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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
111.181854321854031852511852491853421853350.05
211.181854631861321857980.26
单位质量响应值RSD%判断
16577.3716618.780.18数据可信
供试品溶液-2024011221批-依折麦布-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%
5min19031-90314.8815.1515.514.885.1615.51
210299-102995.5665.57
37269-72693.9283.93
411357-113576.1386.14
510525-105255.6885.69
68729-87294.7184.72
10min115201-152018.2158.166.928.248.196.90
214386-143867.7757.81
313592-135927.3467.37
416188-161888.7498.78
514948-149488.0798.11
616305-163058.8128.84
15min116216-162168.7648.932.708.849.012.70
216900-169009.1339.21
316268-162688.7928.85
417119-171199.2529.33
515970-159708.6318.71
616708-167089.0309.10
20min115902-159028.5948.741.908.728.861.86
216525-165258.9319.06
316017-160178.6568.77
416008-160088.6518.79
515971-159718.6318.76
616596-165968.9699.09
30min115539-155398.3988.223.558.578.393.47
215336-153368.2888.46
315226-152268.2298.39
415384-153848.3148.50
515609-156098.4368.61
614144-141447.6447.82
45min115415-154158.3318.572.898.558.792.77
215567-155678.4138.63
316691-166919.0219.23
415622-156228.4438.67
515967-159678.6298.85
615912-159128.6008.82
60min115132-151328.1788.512.788.448.782.68
215948-159488.6198.89
316379-163798.8529.11
415643-156438.4548.73
515917-159178.6028.87
615432-154328.3408.61
极限115345-153458.2938.325.938.608.635.71
215346-153468.2948.61
316562-165628.9519.26
415865-158658.5748.90
513790-137907.4537.77
615438-154388.3438.66
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%
110.871575881574681576021573291575861575150.08
210.931571681587051579360.69
单位质量响应值RSD%判断
14490.8014449.770.21数据可信
供试品溶液-2024011221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%
5min1111860-11186063.85357.0214.1763.8557.0214.17
298028-9802855.95755.96
3116928-11692866.74666.75
479346-7934645.29345.29
588844-8884450.71450.71
6104375-10437559.58059.58
10min1128670-12867073.44872.509.0873.8072.829.09
2135605-13560577.40777.72
3140161-14016180.00880.38
4107362-10736261.28561.54
5121836-12183669.54769.83
6128425-12842573.30873.64
15min1133162-13316276.01276.958.0076.7877.678.00
2130879-13087974.70975.45
3151247-15124786.33687.15
4118460-11846067.62068.21
5139729-13972979.76180.43
6135335-13533577.25377.99
20min1134808-13480876.95279.078.3378.1480.228.32
2137018-13701878.21379.37
3153829-15382987.81089.10
4120004-12000468.50169.47
5146996-14699683.90985.02
6138491-13849179.05480.22
30min1133282-13328276.08180.249.4977.6981.839.44
2134292-13429276.65778.25
3157727-15772790.03591.82
4122589-12258969.97771.33
5153896-15389687.84889.43
6141671-14167180.87082.48
45min1138262-13826278.92482.408.8980.9684.448.87
2141200-14120080.60182.62
3159287-15928790.92593.21
4125095-12509571.40773.14
5157863-15786390.11292.18
6144455-14445582.45984.51
60min1135242-13524277.20082.478.7579.6784.968.71
2143743-14374382.05284.52
3157216-15721689.74392.53
4126945-12694572.46474.60
5160031-16003191.35093.92
6143660-14366082.00584.52
极限1176658-176658100.841100.071.38103.74103.021.35
2171838-17183898.090101.01
3174680-17468099.712103.00
4175199-175199100.008102.54
5174457-17445799.585102.66
6179062-179062102.213105.18
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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
111.181845151850211852521855231856441851910.25
211.181855371863001859180.30
单位质量响应值RSD%判断
16564.4916629.520.28数据可信
供试品溶液-2024011221批-依折麦布-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%
5min17922-79224.2825.0320.964.285.0220.98
29545-95455.1595.16
311624-116246.2836.28
49623-96235.2015.20
510809-108095.8425.84
66262-62623.3843.38
10min113369-133697.2267.8611.337.257.8911.37
215239-152398.2368.27
315754-157548.5158.55
414983-149838.0988.13
516151-161518.7298.76
611809-118096.3836.40
15min115309-153098.2748.593.598.348.663.67
216268-162688.7938.87
316270-162708.7948.88
415882-158828.5848.66
516504-165048.9209.00
615103-151038.1638.22
20min115865-158658.5758.621.038.688.741.10
215881-158818.5838.71
315893-158938.5908.72
415961-159618.6278.75
516281-162818.8008.93
615854-158548.5698.67
30min115237-152378.2358.381.428.398.551.41
215706-157068.4898.66
315322-153228.2818.46
415393-153938.3208.49
515724-157248.4988.68
615688-156888.4798.63
