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%
114.999452594366944199459394415944640.10
214.999474894393945700.27
单位质量响应值RSD%判断
6301.806308.870.08数据可信
供试品溶液-24081401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%
5min144428-4442845.67640.3317.9245.6840.3317.92
233241-3324134.17534.18
345089-4508946.35646.36
428592-2859229.39529.40
538745-3874539.83439.83
645260-4526046.53246.53
10min172889-7288974.93769.6710.2475.0169.7410.24
266116-6611667.97468.03
371825-7182573.84373.92
454657-5465756.19356.24
568604-6860470.53270.60
672498-7249874.53574.61
15min183291-8329185.63183.454.4585.8383.634.47
280083-8008382.33382.50
383034-8303485.36785.57
475296-7529677.41277.55
579724-7972481.96482.15
685566-8556687.97088.17
20min187587-8758790.04889.672.9090.3990.002.91
285102-8510287.49387.80
388128-8812890.60490.95
485234-8523487.62987.90
585600-8560088.00588.33
691679-9167994.25594.60
30min190668-9066893.21693.942.2493.7194.412.25
288626-8862691.11691.57
391380-9138093.94894.44
491893-9189394.47594.89
590794-9079493.34593.81
694879-9487997.54598.05
45min191086-9108693.64594.862.0894.2995.492.08
289521-8952192.03692.64
392247-9224794.83995.49
492807-9280795.41595.99
592681-9268195.28595.91
695256-9525697.93398.60
极限194414-9441497.06797.242.4797.8798.032.48
291395-9139593.96394.72
395485-9548598.16898.98
493538-9353896.16696.90
594219-9421996.86697.65
698456-98456101.223102.05
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.613664203673393659633662163659913663860.16
211.563682063689123685590.14
单位质量响应值RSD%判断
31557.8031882.270.73数据可信
供试品溶液-24081401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%
5min1216975-21697556.50250.0215.0856.5050.0215.08
2180490-18049047.00147.00
3212902-21290255.44255.44
4142172-14217237.02337.02
5186061-18606148.45248.45
6213907-21390755.70455.70
10min1304150-30415079.20474.069.8779.3074.149.88
2291157-29115775.82075.90
3300079-30007978.14478.24
4230207-23020759.94860.01
5279323-27932372.73972.82
6301477-30147778.50878.60
15min1335242-33524287.30085.474.2587.5385.684.27
2335305-33530587.31787.52
3334940-33494087.22287.44
4306955-30695579.93480.10
5314769-31476981.96982.17
6342173-34217389.10589.33
20min1347334-34733490.44990.132.6090.8290.482.61
2349608-34960891.04191.39
3348618-34861890.78491.15
4341659-34165988.97189.27
5331345-33134586.28686.62
6358186-35818693.27593.65
30min1355365-35536592.54193.711.4893.0694.211.47
2358633-35863393.39293.89
3357760-35776093.16493.68
4365727-36572795.23995.68
5354587-35458792.33892.82
6367136-36713695.60696.13
45min1359225-35922593.54694.731.1594.2295.381.12
2361470-36147094.13094.79
3361228-36122894.06794.74
4369525-36952596.22896.83
5362959-36295994.51895.15
6368248-36824895.89696.58
极限1380958-38095899.20598.951.56100.0499.771.57
2375079-37507997.67498.49
3383570-38357099.886100.72
4374094-37409497.41898.18
5376723-37672398.10298.90
6389496-389496101.429102.28
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%
114.999323793254931299333293376932660.11
214.999478694789947880.01
单位质量响应值RSD%判断
6221.886323.421.15数据可信
供试品溶液-24081402批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146149-4614947.69649.049.2847.7049.049.27
246710-4671048.27648.28
340163-4016341.50941.51
453056-5305654.83554.83
548054-4805449.66549.66
650551-5055152.24652.25
10min168783-6878371.08971.854.7371.1771.934.73
268879-6887971.18871.27
364743-6474366.91366.98
471682-7168274.08574.18
574464-7446476.96077.04
668547-6854770.84570.93
15min178223-7822380.84581.655.0781.0481.855.07
277877-7787780.48880.69
374842-7484277.35177.53
481863-8186384.60784.82
585480-8548088.34688.56
675709-7570978.24778.45
20min182173-8217384.92885.534.8485.2685.864.84
280631-8063183.33483.67
379986-7998682.66782.98
485787-8578788.66389.02
589231-8923192.22292.58
678704-7870481.34381.68
30min183605-8360586.40888.314.4686.8888.794.46
283194-8319485.98386.46
386083-8608388.96989.42
488836-8883691.81492.32
590583-9058393.62094.13
680369-8036983.06383.53
45min184563-8456387.39890.224.9788.0290.854.95
284337-8433787.16487.78
389118-8911892.10692.70
491818-9181894.89695.55
592140-9214095.22995.90
681788-8178884.53085.14
极限195371-9537198.56897.911.3499.3398.681.32
294802-9480297.98098.74
396740-9674099.983100.73
494423-9442397.58898.40
594067-9406797.22198.05
692994-9299496.11296.86
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.613658693665943658553665893667373663290.12
