氨氯地平阿托伐他汀钙片项目信息
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%
115.089072290559904909039990375905090.16
215.058916489517893400.28
单位质量响应值RSD%判断
6001.925936.210.78数据可信
中间条件6月-供试品溶液-2025021321批-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%
5min134537-3453737.50938.3514.1237.5138.3514.11
242956-4295646.65246.65
336066-3606639.16939.17
437285-3728540.49340.49
527814-2781430.20730.21
633209-3320936.06736.07
10min168862-6886274.78876.896.0674.8576.956.06
274519-7451980.93181.01
375169-7516981.63781.70
474055-7405580.42780.49
565874-6587471.54271.59
666298-6629872.00372.06
15min176363-7636382.93486.413.5983.1286.603.60
282119-8211989.18589.40
382780-8278089.90390.10
481448-8144888.45788.66
576989-7698983.61483.78
677705-7770584.39284.57
20min180610-8061087.54790.872.5387.8791.212.54
285819-8581993.20493.57
385134-8513492.46092.81
485418-8541892.76893.12
582007-8200789.06489.37
683039-8303990.18590.51
30min184881-8488192.18594.682.1192.6695.162.12
288842-8884296.48797.00
389726-8972697.44797.95
487325-8732594.83995.34
585881-8588193.27193.73
686401-8640193.83694.31
45min185561-8556192.92495.351.3993.5595.991.40
288530-8853096.14896.83
388937-8893796.59097.26
487902-8790295.46696.13
587400-8740094.92195.53
688424-8842496.03396.66
极限185722-8572293.09894.471.8093.8895.271.79
288435-8843596.04596.88
388724-8872496.35997.19
484694-8469491.98292.80
586938-8693894.41995.19
687394-8739494.91495.70
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.871749981748491749701743111741361746530.23
211.851728871731141730000.10
单位质量响应值RSD%判断
14713.8214599.160.56数据可信
中间条件6月-供试品溶液-2025021321批-阿托伐他汀钙-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%
5min185908-8590848.51850.268.3048.5250.268.30
294366-9436653.29553.30
395616-9561654.00154.00
495016-9501653.66253.66
576914-7691443.43943.44
686175-8617548.66948.67
10min1126222-12622271.28674.364.4471.3774.444.43
2137889-13788977.87577.96
3138416-13841678.17378.26
4133996-13399675.67775.77
5125702-12570270.99371.07
6127766-12776672.15872.24
15min1148509-14850983.87386.072.7784.0786.272.77
2156787-15678788.54988.77
3157704-15770489.06689.29
4153489-15348986.68686.90
5149525-14952584.44784.64
6148329-14832983.77283.97
20min1156048-15604888.13191.382.5588.4791.732.55
2165036-16503693.20793.57
3167006-16700694.32094.69
4163006-16300692.06192.42
5161451-16145191.18391.51
6158299-15829989.40289.74
30min1163191-16319192.16595.762.7192.6596.272.71
2171799-17179997.02797.55
3176789-17678999.845100.37
4168633-16863395.23995.75
5169921-16992195.96696.45
6167040-16704094.33994.83
45min1165061-16506193.22196.311.9193.8696.971.91
2171803-17180397.02997.71
3174309-17430998.44499.14
4169936-16993695.97596.65
5172728-17272897.55198.19
6169293-16929395.61296.26
极限1165236-16523693.32096.281.9194.1297.111.91
2172166-17216697.23498.08
3174284-17428498.43099.29
4169359-16935995.64996.48
5172730-17273097.55398.36
6169133-16913395.52196.33
氨氯地平阿托伐他汀钙片项目信息
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%
115.088986989537896618918189199894890.34
215.058826588240882520.03
单位质量响应值RSD%判断
5934.285863.920.85数据可信
中间条件6月-供试品溶液-2025021321批-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%
5min133250-3325036.54039.899.3236.5439.889.32
237801-3780141.54141.54
335771-3577139.31039.31
431859-3185935.01135.01
538041-3804141.80541.80
641046-4104645.10745.11
10min169756-6975676.65777.853.3576.7277.923.35
270931-7093177.94978.02
372433-7243379.59979.66
466663-6666373.25873.32
572100-7210079.23379.30
673156-7315680.39480.47
15min178168-7816885.90287.242.9986.0987.442.99
278196-7819685.93286.13
381089-8108989.11289.31
475796-7579683.29583.48
581556-8155689.62589.83
681536-8153689.60389.81
20min182778-8277890.96892.002.8191.3092.342.82
281982-8198290.09390.44
385405-8540593.85594.20
480337-8033788.28588.60
586039-8603994.55194.90
685736-8573694.21894.58
30min185757-8575794.24295.263.0394.7295.763.03
283305-8330591.54792.04
389359-8935998.20098.70
