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%
110.521809931806761803971804701806211806310.13
210.471818951815731817340.13
单位质量响应值RSD%判断
17170.2517357.590.77数据可信
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%
5min113107-131076.8166.703.466.826.703.47
212073-120736.2786.28
312701-127016.6056.60
413137-131376.8326.83
513304-133046.9186.92
612991-129916.7566.76
10min117088-170888.8868.961.048.929.001.02
217419-174199.0589.09
317236-172368.9639.00
417384-173849.0409.08
516961-169618.8208.86
617317-173179.0059.04
15min116884-168848.7809.021.468.879.101.45
217326-173269.0109.10
317389-173899.0439.13
417649-176499.1789.27
517329-173299.0129.10
617453-174539.0769.16
20min116836-168368.7558.921.618.899.061.59
217537-175379.1209.26
317449-174499.0749.21
417029-170298.8568.99
516996-169968.8388.98
617106-171068.8969.03
30min115834-158348.2348.441.318.428.631.29
216443-164438.5518.74
316367-163678.5118.70
416265-162658.4588.65
516210-162108.4308.62
616234-162348.4428.63
45min116111-161118.3788.431.488.618.661.43
216571-165718.6178.85
316337-163378.4968.73
416273-162738.4628.70
515965-159658.3028.54
615952-159528.2968.53
60min116175-161758.4118.381.328.698.661.28
216476-164768.5688.85
316053-160538.3488.63
415970-159708.3058.59
516164-161648.4068.69
615860-158608.2488.53
极限116092-160928.3688.381.958.698.701.86
216202-162028.4268.75
315901-159018.2698.60
416139-161398.3938.72
515701-157018.1658.49
616627-166278.6478.97
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100590-202406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%
110.741477891480131481221482781478021480010.15
210.731489361488881489120.03
单位质量响应值RSD%判断
13780.3513878.100.50数据可信
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%
5min196099-9609957.52059.943.8057.5259.943.80
296080-9608057.50957.51
3101422-10142260.70660.71
498584-9858459.00859.01
5104372-10437262.47262.47
6104306-10430662.43362.43
10min1137674-13767482.40582.121.3082.7282.461.31
2135643-13564381.18981.51
3138975-13897583.18483.52
4134452-13445280.47780.80
5137852-13785282.51282.86
6138632-13863282.97883.33
15min1147322-14732288.18089.671.2488.9690.461.24
2148878-14887889.11189.88
3150631-15063190.16090.96
4148855-14885589.09789.87
5150571-15057190.12590.93
6152611-15261191.34692.15
20min1154288-15428892.34993.261.6193.6294.541.59
2157207-15720794.09795.36
3159733-15973395.60996.91
4152566-15256691.31992.59
5156130-15613093.45294.76
6154886-15488692.70794.02
30min1152469-15246991.26193.451.5693.0495.261.55
2155971-15597193.35795.15
3158328-15832894.76896.60
4154151-15415192.26794.04
5157352-15735294.18396.01
6158516-15851694.88096.71
45min1161267-16126796.52795.741.0898.8198.071.06
2160819-16081996.25998.57
3161747-16174796.81499.17
4157210-15721094.09896.39
5160034-16003495.78998.14
6158683-15868394.98097.34
60min1161506-16150696.67096.011.8899.4998.871.83
2163427-16342797.820100.66
3160706-16070696.19199.09
4155088-15508892.82895.64
5162571-16257197.307100.19
6159120-15912095.24298.13
极限1159485-15948595.46095.661.3598.8299.051.33
2160467-16046796.04899.43
3160051-16005195.79999.23
4156579-15657993.72197.05
5159154-15915495.26298.68
6163197-16319797.682101.10
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%
110.521816881821601816621821611822281819800.16
210.471815101814381814740.03
单位质量响应值RSD%判断
17298.4817332.760.14数据可信
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%
5min112674-126746.5716.1410.706.576.1410.71
212632-126326.5496.55
312873-128736.6746.67
410374-103745.3795.38
512452-124526.4566.46
610075-100755.2245.22
10min119457-1945710.0889.573.7610.129.603.76
219147-191479.9279.96
318328-183289.5029.54
417995-179959.3309.36
518184-181849.4289.46
617665-176659.1599.19
15min117887-178879.2749.280.839.379.370.83
217954-179549.3089.40
318105-181059.3879.48
417843-178439.2519.33
517662-176629.1579.25
617968-179689.3169.40
20min117536-175369.0929.082.499.249.222.47
217774-177749.2159.36
317673-176739.1639.30
418103-181039.3869.52
517128-171288.8809.02
