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%
115.169340893422930999314093378932890.17
215.239438394275943290.09
单位质量响应值RSD%判断
6153.636193.630.46数据可信
供试品溶液-24102901批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173088-7308876.74681.083.2076.7581.083.20
278184-7818482.09782.10
376963-7696380.81480.81
476345-7634580.16680.17
578257-7825782.17382.17
680469-8046984.49684.50
10min187553-8755391.93495.502.3892.0695.632.38
292042-9204296.64896.78
389717-8971794.20794.34
490600-9060095.13495.27
592029-9202996.63496.77
693726-9372698.41698.56
15min190599-9059995.13398.922.3895.4199.222.39
295136-9513699.897100.19
393186-9318697.84998.14
494098-9409898.80799.10
594913-9491399.66399.96
697321-97321102.191102.50
20min191583-9158396.16699.432.3196.6199.892.31
294944-9494499.695100.16
393249-9324997.91598.37
494633-9463399.36999.83
595738-95738100.529100.99
698007-98007102.912103.39
30min191336-9133695.90798.304.0796.5198.934.06
295216-9521699.981100.61
387127-8712791.48792.11
494457-9445799.18499.81
595781-95781100.574101.21
697772-97772102.665103.31
45min191284-9128495.85298.952.1796.6199.742.17
294762-9476299.504100.30
392835-9283597.48198.25
493940-9394098.64199.43
595458-95458100.235101.03
697114-97114101.974102.79
极限191070-9107095.62798.892.3296.5599.852.33
294486-9448699.214100.18
392639-9263997.27598.21
494249-9424998.96699.92
595171-9517199.934100.90
697456-97456102.333103.32
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%
111.301751811748661739371746901751201747590.29
211.341776541778541777540.08
单位质量响应值RSD%判断
15465.4015674.960.96数据可信
供试品溶液-24102901批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133405-3340517.72218.823.3817.7218.823.38
235951-3595119.07319.07
336630-3663019.43319.43
435251-3525118.70218.70
535080-3508018.61118.61
636539-3653919.38519.38
10min163781-6378133.83735.652.8933.8735.682.89
268806-6880636.50336.54
368875-6887536.54036.57
467700-6770035.91735.95
567860-6786036.00136.03
666156-6615635.09735.13
15min182387-8238743.70846.573.3443.7946.663.34
288976-8897647.20447.30
390558-9055848.04348.14
489519-8951947.49247.58
588476-8847646.93947.03
686763-8676346.03046.12
20min194739-9473950.26153.433.1550.4253.603.15
2100447-10044753.29053.46
3103514-10351454.91755.09
4102713-10271354.49254.66
5102314-10231454.28054.45
6100591-10059153.36653.53
30min1110517-11051758.63261.913.0858.8762.173.08
2116986-11698662.06462.32
3120635-12063564.00064.26
4118260-11826062.74063.00
5118915-11891563.08763.35
6114907-11490760.96161.22
45min1122404-12240464.93867.592.3665.2867.952.36
2127438-12743867.60967.97
3128074-12807467.94768.32
4128854-12885468.36068.73
5131394-13139469.70870.07
6126199-12619966.95267.31
极限1132424-13242470.25472.261.5170.7072.731.52
2135534-13553471.90472.38
3137668-13766873.03673.52
4137651-13765173.02773.51
5137654-13765473.02973.51
6136258-13625872.28872.76
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%
115.169284292906927929286592513927840.17
215.239420794369942880.13
单位质量响应值RSD%判断
6120.326190.940.82数据可信
供试品溶液-24102901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%
5min183790-8379088.24288.792.3288.2488.802.32
288127-8812792.81092.81
383920-8392088.37988.38
484233-8423388.70988.71
582626-8262687.01787.02
683187-8318787.60787.61
10min188518-8851893.22295.721.8793.3795.871.87
293676-9367698.65498.81
390085-9008594.87295.02
491114-9111495.95696.10
590590-9059095.40495.55
691372-9137296.22796.37
15min190157-9015794.94897.622.0395.2597.922.03
295696-95696100.781101.10
391773-9177396.65096.96
492169-9216997.06797.37
592601-9260197.52297.83
693748-9374898.73099.04
20min190905-9090595.73598.001.8396.2098.471.83
295600-95600100.680101.17
392004-9200496.89397.36
492653-9265397.57698.05
592742-9274297.67098.14
694428-9442899.44699.92
30min190243-9024395.03898.242.0095.6698.872.00
295420-95420100.490101.15
392223-9222397.12497.75
493508-9350898.47799.11
