依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221918101918311918851918561918881918540.02
211.351924791925881925340.05
单位质量响应值RSD%判断
17099.2916963.350.57数据可信
中间条件6月-供试品溶液-2024011221批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174357-7435739.19531.7323.8139.2031.7323.81
246016-4601624.25624.26
359848-5984831.54731.55
479559-7955941.93841.94
544827-4482723.62923.63
656539-5653929.80329.80
10min1149553-14955378.83376.462.7379.0576.642.77
2141700-14170074.69474.83
3146338-14633877.13977.31
4149510-14951078.81179.04
5142446-14244675.08775.22
6140760-14076074.19874.36
15min1172390-17239090.87190.011.6091.5390.611.62
2168266-16826688.69789.25
3174577-17457792.02492.63
4171547-17154790.42791.10
5170596-17059689.92690.47
6167131-16713188.09988.68
20min1176084-17608492.81894.872.4793.9895.972.43
2181835-18183595.85096.89
3187818-18781899.004100.12
4177686-17768693.66394.84
5180019-18001994.89395.94
6176397-17639792.98394.05
30min1178908-17890894.30798.453.1295.98100.083.08
2185048-18504897.54499.12
3187213-18721398.685100.35
4196797-196797103.737105.43
5187609-18760998.894100.47
6185076-18507697.55899.14
45min1184972-18497297.50397.941.1999.70100.111.21
2186363-18636398.237100.35
3187941-18794199.069101.28
4188560-18856099.395101.66
5183097-18309796.51598.64
6183872-18387296.92499.05
60min1182139-18213996.01096.030.5098.7598.740.51
2182366-18236696.13098.79
3182792-18279296.35499.12
4182188-18218896.03698.86
5180468-18046895.12997.79
6183061-18306196.49699.16
极限1182136-18213696.00996.320.8999.2899.570.88
2184013-18401396.998100.19
3185109-18510997.576100.87
4182629-18262996.26899.62
5181966-18196695.91999.11
6180522-18052295.15898.36
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241584801585951585511584921584831585200.04
211.241591681591141591410.03
单位质量响应值RSD%判断
14103.2014158.450.28数据可信
中间条件6月-供试品溶液-2024011221批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156887-15688791.70778.3220.2091.7178.3120.20
2140784-14078482.29482.29
3104019-10401960.80360.80
4161073-16107394.15494.15
5143964-14396484.15384.15
697135-9713556.77956.78
10min1167454-16745497.88497.194.0998.3997.624.14
2165285-16528596.61697.07
3154756-15475690.46190.80
4172608-172608100.896101.42
5173413-173413101.367101.83
6164092-16409295.91896.23
15min1170355-17035599.57999.751.51100.63100.721.56
2167659-16765998.00399.00
3168446-16844698.46399.30
4173586-173586101.468102.55
5173815-173815101.602102.63
6169985-16998599.363100.21
20min1167776-16777698.072100.331.6699.68101.861.62
2171357-171357100.165101.70
3174667-174667102.100103.49
4171482-171482100.238101.89
5175056-175056102.327103.92
6169531-16953199.098100.50
30min1167006-16700697.622101.613.8099.77103.693.77
2168601-16860198.554100.65
3171865-171865100.462102.42
4185152-185152108.229110.43
5177157-177157103.555105.72
6173148-173148101.212103.16
45min1170787-17078799.832100.151.31102.53102.811.35
2168630-16863098.571101.21
3171272-171272100.115102.63
4175376-175376102.514105.32
5171619-171619100.318103.06
6170349-17034999.576102.09
60min1168647-16864798.58198.191.19101.83101.401.22
2164907-16490796.39599.58
3166134-16613497.112100.18
4169930-16993099.331102.71
5169158-16915898.880102.18
6169081-16908198.835101.90
极限1168644-16864498.57998.561.02102.38102.311.08
2166277-16627797.196100.92
3168648-16864898.581102.19
4170496-17049699.662103.59
5170472-17047299.648103.49