616913-169138.7698.90
30min117260-172608.9498.912.609.149.102.59
217447-174479.0469.24
317314-173148.9779.17
417656-176569.1549.34
517009-170098.8199.01
616380-163808.4928.67
45min116448-164488.5288.582.508.778.822.46
216400-164008.5038.75
316866-168668.7448.99
417230-172308.9339.17
516210-162108.4048.64
616175-161758.3868.61
60min116607-166078.6108.652.888.908.942.84
216679-166798.6478.94
317216-172168.9269.22
417194-171948.9149.20
515933-159338.2618.54
616480-164808.5448.82
极限116399-163998.5028.541.608.848.871.61
216829-168298.7259.07
316618-166188.6168.96
416566-165668.5898.92
516311-163118.4578.79
616078-160788.3368.66
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100590-202406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%
110.741483341490951488001485081482451485960.24
210.731484591482431483510.11
单位质量响应值RSD%判断
13835.7513825.820.06数据可信
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%
5min194311-9431156.44357.982.6356.4457.982.63
296253-9625357.60557.61
399946-9994659.81559.82
495082-9508256.90456.90
5100174-10017459.95259.95
695549-9554957.18457.18
10min1139472-13947283.47183.152.9383.7883.472.92
2146273-14627387.54187.86
3139258-13925883.34383.68
4136969-13696981.97382.29
5137447-13744782.25982.59
6134209-13420980.32180.64
15min1143037-14303785.60487.861.4786.3888.641.46
2147594-14759488.33289.14
3149179-14917989.28090.08
4147650-14765088.36589.14
5145685-14568587.18987.98
6147672-14767288.37889.14
20min1148834-14883489.07491.081.6390.3392.351.62
2155020-15502092.77694.07
3152718-15271891.39892.69
4154751-15475192.61593.88
5151598-15159890.72892.00
6150203-15020389.89391.15
30min1153303-15330391.74894.241.8393.5096.021.82
2159786-15978695.62897.44
3157814-15781494.44896.25
4160215-16021595.88597.66
5159120-15912095.23097.01
6154593-15459392.52094.27
45min1150730-15073090.20893.662.6092.4795.972.54
2153951-15395192.13694.48
3157188-15718894.07396.40
4162652-16265297.34499.65
5155967-15596793.34395.65
6158531-15853194.87797.15
60min1154707-15470792.58994.802.0295.3597.621.98
2158862-15886295.07597.93
3158403-15840394.80197.65
4162617-16261797.323100.17
5154833-15483392.66495.49
6160949-16094996.32499.12
极限1154090-15409092.21995.061.6195.4998.411.58
2157991-15799194.55497.94
3160781-16078196.22499.60
4159563-15956395.49598.89
5160790-16079096.22999.57
6159835-15983595.65898.99
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%
110.521823861825371827561825431827961826040.10
210.471827151834441830800.29
单位质量响应值RSD%判断
17357.7917486.150.53数据可信
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%
5min111718-117186.0386.304.596.046.304.55
212318-123186.3486.35
311890-118906.1276.13
413281-132816.8446.84
512196-121966.2856.28
611957-119576.1616.16
10min116741-167418.6278.852.128.668.892.12
217605-176059.0729.11
317572-175729.0559.09
417307-173078.9188.96
516945-169458.7328.77
616925-169258.7228.76
15min117100-171008.8128.821.618.898.901.58
217423-174238.9789.06
317454-174548.9949.08
416786-167868.6508.74
516890-168908.7038.79
617015-170158.7688.85
20min116291-162918.3958.692.878.538.832.79
217222-172228.8759.01
317350-173508.9419.07
416287-162878.3938.53
516832-168328.6748.81
617235-172358.8819.01
30min116183-161838.3398.532.788.528.722.75
217177-171778.8519.04
317068-170688.7958.98
416541-165418.5248.71
516104-161048.2988.48
616295-162958.3978.58
45min116317-163178.4088.391.528.638.621.52
216483-164838.4948.73
316549-165498.5288.76
416154-161548.3248.55
516298-162988.3988.62
615865-158658.1758.40
60min115918-159188.2038.261.588.478.541.59
216429-164298.4668.75
316247-162478.3728.65
415753-157538.1188.39
515888-158888.1878.46
615958-159588.2238.50
极限115762-157628.1228.262.698.448.582.66
216589-165898.5488.88
316440-164408.4728.80
416140-161408.3178.64
515548-155488.0128.33
615673-156738.0768.39
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100590-202406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%
110.741482351482651485961483321486791484210.14
210.731493621493451493540.01
