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%
111.441956591956251957691957841956801957030.04
211.521952331955101953720.11
单位质量响应值RSD%判断
17106.9116959.380.62数据可信
长期6月-供试品溶液-2024011221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%
5min110827-108275.7075.593.145.715.593.14
210378-103785.4705.47
311158-111585.8815.88
410429-104295.4975.50
510601-106015.5875.59
610266-102665.4115.41
10min117953-179539.4629.383.549.499.413.52
217603-176039.2789.31
317574-175749.2639.30
417723-177239.3419.37
518916-189169.97010.00
617017-170178.9699.00
15min118089-180899.5349.182.269.629.262.27
217636-176369.2959.38
317433-174339.1889.27
417071-170718.9989.08
517091-170919.0089.09
617198-171989.0659.14
20min117612-176129.2839.132.059.429.272.02
217478-174789.2129.35
317491-174919.2199.35
417013-170138.9679.10
516763-167638.8358.97
617610-176109.2829.41
30min117394-173949.1688.802.579.368.992.54
216758-167588.8339.02
316136-161368.5058.69
416467-164678.6798.86
516569-165698.7338.92
616906-169068.9119.09
45min116678-166788.7908.631.689.038.871.66
216491-164918.6928.93
316638-166388.7699.00
415989-159898.4278.66
516140-161408.5078.74
616350-163508.6188.85
60min116885-168858.9008.562.259.198.842.21
216338-163388.6118.89
315878-158788.3698.65
416010-160108.4388.72
516011-160118.4398.72
616281-162818.5818.86
极限116659-166598.7808.492.679.128.822.61
216467-164678.6799.01
315665-156658.2578.59
415684-156848.2678.59
515825-158258.3418.67
616301-163018.5928.92
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%
111.461581061579731581001579871580091580350.05
211.481577311579251578280.09
单位质量响应值RSD%判断
13790.1413748.080.22数据可信
长期6月-供试品溶液-2024011221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%
5min196495-9649557.88759.032.1457.8959.032.14
299842-9984259.89559.89
399875-9987559.91559.91
495391-9539157.22557.22
5100667-10066760.39060.39
698144-9814458.87658.88
10min1140377-14037784.21184.753.5584.5385.083.55
2143384-14338486.01586.35
3139811-13981183.87284.20
4139919-13991983.93784.25
5149680-14968089.79290.13
6134509-13450980.69181.02
15min1152753-15275391.63690.503.0292.4391.302.99
2156062-15606293.62194.43
3154982-15498292.97393.77
4149798-14979889.86390.65
5147060-14706088.22189.05
6144533-14453386.70587.48
20min1156596-15659693.94193.612.0995.2494.912.07
2159164-15916495.48296.81
3159079-15907995.43196.75
4157142-15714294.26995.55
5151151-15115190.67592.00
6153128-15312891.86193.12
30min1161669-16166996.98495.631.3998.8097.451.38
2162098-16209897.24299.10
3157412-15741294.43196.28
4159872-15987295.90697.71
5158651-15865195.17497.00
6156737-15673794.02695.79
45min1162646-16264697.57197.392.1099.9399.742.09
2164674-16467498.787101.19
3165527-16552799.299101.67
4164165-16416598.482100.82
5160804-16080496.46698.82
6156284-15628493.75496.04
60min1164988-16498898.97597.381.95101.88100.271.94
2164575-16457598.728101.68
3163713-16371398.211101.13
4162673-16267397.587100.47
5161577-16157796.92999.82
6156405-15640593.82796.64
极限1163455-16345598.05697.101.73101.51100.531.72
2165019-16501998.994102.49
3162241-16224197.328100.79
4163333-16333397.983101.41
5159619-15961995.75599.19
6157494-15749494.48097.81
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%
111.441952911952201951991951091951171951870.04
211.521956151962321959240.23
单位质量响应值RSD%判断
17061.8017007.290.23数据可信
长期6月-供试品溶液-2024011221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%
5min112650-126506.6676.389.746.676.389.71
210485-104855.5265.53
311343-113435.9785.98
412968-129686.8346.83
513644-136447.1917.19
611531-115316.0776.08
10min117501-175019.2239.102.669.269.132.65
216981-169818.9498.98
316721-167218.8128.85
417229-172299.0809.12
518031-180319.5039.54
617100-171009.0129.05
15min117307-173079.1219.181.319.219.271.35
217306-173069.1219.20
317258-172589.0959.18
417739-177399.3499.44
517697-176979.3279.42
617250-172509.0919.17
20min117172-171729.0509.445.509.199.585.44
217167-171679.0479.18
318750-187509.88210.01
419499-1949910.27610.42
517665-176659.3109.45
617230-172309.0819.21
30min116169-161698.5218.924.528.719.114.45
216482-164828.6868.87
316782-167828.8449.03
416952-169528.9349.13
518381-183819.6879.88
616830-168308.8709.05
45min116486-164868.6888.804.678.929.034.62
215471-154718.1548.38
316569-165698.7328.97
