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对照品来源工作对照品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%
110.011686041686811686281688961686281686870.08
210.101696901703611700260.28
单位质量响应值RSD%判断
16851.8516834.260.08数据可信
供试品溶液-2023120821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%
5min1106782-10678256.91629.3959.0556.9229.3959.06
256641-5664130.19030.19
356203-5620329.95729.96
451200-5120027.29027.29
555984-5598429.84029.84
64017-40172.1412.14
10min1170775-17077591.02580.437.5191.3480.607.56
2154094-15409482.13482.30
3144849-14484977.20677.37
4143009-14300976.22576.38
5139431-13943174.31874.48
6153250-15325081.68481.70
15min1181245-18124596.60593.152.8197.4393.762.90
2178510-17851095.14795.77
3176212-17621293.92394.52
4173169-17316992.30192.88
5171651-17165191.49292.07
6167733-16773389.40389.87
20min1186071-18607199.17896.853.26100.5497.983.32
2186136-18613699.212100.36
3183373-18337397.73998.86
4181480-18148096.73197.82
5182914-18291497.49598.58
6170235-17023590.73791.70
30min1186868-18686899.60298.513.23101.51100.173.27
2187552-18755299.967101.67
3187275-18727599.819101.48
4186362-18636299.333100.96
5188102-188102100.260101.89
6172701-17270192.05193.52
45min1184413-18441398.29499.084.14100.76101.304.13
2188321-188321100.377102.64
3190065-190065101.306103.52
4189719-189719101.122103.30
5191778-191778102.219104.41
6171057-17105791.17593.15
60min1183806-18380697.97098.203.74100.98100.973.74
2185709-18570998.985101.80
3187407-18740799.890102.67
4187912-187912100.159102.90
5189795-189795101.162103.92
6170827-17082791.05293.54
极限1183860-18386097.99997.793.75101.55101.093.76
2185966-18596699.122102.49
3186450-18645099.380102.71
4186164-18616499.227102.52
5188533-188533100.490103.81
6169780-16978090.49493.48
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%
111.181568491568471567501568151567481568020.04
211.151576551579371577960.13
单位质量响应值RSD%判断
14025.2214152.110.64数据可信
供试品溶液-2023120821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%
5min1151332-15133288.72675.8121.5088.7375.8121.50
2107249-10724962.88062.88
3138499-13849981.20281.20
4138566-13856681.24181.24
5155758-15575891.32191.32
684375-8437549.46949.47
10min1168401-16840198.73394.627.6599.2395.047.70
2143623-14362384.20684.56
3165621-16562197.10397.55
4167112-16711297.97898.43
5174906-174906102.547103.05
6148627-14862787.14087.41
15min1168912-16891299.03398.105.69100.0799.045.76
2157723-15772392.47393.29
3171786-171786100.718101.71
4173353-173353101.637102.63
5178266-178266104.517105.59
6153862-15386290.20990.97
20min1170349-17034999.87598.665.00101.47100.155.07
2164234-16423496.29097.62
3170637-170637100.044101.59
4172147-172147100.930102.49
5178409-178409104.601106.26
6153829-15382990.19091.45
30min1170111-17011199.73698.404.43101.88100.444.51
2166046-16604697.35399.22
3170104-17010499.732101.84
4170406-17040699.909102.03
5176125-176125103.262105.50
6154150-15415090.37892.14
45min1167296-16729698.08598.505.10100.79101.095.15
2168125-16812598.571100.98
3171121-171121100.328102.99
4171530-171530100.568103.24
5177749-177749104.214107.03
6152227-15222789.25191.51
60min1167432-16743298.16597.764.70101.41100.894.76
2166721-16672197.748100.70
3168697-16869798.907102.12
4169482-16948299.367102.60
5175885-175885103.121106.51
6152226-15222689.25092.01
极限1169221-16922199.21497.784.96103.00101.464.99
2171095-171095100.313103.81
3166824-16682497.809101.58
4168400-16840098.733102.52
5174362-174362102.228106.19
6150757-15075788.38991.64