6167122-16712297.689101.30
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221917171919911921101921531922911920520.12
211.351918991924411921700.20
单位质量响应值RSD%判断
17116.9316931.280.78数据可信
中间条件6月-供试品溶液-2024011222批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135493-3549318.71723.2521.3518.7223.2521.35
237018-3701819.52219.52
354287-5428728.62928.63
457276-5727630.20530.20
542592-4259222.46122.46
637854-3785419.96319.96
10min1109085-10908557.52767.007.7257.6367.137.72
2131485-13148569.33969.45
3137743-13774372.64072.80
4126022-12602266.45866.63
5131701-13170169.45369.58
6126257-12625766.58266.69
15min1148539-14853978.33384.244.2578.7684.744.27
2162349-16234985.61686.11
3168634-16863488.93089.49
4156218-15621882.38382.92
5162205-16220585.54086.05
6160460-16046084.62085.10
20min1167717-16771788.44791.571.9289.3192.541.95
2172018-17201890.71591.68
3175542-17554292.57393.63
4176016-17601692.82393.82
5174100-17410091.81392.80
6176441-17644193.04794.00
30min1178992-17899294.39395.170.8895.7496.640.91
2180098-18009894.97696.45
3182256-18225696.11497.68
4178589-17858994.18095.69
5182319-18231996.14797.64
6180532-18053295.20596.67
45min1182186-18218696.07796.520.5297.9598.530.56
2183572-18357296.80898.81
3184519-18451997.30799.41
4182054-18205496.00798.04
5182533-18253396.26098.29
6183308-18330896.66998.67
60min1181667-18166795.80395.980.6398.2198.520.65
2181536-18153695.73498.27
3183792-18379296.92499.57
4182674-18267496.33498.90
5180460-18046095.16797.73
6181875-18187595.91398.45
极限1186192-18619298.18996.101.28101.1399.181.20
2179056-17905694.42697.50
3182542-18254296.26599.45
4181161-18116195.53698.64
5182016-18201695.98799.08
6182433-18243396.20799.27
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241584551586671587451587201588901586950.10
211.241584711589581587140.22
单位质量响应值RSD%判断
14118.7714120.460.01数据可信
中间条件6月-供试品溶液-2024011222批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137449-13744980.40868.4418.7480.4168.4418.74
2122401-12240171.60571.60
3112721-11272165.94265.94
4129238-12923875.60475.60
575433-7543344.12844.13
6124673-12467372.93472.93
10min1163220-16322095.48490.348.9295.9390.728.96
2156219-15621991.38891.79
3158420-15842092.67693.04
4161804-16180494.65695.08
5126781-12678174.16774.41
6160152-16015293.68994.09
15min1166089-16608997.16293.694.4598.1494.574.53
2160652-16065293.98294.89
3164449-16444996.20397.08
4161423-16142394.43395.38
5146216-14621685.53786.19
6162084-16208494.81995.75
20min1166311-16631197.29295.142.3098.8196.542.40
2160125-16012593.67395.10
3162429-16242995.02196.44
4164538-16453896.25597.73
5156600-15660091.61192.74
6165787-16578796.98698.44
30min1164221-16422196.07094.431.3798.1396.361.35
2159725-15972593.43995.39
3162652-16265295.15297.10
4158024-15802492.44494.45
5161845-16184594.68096.32
6161992-16199294.76696.76
45min1162954-16295495.32894.331.0697.9296.781.04
2160259-16025993.75296.22
3162709-16270995.18597.66
4158393-15839392.66095.18
5161504-16150494.48096.65
6161621-16162194.54997.07
60min1161392-16139294.41593.490.9397.5496.470.95
2158246-15824692.57495.56
3161653-16165394.56797.57
4158207-15820792.55195.58
5159532-15953293.32796.02
6159804-15980493.48696.53
极限1164816-16481696.41893.562.10100.0697.062.03
2155645-15564591.05394.55
3160487-16048793.88597.41
4156706-15670691.67395.22
5161631-16163194.55497.77
6160352-16035293.80697.37