593478-9347898.44599.07
694804-9480499.842100.48
45min191047-9104795.88598.331.9896.6699.131.98
296129-96129101.237102.06
391881-9188196.76397.55
493079-9307998.02598.82
593414-9341498.37899.17
694683-9468399.714100.52
极限190280-9028095.07797.922.0496.0298.882.04
295841-95841100.934101.92
391988-9198896.87697.83
493127-9312798.07699.04
592520-9252097.43698.39
694113-9411399.114100.08
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%
111.301747221749011746921749741748721748320.07
211.341786861788131787500.06
单位质量响应值RSD%判断
15471.8615762.791.32数据可信
供试品溶液-24102901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%
5min192094-9209448.71348.881.4248.7148.881.42
294086-9408649.76649.77
393067-9306749.22749.23
492795-9279549.08449.08
590156-9015647.68847.69
692287-9228748.81548.81
10min1134416-13441671.09975.082.9671.1875.162.96
2141746-14174674.97675.06
3142547-14254775.40075.48
4141551-14155174.87374.95
5144490-14449076.42776.51
6146896-14689677.70077.78
15min1156344-15634482.69887.012.8382.9087.222.83
2165098-16509887.32887.54
3164817-16481787.17987.39
4163395-16339586.42786.63
5166976-16697688.32188.53
6170309-17030990.08490.30
20min1167339-16733988.51392.602.5588.8592.952.55
2175386-17538692.77093.12
3177346-17734693.80694.16
4173423-17342391.73192.08
5176357-17635793.28393.64
6180527-18052795.48995.85
30min1174354-17435492.22496.352.2792.7196.862.27
2182799-18279996.69197.20
3183908-18390897.27797.79
4181753-18175396.13796.64
5183673-18367397.15397.66
6186471-18647198.63399.15
45min1178731-17873194.53997.931.9395.1898.601.93
2187665-18766599.26599.93
3186876-18687698.84799.52
4184133-18413397.39698.06
5184937-18493797.82298.49
6188558-18855899.737100.42
极限1178960-17896094.66098.242.0495.4699.072.04
2188589-18858999.753100.59
3187351-18735199.09999.93
4186068-18606898.42099.25
5184136-18413697.39898.23
6189250-189250100.103100.95
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%
115.169320693362931009302693212931810.14
215.239412594164941440.03
单位质量响应值RSD%判断
6146.506181.480.41数据可信
供试品溶液-24102901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%
5min153554-5355456.32253.574.8956.3253.574.88
253699-5369956.47456.47
347762-4776250.23050.23
451558-5155854.22354.22
548532-4853251.04051.04
650527-5052753.13853.14
10min178848-7884882.92383.352.3183.0283.442.31
282393-8239386.65186.75
379489-7948983.59783.68
479252-7925283.34883.44
578851-7885182.92683.01
676705-7670580.66980.76
15min183083-8308387.37790.223.0087.6190.453.00
288214-8821492.77393.01
389386-8938694.00694.23
485532-8553289.95290.18
585291-8529189.69989.92
683211-8321187.51287.73
20min186974-8697491.46992.712.3691.8593.082.35
289726-8972694.36394.76
391529-9152996.25996.64
487472-8747291.99392.37
587284-8728491.79592.17
685914-8591490.35490.72
30min187499-8749992.02191.612.8592.5592.142.84
285245-8524589.65190.20
391848-9184896.59597.14
485193-8519389.59690.13
586690-8669091.17091.70
686178-8617890.63291.15
45min186090-8609090.53992.872.8891.2293.552.87
290967-9096795.66896.37
392018-9201896.77497.47
487422-8742291.94092.62
586322-8632290.78391.46
686996-8699691.49292.16
极限187747-8774792.28292.881.7393.1293.721.73
288525-8852593.10093.96
391174-9117495.88696.75
488163-8816392.71993.55
587545-8754592.07092.90
686736-8673691.21992.04
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100590-202005 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%
111.301758551757781757261757611756971757630.04
211.341772191774061773120.08
单位质量响应值RSD%判断
15554.2515635.980.38数据可信
供试品溶液-24102901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%
5min1104763-10476355.48852.504.8755.4952.504.87
2102696-10269654.39454.39
390766-9076648.07548.07
499901-9990152.91352.91
598527-9852752.18552.19
698124-9812451.97251.97
10min1149186-14918679.01779.051.6679.1179.141.66
2150655-15065579.79579.89
3148334-14833478.56678.65
4149521-14952179.19579.28