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DSMF-387-240606对照品来源工作对照品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%
110.011685131687531684471684191683631684990.10
210.101685761688591687180.12
单位质量响应值RSD%判断
16833.0716704.750.55数据可信
供试品溶液-2023120822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%
5min154600-5460029.23133.3221.9629.2333.3221.97
286945-8694546.54846.55
355614-5561429.77429.77
469645-6964537.28637.29
551325-5132527.47827.48
655344-5534429.63029.63
10min1122440-12244065.55177.0810.9865.7177.2711.00
2167749-16774989.80890.07
3143235-14323576.68476.85
4155338-15533883.16483.37
5139585-13958574.73074.88
6135553-13555372.57172.74
15min1149770-14977080.18390.376.1880.7190.986.21
2179872-17987296.29997.06
3170135-17013591.08691.68
4176219-17621994.34395.01
5169058-16905890.50991.08
6167723-16772389.79490.36
20min1167051-16705189.43595.383.3590.4196.493.41
2183754-18375498.37799.67
3179453-17945396.07497.17
4182470-18247097.69098.88
5176931-17693194.72495.79
6179245-17924595.96397.03
30min1179086-17908695.87898.141.3397.3599.791.41
2184440-18444098.744100.58
3184498-18449898.775100.41
4185826-18582699.486101.22
5181906-18190697.38898.98
6184154-18415498.591100.19
45min1181491-18149197.16598.550.9299.17100.740.98
2183595-18359598.292100.68
3184877-18487798.978101.16
4186611-18661199.907102.20
5183921-18392198.466100.60
6183943-18394398.478100.63
60min1182637-18263797.77998.560.59100.32101.300.62
2183620-18362098.305101.24
3184508-18450898.781101.51
4184439-18443998.744101.59
5183586-18358698.287100.97
6185794-18579499.469102.16
极限1181788-18178897.32498.620.96100.41101.910.95
2183338-18333898.154101.63
3184986-18498699.037102.32
4183508-18350898.245101.64
5184737-18473798.903102.13
6186927-186927100.076103.32
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%
111.181564451566471566601566171565911565920.06
211.151564351566131565240.09
单位质量响应值RSD%判断
14006.4414038.030.16数据可信
供试品溶液-2023120822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%
5min134741-3474120.46562.9537.5220.4662.9537.52
2110293-11029364.97064.97
3140350-14035082.67582.68
4146690-14669086.41086.41
597328-9732857.33357.33
6111770-11177065.84065.84
10min199838-9983858.81189.7217.5858.9290.0717.65
2150619-15061988.72489.09
3166368-16636898.00298.46
4172514-172514101.622102.10
5158955-15895593.63593.95
6165566-16556697.52997.89
15min1140566-14056682.80396.267.6083.2497.117.75
2157733-15773392.91593.77
3169733-16973399.984100.99
4173641-173641102.286103.33
5169192-16919299.665100.50
6169597-16959799.904100.81
20min1157971-15797193.05598.553.5193.9699.943.69
2162761-16276195.87797.25
3168612-16861299.323100.88
4173742-173742102.345103.96
5169348-16934899.757101.15
6171379-171379100.953102.42
30min1167568-16756898.70899.351.74100.13101.281.84
2164764-16476497.05798.96
3167205-16720598.495100.61
4173475-173475102.188104.37
5169374-16937499.772101.72
6169536-16953699.868101.89
45min1167603-16760398.72999.001.81100.69101.481.87
2164549-16454996.93099.37
3166033-16603397.804100.46
4173241-173241102.050104.80
5169493-16949399.842102.34
6167483-16748398.658101.24
60min1168072-16807299.00598.991.40101.52102.021.45
2165071-16507197.238100.22
3165658-16565897.583100.78
4171334-171334100.927104.24
5168989-16898999.546102.60
6169177-16917799.656102.78
极限1167356-16735698.58499.081.30101.65102.661.38
2165364-16536497.410100.93
3166209-16620997.908101.65
4170496-170496100.433104.31
5169696-16969699.962103.57
6170057-170057100.175103.85
