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%
115.239540895489954239550895400954460.06
215.20 9674697000968730.19
单位质量响应值RSD%判断
6266.976373.221.19数据可信
供试品溶液-24080101批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177878-7787879.88582.185.6179.8882.185.61
286600-8660088.83288.83
375031-7503176.96576.96
476136-7613678.09878.10
582893-8289385.02985.03
682183-8218384.30184.30
10min185377-8537787.57791.955.8887.7192.095.88
296378-9637898.86299.01
384073-8407386.24086.37
485580-8558087.78587.92
594243-9424396.67296.81
692217-9221794.59394.73
15min188198-8819890.47195.526.3290.7595.826.31
2101131-101131103.737104.05
386517-8651788.74789.02
489504-8950491.81192.09
597709-97709100.227100.53
695682-9568298.14898.45
20min188816-8881691.10596.636.2091.5397.086.20
2101884-101884104.510105.00
387420-8742089.67390.09
491687-9168794.05094.48
599297-99297101.856102.33
696137-9613798.61499.08
30min188592-8859290.87597.506.5591.4698.116.55
2103171-103171105.830106.49
388169-8816990.44191.01
492537-9253794.92295.51
5100077-100077102.656103.30
697729-97729100.248100.87
45min189439-8943991.74497.876.4692.4898.646.46
2103352-103352106.015106.85
388240-8824090.51491.23
492929-9292995.32496.07
5100683-100683103.278104.09
697800-97800100.320101.11
极限189582-8958291.89198.166.5492.7899.106.53
2104126-104126106.809107.82
388557-8855790.83991.71
493242-9324295.64596.55
5100653-100653103.247104.23
698002-98002100.528101.49
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%
111.68 3623993620413617533620953614273619430.11
211.693677063686183681620.18
单位质量响应值RSD%判断
30988.2731493.761.15数据可信
供试品溶液-24080101批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146268-14626838.67535.944.2938.6835.944.29
2133745-13374535.36435.36
3138681-13868136.66936.67
4132297-13229734.98134.98
5129970-12997034.36634.37
6134587-13458735.58735.59
10min1235656-23565662.31158.584.4062.3858.644.40
2210888-21088855.76255.82
3227628-22762860.18860.25
4211427-21142755.90455.96
5218651-21865157.81457.87
6225145-22514559.53159.59
15min1281982-28198274.56071.603.1274.7371.763.12
2262534-26253469.41869.57
3274845-27484572.67372.83
4259413-25941368.59268.74
5271204-27120471.71071.86
6274773-27477372.65472.81
20min1307905-30790581.41478.932.6381.7179.212.64
2291036-29103676.95477.22
3301846-30184679.81280.09
4287020-28702075.89276.16
5302335-30233579.94180.21
6301018-30101879.59379.87
30min1329330-32933087.07985.602.4887.5186.002.48
2316204-31620483.60984.00
3325908-32590886.17486.59
4311311-31131182.31582.71
5330047-33004787.26987.68
6329515-32951587.12887.54
45min1346065-34606591.50489.542.3192.0890.092.31
2329715-32971587.18187.72
3339227-33922789.69690.26
4328351-32835186.82087.35
5344345-34434591.04991.60
6344143-34414390.99691.55
极限1358681-35868194.84093.091.8495.5793.791.85
2341979-34197990.42491.10
3355350-35535093.95994.67
4347892-34789291.98792.66
5350650-35065092.71793.42
6357836-35783694.61795.33
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%
115.239651496762964889666796392965650.16
215.20 9758798155978710.42
单位质量响应值RSD%判断
6340.456438.881.09数据可信
供试品溶液-24080101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%
5min131166-3116631.62132.558.3231.6232.568.32
235838-3583836.36136.36
333893-3389334.38834.39
428018-2801828.42728.43
532391-3239132.86432.86
631213-3121331.66831.67
10min146277-4627746.95250.656.2647.0050.706.26
254929-5492955.73055.79
349176-4917649.89449.95
450421-5042151.15751.20
551477-5147752.22852.28
647250-4725047.93947.99
15min152476-5247653.24258.226.2353.3758.366.22
262666-6266663.58063.73
355807-5580756.62156.76
458362-5836259.21459.35
559533-5953360.40260.54
655462-5546256.27156.40
20min157439-5743958.27763.135.7758.5063.375.77
267000-6700067.97868.24
360109-6010960.98661.22
463556-6355664.48364.71
565068-6506866.01766.26
660165-6016561.04361.27
30min164096-6409665.03169.194.8265.3569.534.82
271883-7188372.93273.30