45min115316-153168.2788.412.438.488.622.29
215501-155018.3788.60
315366-153668.3058.53
415247-152478.2418.46
515636-156368.4518.68
616274-162748.7968.99
60min115256-152568.2468.302.338.498.562.20
215310-153108.2758.54
315321-153218.2818.55
414810-148108.0048.27
515582-155828.4228.70
615878-158788.5828.82
极限115906-159068.5978.362.498.898.662.30
215369-153698.3078.62
315025-150258.1218.44
415072-150728.1468.45
515498-154988.3768.70
615899-158998.5938.88
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%
110.871574661566881580531580271583811577230.43
210.931578651590321584480.53
单位质量响应值RSD%判断
14509.9414496.610.07数据可信
供试品溶液-2024011221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%
5min177696-7769644.25039.6818.5644.2539.6818.56
289608-8960851.03451.03
369947-6994739.83739.84
452652-5265229.98729.99
560796-6079634.62534.62
667333-6733338.34838.35
10min1115630-11563065.85465.3510.3966.1065.5810.37
2121087-12108768.96269.25
3122750-12275069.90970.13
4123459-12345970.31370.48
591770-9177052.26552.46
6113803-11380364.81465.03
15min1134639-13463976.68173.919.7877.2974.509.76
2131063-13106374.64475.31
3138918-13891879.11879.73
4140766-14076680.17080.73
5105918-10591860.32360.81
6127358-12735872.53473.11
20min1145493-14549382.86276.999.1083.9077.999.09
2132758-13275875.60976.69
3142263-14226381.02382.07
4143380-14338081.65982.66
5112226-11222663.91664.73
6135008-13500876.89177.87
30min1154504-15450487.99479.358.1989.4980.778.18
2137747-13774778.45179.95
3142380-14238081.08982.59
4144605-14460582.35683.81
5119981-11998168.33269.51
6136764-13676477.89179.29
45min1160650-16065091.49481.948.0893.4883.808.07
2139299-13929979.33581.27
3146917-14691783.67385.62
4147703-14770384.12186.03
5125188-12518871.29872.85
6143459-14345981.70483.54
60min1160865-16086591.61782.447.2594.1184.757.25
2140323-14032379.91882.30
3147147-14714783.80486.22
4145272-14527282.73685.12
5128552-12855273.21475.16
6146299-14629983.32185.61
极限1174745-17474599.522100.321.05102.53103.091.08
2174846-17484699.579102.40
3176356-176356100.439103.32
4177075-177075100.849103.69
5174534-17453499.402101.76
6179292-179292102.112104.86
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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
111.181869161865791864931865601863231865740.12
211.181841981849891845940.31
单位质量响应值RSD%判断
16688.1916511.090.76数据可信
供试品溶液-2024011222批-依折麦布-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%
5min19962-99625.3845.838.195.385.838.23
210813-108135.8435.84
311687-116876.3166.32
411909-119096.4366.44
510603-106035.7305.73
69732-97325.2595.26
10min114044-140447.5898.026.467.628.066.46
214558-145587.8677.90
316057-160578.6778.71
414879-148798.0418.08
515872-158728.5778.61
613682-136827.3947.42
15min115659-156598.4628.642.278.538.722.28
215740-157408.5068.58
316224-162248.7688.85
415769-157698.5228.60
516607-166078.9759.05
615960-159608.6258.70
20min115408-154088.3278.692.428.458.812.43
215947-159478.6188.74
316460-164608.8959.03
416056-160568.6778.80
516450-164508.8909.02
616117-161178.7108.83
30min116025-160258.6608.781.528.838.961.45
216258-162588.7868.96
316014-160148.6548.84
416118-161188.7108.89
516419-164198.8739.05
616638-166388.9919.16
45min116074-160748.6868.743.608.908.963.53
215984-159848.6388.86
315570-155708.4148.64
415671-156718.4698.69
516966-169669.1699.40
616802-168029.0809.30
60min116047-160478.6728.521.778.938.791.68
215815-158158.5478.81
315336-153368.2888.56
415579-155798.4198.69
515789-157898.5328.81
616059-160598.6788.95
极限116055-160558.6768.532.368.998.852.24
215736-157368.5048.82
315230-152308.2308.55
415641-156418.4528.77
515737-157378.5048.83
616316-163168.8179.13
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%
110.871585511583521583931582611581861583490.09
210.931560131565701562920.26
单位质量响应值RSD%判断
14567.5314299.361.32数据可信
供试品溶液-2024011222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%
5min141350-4135023.66637.9838.0123.6737.9838.01
236033-3603320.62320.62
355274-5527431.63531.64
488047-8804750.39250.39
593312-9331253.40553.41
684106-8410648.13748.14
10min193914-9391453.75062.4217.0653.8862.6317.13
282954-8295447.47747.59
3104770-10477059.96360.14
4122454-12245470.08470.36
5132355-13235575.75176.05
6117924-11792467.49267.76
15min1136717-13671778.24777.269.4178.6877.829.49
