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%
115.129542095370954299496795077952530.23
215.099511995062950900.05
单位质量响应值RSD%判断
6299.806301.520.02数据可信
加速6月-供试品溶液-LC1771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%
5min152819-5281954.34352.366.0654.3452.366.06
246576-4657647.92047.92
350677-5067752.14052.14
455398-5539856.99757.00
551166-5116652.64352.64
648714-4871450.12050.12
10min193579-9357996.28093.772.8996.3793.862.88
292751-9275195.42895.51
386165-8616588.65288.74
491532-9153294.17494.27
592077-9207794.73594.82
690727-9072793.34693.43
15min197291-97291100.09997.901.37100.3598.151.37
294598-9459897.32897.57
393612-9361296.31496.55
494538-9453897.26797.52
596013-9601398.78499.03
694883-9488397.62197.86
20min196890-9689099.68697.044.47100.1097.454.45
292365-9236595.03195.43
398478-98478101.320101.72
486793-8679389.29889.71
596240-9624099.01899.43
695146-9514697.89298.29
30min196754-9675499.54698.731.85100.1399.301.84
294288-9428897.00997.57
398940-98940101.796102.36
496399-9639999.18199.74
594746-9474697.48198.06
694657-9465797.38997.95
45min196558-9655899.34598.181.21100.0998.911.21
294243-9424396.96397.68
396729-9672999.521100.25
495346-9534698.09898.83
595695-9569598.45799.19
693963-9396396.67597.40
极限194526-9452697.25497.021.6098.1797.911.59
294047-9404796.76197.64
396397-9639799.179100.08
491762-9176294.41095.30
594125-9412596.84297.74
694906-9490697.64598.53
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%
1 11.541795261794011796641787151785401791690.29
2 11.521793511788661791080.20
单位质量响应值RSD%判断
15525.9115547.570.10数据可信
加速6月-供试品溶液-LC1771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%
5min1116154-11615461.88360.221.8661.8860.221.85
2114055-11405560.76460.76
3114221-11422160.85360.85
4110888-11088859.07759.08
5111278-11127859.28559.28
6111614-11161459.46459.46
10min1163577-16357787.14886.241.1787.2586.341.17
2161263-16126385.91586.02
3163898-16389887.31987.42
4158816-15881684.61184.71
5162535-16253586.59386.69
6161158-16115885.85985.96
15min1180044-18004495.92194.811.4096.1795.051.40
2175870-17587093.69793.94
3180462-18046296.14496.39
4174467-17446792.95093.19
5179726-17972695.75295.99
6177142-17714294.37594.62
20min1183496-18349697.76096.941.3498.1797.341.34
2180102-18010295.95296.35
3184982-18498298.55298.96
4178480-17848095.08895.48
5183353-18335397.68498.09
6181357-18135796.62097.02
30min1185348-18534898.74798.691.8099.3299.261.80
2180324-18032496.07096.63
3190145-190145101.302101.87
4183389-18338997.70398.26
5187198-18719899.732100.30
6185076-18507698.60299.16
45min1186853-18685399.54998.271.37100.2899.001.37
2182713-18271397.34398.06
3187469-18746999.877100.62
4181048-18104896.45697.17
5185331-18533198.73899.47
6183346-18334697.68098.40
极限1185742-18574298.95798.071.1199.8698.971.11
2182165-18216597.05197.93
3186179-18617999.189100.10
4181186-18118696.52997.41
5185247-18524798.69399.59
6183991-18399198.02498.91
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%
115.129499595270949359556294984951490.28
215.099531595810955620.37
单位质量响应值RSD%判断
6292.926332.800.45数据可信
加速6月-供试品溶液-LA6362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%
5min169360-6936071.22567.803.5471.2267.803.53
267606-6760669.42369.42
363039-6303964.73464.73
463899-6389965.61765.62
565906-6590667.67867.68
666348-6634868.13268.13
10min189514-8951491.92089.661.8392.0489.781.83
288182-8818290.55390.67
386012-8601288.32488.43
485589-8558987.89088.00
588409-8840990.78690.90
686199-8619988.51688.63
15min193081-9308195.58392.862.6295.8693.122.62
290870-9087093.31393.58
386406-8640688.72988.98
489925-8992592.34392.60
592432-9243294.91795.18
689864-8986492.28092.54
20min193922-9392296.44794.621.3396.8895.041.33
292830-9283095.32695.75
391019-9101993.46693.87
490877-9087793.32093.73
592770-9277095.26495.69
691416-9141693.87494.29
30min194129-9412996.66094.611.7097.2595.191.70
290376-9037692.80693.39
391872-9187294.34294.90
490753-9075393.19393.76
593878-9387896.40296.98
691802-9180294.27094.84
45min193527-9352796.04194.431.4596.7995.171.45
292692-9269295.18495.92
390234-9023492.66093.38
492625-9262595.11595.84
592267-9226794.74795.49
690427-9042792.85893.59
极限193284-9328495.79294.521.8696.7095.411.86
293851-9385196.37497.27
390500-9050092.93393.80
489691-8969192.10292.98
593332-9333295.84196.74
691604-9160494.06794.95
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%