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对照品来源工作对照品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%
110.011700061698311695791697011697991697830.10
210.101726031728021727020.09
单位质量响应值RSD%判断
16961.3417099.210.58数据可信
供试品溶液-2023120823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%
5min161407-6140732.37129.3134.4632.3729.3034.47
244058-4405823.22623.23
351942-5194227.38227.38
444394-4439423.40323.40
591538-9153848.25548.26
640205-4020521.19421.19
10min1132894-13289470.05671.2010.1170.2471.3610.15
2116923-11692361.63761.77
3136461-13646171.93772.09
4139169-13916973.36473.49
5157776-15777683.17383.44
6127147-12714767.02767.14
15min1160888-16088884.81387.694.0385.3888.254.06
2155604-15560482.02882.50
3169246-16924689.21989.77
4172254-17225490.80591.34
5172083-17208390.71591.45
6168023-16802388.57589.06
20min1173136-17313691.27093.471.8292.3194.511.87
2173302-17330291.35892.28
3178454-17845494.07395.12
4180113-18011394.94895.99
5179949-17994994.86296.10
6178860-17886094.28895.27
30min1185573-18557397.82697.441.5899.3799.001.66
2180538-18053895.17296.61
3184085-18408597.04298.61
4186842-18684298.495100.06
5188863-18886399.561101.32
6183162-18316296.55598.06
45min1183928-18392896.95997.921.1199.05100.021.08
2184387-18438797.20199.16
3184982-18498297.51599.62
4188756-18875699.504101.62
5184514-18451497.26899.58
6187923-18792399.065101.11
60min1185658-18565897.87197.660.72100.50100.310.65
2184547-18454797.28599.79
3185570-18557097.825100.48
4186775-18677598.460101.13
5182975-18297596.45799.31
6185994-18599498.048100.64
极限1183259-18325996.60696.951.3599.78100.141.25
2183147-18314796.54799.59
3185186-18518697.622100.82
4186912-18691298.532101.75
5179757-17975794.76098.15
6185164-18516497.611100.75
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%
111.181574331570211569981569561571251571070.13
211.151588841591571590200.13
单位质量响应值RSD%判断
14052.5014261.881.05数据可信
供试品溶液-2023120823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%
5min1139778-13977881.55875.1110.0581.5675.1110.05
2137625-13762580.30280.30
3136521-13652179.65779.66
4128488-12848874.97074.97
5105072-10507261.30861.31
6124865-12486572.85672.86
10min1165583-16558396.61596.921.1097.0797.341.12
2165539-16553996.58997.03
3167596-16759697.78998.23
4167753-16775397.88198.30
5162998-16299895.10695.45
6167219-16721997.56997.97
15min1166903-16690397.38599.872.0398.37100.822.02
2170854-17085499.690100.67
3171077-17107799.820100.81
4174966-174966102.089103.05
5167898-16789897.96598.83
6175263-175263102.263103.21
20min1166313-16631397.04099.671.4998.57101.181.47
2171571-171571100.108101.64
3170206-17020699.312100.85
4173474-173474101.219102.75
5170576-17057699.528100.94
6172749-172749100.796102.31
30min1169373-16937398.82699.841.79100.90101.901.72
2168370-16837098.241100.33
3169569-16956998.940101.03
4173796-173796101.407103.50
5176019-176019102.704104.67
6169543-16954398.925101.00
45min1165307-16530796.45399.231.7499.07101.851.69
2169354-16935498.815101.45
3168579-16857998.363101.00
4173502-173502101.235103.89
5171572-171572100.109102.65
6172079-172079100.405103.03
60min1166463-16646397.12898.751.02100.28101.921.00
2169362-16936298.819102.01
3168654-16865498.406101.59
4171716-171716100.193103.41
5169433-16943398.861101.95
6169868-16986899.115102.30
极限1164354-16435495.89797.881.4499.59101.601.42
2167448-16744897.703101.44
3168132-16813298.102101.84
4171450-171450100.038103.81
5166278-16627897.020100.66
6168827-16882798.507102.24
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