211.563722353717793720070.09
单位质量响应值RSD%判断
31552.8932180.541.40数据可信
供试品溶液-24081402批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183455-18345547.55751.4512.1947.5651.4512.19
2190337-19033749.34149.34
3161784-16178441.93941.94
4215455-21545555.85255.85
5226159-22615958.62758.63
6213634-21363455.38055.38
10min1258317-25831766.96370.689.9567.0470.779.95
2261715-26171567.84467.93
3241612-24161262.63362.70
4282704-28270473.28573.38
5320440-32044083.06883.17
6271224-27122470.30970.40
15min1283775-28377573.56377.579.5273.7577.779.52
2287934-28793474.64174.84
3271475-27147570.37470.55
4309629-30962980.26580.48
5351590-35159091.14391.38
6290910-29091075.41375.62
20min1292550-29255075.83880.599.1676.1580.929.16
2297143-29714377.02877.35
3289150-28915074.95675.25
4324005-32400583.99284.34
5363225-36322594.15994.55
6299188-29918877.55877.89
30min1297152-29715277.03182.908.8677.4783.378.86
2303217-30321778.60379.05
3307547-30754779.72580.14
4338856-33885687.84288.33
5369078-36907895.67696.22
6302963-30296378.53779.00
45min1299372-29937277.60684.408.8178.1785.008.80
2305952-30595279.31279.89
3316812-31681282.12782.68
4351460-35146091.10991.74
5370549-37054996.05796.76
6309283-30928380.17580.77
极限1363559-36355994.24596.432.2694.9497.182.30
2366643-36664395.04595.76
3367123-36712395.16995.86
4371655-37165596.34497.13
5386303-386303100.141101.01
6376732-37673297.66098.39
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%
114.999478194458946659362094749944550.52
214.999402194092940560.06
单位质量响应值RSD%判断
6301.206274.580.30数据可信
供试品溶液-24081403批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127895-2789528.75926.7318.0828.7626.7318.07
230691-3069131.64131.64
318989-1898919.57719.58
428753-2875329.64329.64
528043-2804328.91128.91
621170-2117021.82521.83
10min158739-5873960.55753.3318.1460.6153.3818.14
258021-5802159.81759.87
342735-4273544.05844.09
448425-4842549.92449.97
562612-6261264.55064.60
639860-3986041.09441.13
15min174226-7422676.52467.8716.3576.6768.0016.36
272464-7246474.70774.86
353773-5377355.43855.54
457967-5796759.76159.89
579364-7936481.82181.98
657204-5720458.97559.08
20min181895-8189584.43076.8713.9684.7177.1213.96
279762-7976282.23182.51
359982-5998261.83962.04
465602-6560267.63367.86
587379-8737990.08490.38
672734-7273474.98675.19
30min187536-8753690.24687.556.4290.6687.936.45
285060-8506087.69388.11
376321-7632178.68478.99
482109-8210984.65185.00
592589-9258995.45595.90
685933-8593388.59388.92
45min188817-8881791.56693.632.0092.1394.152.00
290296-9029693.09193.65
391721-9172194.56094.99
489061-8906191.81892.30
593627-9362796.52597.13
691417-9141794.24794.72
极限196865-9686599.86497.951.52100.5898.621.57
295434-9543498.38899.10
392955-9295595.83396.42
495522-9552298.47999.12
595638-9563898.59999.36
693628-9362896.52697.16
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.613709913724283714553706183716033714190.19
211.563660783666403663590.11
单位质量响应值RSD%判断
31991.3031691.960.67数据可信
供试品溶液-24081403批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130106-13010633.75131.7514.9633.7531.7514.95
2137844-13784435.75935.76
391669-9166923.78023.78
4134891-13489134.99334.99
5131455-13145534.10134.10
6108472-10847228.13928.14
10min1246917-24691764.05457.8415.7264.1157.8915.72
2243771-24377163.23863.30
3188121-18812148.80148.84
4209286-20928654.29254.35
5267943-26794369.50869.57
6181659-18165947.12547.17
15min1297431-29743177.15870.3314.4577.3270.4814.45
2292384-29238475.84976.01
3227772-22777259.08759.21
4239799-23979962.20762.36
5325263-32526384.37884.55
6244034-24403463.30663.43
20min1320505-32050583.14477.9612.3683.4478.2312.36
2315777-31577781.91782.21
3250296-25029664.93065.15
4266066-26606669.02169.27
5350979-35097991.04991.36
6299547-29954777.70777.94
30min1336436-33643687.27687.765.2787.7188.165.28
2336081-33608187.18487.61
3315213-31521381.77182.10
4325574-32557484.45984.83
5364843-36484394.64695.11
6351607-35160791.21291.57
45min1340610-34061088.35993.234.2088.9393.774.16
2348781-34878190.47991.05
3380443-38044398.69299.16
4350427-35042790.90691.41
5367936-36793695.44896.07
6368164-36816495.50796.02
极限1386262-386262100.20299.961.44100.92100.661.40
2379264-37926498.38799.11
3389891-389891101.143101.77
4393483-393483102.075102.74
5381688-38168899.01599.80
6381415-38141598.94599.62
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