366863-6686367.83968.18
468597-6859769.59869.94
572073-7207373.12573.48
665658-6565866.61666.94
45min170954-7095471.98974.843.8372.4175.303.84
277217-7721778.34478.84
372635-7263573.69574.14
473589-7358974.66375.12
577141-7714178.26778.74
671064-7106472.10172.54
极限186539-8653987.80290.593.7988.3591.183.79
295848-9584897.24797.87
386876-8687688.14488.72
488840-8884090.13690.72
588697-8869789.99190.60
688942-8894290.24090.80
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%
111.68 3666693673533666123663103650833664050.23
211.693711543732693722120.41
单位质量响应值RSD%判断
31370.2931840.211.06数据可信
供试品溶液-24080101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%
5min1152866-15286639.95439.646.9339.9539.646.93
2156641-15664140.94040.94
3166289-16628943.46243.46
4134423-13442335.13335.13
5147943-14794338.66738.67
6151871-15187139.69439.69
10min1186178-18617848.66052.554.5748.7352.624.57
2209585-20958554.77854.85
3209593-20959354.78054.85
4203002-20300253.05753.12
5203598-20359853.21353.28
6194370-19437050.80150.87
15min1201995-20199552.79458.205.4252.9458.365.41
2230395-23039560.21760.38
3231938-23193860.62060.78
4226764-22676459.26859.41
5230768-23076860.31460.47
6214267-21426756.00256.15
20min1214702-21470256.11561.935.5456.3562.185.53
2241625-24162563.15263.41
3245603-24560364.19264.46
4242092-24209263.27463.52
5249621-24962165.24265.50
6227957-22795759.58059.82
30min1233233-23323360.95966.575.7661.2966.925.75
2256704-25670467.09367.46
3267654-26765469.95570.33
4254049-25404966.39966.75
5272651-27265171.26171.62
6243823-24382363.72664.07
45min1256049-25604966.92271.125.0267.3571.585.01
2272483-27248371.21771.69
3288842-28884275.49375.98
4269065-26906570.32470.79
5286920-28692074.99075.47
6259318-25931867.77668.23
极限1363654-36365495.04697.252.7095.5997.842.69
2389438-389438101.785102.38
3376356-37635698.36698.98
4370542-37054296.84697.43
5361753-36175394.54995.16
6370771-37077196.90697.47
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%
115.239685596993965249706696596968070.25
215.20 9840798737985720.24
单位质量响应值RSD%判断
6356.346485.001.42数据可信
供试品溶液-24080102批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170825-7082571.51475.734.6671.5175.734.66
273626-7362674.34374.34
378922-7892279.69079.69
473543-7354374.25974.26
579663-7966380.43880.44
673441-7344174.15674.16
10min187695-8769588.54989.573.7588.6789.693.74
284370-8437085.19185.32
392001-9200192.89693.03
487786-8778688.64088.76
593279-9327994.18794.32
687087-8708787.93588.06
15min192040-9204092.93693.323.6893.2093.593.68
288347-8834789.20789.47
394979-9497995.90396.19
491373-9137392.26292.53
597686-9768698.63798.93
690084-9008490.96191.23
20min193585-9358594.49694.763.6794.9295.193.67
289857-8985790.73291.15
395942-9594296.87697.32
492715-9271593.61794.04
599507-99507100.476100.93
691484-9148492.37492.80
30min195198-9519896.12595.963.4996.7096.553.49
291067-9106791.95392.52
397317-9731798.26498.87
493642-9364294.55395.13
5100219-100219101.194101.82
692787-9278793.69094.27
45min196115-9611597.05196.393.6497.7997.143.64
291184-9118492.07292.79
397173-9717398.11998.89
493582-9358294.49395.23
5101087-101087102.071102.86
693612-9361294.52395.26
极限197642-9764298.59296.843.3499.4997.753.34
291771-9177192.66493.54
397148-9714898.09499.03
493943-9394394.85795.75
5100687-100687101.667102.63
694244-9424495.16196.05
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%
111.68 3679363687083667103684483664893676580.28
211.693731313744083737700.25
单位质量响应值RSD%判断
31477.5731973.481.11数据可信
供试品溶液-24080102批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113780-11378029.62532.104.5029.6332.104.50
2125280-12528032.62032.62
3125822-12582232.76132.76
4123468-12346832.14832.15
5130217-13021733.90533.91
6121144-12114431.54331.54
10min1208327-20832754.24356.453.5654.2956.503.56
2216038-21603856.25156.31
3221085-22108557.56557.62
4216402-21640256.34556.40