484180-8418092.50992.97
588945-8894597.74598.25
688569-8856997.33297.85
45min187380-8738096.02596.822.3296.6797.482.33
285407-8540793.85794.50
390040-9004098.94899.62
486315-8631594.85595.48
590359-9035999.29999.97
689126-8912697.94498.62
极限186865-8686595.45995.922.5596.2696.732.55
284629-8462993.00293.80
389576-8957698.43899.27
484735-8473593.11893.90
589251-8925198.08198.92
688639-8863997.40998.25
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.871734891735411735811731611732441734030.11
211.851731851737921734880.25
单位质量响应值RSD%判断
14608.5114640.340.16数据可信
中间条件6月-供试品溶液-2025021321批-阿托伐他汀钙-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%
5min186238-8623848.81151.055.6848.8151.055.68
293918-9391853.15853.16
392963-9296352.61752.62
481569-8156946.16846.17
592543-9254352.37952.38
693947-9394753.17453.17
10min1131188-13118874.25275.354.3874.3375.444.39
2133943-13394375.81275.90
3136382-13638277.19277.28
4122503-12250369.33769.41
5139042-13904278.69878.79
6135741-13574176.82976.92
15min1151734-15173485.88186.503.8586.0986.703.85
2150742-15074285.32085.53
3156812-15681288.75688.97
4142865-14286580.86281.05
5159622-15962290.34690.56
6155141-15514187.81088.03
20min1162685-16268592.08092.363.7092.4392.713.70
2158601-15860189.76890.13
3168101-16810195.14595.51
4154354-15435487.36487.69
5170725-17072596.63097.00
6164581-16458193.15393.52
30min1171257-17125796.93196.303.4897.4396.813.48
2163783-16378392.70193.21
3175487-17548799.32699.85
4162622-16262292.04492.52
5177035-177035100.202100.73
6170715-17071596.62597.14
45min1173204-17320498.03397.493.3998.7098.163.39
2165136-16513693.46794.13
3176794-176794100.065100.75
4165958-16595893.93294.56
5179862-179862101.802102.50
6172461-17246197.61398.29
极限1173067-17306797.95697.503.0598.7898.333.06
2167347-16734794.71895.54
3176524-17652499.913100.77
4165239-16523993.52594.31
5179008-179008101.318102.19
6172382-17238297.56898.41
氨氯地平阿托伐他汀钙片项目信息
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%
115.088790888312879888817388214881190.19
215.058821387964880880.20
单位质量响应值RSD%判断
5843.445853.020.12数据可信
中间条件6月-供试品溶液-2025021421批-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%
5min148356-4835653.60152.436.1753.6052.436.17
241984-4198446.53746.54
348280-4828053.51653.52
449790-4979055.19055.19
549371-4937154.72654.73
646008-4600850.99851.00
10min170003-7000377.59576.481.8977.6876.561.89
268087-6808775.47275.55
367808-6780875.16275.25
470583-7058378.23878.33
569864-6986477.44177.53
667620-6762074.95475.04
15min178476-7847686.98786.373.0787.2186.593.07
279964-7996488.63788.84
377298-7729885.68285.90
478693-7869387.22887.45
579665-7966588.30588.53
673437-7343781.40281.61
20min184839-8483994.04092.251.8394.4092.611.83
285071-8507194.29894.65
381146-8114689.94790.30
482916-8291691.90992.28
583204-8320492.22892.60
682158-8215891.06991.41
30min186203-8620395.55295.672.3296.0796.182.31
290103-9010399.875100.38
384195-8419593.32793.83
485741-8574195.04095.56
586134-8613495.47696.00
685463-8546394.73295.23
45min188227-8822797.79696.232.5298.4896.902.51
290592-90592100.417101.09
385053-8505394.27894.94
486122-8612295.46396.14
585769-8576995.07195.75
685103-8510394.33394.99
极限187774-8777497.29495.882.5098.1496.712.49
290283-90283100.075100.92
384867-8486794.07194.89
484727-8472793.91694.75
585418-8541894.68295.52
685909-8590995.22796.04
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.871715161719971714961716521719651717250.15
211.851721681719991720840.07
单位质量响应值RSD%判断
14467.1414521.860.27数据可信
中间条件6月-供试品溶液-2025021421批-阿托伐他汀钙-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%
5min198438-9843856.21554.636.5656.2254.626.55
284398-8439848.19848.20
396930-9693055.35455.35
495913-9591354.77354.77
5103373-10337359.03459.03
694882-9488254.18554.18
10min1140790-14079080.40278.483.0880.5078.573.09
2134203-13420376.64076.72
3137922-13792278.76478.86
4133531-13353176.25676.35
5143894-14389482.17482.27
6134176-13417676.62476.71