416795-167958.8519.10
517879-178799.4239.67
616930-169308.9229.16
60min116097-160978.4838.726.098.779.015.87
216006-160068.4358.71
316300-163008.5908.88
415608-156088.2268.52
516868-168688.8909.19
618427-184279.7119.99
极限116520-165208.7068.363.469.048.703.32
215827-158278.3418.66
315812-158128.3338.67
414889-148897.8478.19
516198-161988.5378.89
615914-159148.3878.72
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%
111.461575341575311575861574591573281574880.07
211.481578391583731581060.24
单位质量响应值RSD%判断
13742.4113772.300.16数据可信
长期6月-供试品溶液-2024011221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%
5min1102401-10240161.48259.015.0861.4859.015.08
292039-9203955.26155.26
399308-9930859.62559.63
494801-9480156.91956.92
5105309-10530963.22863.23
695824-9582457.53357.53
10min1138877-13887783.38382.442.9583.7282.772.95
2137687-13768782.66882.98
3136783-13678382.12582.46
4131409-13140978.89979.22
5143678-14367886.26586.62
6135439-13543981.31981.64
15min1147308-14730888.44589.941.8689.2590.731.87
2149381-14938189.68990.46
3153095-15309591.91992.71
4147512-14751288.56789.32
5153438-15343892.12592.96
6148065-14806588.89989.67
20min1152279-15227991.42993.202.0592.7394.492.04
2156679-15667994.07195.34
3157831-15783194.76396.06
4151599-15159991.02192.27
5159357-15935795.67997.02
6153636-15363692.24493.51
30min1158286-15828695.03696.292.5796.8498.092.56
2159813-15981395.95397.74
3164472-16447298.750100.57
4156038-15603893.68695.44
5166305-16630599.851101.72
6157316-15731694.45496.23
45min1159056-15905695.49896.481.7897.8398.821.78
2158120-15812094.93697.26
3164081-16408198.515100.89
4159273-15927395.62997.90
5164581-16458198.816101.24
6159083-15908395.51597.82
60min1159121-15912195.53796.811.4298.4099.681.43
2162250-16225097.416100.26
3163870-16387098.389101.31
4160238-16023896.20899.01
5163469-16346998.148101.13
6158495-15849595.16197.99
极限1163379-16337998.09496.711.82101.49100.121.80
2158657-15865795.25998.65
3162967-16296797.847101.31
4156341-15634193.86897.21
5163288-16328898.039101.56
6161806-16180697.149100.51
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%
111.441971631974791974281974441973761973780.07
211.521958191968581963380.38
单位质量响应值RSD%判断
17253.3217043.230.87数据可信
长期6月-供试品溶液-2024011222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%
5min19543-95434.9966.1411.425.006.1411.38
212395-123956.4896.49
312115-121156.3436.34
413145-131456.8826.88
512434-124346.5106.51
610695-106955.5995.60
10min117314-173149.0659.132.009.099.172.03
217325-173259.0709.11
317295-172959.0559.09
418146-181469.5009.54
517377-173779.0989.13
617209-172099.0109.04
15min117232-172329.0229.302.959.109.382.92
218539-185399.7069.79
317715-177159.2759.36
417566-175669.1979.29
517298-172989.0569.14
618237-182379.5489.63
20min117408-174089.1149.121.939.249.261.91
217430-174309.1259.27
316930-169308.8649.00
417315-173159.0659.21
517974-179749.4109.55
617486-174869.1559.29
30min116638-166388.7118.921.938.899.111.93
217342-173429.0799.27
316901-169018.8489.03
416763-167638.7768.97
517457-174579.1399.33
617177-171778.9939.18
45min116410-164108.5918.692.028.828.931.98
217253-172539.0339.27
316569-165698.6758.91
416429-164298.6018.84
516340-163408.5558.79
616627-166278.7058.94
60min116254-162548.5108.491.848.788.771.76
216543-165438.6618.95
316327-163278.5488.83
415722-157228.2318.52
516029-160298.3928.68
616417-164178.5958.88
极限115500-155008.1158.261.228.448.591.23
216082-160828.4208.76
315761-157618.2528.58
415679-156798.2098.54
515847-158478.2978.63
615789-157898.2668.60
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%
111.461583251584171584281583021583151583570.04
211.481577601583701580650.28
单位质量响应值RSD%判断
13818.2413768.730.26数据可信
长期6月-供试品溶液-2024011222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%
5min182776-8277649.56954.445.6949.5754.455.69
295314-9531457.07757.08
389505-8950553.59953.60
496580-9658057.83657.84
593270-9327055.85355.85
688063-8806352.73552.74
10min1125150-12515074.94477.532.8375.2277.832.83
2130631-13063178.22678.54
3125606-12560675.21775.52
4135017-13501780.85381.17
5130154-13015477.94178.25
6130257-13025778.00378.30
15min1138204-13820482.76185.151.8383.4585.881.84
2145287-14528787.00387.75
3140517-14051784.14784.86
4144241-14424186.37787.15
