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%
111.441946351950651956891954761946121950950.25
211.521961611955451958530.23
单位质量响应值RSD%判断
17053.7617001.130.22数据可信
加速6月-供试品溶液-2024011223批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17028-70283.7054.307.493.714.307.44
28680-86804.5764.58
38655-86554.5634.56
47983-79834.2094.21
58259-82594.3544.35
68316-83164.3854.38
10min117868-178689.4219.321.149.449.341.14
217665-176659.3149.34
317691-176919.3279.35
417523-175239.2399.26
517894-178949.4349.46
617372-173729.1599.18
15min118828-188289.9279.632.7810.009.702.75
218336-183369.6679.74
317526-175269.2409.32
417765-177659.3669.44
518456-184569.7319.81
618626-186269.8209.90
20min118655-186559.8369.363.509.969.493.45
218057-180579.5209.65
317358-173589.1529.28
417134-171349.0349.16
518158-181589.5749.70
617190-171909.0639.19
30min116933-169338.9289.102.489.119.282.44
217824-178249.3979.58
316906-169068.9139.09
417612-176129.2869.46
516824-168248.8709.05
617488-174889.2209.40
45min116996-169968.9619.062.939.199.302.86
217771-177719.3709.61
316786-167868.8509.08
417841-178419.4069.63
517100-171009.0169.25
616646-166468.7769.01
60min116839-168398.8788.702.369.168.982.29
216657-166578.7829.07
315813-158138.3378.62
416323-163238.6068.89
516832-168328.8749.16
616491-164918.6958.97
极限116308-163088.5988.681.238.939.001.24
216752-167528.8329.17
316384-163848.6388.96
416527-165278.7149.04
516565-165658.7349.07
616187-161878.5348.86
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%
111.461568141571891568821573741574501571420.19
211.481577581577121577350.03
单位质量响应值RSD%判断
13712.2213739.980.15数据可信
加速6月-供试品溶液-2024011223批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189898-8989854.09854.191.3054.1054.181.31
291530-9153055.08055.08
391361-9136154.97954.98
489254-8925453.71153.71
588611-8861153.32453.32
689600-8960053.91953.92
10min1133998-13399880.63780.050.6180.9480.350.61
2132050-13205079.46479.77
3133973-13397380.62180.93
4132472-13247279.71880.02
5132898-13289879.97580.27
6132709-13270979.86180.16
15min1150486-15048690.55989.401.7591.3190.141.74
2146370-14637088.08288.83
3146427-14642788.11688.87
4148451-14845189.33490.08
5146843-14684388.36689.11
6152758-15275891.92692.67
20min1154507-15450792.97891.731.7294.2392.971.69
2155489-15548993.56994.81
3151394-15139491.10592.35
4150311-15031190.45391.69
5153950-15395092.64393.87
6148898-14889889.60390.86
30min1153649-15364992.46293.261.5494.2395.011.51
2155713-15571393.70495.46
3157264-15726494.63796.39
4157227-15722794.61596.36
5151011-15101190.87492.62
6154973-15497393.25995.01
45min1160161-16016196.38196.842.3398.6699.112.28
2162902-16290298.030100.31
3157898-15789895.01997.29
4167563-167563100.835103.10
5159037-15903795.70497.96
6157944-15794495.04797.32
60min1160366-16036696.50495.261.1999.3298.061.16
2157752-15775294.93197.75
3154932-15493293.23496.04
4158894-15889495.61898.44
5159502-15950295.98498.77
6158316-15831695.27098.07
极限1156989-15698994.47295.180.7497.8398.520.72
2158548-15854895.41098.76
3158415-15841595.33098.65
4159928-15992896.24199.60
5158376-15837695.30798.62
6156733-15673394.31897.64
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%
111.441945061942431944271949701947411945770.15
211.521949631961211955420.42
单位质量响应值RSD%判断
17008.4816974.130.15数据可信
加速6月-供试品溶液-2024011223批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19155-91554.8375.699.984.845.699.98
210316-103165.4515.45
311029-110295.8275.83
412371-123716.5366.54
510485-104855.5405.54
611261-112615.9505.95
10min117681-176819.3429.372.349.379.402.36
217527-175279.2619.29
317222-172229.0999.13
418305-183059.6729.71
517537-175379.2669.30
618165-181659.5989.63
15min117863-178639.4389.321.899.529.401.89
217564-175649.2809.36
317031-170318.9989.08
417889-178899.4529.54
517607-176079.3039.39
617894-178949.4549.54
20min116864-168648.9109.212.159.049.352.15
217529-175299.2629.39
317123-171239.0479.18
417866-178669.4409.58
517672-176729.3379.47
617581-175819.2899.43
30min116972-169728.9678.941.399.159.121.42
217002-170028.9839.17
316506-165068.7218.90
417063-170639.0159.21
516795-167958.8749.06
617156-171569.0659.26
45min116770-167708.8618.822.879.099.052.83
216689-166898.8189.05