2114795-11479565.70166.08
3129806-12980674.29274.80
4144688-14468882.81083.48
5151362-15136286.62987.35
6132535-13253575.85476.50
20min1149689-14968985.67284.236.3586.5485.226.42
2135663-13566377.64478.39
3144814-14481482.88283.80
4155507-15550789.00290.13
5159109-15910991.06392.26
6138274-13827479.13980.20
30min1159244-15924491.14091.013.7792.4892.463.80
2159345-15934591.19892.37
3157167-15716789.95291.33
4162764-16276493.15594.78
5166715-16671595.41697.12
6148881-14888185.20986.71
45min1162880-16288093.22193.043.2795.0795.003.27
2164240-16424094.00095.68
3162387-16238792.93994.82
4163438-16343893.54195.68
5169376-16937696.93999.17
6153018-15301887.57789.55
60min1167387-16738795.80194.403.9098.1796.883.86
2165628-16562894.79497.00
3167345-16734595.77798.17
4166255-16625595.15397.81
5170707-17070797.701100.47
6152307-15230787.17089.63
极限1169060-16906096.75896.571.3999.6699.571.35
2169051-16905196.75399.48
3168571-16857196.47899.41
4164395-16439594.08897.28
5171294-17129498.037101.35
6169995-16999597.293100.24
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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
111.181859101858791857801859421858161858650.04
211.181863291863571863430.02
单位质量响应值RSD%判断
16624.7816667.530.19数据可信
供试品溶液-2024011222批-依折麦布-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%
5min15541-55412.9865.7324.462.995.7424.43
211237-112376.0556.06
311723-117236.3176.32
411069-110695.9655.96
513052-130527.0337.03
611228-112286.0516.05
10min113468-134687.2588.387.827.278.417.88
215886-158868.5618.59
315404-154048.3018.34
415575-155758.3938.43
517249-172499.2959.33
615749-157498.4878.52
15min115454-154548.3288.773.728.388.853.79
216438-164388.8588.94
315823-158238.5278.61
416177-161778.7178.80
517170-171709.2539.34
616604-166048.9489.03
20min116076-160768.6638.912.288.779.042.35
216875-168759.0949.22
316222-162228.7428.87
416337-163378.8048.93
516968-169689.1449.29
616775-167759.0409.17
30min115943-159438.5918.751.588.748.931.67
216385-163858.8309.01
316011-160118.6288.81
416095-160958.6738.85
516548-165488.9179.11
616465-164658.8739.05
45min115705-157058.4638.560.938.668.781.01
215922-159228.5808.81
315684-156848.4528.68
415988-159888.6168.84
515999-159998.6228.86
615984-159848.6138.84
60min115637-156378.4268.520.768.678.800.88
215923-159238.5818.86
315790-157908.5098.78
415892-158928.5648.84
515918-159188.5788.87
615715-157158.4698.75
极限115300-153008.2458.351.368.548.671.40
215890-158908.5638.89
315419-154198.3098.63
415498-154988.3528.67
515535-155358.3728.71
615361-153618.2788.60
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%
110.871569631570561570691571141569681570340.05
210.931574241579791577020.25
单位质量响应值RSD%判断
14446.5514428.360.09数据可信
供试品溶液-2024011222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%
5min145252-4525225.89042.9036.0025.8942.9036.00
238919-3891922.26622.27
396689-9668955.31855.32
475446-7544643.16443.16
5100981-10098157.77457.77
692603-9260352.98052.98
10min1117966-11796667.49166.1211.5767.6366.3611.61
294690-9469054.17454.30
3131864-13186475.44275.75
4110126-11012663.00663.25
5127335-12733572.85173.17
6111416-11141663.74464.04
15min1135118-13511877.30474.279.1277.8274.879.14
2115356-11535665.99866.42
3148634-14863485.03785.76
4130257-13025774.52375.11
5130125-13012574.44875.17
6119386-11938668.30468.95
20min1141399-14139980.89879.147.1581.8580.167.14
2132570-13257075.84676.64
3155449-15544988.93690.13
4140878-14087880.60081.60
5130874-13087474.87676.02
6128797-12879773.68874.72
30min1146489-14648983.81084.286.0885.2185.746.01
2149891-14989185.75686.97
3160295-16029591.70893.40
4151214-15121486.51387.96
5133801-13380176.55178.11
6142177-14217781.34382.78
45min1154978-15497888.66788.215.8690.5390.145.73
2159797-15979791.42493.11
3162154-16215492.77294.97
4158131-15813190.47092.40
5137020-13702078.39280.37
6153019-15301987.54689.43
60min1160114-16011491.60590.895.3793.9693.305.24
2163769-16376993.69695.89
3164510-16451094.12096.84
4160793-16079391.99394.43
5141814-14181481.13583.55
6162154-16215492.77295.15
极限1163854-16385493.74595.291.6496.6198.211.48
2168520-16852096.41499.13
3162598-16259893.02696.27
4169185-16918596.79599.74
5168294-16829496.28599.15
6166904-16690495.49098.38
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