5141771-14177184.89885.64
6143146-14314685.72186.45
20min1145061-14506186.86888.141.9088.0289.341.91
2150690-15069090.23991.47
3144297-14429786.41087.59
4150521-15052190.13791.39
5145536-14553687.15288.37
6146982-14698288.01889.22
30min1147190-14719088.14392.132.5689.7893.822.55
2156777-15677793.88495.62
3151839-15183990.92792.59
4155420-15542093.07194.82
5158083-15808394.66696.36
6153732-15373292.06093.75
45min1151545-15154590.75193.262.1592.8795.472.15
2160273-16027395.97798.24
3154521-15452192.53394.70
4159028-15902895.23297.50
5153461-15346191.89894.12
6155626-15562693.19495.40
60min1152502-15250291.32492.821.7193.9595.551.71
2159324-15932495.40998.20
3153398-15339891.86094.54
4154785-15478592.69195.49
5153070-15307091.66494.40
6156956-15695693.99196.71
极限1148060-14806088.66490.792.1191.8094.042.10
2156153-15615393.51096.83
3149079-14907989.27492.47
4154353-15435392.43295.74
5152258-15225891.17894.42
6149801-14980189.70692.95
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%
111.441959941958701958171957521955931958050.08
211.521963701968611966160.18
单位质量响应值RSD%判断
17115.8217067.360.21数据可信
长期6月-供试品溶液-2024011222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%
5min113439-134397.0596.719.107.066.719.12
211444-114446.0116.01
312432-124326.5306.53
413766-137667.2317.23
514088-140887.4007.40
611469-114696.0246.02
10min117916-179169.4119.602.329.459.632.34
218295-182959.6109.64
317695-176959.2949.33
418639-186399.7909.83
518822-188229.8869.93
618239-182399.5809.61
15min117257-172579.0649.542.539.169.632.46
218406-184069.6689.75
318254-182549.5889.68
418171-181719.5449.64
518348-183489.6379.73
618518-185189.7279.81
20min117022-170228.9419.403.119.089.543.08
218654-186549.7989.94
317785-177859.3429.48
417637-176379.2649.41
518203-182039.5619.71
618086-180869.5009.64
30min116736-167368.7919.092.488.989.292.46
217445-174459.1639.36
317651-176519.2719.46
417704-177049.2999.50
517510-175109.1979.40
616802-168028.8259.02
45min116883-168838.8688.912.669.119.162.61
217353-173539.1159.36
317009-170098.9349.18
417379-173799.1289.38
516999-169998.9299.18
616141-161418.4788.72
60min116160-161608.4888.641.918.788.941.90
216533-165338.6848.98
316144-161448.4808.77
416909-169098.8829.18
516704-167048.7749.08
616272-162728.5478.84
极限115765-157658.2818.561.888.628.911.87
216277-162778.5508.89
316522-165228.6789.02
416430-164308.6308.98
516629-166298.7359.09
616209-162098.5148.85
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%
111.461578271577151575831575111575201576310.09
211.481581551585391583470.18
单位质量响应值RSD%判断
13754.8913793.290.20数据可信
长期6月-供试品溶液-2024011222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%
5min192897-9289755.70857.302.3655.7157.302.36
295650-9565057.35957.36
395889-9588957.50357.50
497371-9737158.39158.39
598487-9848759.06059.06
693062-9306255.80755.81
10min1131487-13148778.85080.161.8179.1680.481.81
2134567-13456780.69781.02
3130363-13036378.17678.50
4136963-13696382.13482.46
5133602-13360280.11880.45
6135043-13504380.98281.29
15min1141211-14121184.68187.211.9685.4387.971.95
2147280-14728088.32189.09
3145493-14549387.24988.00
4144215-14421586.48387.26
5144757-14475786.80887.58
6149593-14959389.70890.47
20min1147141-14714188.23788.882.4089.4690.132.37
2152922-15292291.70492.96
3147473-14747388.43689.67
4149658-14965889.74791.01
5149760-14976089.80891.06
6142308-14230885.33986.60
30min1150586-15058690.30392.051.3292.0193.791.31
2153236-15323691.89293.66
3153587-15358792.10393.83
4156891-15689194.08495.84
5153098-15309891.80993.56
6153590-15359092.10593.84
45min1155166-15516693.05093.281.0195.2695.541.00
2156221-15622193.68295.96
3154738-15473892.79395.03
4157971-15797194.73297.01
5155911-15591193.49695.76
6153344-15334491.95794.20
60min1153773-15377392.21493.271.7894.9496.041.74
2154576-15457692.69695.49
3152720-15272091.58394.34
4160577-16057796.29499.10
5155323-15532393.14495.93
6156249-15624993.69996.45
极限1152126-15212691.22793.211.4394.4796.501.40
2153414-15341491.99995.31
3155446-15544693.21896.48
4157154-15715494.24297.59
5157387-15738794.38297.68
6157120-15712094.22197.50
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-08-17 13:14:51 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-08-17 13:15:12 完成)
Current page cost:355 ms