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%
111.551926201926321924121922441926301925080.10
211.451930951930661930800.02
单位质量响应值RSD%判断
16667.3616862.880.83数据可信
长期24月-供试品溶液-2024011223批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159308-5930831.76034.1426.8131.7634.1426.81
268211-6821136.52736.53
370639-7063937.82837.83
433490-3349017.93417.93
585028-8502845.53345.53
665875-6587535.27635.28
10min1142876-14287676.51176.3310.5976.6976.5210.62
2141075-14107575.54675.75
3159397-15939785.35885.57
4114877-11487761.51761.62
5151215-15121580.97681.23
6145813-14581378.08478.28
15min1169393-16939390.71189.963.4391.3190.583.49
2165222-16522288.47789.10
3177509-17750995.05795.74
4160443-16044385.91886.36
5169775-16977590.91591.62
6165655-16565588.70989.34
20min1176070-17607094.28694.173.1095.3995.283.14
2169557-16955790.79991.91
3184556-18455698.831100.04
4171042-17104291.59492.51
5178784-17878495.74096.95
6175089-17508993.76194.88
30min1181417-18141797.15097.301.5398.7898.941.57
2178004-17800495.32296.94
3185952-18595299.578101.34
4181040-18104096.94898.38
5183634-18363498.337100.08
6180172-18017296.48398.13
45min1184758-18475898.93998.781.56101.11100.961.57
2179814-17981496.29198.44
3188669-188669101.033103.35
4185342-18534299.252101.22
5184815-18481598.969101.26
6183413-18341398.219100.40
60min1183406-18340698.21598.501.31100.93101.231.32
2179579-17957996.16598.85
3185553-18555399.365102.24
4184951-18495199.042101.56
5186346-18634699.789102.63
6183846-18384698.450101.18
极限1183116-18311698.06098.801.04101.32102.071.05
2181917-18191797.417100.63
3185602-18560299.391102.82
4184492-18449298.796101.86
5184426-18442698.761102.15
6187427-187427100.368103.64
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(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.321582391576991576361578241579741578740.16
211.301575971581491578730.25
单位质量响应值RSD%判断
13946.4713971.060.13数据可信
长期24月-供试品溶液-2024011223批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189653-8965353.16381.8718.1753.1681.8718.17
2150934-15093489.50289.50
3152972-15297290.71190.71
4133185-13318578.97778.98
5156492-15649292.79892.80
6145168-14516886.08386.08
10min1145296-14529686.15996.267.7386.4596.727.77
2163307-16330796.84097.34
3180045-180045106.765107.27
4151074-15107489.58590.02
5169141-169141100.299100.81
6165162-16516297.94098.42
15min1160914-16091495.42097.532.4496.1998.522.50
2165774-16577498.30299.34
3164536-16453697.56898.67
4158987-15898794.27895.21
5170089-170089100.861101.93
6166514-16651498.74199.76
20min1161926-16192696.02197.572.9597.3299.102.98
2162324-16232496.25797.84
3165622-16562298.21299.85
4157888-15788893.62695.09
5171505-171505101.701103.33
6167955-16795599.596101.17
30min1162626-16262696.43697.642.2398.2799.712.28
2164795-16479597.72299.84
3163704-16370497.07599.26
4159607-15960794.64596.63
5170288-170288100.979103.18
6166900-16690098.970101.09
45min1163435-16343596.91597.951.7699.29100.561.82
2164681-16468197.654100.31
3165305-16530598.024100.75
4160966-16096695.45197.96
5169082-169082100.264103.02
6167580-16758099.373102.05
60min1162306-16230696.24697.362.0599.16100.522.10
2163648-16364897.042100.24
3162436-16243696.32399.59
4160286-16028695.04898.08
5169243-169243100.360103.68
6167167-16716799.128102.35
极限1162924-16292496.61297.351.70100.06101.051.72
2163260-16326096.812100.55
3162503-16250396.363100.17
4161361-16136195.68699.25
5166192-16619298.550102.42
6168794-168794100.093103.87