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221919061920061919701920521920681920000.04
211.351918821924991921900.23
单位质量响应值RSD%判断
17112.3016933.040.75数据可信
中间条件6月-供试品溶液-2024011223批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151498-5149827.16030.9219.7027.1630.9219.71
263370-6337033.42133.42
375030-7503039.57139.57
442005-4200522.15322.15
555199-5519929.11229.11
664658-6465834.10134.10
10min1141588-14158874.67377.404.6574.8277.574.67
2146222-14622277.11777.30
3158449-15844983.56683.79
4144011-14401175.95176.07
5150439-15043979.34179.50
6139850-13985073.75773.95
15min1165792-16579287.43989.363.1288.0089.963.13
2166770-16677087.95488.57
3178888-17888894.34595.03
4169441-16944189.36389.91
5171325-17132590.35790.96
6164372-16437286.69087.29
20min1175926-17592692.78393.622.0793.8394.722.07
2174908-17490892.24693.35
3181405-18140595.67396.88
4182042-18204296.00997.05
5178023-17802393.88994.99
6172811-17281191.14092.22
30min1180529-18052995.21196.321.5696.7897.941.56
2180103-18010394.98696.60
3185040-18504097.59099.33
4186580-18658098.40299.98
5183623-18362396.84398.47
6179966-17996694.91496.50
45min1184680-18468097.40096.201.6899.5098.361.63
2179192-17919294.50696.65
3182081-18208196.02998.31
4187357-18735798.812100.93
5180496-18049695.19497.36
6180656-18065695.27897.39
60min1179750-17975094.80096.231.7697.4498.921.72
2181372-18137295.65698.32
3182529-18252996.26699.08
4188592-18859299.463102.13
5182311-18231196.15198.84
6180217-18021795.04697.69
极限1181648-18164895.80194.132.0798.9697.351.99
2176000-17600092.82296.02
3177347-17734793.53396.88
4184358-18435897.230100.45
5176330-17633092.99696.22
6175167-17516792.38395.55
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241579931581881580601580921581051580880.05
211.241583571587151585360.16
单位质量响应值RSD%判断
14064.7714104.630.21数据可信
中间条件6月-供试品溶液-2024011223批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131779-13177977.28272.1020.9277.2872.1020.92
288329-8832951.80151.80
3151335-15133588.75188.75
4128785-12878575.52675.53
5142719-14271983.69883.70
694678-9467855.52455.52
10min1166635-16663597.72495.125.2698.1595.525.32
2156808-15680891.96192.25
3167936-16793698.48798.98
4167497-16749798.22998.65
5167210-16721098.06198.53
6147076-14707686.25386.56
15min1164719-16471996.60096.972.3497.5797.902.42
2162560-16256095.33496.13
3170529-170529100.007101.05
4167649-16764998.31899.28
5166953-16695397.91098.92
6159719-15971993.66894.46
20min1165331-16533196.95997.392.1098.4798.862.15
2165014-16501496.77398.10
3167681-16768198.33799.93
4171317-171317100.469101.98
5166343-16634397.55299.11
6160725-16072594.25895.57
30min1164146-16414696.26497.331.6298.3199.341.67
2166524-16652497.65999.52
3167412-16741298.179100.32
4169446-16944699.372101.44
5166533-16653397.66499.76
6161744-16174494.85596.69
45min1165959-16595997.32796.301.5899.9198.851.60
2164331-16433196.37298.78
3163426-16342695.84298.53
4168091-16809198.578101.20
5162739-16273995.43998.08
6160686-16068694.23596.59
60min1161587-16158794.76396.311.9297.8999.391.92
2166218-16621897.479100.42
3164104-16410496.23999.46
4168941-16894199.076102.25
5164285-16428596.34599.51
6160180-16018093.93896.82
极限1163004-16300495.59494.132.1499.2497.752.13
2161637-16163794.79398.28
3159120-15912093.31697.07
4165033-16503396.784100.50
5158789-15878993.12296.83
6155447-15544791.16294.57
