奥美沙坦酯氢氯噻嗪片项目信息
介质体积(ml) 900 取样体积(ml) 5补液体积(ml) 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4000
标示量(mg)12.5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.243467334687345373453834482345830.27
211.243468134879347800.41
单位质量响应值RSD%判断
3076.783094.310.41数据可信
供试品溶液-24122501批-氢氯噻嗪-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%
5min127102-2710278.81581.5113.1378.8281.5113.12
225645-2564574.57874.58
330710-3071089.30889.31
422279-2227964.79064.79
531705-3170592.20192.20
630733-3073389.37589.37
10min132623-3262394.87194.085.9895.3194.546.01
231239-3123990.84691.26
332566-3256694.70595.20
429258-2925885.08585.45
534845-34845101.333101.85
633579-3357997.65198.15
15min133578-3357897.64894.874.3498.6195.844.37
231282-3128290.97191.89
332311-3231193.96494.99
430922-3092289.92490.76
534669-34669100.821101.90
632967-3296795.87196.91
20min133537-3353797.52995.253.3299.0496.763.36
232167-3216793.54594.97
332157-3215793.51695.06
431154-3115490.59991.93
533666-3366697.90499.54
633842-3384298.41699.99
30min133830-3383098.38196.702.35100.4398.732.41
232998-3299895.96297.91
333390-3339097.10299.17
431794-3179492.46094.30
533758-3375898.172100.35
633739-3373998.116100.23
45min133027-3302796.04697.011.9898.6499.582.00
233677-3367797.936100.41
333305-3330596.85499.46
432556-3255694.67697.03
533111-3311196.29099.01
634478-34478100.266102.93
60min134371-3437199.95499.011.82103.08102.121.89
234003-3400398.884101.91
333766-3376698.195101.34
432971-3297195.88398.76
534613-34613100.658103.92
634544-34544100.457103.68
极限135533-35533103.334101.382.27107.02105.042.25
235513-35513103.275106.85
334711-34711100.943104.63
433863-3386398.477101.88
535556-35556103.400107.22
633998-3399898.870102.65
奥美沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml) 5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.961644721645631646861645861645091645630.05
2 9.991647731656571652150.38
单位质量响应值RSD%判断
16522.3916538.040.07数据可信
供试品溶液-24122501批-奥美沙坦酯-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%
5min168330-6833037.12840.2115.0237.1340.2115.03
267890-6789036.88936.89
383343-8334345.28645.29
457384-5738431.18131.18
584902-8490246.13346.13
682113-8211344.61844.62
10min1113836-11383661.85563.517.1262.0663.747.15
2115219-11521962.60662.81
3120113-12011365.26665.52
4102922-10292255.92556.10
5126769-12676968.88269.14
6122464-12246466.54366.79
15min1135939-13593973.86573.674.3974.4174.244.42
2132286-13228671.88072.43
3135535-13553573.64574.26
4126740-12674068.86769.35
5144442-14444278.48579.12
6138542-13854275.27975.90
20min1146554-14655479.63379.523.1380.5980.513.17
2145606-14560679.11880.07
3144456-14445678.49379.52
4139114-13911475.59076.46
5150429-15042981.73882.81
6151964-15196482.57283.61
30min1160541-16054187.23387.312.0488.6488.742.10
2161313-16131387.65289.04
3161250-16125087.61889.08
4154438-15443883.91785.20
5163182-16318288.66890.20
6163390-16339088.78190.28
45min1163634-16363488.91489.681.6490.8091.591.68
2166125-16612590.26792.15
3163352-16335288.76090.71
4161763-16176387.89789.65
5166006-16600690.20292.22
6169386-16938692.03994.03
60min1169323-16932392.00592.011.4794.3994.421.53
2169151-16915191.91194.29
3167769-16776991.16093.60
4165708-16570890.04192.28
5172579-17257993.77496.30
6171463-17146393.16895.67
极限1174297-17429794.70893.162.3197.6096.082.29
2174308-17430894.71497.60
3170411-17041192.59695.54
4165950-16595090.17292.91
5175764-17576495.50598.55
6168011-16801191.29294.31
奥美沙坦酯氢氯噻嗪片项目信息