315898-158988.4008.63
416924-169248.9429.19
516522-165228.7308.96
617343-173439.1639.40
60min116099-160998.5068.732.208.799.022.18
216369-163698.6498.93
316178-161788.5488.83
416666-166668.8069.10
516961-169618.9619.25
616872-168728.9149.21
极限115834-158348.3668.481.498.698.811.49
216081-160818.4978.83
315982-159828.4448.77
416219-162198.5698.91
515769-157698.3328.67
616405-164058.6689.01
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%
111.461563391565611572121563851566811566360.23
211.481570271568271569270.10
单位质量响应值RSD%判断
13668.0613669.600.01数据可信
加速6月-供试品溶液-2024011223批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190389-9038954.62255.222.3754.6255.222.37
292574-9257455.94255.94
393004-9300456.20256.20
490029-9002954.40454.40
594011-9401156.81056.81
688278-8827853.34653.35
10min1130041-13004178.58378.901.1278.8979.211.12
2130089-13008978.61278.92
3130725-13072578.99679.31
4131657-13165779.56079.86
5132550-13255080.09980.41
6128359-12835977.56777.86
15min1148070-14807089.47887.191.7290.2287.931.71
2144795-14479587.49988.25
3143601-14360186.77787.53
4141825-14182585.70486.45
5145780-14578088.09488.85
6141607-14160785.57286.30
20min1150842-15084291.15390.431.8092.3991.661.79
2149335-14933590.24291.48
3151680-15168091.65992.89
4148623-14862389.81291.03
5152390-15239092.08893.34
6144980-14498087.61188.81
30min1161008-16100897.29693.882.3399.0495.622.31
2156406-15640694.51596.25
3155874-15587494.19495.94
4152968-15296892.43894.16
5155694-15569494.08595.85
6150223-15022390.77992.47
45min1161494-16149497.59095.591.4299.8797.841.40
2159975-15997596.67298.93
3155663-15566394.06696.33
4156534-15653494.59396.83
5158545-15854595.80898.09
6156918-15691894.82597.02
60min1160099-16009996.74796.051.9099.5798.841.88
2160537-16053797.01299.81
3161900-16190097.835100.62
4155988-15598894.26397.02
5160756-16075697.14499.96
6154411-15441193.31096.03
极限1159266-15926696.24494.342.1999.6197.652.15
2159357-15935796.29999.63
3158528-15852895.79899.13
4152628-15262892.23295.51
5155069-15506993.70797.06
6151816-15181691.74294.98
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%
111.441957641958691957221963221965821960520.20
211.521980991988861984920.29
单位质量响应值RSD%判断
17137.4117230.210.39数据可信
长期6月-供试品溶液-2024011223批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18240-82404.3054.3213.174.304.3213.22
27143-71433.7323.73
39776-97765.1075.11
48661-86614.5254.52
58856-88564.6274.63
66896-68963.6033.60
10min116896-168968.8278.741.258.858.761.26
216910-169108.8358.86
316879-168798.8188.85
416582-165828.6638.69
516656-166568.7028.73
616399-163998.5688.59
15min117221-172218.9979.193.809.079.263.77
217479-174799.1329.20
317428-174289.1059.18
417491-174919.1389.21
516990-169908.8768.95
618887-188879.8679.94
20min117514-175149.1508.942.029.279.071.98
217510-175109.1489.27
316860-168608.8088.94
416652-166528.7008.82
517068-170688.9179.04
617118-171188.9439.07
30min116705-167058.7278.701.128.908.871.10
216898-168988.8289.00
316775-167758.7648.94
416422-164228.5808.75
516620-166208.6838.86
616453-164538.5968.77
45min119707-1970710.2969.127.8210.529.347.65
217045-170458.9059.13
318485-184859.6579.88
416307-163078.5198.74
516873-168738.8159.04
616292-162928.5128.73
60min117167-171678.9698.562.709.258.832.66
216603-166038.6748.94
316272-162728.5018.78
415964-159648.3408.61
516086-160868.4048.67
616200-162008.4648.73
极限115967-159678.3428.292.048.678.611.99
216234-162348.4818.80
316152-161528.4398.76
415789-157898.2498.56
515340-153408.0148.33
615766-157668.2378.55
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%
111.461578551577261577161577571576091577330.06
211.481594281597771596020.16
单位质量响应值RSD%判断
13763.7913902.610.71数据可信
长期6月-供试品溶液-2024011223批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191351-9135154.54855.311.6054.5555.311.60
293338-9333855.73555.73
394947-9494756.69656.70
493114-9311455.60155.60
592065-9206554.97554.97
690948-9094854.30854.31
10min1133240-13324079.56279.751.4079.8680.051.39
2136306-13630681.39281.70
3132508-13250879.12479.44
4131350-13135078.43378.74
5135243-13524380.75881.06
6132663-13266379.21779.52
15min1142981-14298185.37887.311.6886.1288.061.67
2146030-14603087.19987.96