5229270-22927059.69659.75
6209664-20966454.59154.64
15min1258641-25864167.34370.134.4467.4870.284.44
2268105-26810569.80869.96
3274032-27403271.35171.50
4268609-26860969.93970.09
5289819-28981975.46175.62
6256836-25683666.87367.02
20min1284390-28439074.04877.465.1974.3077.725.19
2295474-29547476.93477.20
3300975-30097578.36678.64
4297145-29714577.36977.63
5325044-32504484.63384.91
6281859-28185973.38973.64
30min1309300-30930080.53484.895.4580.9185.295.45
2324729-32472984.55184.94
3331169-33116986.22886.63
4326636-32663685.04885.44
5356631-35663192.85793.28
6307784-30778480.13980.52
45min1327079-32707985.16389.595.5985.6790.135.58
2342158-34215889.08989.62
3348342-34834290.69991.24
4342389-34238989.14989.68
5378731-37873198.61299.19
6325873-32587384.84985.36
极限1348962-34896290.86193.524.2091.5194.204.20
2356886-35688692.92493.61
3358535-35853593.35394.05
4354697-35469792.35493.04
5388572-388572101.174101.92
6347364-34736490.44591.10
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%
115.239832897823984949848298082982420.30
215.20 9863298392985120.18
单位质量响应值RSD%判断
6450.566481.050.34数据可信
供试品溶液-24080102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%
5min142798-4279842.90938.2915.7542.9138.2915.74
228503-2850328.57728.58
341945-4194542.05442.05
432831-3283132.91632.92
541167-4116741.27441.27
641926-4192642.03542.03
10min165588-6558865.75862.328.7265.8362.388.73
253627-5362753.76653.81
364710-6471064.87864.95
457069-5706957.21757.27
566431-6643166.60366.67
665531-6553165.70165.77
15min173409-7340973.59972.185.8473.7872.355.85
266725-6672566.89867.04
374261-7426174.45374.63
466824-6682466.99767.15
576727-7672776.92677.11
674024-7402474.21674.40
20min178158-7815878.36077.444.3678.6677.734.37
274133-7413374.32574.57
378656-7865678.86079.16
472217-7221772.40472.67
581122-8112281.33281.64
679181-7918179.38679.69
30min180503-8050380.71181.572.2581.1581.982.25
282919-8291983.13483.51
381847-8184782.05982.49
478239-7823978.44278.82
583243-8324383.45983.90
681386-8138681.59782.03
45min179765-7976579.97282.943.4180.5483.493.37
287117-8711787.34387.85
381164-8116481.37481.94
482033-8203382.24582.76
585181-8518185.40285.98
681085-8108581.29581.87
极限194588-9458894.83395.561.9295.5496.251.91
296071-9607196.32096.98
396452-9645296.70297.41
495294-9529495.54196.19
597331-9733197.58398.31
692116-9211692.35593.06
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%
111.68 3738083715083739773737793719233729990.32
211.693772713756983764840.30
单位质量响应值RSD%判断
31934.8532205.650.60数据可信
供试品溶液-24080102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%
5min1184544-18454447.53243.5518.7347.5343.5518.73
2119562-11956230.79530.79
3184718-18471847.57747.58
4139072-13907235.82035.82
5192028-19202849.46049.46
6194546-19454650.10850.11
10min1258512-25851266.58364.0511.4366.6664.1311.44
2203613-20361352.44352.49
3259494-25949466.83666.92
4224254-22425457.76057.82
5273134-27313470.35070.43
6273159-27315970.35670.44
15min1284903-28490373.38172.118.5373.5772.298.55
2246100-24610063.38763.53
3286939-28693973.90574.10
4256010-25601065.93966.09
5303297-30329778.11878.32
6302603-30260377.94078.14
20min1295089-29508976.00475.626.9676.3275.926.98
2266794-26679468.71768.96
3298763-29876376.95177.26
4271989-27198970.05570.32
5313825-31382580.83081.16
6315041-31504181.14381.47
30min1300459-30045977.38779.043.7477.8379.463.77
2296281-29628176.31176.67
3308100-30810079.35679.80
4295396-29539676.08376.47
5319592-31959282.31582.78
6321357-32135782.77083.24
45min1300769-30076977.46780.782.9378.0481.342.93
2313586-31358680.76981.25
3309392-30939279.68880.26
4309919-30991979.82480.33
5325620-32562083.86884.47
6322516-32251683.06983.67
极限1367706-36770694.70896.861.7795.4197.551.78
2369417-36941795.14995.77
3376148-37614896.88297.59
4378933-37893397.60098.24
5385626-38562699.323100.07
6378464-37846497.47998.22
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