单位质量响应值RSD%判断
13819.4613919.290.51数据可信
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%
5min193837-9383756.00457.091.9356.0057.091.94
298516-9851658.79658.80
394313-9431356.28856.29
494218-9421856.23156.23
596773-9677357.75657.76
696309-9630957.47957.48
10min1133167-13316779.47780.271.2579.7980.591.25
2137427-13742782.01982.35
3134876-13487680.49780.81
4133235-13323579.51779.83
5135039-13503980.59480.91
6133258-13325879.53179.85
15min1145053-14505386.57086.300.9987.3287.060.98
2142671-14267185.14985.93
3145032-14503286.55887.32
4143456-14345685.61786.37
5146794-14679487.61088.38
6144585-14458586.29187.05
20min1147368-14736887.95289.561.7789.1990.811.75
2151097-15109790.17891.43
3146761-14676187.59088.83
4149556-14955689.25890.49
5152380-15238090.94392.20
6153241-15324191.45792.70
30min1157221-15722193.83393.451.0695.5595.191.04
2159419-15941995.14496.90
3156397-15639793.34195.07
4156478-15647893.38995.11
5154889-15488992.44194.20
6155074-15507492.55194.30
45min1159666-15966695.29294.641.5297.5496.901.50
2159634-15963495.27397.56
3157160-15716093.79696.04
4158367-15836794.51796.76
5161818-16181896.57698.85
6154824-15482492.40294.66
60min1160519-16051995.80194.461.0598.5797.241.03
2158946-15894694.86297.68
3156390-15639093.33796.10
4156315-15631593.29296.06
5159111-15911194.96197.77
6158319-15831994.48897.26
极限1161012-16101296.09594.761.4599.4098.071.40
2160050-16005095.52198.86
3157403-15740393.94197.23
4161356-16135696.30099.59
5156588-15658893.45596.79
6156237-15623793.24596.55
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%
110.521838931848921849271848941847001846610.24
210.471847391842991845190.17
单位质量响应值RSD%判断
17553.3317623.590.29数据可信
供试品溶液-2024011821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%
5min111033-110335.6316.066.485.636.066.49
212380-123806.3196.32
312424-124246.3416.34
412515-125156.3886.39
512140-121406.1976.20
610775-107755.5005.50
10min117980-179809.1779.453.369.219.493.38
218263-182639.3229.36
318863-188639.6289.66
419515-195159.96110.00
518663-186639.5269.56
617850-178509.1119.14
15min118597-185979.4929.574.119.579.664.03
218062-180629.2199.31
318307-183079.3449.43
418191-181919.2859.38
519332-193329.8679.95
620024-2002410.22110.30
20min117944-179449.1599.152.959.299.292.88
218593-185939.4909.63
317907-179079.1409.28
417020-170208.6878.83
517853-178539.1139.25
618272-182729.3269.46
30min116381-163818.3618.712.138.558.902.09
216966-169668.6608.85
317142-171428.7508.94
417156-171568.7578.95
517313-173138.8379.03
617386-173868.8749.06
45min116693-166938.5208.541.628.758.781.59
216591-165918.4688.71
316984-169848.6698.91
416346-163468.3438.58
517088-170888.7228.96
616658-166588.5038.74
60min116290-162908.3158.351.848.598.631.80
216322-163228.3318.62
316340-163408.3408.63
415961-159618.1478.43
516889-168898.6218.91
616307-163078.3238.61
极限116215-162158.2768.311.288.608.641.24
216163-161638.2508.58
316087-160878.2118.55
416159-161598.2488.58
516387-163878.3648.70
616646-166468.4968.83
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100590-202406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%
110.743007103022483013043019473019443016310.21
210.733018553002843010700.37
单位质量响应值RSD%判断
28084.8228058.710.07数据可信
供试品溶液-2024011821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%
5min1129708-12970838.24639.844.7138.2539.844.70
2128228-12822837.81037.81
3140400-14040041.39941.40
4133940-13394039.49439.49
5144782-14478242.69142.69
6133618-13361839.39939.40
10min1227373-22737367.04567.933.2267.2668.153.21
2223654-22365465.94866.16
3230954-23095468.10068.33
4244685-24468572.14972.37
5228840-22884067.47767.71
6226799-22679966.87567.09
15min1267195-26719578.78779.235.0879.3779.835.05
2255625-25562575.37575.95
3257576-25757675.95076.56
4285734-28573484.25384.87
5260641-26064176.85477.47
6285410-28541084.15884.75
20min1279040-27904082.27981.512.0883.3082.552.03
2285802-28580284.27385.27
3272798-27279880.43981.47
4271547-27154780.07081.16
5271016-27101679.91380.95