介质体积(ml) 900 取样体积(ml) 5补液体积(ml) 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4000
标示量(mg)12.5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.243471934726346993487634737347510.21
211.243489934826348620.15
单位质量响应值RSD%判断
3091.733101.600.23数据可信
供试品溶液-24122501批-氢氯噻嗪-pH4.5(内含0.1%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119435-1943556.31663.9112.4556.3263.9112.45
220746-2074660.11460.11
321491-2149162.27362.27
423493-2349368.07468.07
520263-2026358.71558.71
626903-2690377.95577.96
10min127107-2710778.54683.165.7078.8683.515.71
226603-2660377.08677.42
329145-2914584.45284.80
428639-2863982.98683.36
529722-2972286.12486.45
630977-3097789.76090.19
15min129031-2903184.12187.434.0384.8788.254.06
228789-2878983.42084.18
330123-3012387.28688.10
430021-3002186.99087.83
531072-3107290.03690.84
632000-3200092.72593.66
20min129157-2915784.48788.833.5285.7090.133.56
229577-2957785.70486.93
330793-3079389.22790.53
431120-3112090.17591.50
531308-3130890.71992.02
631975-3197592.65294.10
30min130839-3083989.36092.052.2591.0593.852.28
231121-3112190.17891.88
331947-3194792.57194.37
431756-3175692.01893.84
532815-3281595.08696.89
632131-3213193.10495.07
45min130815-3081589.29193.092.5991.4795.402.62
231379-3137990.92593.13
332394-3239493.86696.18
432866-3286695.23497.57
532673-3267394.67597.01
632631-3263194.55397.03
60min132321-3232193.65594.831.5096.3397.661.53
232072-3207292.93395.64
333436-3343696.88699.72
432710-3271094.78297.65
533031-3303195.71298.58
632794-3279495.02598.03
极限133308-3330896.51597.671.6299.71101.031.68
232821-3282195.10498.33
333821-3382198.001101.37
434155-3415598.969102.36
533894-3389498.213101.61
634250-3425099.244102.78
奥美沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml) 5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.961652051654021652931652941655231653430.08
2 9.991657821661471659640.16
单位质量响应值RSD%判断
16600.7016613.010.06数据可信
供试品溶液-24122501批-奥美沙坦酯-pH4.5(内含0.1%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148753-4875326.36930.2613.8226.3730.2613.83
252794-5279428.55428.55
354432-5443229.44029.44
459140-5914031.98731.99
550586-5058627.36027.36
669940-6994037.82837.83
10min195203-9520351.49255.196.5051.6455.366.52
295337-9533751.56451.72
3103798-10379856.14056.30
4102642-10264255.51555.69
5102049-10204955.19455.35
6113213-11321361.23261.44
15min1120437-12043765.14067.544.7465.5768.014.77
2118454-11845464.06764.51
3124779-12477967.48867.96
4124273-12427367.21467.70
5125822-12582268.05268.51
6135487-13548773.28073.83
20min1130685-13068570.68274.544.1071.4875.394.12
2131872-13187271.32472.13
3139193-13919375.28476.13
4139454-13945475.42576.28
5139906-13990675.67076.51
6145831-14583178.87479.83
30min1149773-14977381.00683.992.5782.1985.252.60
2151604-15160481.99783.19
3156733-15673384.77186.04
4155022-15502283.84585.12
5159989-15998986.53287.79
6158589-15858985.77587.17
45min1157629-15762985.25589.242.7886.8990.972.80
2161339-16133987.26288.91
3165575-16557589.55391.29
4168448-16844891.10792.85
5169115-16911591.46893.21
6167837-16783790.77692.65
60min1165433-16543389.47692.202.2191.5994.432.23
2166367-16636789.98192.12
3174333-17433394.29096.53
4171224-17122492.60894.86
5173835-17383594.02196.27
6171627-17162792.82695.20
极限1173085-17308593.61595.121.5896.2297.861.63
2172037-17203793.04895.69
3175747-17574795.05597.82
4178906-17890696.76399.53
5177516-17751696.01198.78
6177916-17791696.22899.12
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