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221921481925511928021930571932721927660.23
211.351938751939711939230.04
单位质量响应值RSD%判断
17180.5717085.730.40数据可信
长期6月-供试品溶液-2024011223批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105398-10539855.22736.1926.4555.2336.1926.45
259284-5928431.06431.06
368656-6865635.97535.97
457208-5720829.97629.98
559741-5974131.30431.30
664140-6414033.60933.61
10min1160685-16068584.19772.188.9284.5072.388.96
2126747-12674766.41466.59
3133676-13367670.04570.24
4136985-13698571.77971.95
5139887-13988773.29973.47
6128494-12849467.32967.52
15min1172987-17298790.64385.293.6391.4285.893.70
2156284-15628481.89182.43
3159704-15970483.68384.27
4164408-16440886.14886.71
5164207-16420786.04386.62
6159060-15906083.34683.91
20min1174020-17402091.18490.140.6992.4691.220.78
2170625-17062589.40590.40
3171572-17157289.90290.96
4172572-17257290.42691.47
5171375-17137589.79890.86
6172043-17204390.14991.17
30min1173184-17318490.74693.931.9392.5395.501.81
2178518-17851893.54195.03
3182076-18207695.40696.96
4181035-18103594.86096.41
5178304-17830493.42994.99
6182407-18240795.57997.10
45min1176485-17648592.47694.521.2394.7696.621.13
2180664-18066494.66696.68
3182981-18298195.88097.96
4181281-18128194.98997.06
5179543-17954394.07896.16
6181356-18135695.02897.08
60min1176152-17615292.30294.151.3995.1096.781.29
2179623-17962394.12096.66
3178808-17880893.69396.31
4182367-18236795.55898.16
5178466-17846693.51496.11
6182682-18268295.72398.31
极限1174476-17447691.42394.061.5394.7497.201.41
2179283-17928393.94297.00
3182784-18278495.77798.91
4179830-17983094.22997.36
5180377-18037794.51597.63
6180277-18027794.46397.58
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241583941587161588321590841591551588360.20
211.241596021596861596440.04
单位质量响应值RSD%判断
14131.3214203.200.36数据可信
长期6月-供试品溶液-2024011223批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129730-12973075.63869.356.9075.6469.356.90
2109273-10927363.71063.71
3119042-11904269.40669.41
4124602-12460272.64872.65
5109542-10954263.86763.87
6121476-12147670.82570.83
10min1148064-14806486.32789.263.7886.7589.643.77
2155043-15504390.39690.75
3160432-16043293.53893.92
4153271-15327189.36389.77
5144774-14477484.40984.76
6156983-15698391.52791.92
15min1153567-15356789.53594.003.6090.4494.883.57
2167493-16749397.65598.51
3167866-16786697.87298.78
4160172-16017293.38694.29
5156265-15626591.10891.93
6161959-16195994.42895.33
20min1152603-15260388.97394.263.7990.3795.673.76
2168841-16884198.44199.84
3167738-16773897.79899.25
4159967-15996793.26794.69
5158107-15810792.18293.51
6162786-16278694.91096.34
30min1151769-15176988.48794.743.7790.3896.673.74
2167422-16742297.61399.56
3168286-16828698.117100.11
4162881-16288194.96696.90
5159645-15964593.07994.92
6164973-16497396.18698.14
45min1156411-15641191.19494.272.4193.5896.722.40
2166374-16637497.00299.49
3166017-16601796.79499.33
4161578-16157894.20696.67
5159549-15954993.02395.38
6160192-16019293.39895.89
60min1156485-15648591.23793.751.8694.1396.731.87
2164711-16471196.03399.06
3161699-16169994.27797.35
4162518-16251894.75497.74
5158180-15818092.22595.10
6161188-16118893.97996.99
极限1155131-15513190.44793.612.2893.8497.112.26
2164127-16412795.69299.25
3164987-16498796.19499.79
4160646-16064693.66397.18
5160007-16000793.29096.68
6158482-15848292.40195.93
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