15min1160359-16035991.57789.242.7291.8089.462.72
2157487-15748789.93790.14
3154941-15494188.48388.71
4150735-15073586.08186.30
5161405-16140592.17492.41
6152623-15262387.15987.38
20min1170185-17018597.18894.513.0997.5794.883.08
2169330-16933096.70097.06
3162538-16253892.82193.19
4158414-15841490.46690.83
5170337-17033797.27597.66
6162175-16217592.61492.98
30min1176305-176305100.68398.213.30101.2398.743.30
2178258-178258101.799102.32
3168236-16823696.07596.60
4164037-16403793.67794.19
5176038-176038100.531101.08
6168969-16896996.49497.01
45min1177096-177096101.13598.803.45101.8599.493.44
2179385-179385102.442103.13
3169444-16944496.76597.45
4164703-16470394.05894.73
5178028-178028101.667102.39
6169389-16938996.73497.41
极限1177891-177891101.58998.743.36102.4799.593.35
2179338-179338102.415103.27
3169378-16937896.72797.57
4164697-16469794.05494.88
5176395-176395100.735101.62
6169689-16968996.90597.74
氨氯地平阿托伐他汀钙片项目信息
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%
115.088741687530875218753987540875090.07
215.058614086086861130.05
单位质量响应值RSD%判断
5802.985721.791.00数据可信
中间条件6月-供试品溶液-2025021421批-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%
5min151443-5144357.87555.844.1057.8755.844.10
251300-5130057.71457.71
350080-5008056.34156.34
449200-4920055.35155.35
549911-4991156.15156.15
645877-4587751.61351.61
10min170184-7018478.95978.823.0679.0678.923.07
272267-7226781.30281.40
371770-7177080.74380.84
468370-6837076.91877.01
571084-7108479.97180.06
666703-6670375.04375.13
15min181379-8137991.55389.272.7991.7889.502.79
280319-8031990.36190.59
379992-7999289.99390.22
477830-7783087.56187.78
580981-8098191.10691.33
675608-7560885.06185.27
20min184255-8425594.78993.443.2995.1793.823.29
283787-8378794.26294.64
386129-8612996.89797.28
481539-8153991.73392.10
584288-8428894.82695.20
678357-7835788.15488.51
30min188832-8883299.93897.533.26100.4898.063.26
287101-8710197.99198.53
389390-89390100.566101.11
484038-8403894.54595.06
588353-8835399.39999.94
682443-8244392.75093.25
45min188654-8865499.73897.802.84100.4498.502.83
286813-8681397.66798.37
388777-8877799.876100.58
486007-8600796.76097.44
588834-8883499.940100.64
682524-8252492.84293.50
极限189152-89152100.29897.603.08101.1798.453.08
285541-8554196.23697.10
389518-89518100.710101.58
485237-8523795.89496.73
588317-8831799.359100.23
682749-8274993.09593.90
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.871706961708461710061711411713771710130.16
211.851692121691371691740.04
单位质量响应值RSD%判断
14407.1614276.290.65数据可信
中间条件6月-供试品溶液-2025021421批-阿托伐他汀钙-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%
5min197000-9700055.98557.234.5355.9957.234.52
2105779-10577961.05261.05
397674-9767456.37456.37
4100092-10009257.77057.77
5101721-10172158.71058.71
692654-9265453.47753.48
10min1137415-13741579.31280.223.8479.4080.313.84
2146679-14667984.65884.76
3139416-13941680.46680.56
4139109-13910980.28980.39
5141044-14104481.40681.50
6130262-13026275.18375.27
15min1155901-15590189.98190.813.2790.2191.043.27
2164063-16406394.69294.93
3159936-15993692.31092.54
4156466-15646690.30790.54
5158939-15893991.73491.97
6148685-14868585.81686.03
20min1165665-16566595.61795.503.8695.9995.883.86
2172215-17221599.39799.80
3168805-16880597.42997.81
4164529-16452994.96195.34
5167930-16793096.92497.31
6153655-15365588.68589.04
30min1171573-17157399.02699.283.5299.5699.823.52
2179147-179147103.398103.96
3175239-175239101.142101.69
4170022-17002298.13198.67
5174565-174565100.753101.30
6161490-16149093.20793.71
45min1171721-17172199.11299.853.1299.81100.563.12
2178786-178786103.190103.93
3175813-175813101.474102.19
4172694-17269499.673100.38
5175739-175739101.431102.15
6163282-16328294.24194.90
极限1171749-17174999.12899.463.3299.99100.333.32
2178234-178234102.871103.78
3175689-175689101.402102.28
4170659-17065998.49999.37
5175449-175449101.264102.15
6162132-16213293.57794.40
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