替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)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10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.902532125554255022531525472254330.43
213.902547525408254420.19
单位质量响应值RSD%判断
1829.711830.360.03数据可信
加速3月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121125163251232514396.3898.813.7994.89%～102.73%
2268472661526731102.47
325840257662580398.91
4271472717127159104.11
525165249312504896.02
624758247982477894.98
2024030221125050249542500295.8499.223.0396.07%～102.38%
2261602617426167100.31
3266732667126672102.25
425175249892508296.15
525732254132557298.03
6268072680426806102.76
2024030321125602255162555997.9898.710.9197.78%～99.64%
225792258582582599.00
326043257452589499.26
425448252962537297.26
526119256902590499.30
625949259492594999.47
223131270762703227054103.7197.064.1792.82%～101.31%
224542245022452294.00
325813255612568798.47
424297240872419292.74
525789256732573198.64
624794246782473694.82
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)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10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.902596125993257532562025798258250.60
213.902550725624255660.33
单位质量响应值RSD%判断
1857.911839.280.72数据可信
长期3月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121126267259202609499.03100.123.7396.20%～104.03%
225610252952545296.59
326233260862616099.28
4283172813428226107.12
5265232666326593100.92
625897256152575697.75
2024030221126083260392606198.9099.271.4397.78%～100.76%
225659257462570297.54
3268532654826700101.33
425796260262591198.33
5266282637626502100.58
626052261012607698.96
2024030321125385252232530496.0395.713.0292.68%～98.74%
225020251282507495.16
324596245852459093.32
424430244682444992.79
525288253432531696.08
6266062656126584100.89
22313124583245202455293.1897.912.9394.90%～100.92%
226010260962605398.87
326296262852629099.77
425338251482524395.80
5266352651926577100.86
626045261252608598.99
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)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10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.902538825757255672570425558255950.57
213.902574625854258000.30
单位质量响应值RSD%判断
1841.371856.120.57数据可信
中间条件3月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121126047260112602998.7798.402.2796.06%～100.73%
225179249012504095.02
326284262562627099.69
425583255972559097.11
5268432667326758101.54
625957258332589598.26
2024030221125111252272516995.5197.562.3395.18%～99.94%
225526255562554196.92
3268652666226764101.56
425691256202565697.36
525985259222595498.49
625128252082516895.51
20240303211289512877328862109.52100.295.8494.15%～106.43%
2274082756427486104.30
325834260952596498.53
425399252382531896.07
5263172640326360100.03
624376247982458793.30
22313125467255402550496.7899.103.4495.53%～102.67%
225574255392555696.98
325604256852564497.31
425433254722545296.58
5270362729827167103.09
6272732745827366103.85
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