6278453-27845382.10683.16
30min1282712-28271283.36284.731.9584.8486.221.94
2281165-28116582.90684.37
3283745-28374583.66785.14
4290301-29030185.60087.13
5291108-29110885.83887.32
6295168-29516887.03588.55
45min1306788-30678890.46188.692.1592.4090.652.11
2291485-29148585.94987.87
3301110-30111088.78790.73
4294448-29444886.82388.83
5304296-30429689.72791.69
6306535-30653590.38792.38
60min1303788-30378889.57789.241.6992.0291.701.66
2295907-29590787.25389.65
3304244-30424489.71192.15
4297026-29702687.58390.07
5306387-30638790.34392.80
6308578-30857890.98993.49
极限1307697-30769790.72990.671.2993.6793.621.29
2303356-30335689.44992.34
3303349-30334989.44792.38
4309466-30946691.25194.23
5307298-30729890.61293.57
6313823-31382392.53695.54
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%
110.521834781828451837361842421841971837000.32
210.471826831826811826820.01
单位质量响应值RSD%判断
17461.9817448.140.06数据可信
供试品溶液-2024012021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%
5min112831-128316.5996.572.216.606.572.20
213035-130356.7046.70
312928-129286.6496.65
412835-128356.6016.60
512229-122296.2906.29
612816-128166.5926.59
10min118235-182359.3799.191.939.429.231.90
217901-179019.2079.24
317906-179069.2099.25
418212-182129.3679.40
517383-173838.9408.98
617555-175559.0299.07
15min117583-175839.0439.201.849.139.281.86
218115-181159.3179.41
318009-180099.2629.35
418350-183509.4389.53
517669-176699.0889.17
617547-175479.0259.11
20min117299-172998.8979.242.819.049.382.76
218073-180739.2959.44
317863-178639.1879.33
418234-182349.3789.52
518733-187339.6359.77
617588-175889.0469.18
30min118382-183829.4549.054.139.649.244.05
218606-186069.5699.76
316857-168578.6708.86
417400-174008.9499.14
516996-169968.7418.93
617358-173588.9289.11
45min116554-165548.5148.732.708.768.972.63
217611-176119.0589.30
316978-169788.7328.97
417435-174358.9679.21
516581-165818.5288.77
616665-166658.5718.81
60min116073-160738.2678.613.088.558.903.04
217009-170098.7489.04
316690-166908.5848.87
417252-172528.8739.17
516171-161718.3178.60
617211-172118.8529.14
极限116246-162468.3568.393.898.698.723.79
216740-167408.6108.95
316147-161478.3058.64
417267-172678.8819.22
515421-154217.9318.26
616018-160188.2388.57
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100590-202406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%
110.742992292994962991633007943006142998590.27
210.732984482969702977090.36
单位质量响应值RSD%判断
27919.8327745.480.45数据可信
供试品溶液-2024012021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%
5min1133409-13340939.67641.163.3639.6841.163.36
2133938-13393839.83339.83
3140380-14038041.74941.75
4136497-13649740.59440.59
5145459-14545943.26043.26
6140765-14076541.86441.86
10min1228355-22835567.91366.381.5568.1366.611.54
2223970-22397066.60966.83
3222790-22279066.25866.49
4219243-21924365.20365.43
5225248-22524866.98967.23
6219696-21969665.33865.57
15min1254723-25472375.75575.251.4476.3575.851.44
2256536-25653676.29476.89
3254748-25474875.76376.36
4246510-24651073.31373.90
5254541-25454175.70176.31
6251182-25118274.70275.30
20min1271828-27182880.84281.953.6281.8682.963.58
2274960-27496081.77482.79
3272078-27207880.91781.94
4269950-26995080.28481.28
5295415-29541587.85788.89
6269004-26900480.00281.01
30min1314525-31452593.54088.084.3895.0189.554.31
2309885-30988592.16093.63
3288701-28870185.86087.33
4283176-28317684.21785.66
5286988-28698885.35186.87
6293737-29373787.35888.81
45min1302500-30250089.96489.821.9091.9591.781.87
2313221-31322193.15395.13
3297273-29727388.41090.36
4299892-29989289.18991.10
5299600-29960089.10291.10
6299651-29965189.11791.06
60min1308809-30880991.84091.410.8694.3393.870.85
2309085-30908591.92394.42
3311092-31109292.51994.96
4305086-30508690.73393.14
5305064-30506490.72793.22
6305037-30503790.71993.15
极限1310053-31005392.21091.191.7495.2194.161.69
2311342-31134292.59495.60
3306952-30695291.28894.24
4310395-31039592.31295.22
5297421-29742188.45491.45
6303586-30358690.28793.23
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