3146324-14632487.37488.13
4144374-14437486.21086.95
5147681-14768188.18588.94
6149955-14995589.54390.28
20min1153725-15372591.79490.652.3693.0191.892.33
2153446-15344691.62792.87
3147942-14794288.34189.58
4146656-14665687.57388.80
5153835-15383591.85993.10
6155282-15528292.72393.96
30min1154088-15408892.01092.881.5293.7494.621.51
2155904-15590493.09594.85
3155080-15508092.60394.33
4152328-15232890.96092.67
5156645-15664593.53795.29
6159251-15925195.09396.85
45min1159445-15944595.20996.051.9097.4598.301.88
2162920-16292097.28499.56
3160527-16052795.85598.10
4155624-15562492.92895.14
5163939-16393997.893100.17
6162648-16264897.12299.40
60min1166904-16690499.66397.771.56102.43100.561.53
2164274-16427498.093100.91
3163520-16352097.643100.42
4159232-15923295.08297.81
5163479-16347997.618100.44
6164986-16498698.518101.34
极限1156490-15649093.44595.641.6796.7798.971.63
2158383-15838394.57597.93
3163090-16309097.386100.71
4159369-15936995.16498.42
5160359-16035995.75599.12
6163283-16328397.501100.87
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%
111.441952821953781961041963191964301959030.28
211.521943841946031944940.08
单位质量响应值RSD%判断
17124.3916883.161.01数据可信
长期6月-供试品溶液-2024011223批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19775-97755.1615.899.475.165.899.45
210437-104375.5115.51
312810-128106.7646.76
411750-117506.2046.20
510928-109285.7705.77
611272-112725.9525.95
10min116864-168648.9049.262.008.939.302.03
217524-175249.2539.28
317676-176769.3339.37
417820-178209.4099.44
517622-176229.3049.34
617770-177709.3839.42
15min117123-171239.0419.211.029.129.291.04
217368-173689.1709.25
317598-175989.2929.38
417591-175919.2889.37
517449-174499.2139.30
617486-174869.2339.32
20min116798-167988.8699.082.279.009.212.25
216731-167318.8348.97
317666-176669.3289.47
417136-171369.0489.19
517590-175909.2879.42
617221-172219.0939.23
30min115999-159998.4478.862.958.639.042.91
216789-167898.8659.05
317518-175189.2499.44
416576-165768.7528.94
516910-169108.9289.11
616868-168688.9069.09
45min115544-155448.2078.553.318.438.783.23
216483-164838.7038.93
315766-157668.3248.57
415984-159848.4408.68
517013-170138.9839.22
616352-163528.6348.87
60min115777-157778.3308.561.818.608.841.83
216044-160448.4718.75
316512-165128.7189.01
416061-160618.4808.76
516465-164658.6938.98
616395-163958.6578.94
极限115787-157878.3358.501.498.658.821.50
216152-161528.5288.85
316030-160308.4648.80
415929-159298.4108.74
516481-164818.7029.04
616161-161618.5338.87
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%
111.461567711571451571451579701572441572550.28
211.481562361561411561880.05
单位质量响应值RSD%判断
13722.0813605.230.61数据可信
长期6月-供试品溶液-2024011223批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192603-9260355.98257.261.9855.9857.261.98
293373-9337356.44756.45
396883-9688358.56958.57
495320-9532057.62457.62
593358-9335856.43856.44
696790-9679058.51358.51
10min1129949-12994978.55980.541.4878.8780.861.48
2136026-13602682.23282.55
3133010-13301080.40980.73
4133150-13315080.49480.81
5133086-13308680.45580.77
6134105-13410581.07181.40
15min1144591-14459187.41087.881.0188.1688.641.00
2145747-14574788.10988.88
3144033-14403387.07387.85
4147957-14795789.44590.21
5145674-14567488.06588.83
6144167-14416787.15487.93
20min1148721-14872189.90791.411.4791.1492.661.46
2149820-14982090.57191.83
3152849-15284992.40393.66
4150652-15065291.07492.34
5154792-15479293.57794.83
6150374-15037490.90692.17
30min1151591-15159191.64293.441.5693.3795.201.54
2157709-15770995.34197.10
3153877-15387793.02494.79
4153126-15312692.57094.34
5157225-15722595.04896.82
6153856-15385693.01194.78
45min1152462-15246292.16994.732.9994.4197.012.93
2160824-16082497.22499.52
3151888-15188891.82294.11
4154658-15465893.49695.78
5163545-16354598.869101.17
6156802-15680294.79297.07
60min1156268-15626894.46995.951.2997.2298.751.26
2160592-16059297.08399.92
3160865-16086597.248100.04
4157479-15747995.20298.01
5156937-15693794.87497.72
6160125-16012596.80199.61
极限1158090-15809095.57195.681.1598.8599.021.13
2161471-16147197.615100.99
3156925-15692594.86798.20
4156236-15623694.45097.78
5158381-15838195.74799.12
6158548-15854895.84899.19
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