坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.973809738304383303792738165381650.44
215.943862638521385740.20
单位质量响应值RSD%判断
2389.792419.950.89数据可信
供试品溶液-2025030321批-4mg规格-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19591-959122.38924.7511.1922.3924.7511.19
211532-1153226.92026.92
38903-890320.78320.78
410653-1065324.86924.87
512081-1208128.20228.20
610856-1085625.34225.34
10min122514-2251452.55754.928.0452.5954.968.04
224741-2474157.75657.80
320434-2043447.70147.74
423548-2354854.97155.01
525875-2587560.40360.45
624056-2405656.15756.20
15min131822-3182274.28674.855.3774.4174.985.38
233064-3306477.18577.33
328831-2883167.30467.42
432431-3243175.70775.84
533810-3381078.92779.07
632424-3242475.69175.83
20min136889-3688986.11484.653.7586.3684.913.75
237294-3729487.06087.33
333573-3357378.37378.60
436272-3627284.67484.93
536779-3677985.85786.14
636760-3676085.81386.08
30min139196-3919691.50089.791.5591.8990.191.56
238650-3865090.22590.64
337421-3742187.35687.71
438598-3859890.10490.50
538669-3866990.27090.69
638246-3824689.28289.69
45min138882-3888290.76790.080.8191.3190.630.80
238455-3845589.77090.34
338522-3852289.92690.43
438874-3887490.74891.30
538726-3872690.40390.98
638069-3806988.86989.42
60min138789-3878990.55089.530.9091.2590.230.90
238139-3813989.03289.75
338054-3805488.83489.49
438756-3875690.47391.17
538337-3833789.49590.22
638028-3802888.77389.48
极限138907-3890790.82589.321.1991.6790.171.19
238490-3849089.85290.71
337774-3777488.18088.98
438286-3828689.37590.23
538414-3841489.67490.55
637714-3771488.04088.89
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.973819938125382083809338221381690.15
215.943826338151382070.21
单位质量响应值RSD%判断
2390.042396.930.21数据可信
供试品溶液-2025030321批-4mg规格-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110947-1094725.67522.1911.2925.6822.1911.30
28751-875120.52520.52
310451-1045124.51224.51
48595-859520.15920.16
58358-835819.60319.60
69667-966722.67322.67
10min122351-2235152.42351.603.1852.4751.643.19
221571-2157150.59350.63
322665-2266553.15953.20
422761-2276153.38453.42
520996-2099649.24549.28
621669-2166950.82350.86
15min129923-2992370.18271.832.2170.3171.952.21
230567-3056771.69371.81
331221-3122173.22773.36
431623-3162374.17074.29
530426-3042671.36271.48
629994-2999470.34970.47
20min135032-3503282.16582.570.6982.4182.810.68
235111-3511182.35182.59
335269-3526982.72182.97
435630-3563083.56883.81
535223-3522382.61382.85
634953-3495381.98082.22
30min138245-3824589.70188.750.6690.0989.130.67
237735-3773588.50588.88
337792-3779288.63989.03
438023-3802389.18089.57
537603-3760388.19588.57
637632-3763288.26388.64
45min138093-3809389.34588.970.7689.8889.500.76
237461-3746187.86288.39
338141-3814189.45789.99
438190-3819089.57290.11
538001-3800189.12989.65
637715-3771588.45888.98
60min137745-3774588.52888.580.5889.2189.260.58
237367-3736787.64288.31
337807-3780788.67489.36
437975-3797589.06889.75
537948-3794889.00589.67
637758-3775888.55989.23
极限138062-3806289.27288.281.1590.1089.101.14
237106-3710687.03087.84
337324-3732487.54188.37
437465-3746587.87288.70
538221-3822189.64590.46
637644-3764488.29289.11
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.973830238255382013824338362382730.17
215.943872838856387920.24
单位质量响应值RSD%判断
2396.562433.631.09数据可信
供试品溶液-2025030421批-4mg规格-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112527-1252729.12028.1711.0829.1228.1711.08
212226-1222628.42028.42
313078-1307830.40130.40
411876-1187627.60727.61
513387-1338731.11931.12
69621-962122.36522.36
10min122507-2250752.31952.426.2152.3752.466.21
222299-2229951.83651.88
323287-2328754.13354.18
422375-2237552.01352.06
524546-2454657.05957.11
620279-2027947.14047.18
15min130006-3000669.75172.652.5269.8972.792.52
231672-3167273.62473.76
331464-3146473.14173.28
431512-3151273.25273.38
532202-3220274.85675.00
630669-3066971.29371.41
20min134081-3408179.22482.892.5579.4883.152.55
236300-3630084.38284.64
336470-3647084.77885.04
435981-3598183.64183.90
536030-3603083.75584.03
635096-3509681.58481.82
30min136968-3696885.93589.251.9486.3289.641.94
238816-3881690.23190.63
338952-3895290.54790.95
438688-3868889.93390.33
538719-3871990.00690.42
638211-3821188.82589.20
45min137717-3771787.67689.861.3188.2090.401.31
239144-3914490.99391.54
338966-3896690.58091.13
438537-3853789.58290.13
538828-3882890.25990.82
638758-3875890.09690.61
60min137837-3783787.95589.451.0688.6390.141.06
239111-3911190.91791.62
338424-3842489.32090.03
438580-3858089.68290.38
538438-3843889.35290.06
638478-3847889.44590.11
极限137778-3777887.81888.720.9188.6489.560.91
238770-3877090.12490.97
338030-3803088.40489.26
438292-3829289.01389.86
538181-3818188.75589.62
637939-3793988.19289.01
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.973808638025380973823438207381300.24
215.943838338218383000.31
单位质量响应值RSD%判断
2387.602402.760.45数据可信
供试品溶液-2025030421批-4mg规格-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112544-1254429.40127.636.4629.4027.636.47
211977-1197728.07228.07
312062-1206228.27128.27
411843-1184327.75827.76
510314-1031424.17424.17
611983-1198328.08628.09
10min123320-2332054.65753.718.2354.7153.768.22
223982-2398256.20956.26
323417-2341754.88554.93
425334-2533459.37859.42
520125-2012547.16947.21
621317-2131749.96350.01
15min131809-3180974.55474.928.0774.6975.058.07
234084-3408479.88680.03
332530-3253076.24476.38
435200-3520082.50182.65
528274-2827466.26866.39
629889-2988970.05470.18
20min135570-3557083.36984.884.9683.6385.144.97
237570-3757088.05688.33
337339-3733987.51587.78
438242-3824289.63189.91
533558-3355878.65378.88
635013-3501382.06382.31
30min137834-3783488.67590.412.6589.0890.812.66
238922-3892291.22591.65
339318-3931892.15392.56
440018-4001893.79494.23
537300-3730087.42387.78
638057-3805789.19889.58
45min138402-3840290.00691.181.4090.5691.731.41
238815-3881590.97491.55
339389-3938992.32092.88
439612-3961292.84293.43
538224-3822489.58990.10
638970-3897091.33891.87
60min138149-3814989.41390.721.4290.1191.431.43
238461-3846190.14590.87
338972-3897291.34292.06
439412-3941292.37493.12
538102-3810289.30389.96
639148-3914891.75592.44
极限138562-3856290.38190.331.2391.2391.191.25
238178-3817889.48190.36
338948-3894891.28692.16
439036-3903691.49292.39
537805-3780588.60789.41
638722-3872290.75691.59
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