082.68583.613.4583.2984.223.43
2289538-28953883.49784.08
3276820-27682079.83080.45
4306520-30652088.39589.03
5294460-29446084.91785.55
6285430-28543082.31382.92
极限1299659-29965986.41687.662.3787.1688.422.37
2304804-30480487.90088.62
3294556-29455684.94485.70
4316200-31620091.18691.97
5305199-30519988.01488.79
6303487-30348787.52088.27
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.565932575932065936215927395934755932600.06
2 22.455947235954325950780.09
单位质量响应值RSD%判断
26296.9926506.820.57数据可信
供试品溶液-24FA489批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13236-32360.2480.2561.080.250.2561.56
22314-23140.1770.18
32109-21090.1620.16
41086-10860.0830.08
54094-40940.3140.31
66770-67700.5180.52
10min110845-108450.8312.1143.500.832.1143.55
227602-276022.1142.11
323316-233161.7861.79
424967-249671.9121.91
547627-476273.6483.65
630983-309832.3732.37
15min146220-462203.5404.2920.083.544.2920.06
251889-518893.9743.98
351135-511353.9163.92
452287-522874.0044.01
577926-779265.9685.97
656259-562594.3094.31
20min173596-735965.6365.7912.385.645.8012.40
268071-680715.2135.22
367899-678995.2005.21
478858-788586.0396.05
592767-927677.1057.12
672192-721925.5295.54
30min1102875-1028757.8799.5423.187.909.5623.14
2119991-1199919.1909.21
396336-963367.3787.40
4164155-16415512.57212.59
5156550-15655011.99012.02
6107524-1075248.2358.26
45min1167106-16710612.79813.4518.4312.8313.4918.40
2183202-18320214.03114.07
3126080-1260809.6569.69
4221831-22183116.98917.03
5193569-19356914.82514.87
6161801-16180112.39212.43
60min1196569-19656915.05515.4512.2515.1115.5112.24
2205071-20507115.70615.76
3169749-16974913.00113.05
4242779-24277918.59418.66
5209810-20981016.06916.14
6186215-18621514.26214.32
极限1244002-24400218.68719.163.6318.7619.243.67
2252014-25201419.30119.38
3241822-24182218.52018.59
4266643-26664320.42120.52
5251703-25170319.27719.38
6244920-24492018.75818.84
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.561088906108868210892421087936108932310888180.06
2 22.451089213109077110899920.11
单位质量响应值RSD%判断
48263.2148551.980.43数据可信
供试品溶液-24FA489批-缬沙坦钠-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14753-47530.1880.2183.380.190.2182.48
23939-39390.1560.16
32969-29690.1170.12
4-0.0000.00
56983-69830.2760.28
612887-128870.5090.51
10min120516-205160.8102.2645.840.812.2645.82
257707-577072.2792.28
347313-473131.8691.87
451613-516132.0382.04
5100787-1007873.9803.98
666053-660532.6092.61
15min197000-970003.8314.6420.793.834.6520.81
2108430-1084304.2824.29
3107683-1076834.2534.26
4108968-1089684.3044.31
5165632-1656326.5416.55
6117945-1179454.6584.66
20min1153945-1539456.0806.2512.996.096.2613.01
2142122-1421225.6135.62
3141509-1415095.5895.60
4164827-1648276.5106.52
5196345-1963457.7547.77
6150609-1506095.9485.96
30min1212909-2129098.40910.2423.818.4310.2623.77
2249106-2491069.8389.86
3198976-1989767.8587.88
4342416-34241613.52313.54
5329102-32910212.99813.03
6222515-2225158.7888.81
45min1345015-34501513.62614.3119.1513.6614.3619.13
2375972-37597214.84914.89
3256489-25648910.13010.16
4463004-46300418.28618.33
5400214-40021415.80615.86
6333933-33393313.18813.23
60min1401155-40115515.84316.2812.8315.9016.3412.84
2415758-41575816.42016.48
3343977-34397713.58513.63
4501423-50142319.80319.88
5429488-42948816.96217.04
6381785-38178515.07815.14
极限1488326-48832619.28619.874.2919.3719.964.34
2499152-49915219.71319.80
3484616-48461619.13919.21
4543487-54348721.46421.57
5508895-50889520.09820.21
6493700-49370019.49819.58
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
114.033516663525683523603528543525803524060.13
214.013539243539263539250.01
单位质量响应值RSD%判断
25118.0325262.310.41数据可信
供试品溶液-24FA489批-氢氯噻嗪-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%
5min1101475-10147528.91723.4920.1028.9223.4920.09
281913-8191323.34323.34
357368-5736816.34816.35
4100227-10022728.56228.56
576074-7607421.67921.68
677587-7758722.11022.11
10min1170119-17011948.47945.986.0348.5346.026.04
2168064-16806447.89347.93
3148122-14812242.21042.24
4171289-17128948.81248.86
5154345-15434543.98444.02
6156136-15613644.49444.53
15min1202791-20279157.78957.062.9657.9257.182.97
2208234-20823459.34159.46
3194940-19494055.55255.65
4204786-20478658.35858.49
5193435-19343555.12355.23
6197233-19723356.20656.32
20min1224364-22436463.93764.162.3064.1664.372.30