5152601-15260180.82680.91
6145187-14518776.89976.99
15min1162290-16229085.95886.411.7286.1886.631.72
2164459-16445987.10787.33
3165386-16538687.59887.81
4161329-16132985.44985.67
5166447-16644788.16088.38
6158955-15895584.19284.41
20min1166098-16609887.97588.652.2088.3489.012.19
2170055-17005590.07190.44
3170691-17069190.40890.76
4163640-16364086.67387.04
5170927-17092790.53390.90
6162778-16277886.21686.57
30min1166673-16667388.27989.031.8488.7989.541.83
2169807-16980789.93990.46
3172001-17200191.10191.61
4165539-16553987.67988.19
5170343-17034390.22390.74
6164139-16413986.93787.44
45min1170027-17002790.05689.602.2490.7290.262.23
2173002-17300291.63292.30
3172108-17210891.15891.82
4164874-16487487.32787.98
5170934-17093490.53691.21
6164100-16410086.91787.56
极限1166750-16675088.32089.151.7389.1389.961.73
2170017-17001790.05190.87
3172141-17214191.17691.99
4165881-16588187.86088.66
5170291-17029190.19691.02
6164811-16481187.29388.08
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%
115.169452494517946029447494522945280.05
215.239454094394944670.11
单位质量响应值RSD%判断
6235.366202.690.38数据可信
供试品溶液-24102901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%
5min162704-6270465.36162.457.5565.3662.467.55
265646-6564668.42868.43
361800-6180064.41964.42
458367-5836760.84060.84
552616-5261654.84654.85
658354-5835460.82760.83
10min184005-8400587.56586.983.8187.6787.083.81
288089-8808991.82291.94
385346-8534688.96389.07
483359-8335986.89186.99
580210-8021083.60983.70
679656-7965683.03183.13
15min189146-8914692.92492.303.1293.1892.563.13
290906-9090694.75895.03
391464-9146495.34095.60
489099-8909992.87593.12
586564-8656490.23290.46
684135-8413587.70087.94
20min189112-8911292.88893.812.6193.3094.212.60
289940-8994093.75194.18
393736-9373697.70898.12
491593-9159395.47495.88
588189-8818991.92692.31
687387-8738791.09091.48
30min191311-9131195.18094.592.0795.7495.142.08
291955-9195595.85296.43
392981-9298196.92197.50
491075-9107594.93495.49
589332-8933293.11793.65
687792-8779291.51292.05
45min191248-9124895.11594.183.4795.8494.903.47
291744-9174495.63296.37
393202-9320297.15197.89
492475-9247596.39497.11
588664-8866492.42193.11
684791-8479188.38489.07
极限191008-9100894.86494.092.1695.7594.962.16
290771-9077194.61795.52
391268-9126895.13596.04
492364-9236496.27897.16
589344-8934493.13093.97
686826-8682690.50591.34
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%
111.301777311776521778101777671777391777400.04
211.341802431802201802320.01
单位质量响应值RSD%判断
15729.2015893.470.74数据可信
供试品溶液-24102901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%
5min1123796-12379664.67461.765.5364.6761.765.53
2125285-12528565.45265.45
3119497-11949762.42862.43
4111792-11179258.40358.40
5108936-10893656.91156.91
6120035-12003562.70962.71
10min1161401-16140184.32083.651.4684.4383.751.46
2161967-16196784.61584.72
3162187-16218784.73084.83
4156584-15658481.80381.90
5157903-15790382.49282.59
6160676-16067683.94184.05
15min1171659-17165989.67989.311.2689.9389.551.26
2169838-16983888.72788.98
3174270-17427091.04391.29
4168901-16890188.23888.47
5172216-17221689.97090.20
6168815-16881588.19388.44
20min1172722-17272290.23490.831.6090.6391.221.59
2171925-17192589.81890.22
3178164-17816493.07793.47
4172392-17239290.06290.44
5176526-17652692.22192.60
6171484-17148489.58789.98
30min1173791-17379190.79391.401.4291.3491.951.41
2172576-17257690.15890.71
3178793-17879393.40693.96
4173708-17370890.74991.28
5177300-17730092.62693.16
6173592-17359290.68991.23
45min1174165-17416590.98891.501.5291.6992.191.51
2172885-17288590.31991.02
3178772-17877293.39594.10
4174687-17468791.26191.94
5177956-17795692.96893.66
6172360-17236090.04590.74
极限1173919-17391990.85991.601.3091.7192.451.29
2174512-17451291.16992.02
3178268-17826893.13193.99
4174882-17488291.36392.20
5177886-17788692.93293.78
6172564-17256490.15290.99
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