1 11.543567593580953565293587793570543574430.27
2 11.523610643635243622940.49
单位质量响应值RSD%判断
30974.2631449.131.08数据可信
加速6月-供试品溶液-LA6362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%
5min1247970-24797065.76663.883.9465.7763.883.94
2250444-25044466.42266.42
3227980-22798060.46460.46
4232151-23215161.57161.57
5248454-24845465.89465.89
6238180-23818063.17063.17
10min1328946-32894687.24286.133.0287.3586.243.02
2324000-32400085.93086.04
3317493-31749384.20584.31
4315801-31580183.75683.86
5342260-34226090.77390.88
6319989-31998984.86784.97
15min1349840-34984092.78491.423.3493.0491.673.34
2339608-33960890.07090.32
3336032-33603289.12289.36
4336488-33648889.24389.48
5365890-36589097.04097.30
6340373-34037390.27390.52
20min1355129-35512994.18692.713.4094.6093.113.40
2343885-34388591.20491.61
3341313-34131390.52290.91
4340505-34050590.30890.70
5371310-37131098.47898.90
6345231-34523191.56191.96
30min1356751-35675194.61793.303.4095.1893.853.40
2345919-34591991.74492.30
3343275-34327591.04391.58
4342993-34299390.96891.51
5373895-37389599.16399.75
6347791-34779192.24092.79
45min1355529-35552994.29393.403.1695.0294.113.15
2347228-34722892.09192.80
3342873-34287390.93691.63
4344857-34485791.46292.16
5372982-37298298.92199.67
6349500-34950092.69493.40
极限1356219-35621994.47693.653.0395.3694.523.03
2349146-34914692.60093.46
3343254-34325491.03791.88
4344856-34485691.46292.31
5372596-37259698.81999.74
6352570-35257093.50894.37
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%
115.129665595832961539606796099961610.32
215.099518795343952650.12
单位质量响应值RSD%判断
6359.856313.120.53数据可信
长期6月-供试品溶液-LA6362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%
5min157398-5739858.72255.859.8458.7255.859.84
246524-4652447.59747.60
352240-5224053.44553.44
454635-5463555.89555.89
562686-6268664.13164.13
654082-5408255.32955.33
10min185741-8574187.71884.104.1187.8284.204.12
281070-8107082.93983.02
385492-8549287.46387.55
478109-7810979.91080.00
584099-8409986.03886.15
678727-7872780.54280.63
15min191994-9199494.11591.403.7194.3691.633.71
289730-8973091.79992.02
391605-9160593.71793.95
486405-8640588.39788.62
592075-9207594.19894.45
684216-8421686.15886.38
20min194879-9487997.06792.326.6897.4792.706.66
292350-9235094.47994.85
393818-9381895.98196.37
480257-8025782.10882.48
594686-9468696.86997.28
685440-8544087.41087.78
30min194156-9415696.32793.464.2496.8994.004.24
293514-9351495.67096.20
394539-9453996.71997.27
488252-8825290.28790.80
592700-9270094.83895.41
684968-8496886.92787.44
45min194226-9422696.39994.093.4097.1294.793.40
293774-9377495.93696.62
393751-9375195.91396.62
489467-8946791.53092.19
593868-9386896.03296.76
686752-8675288.75289.41
极限193415-9341595.56993.753.0896.4594.603.08
293989-9398996.15697.00
394117-9411796.28797.16
489748-8974891.81792.63
591528-9152893.63994.53
687021-8702189.02889.84
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%
1 11.543628283605313628133626263627713623140.28
2 11.523572683580523576600.16
单位质量响应值RSD%判断
31396.3631046.880.80数据可信
长期6月-供试品溶液-LA6362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%
5min1208125-20812555.17952.5610.2055.1852.5610.20
2175242-17524246.46146.46
3187743-18774349.77649.78
4191423-19142350.75150.75
5233404-23340461.88261.88
6193511-19351151.30551.30
10min1321866-32186685.33581.256.4085.4381.346.39
2310590-31059082.34682.42
3310877-31087782.42282.50
4283567-28356775.18175.27
5329576-32957687.37987.48
6282271-28227174.83774.92
15min1357574-35757494.80289.726.4595.0489.946.45
2350131-35013192.82993.04
3344292-34429291.28191.50
4315346-31534683.60683.82
5356197-35619794.43794.69
6306889-30688981.36481.57
20min1367044-36704497.31391.956.4397.7192.326.43
2359299-35929995.26095.63
3352637-35263793.49393.87
4322479-32247985.49885.85
5364153-36415396.54696.95
6315307-31530783.59683.94
30min1370086-37008698.11993.105.9398.6793.625.93
2363360-36336096.33696.86
3355980-35598094.38094.91
4331389-33138987.86088.35
5366667-36666797.21397.78
6319446-31944684.69385.18
45min1368064-36806497.58392.945.7298.3093.625.72
2364311-36431196.58897.28
3354687-35468794.03794.72
4330817-33081787.70888.35
5364926-36492696.75197.48
6320573-32057384.99285.62
极限1367380-36738097.40292.795.5898.2893.635.58
2363975-36397596.49997.35
3353598-35359893.74894.59
4331068-33106887.77588.56
5363187-36318796.29097.18
6320707-32070785.02885.80
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