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%
111.551932051933431935131934141934761933900.07
211.451934821938311936560.13
单位质量响应值RSD%判断
16743.7216913.190.72数据可信
长期24月-供试品溶液-2024011223批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141883-4188322.34428.4318.0722.3428.4318.08
249940-4994026.64226.64
343473-4347323.19223.19
463487-6348733.86933.87
557456-5745630.65230.65
663504-6350433.87833.88
10min1149819-14981979.92676.433.8180.0576.593.81
2141937-14193775.72175.87
3135391-13539172.22972.36
4147084-14708478.46778.66
5139032-13903274.17174.34
6146358-14635878.08078.27
15min1176136-17613693.96691.561.6694.5392.141.66
2170845-17084591.14391.71
3167374-16737489.29289.82
4171947-17194791.73192.36
5171040-17104091.24791.83
6172456-17245692.00392.62
20min1182750-18275097.49496.001.0898.5897.091.09
2180166-18016696.11697.19
3176669-17666994.25095.28
4180134-18013496.09997.23
5180128-18012896.09697.18
6179861-17986195.95397.09
30min1186976-18697699.74999.081.74101.38100.701.72
2182519-18251997.37198.98
3183879-18387998.09799.65
4183682-18368297.99299.66
5191446-191446102.134103.76
6185782-18578299.112100.78
45min1187960-187960100.27499.680.79102.46101.860.77
2185776-18577699.109101.26
3187085-18708599.807101.90
4184771-18477198.573100.78
5188856-188856100.752102.94
6186659-18665999.580101.80
60min1183836-18383698.07498.420.59100.82101.150.58
2183347-18334797.813100.51
3185049-18504998.721101.37
4183441-18344197.863100.62
5185869-18586999.158101.91
6185352-18535298.883101.65
极限1185633-18563399.03298.600.94102.32101.880.92
2184789-18478998.582101.83
3183842-18384298.077101.27
4182316-18231697.263100.57
5187465-187465100.010103.31
6184932-18493298.658101.98
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(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.321580471588611584821586381584701585000.19
211.301582491585761584120.15
单位质量响应值RSD%判断
14001.7714018.760.09数据可信
长期24月-供试品溶液-2024011223批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137418-13741881.18884.464.4181.1984.464.41
2140703-14070383.12983.13
3136654-13665480.73780.74
4149824-14982488.51888.52
5151564-15156489.54689.55
6141564-14156483.63883.64
10min1166845-16684598.57496.771.6799.0297.231.67
2159332-15933294.13594.60
3162583-16258396.05696.50
4163257-16325796.45496.95
5166220-16622098.20598.70
6164465-16446597.16897.63
15min1168074-16807499.30098.451.23100.3099.461.23
2163496-16349696.59597.58
3166073-16607398.11899.10
4165529-16552997.79698.82
5169179-16917999.953101.00
6167499-16749998.96099.96
20min1167175-16717598.76998.270.94100.3299.820.95
2163579-16357996.64498.17
3165530-16553097.79799.32
4166599-16659998.428100.00
5167915-16791599.206100.80
6167173-16717398.768100.32
30min1166046-16604698.10298.122.08100.20100.222.07
2160635-16063594.90596.96
3165193-16519397.59899.67
4165827-16582797.972100.09
5171284-171284101.196103.35
6167526-16752698.976101.08
45min1165786-16578697.94897.491.12100.59100.131.12
2161563-16156395.45398.04
3164743-16474397.33299.94
4165112-16511297.550100.21
5166078-16607898.121100.83
6166769-16676998.529101.18
60min1162402-16240295.94996.241.2399.1499.431.23
2159563-15956394.27297.39
3162464-16246495.98599.14
4163421-16342196.55199.75
5164017-16401796.903100.16
6165534-16553497.799101.00
极限1163947-16394796.86296.401.19100.58100.121.19
2160973-16097395.10598.74
3161312-16131295.30598.99
4162248-16224895.85899.60
5165397-16539797.718101.51
6165143-16514397.568101.31