2233992-23399266.68166.90
3222855-22285563.50763.70
4227090-22709064.71464.94
5218517-21851762.27162.47
6224029-22402963.84264.05
30min1250131-25013171.28073.642.5871.6173.962.58
2270444-27044477.06977.40
3258718-25871873.72774.02
4258385-25838573.63273.97
5255820-25582072.90173.21
6257074-25707473.25973.57
45min1275675-27567578.55982.312.8579.0182.752.83
2300133-30013385.52985.99
3289298-28929882.44182.86
4285819-28581981.45081.91
5294011-29401183.78484.21
6288099-28809982.10082.53
60min1289509-28950982.50287.273.2783.0887.843.25
2316870-31687090.29990.90
3306866-30686687.44888.00
4301609-30160985.95086.54
5315413-31541389.88390.45
6307125-30712587.52288.09
极限1300254-30025485.56491.343.5886.2892.063.56
2329309-32930993.84394.59
3323482-32348292.18392.88
4315184-31518489.81890.55
5331733-33173394.53495.25
6323171-32317192.09492.81
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.566034946048986043326046686039056042590.10
2 22.456151726132476142100.23
单位质量响应值RSD%判断
26784.5327359.021.51数据可信
供试品溶液-24FA489批-沙库巴曲-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%
5min1170216-17021612.71512.275.1812.7112.275.16
2174588-17458813.04213.04
3155762-15576211.63511.64
4170293-17029312.72112.72
5160062-16006211.95611.96
6154634-15463411.55111.55
10min1374609-37460927.98327.312.9228.0027.332.93
2381210-38121028.47628.50
3359562-35956226.85926.88
4366135-36613527.35027.37
5352803-35280326.35426.37
6359063-35906326.82226.84
15min1511949-51194938.24238.152.7238.3138.222.72
2535987-53598740.03840.11
3505678-50567837.77437.84
4511684-51168438.22238.29
5494768-49476836.95937.02
6504412-50441237.67937.74
20min1608238-60823845.43545.402.7145.5745.532.71
2633382-63338247.31347.45
3599732-59973244.79944.93
4618047-61804746.16746.30
5585884-58588443.76543.89
6601207-60120744.90945.04
30min1662780-66278049.50949.861.5049.7250.061.50
2680519-68051950.83451.05
3655526-65552648.96749.17
4678739-67873950.70150.91
5662147-66214749.46249.66
6664911-66491149.66849.87
45min1663684-66368449.57649.901.3949.8750.181.39
2678849-67884950.70951.01
3655194-65519448.94249.23
4678836-67883650.70851.00
5664822-66482249.66149.94
6666416-66641649.78150.06
60min1660561-66056149.34349.731.4249.7250.101.42
2678336-67833650.67151.05
3652628-65262848.75149.12
4674726-67472650.40150.78
5662809-66280949.51149.87
6665418-66541849.70650.07
极限1657777-65777749.13549.551.2249.5950.001.22
2673812-67381250.33350.80
3652935-65293548.77349.22
4671656-67165650.17250.63
5662013-66201349.45249.90
6661626-66162649.42349.87
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.561101283110508911048641104889110428911040830.15
2 22.451116261111610811161840.01
单位质量响应值RSD%判断
48939.8549718.661.12数据可信
供试品溶液-24FA489批-缬沙坦钠-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%
5min1300166-30016611.63411.265.5111.6311.265.51
2310415-31041512.03112.03
3274888-27488810.65410.65
4302523-30252311.72511.73
5282089-28208910.93310.93
6272411-27241110.55810.56
10min1673869-67386926.11825.462.9526.1425.482.95
2684593-68459326.53426.55
3646604-64660425.06125.08
4657492-65749225.48325.50
5632644-63264424.52024.54
6645816-64581625.03125.05
15min1925479-92547935.87035.732.7735.9335.802.77
2969221-96922137.56537.63
3917655-91765535.56735.63
4913340-91334035.39935.46
5892891-89289134.60734.67
6913371-91337135.40135.46
20min11104724-110472442.81742.732.7742.9442.852.77
21149149-114914944.53944.67
31089364-108936442.22242.34
41119699-111969943.39743.52
51058872-105887241.04041.16
61092343-109234342.33742.46
30min11208408-120840846.83647.141.4947.0347.341.50
21240769-124076948.09048.29
31196285-119628546.36646.55
41236449-123644947.92248.12
51203577-120357746.64846.83
61212682-121268247.00147.19
45min11213744-121374447.04247.321.3747.3147.591.37
21240925-124092548.09648.38
31198991-119899146.47146.74
41240513-124051348.08048.35
51213386-121338647.02947.29
61217973-121797347.20647.47
60min11206763-120676346.77247.191.4347.1247.541.43
21240565-124056548.08248.44
31195014-119501446.31646.66
41234738-123473847.85648.21
51210563-121056346.91947.26
61218313-121831347.21947.57
极限11201975-120197546.58647.091.2147.0147.521.21
21233850-123385047.82248.26
31199263-119926346.48146.90
41231512-123151247.73148.16
51210771-121077146.92747.35
61212229-121222946.98447.41
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