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%
111.551934491932171932921932921934121933320.05
211.451921761928841925300.27
单位质量响应值RSD%判断
16738.7016814.850.33数据可信
长期24月-供试品溶液-2024011621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125074-2507413.41823.6927.3313.4223.6927.33
248898-4889826.16626.17
340117-4011721.46721.47
439645-3964521.21521.21
551973-5197327.81227.81
659884-5988432.04532.04
10min191145-9114548.77367.5415.2948.8567.6715.31
2141304-14130475.61475.76
3136219-13621972.89373.01
4124134-12413466.42666.54
5121558-12155865.04865.20
6142892-14289276.46476.64
15min1139684-13968474.74786.628.2875.0987.138.33
2172021-17202192.05192.62
3172789-17278992.46292.99
4162511-16251186.96287.45
5152566-15256681.64182.16
6171670-17167091.86492.47
20min1161059-16105986.18592.924.9486.9593.915.01
2179088-17908895.83396.91
3181543-18154397.14798.18
4173347-17334792.76193.73
5165755-16575588.69889.67
6181063-18106396.89098.00
30min1173075-17307592.61596.312.8493.8697.822.92
2183860-18386098.387100.00
3185444-18544499.234100.81
4180154-18015496.40497.89
5174572-17457293.41794.88
6182808-18280897.82499.48
45min1177358-17735894.90797.151.9596.6699.192.05
2185040-18504099.018101.17
3186050-18605099.559101.69
4179932-17993296.28598.31
5178533-17853395.53697.52
6182339-18233997.57399.77
60min1176725-17672594.56997.252.0696.8599.832.16
2183772-18377298.340101.05
3186292-18629299.688102.37
4181304-18130497.01999.57
5178100-17810095.30497.82
6184270-18427098.606101.34
极限1179805-17980596.21797.731.0999.02100.851.13
2182125-18212597.458100.71
3184477-18447798.717101.95
4182789-18278997.814100.91
5185177-18517799.091102.13
6181440-18144097.092100.38
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(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.323118893112783114773111733115093114650.09
211.303101863107413104640.13
单位质量响应值RSD%判断
27514.5827474.690.11数据可信
长期24月-供试品溶液-2024011621批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1224367-22436767.54772.6312.0367.5572.6312.03
2268865-26886580.94380.94
3240941-24094172.53772.54
4266698-26669880.29180.29
5253908-25390876.44076.44
6192718-19271858.01958.02
10min1300779-30077990.55193.564.3290.9393.964.35
2318571-31857195.90896.36
3311879-31187993.89394.30
4326227-32622798.21298.66
5317610-31761095.61896.04
6289566-28956687.17587.50
15min1316751-31675195.36097.292.8096.2498.212.84
2325845-32584598.09799.08
3327176-32717698.49899.42
4335270-335270100.935101.93
5324652-32465297.73898.69
6309245-30924593.10093.91
20min1324124-32412497.57998.121.6798.9999.581.72
2324354-32435497.64999.18
3329176-32917699.100100.57
4334313-334313100.647102.20
5325396-32539697.96299.46
6318148-31814895.78097.10
30min1324173-32417397.59498.021.8999.54100.031.93
2324398-32439897.66299.73
3328373-32837398.859100.88
4335384-335384100.969103.08
5324671-32467197.74499.79
6316608-31660895.31797.17
45min1325122-32512297.88097.781.67100.37100.331.72
2324626-32462697.730100.34
3327581-32758198.620101.19
4330053-33005399.364102.04
5326898-32689898.414101.00
6314490-31449094.67997.06
60min1322364-32236497.04997.751.55100.09100.851.59
2322314-32231497.034100.19
3327749-32774998.671101.79
4332411-332411100.074103.30
5325403-32540397.964101.10
6317971-31797195.72798.64
极限1324009-32400997.54597.891.53101.12101.531.55
2319697-31969796.24799.94
3328690-32869098.954102.62
4328220-32822098.812102.59
5331072-33107299.671103.35
6319200-31920096.09799.54
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%
111.551928901930431930811931841932611930920.08
211.451947431952741950080.20
单位质量响应值RSD%判断
16717.9217031.271.32数据可信
长期24月-供试品溶液-2024011621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132898-3289817.50424.5720.1617.5024.5720.16
242353-4235322.53422.53
341002-4100221.81521.82
448089-4808925.58625.59
554935-5493529.22929.23
657790-5779030.74830.75
10min1101705-10170554.11366.4410.2654.2166.5710.27
2127716-12771667.95268.08
3118918-11891863.27163.39
4131079-13107969.74269.88
5135099-13509971.88172.04
6134673-13467371.65471.82
15min1146068-14606877.71785.725.1278.1186.235.15
2157105-15710583.58984.09
3166046-16604688.34688.82
4167840-16784089.30189.83
5165228-16522887.91188.47
6164429-16442987.48688.05
20min1160492-16049285.39192.074.0486.2293.054.07
2170173-17017390.54291.51
3178431-17843194.93695.90
4179540-17954095.52696.55
5175160-17516093.19594.25
6174439-17443992.81293.87
30min1175933-17593393.60796.882.1194.9198.382.16
2181216-18121696.41897.89
3183996-18399697.89799.39
4187537-18753799.781101.34
5182820-18282097.27198.84
6181052-18105296.33097.90
45min1178441-17844194.94197.511.5996.7799.541.66
2183712-18371297.74699.75
3181424-18142496.52898.56
4186011-18601198.969101.08
5185905-18590598.912101.02
6184074-18407497.938100.04
60min1185442-18544298.66698.331.02101.02100.910.99
2182643-18264397.17799.73
3186541-18654199.251101.82
4186906-18690699.445102.11
5184776-18477698.312100.97
6182565-18256597.13599.79
极限1187836-18783699.94098.781.64102.84101.901.56
2183108-18310897.424100.51
3187636-18763699.833102.96
4189205-189205100.668103.88
5184582-18458298.208101.41
6181536-18153696.58899.78
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(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.323107043107083105713110373110453108130.07
211.303141693149923145800.19
单位质量响应值RSD%判断
27456.9827838.940.98数据可信
长期24月-供试品溶液-2024011621批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1237203-23720371.01967.7815.0971.0267.7815.09
2255577-25557776.52076.52
3260103-26010377.87577.87
4176634-17663452.88452.88
5192462-19246257.62357.62
6236404-23640470.77970.78
10min1302975-30297590.71193.662.0891.1194.032.09
2321001-32100196.10896.53
3316185-31618594.66695.10
4307552-30755292.08192.37
5314012-31401294.01594.34
6315163-31516394.36094.75
15min1322443-32244396.53997.191.3197.4498.081.32
2322496-32249696.55597.51
3331701-33170199.311100.27
4321003-32100396.10896.91
5327937-32793798.18499.03
6322063-32206396.42697.34
20min1321244-32124496.18197.571.2797.6299.011.27
2325285-32528597.39098.89
3331823-33182399.348100.86
4323736-32373696.92798.27
5329898-32989898.772100.16
6323314-32331496.80098.25
30min1322623-32262396.59398.020.8998.56100.000.87
2328325-32832598.301100.34
3329216-32921698.567100.63
4329679-32967998.706100.58
5329435-32943598.633100.57
6325073-32507397.32799.32
45min1316449-31644994.74596.931.5797.2599.461.51
2325745-32574597.528100.11
3319505-31950595.66098.27
4323952-32395296.99199.42
5330494-33049498.950101.43
6326374-32637497.716100.25
60min1327964-32796498.19297.650.83101.22100.710.80
2323303-32330396.79799.92
3327974-32797498.195101.34
4325206-32520697.367100.33
5329481-32948198.647101.68
6323035-32303596.71799.79
极限1327694-32769498.11298.271.69101.69101.881.60
2322695-32269596.615100.28
3328755-32875598.429102.12
4333376-33337699.813103.32
5335356-335356100.406103.99
6321553-32155396.27399.88
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