依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.314741424736834737764737404738494738380.04
211.344738274739894739080.03
单位质量响应值RSD%判断
41895.4941790.830.18数据可信
加速3月-供试品溶液-2024030921批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1377829-37782977.15883.8112.6977.1683.8112.69
2468365-46836595.64795.65
3344224-34422470.29570.30
4382494-38249478.11178.11
5473130-47313096.62096.62
6416410-41641085.03785.04
10min1506502-506502103.435101.491.43103.56101.631.42
2493632-493632100.807100.97
3502199-502199102.556102.67
4488826-48882699.82599.96
5490335-490335100.133100.29
6500325-500325102.174102.32
15min1509125-509125103.971101.971.64104.27102.281.62
2493674-493674100.815101.14
3507162-507162103.570103.86
4493459-493459100.771101.07
5489576-48957699.978100.31
6502919-502919102.703103.02
20min1508624-508624103.868101.911.56104.34102.391.55
2493483-493483100.776101.27
3505932-505932103.319103.78
4493842-493842100.850101.31
5489517-48951799.966100.46
6502884-502884102.696103.18
30min1507256-507256103.589101.721.61104.24102.371.59
2491566-491566100.385101.05
3506106-506106103.354103.99
4493600-493600100.800101.43
5488365-48836599.731100.39
6501722-501722102.459103.11
45min1506623-506623103.460101.561.57104.28102.381.55
2491707-491707100.414101.24
3505230-505230103.175103.98
4492006-492006100.475101.28
5488149-48814999.687100.51
6500305-500305102.169102.99
60min1506678-506678103.471101.421.60104.46102.411.58
2491100-491100100.290101.29
3504052-504052102.935103.91
4491424-491424100.356101.32
5487068-48706899.466100.46
6499563-499563102.018103.01
极限1504923-504923103.113101.191.61104.28102.341.60
2489995-489995100.064101.23
3503118-503118102.744103.89
4491176-491176100.305101.44
5484994-48499499.043100.20
6498768-498768101.856103.02
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.694118304113404115004115254109534114300.08
210.734115844113944114890.04
单位质量响应值RSD%判断
38487.3738349.390.26数据可信
加速3月-供试品溶液-2024030921批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160603-16060337.62346.3235.4937.6246.3235.50
2245089-24508957.41557.42
3122784-12278428.76428.76
4201378-20137847.17647.18
5310412-31041272.71872.72
6146051-14605134.21434.21
10min1406371-40637195.19893.395.3795.2693.465.39
2406800-40680095.29895.39
3361442-36144284.67384.72
4411391-41139196.37496.45
5419984-41998498.38798.51
6385910-38591090.40590.46
15min1430974-430974100.962100.201.09101.18100.431.11
2430743-430743100.907101.16
3419663-41966398.31298.50
4429342-429342100.579100.82
5430966-430966100.960101.24
6424600-42460099.46899.68
20min1434375-434375101.758101.090.51102.15101.500.52
2433597-433597101.576102.00
3428605-428605100.407100.76
4431578-431578101.103101.51
5431004-431004100.969101.42
6430079-430079100.752101.13
30min1433207-433207101.485101.250.25102.04101.810.23
2432851-432851101.401101.99
3432475-432475101.313101.83
4431884-431884101.175101.75
5430241-430241100.790101.41
6432465-432465101.311101.85
45min1433149-433149101.471101.130.28102.20101.870.26
2432106-432106101.227101.99
3432769-432769101.382102.07
4430552-430552100.863101.61
5430107-430107100.758101.55
6431572-431572101.102101.81
60min1432963-432963101.427101.020.35102.32101.930.32
2431949-431949101.190102.12
3432243-432243101.259102.12
4429917-429917100.714101.63
5429049-429049100.511101.47
6431294-431294101.036101.92
极限1432570-432570101.335100.830.39102.40101.900.37
2430812-430812100.924102.02
3431186-431186101.011102.04
4429561-429561100.631101.71
5427610-427610100.173101.30
6430623-430623100.879101.93
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.314737424735024734344738584736944736460.04
211.344747444743454745440.06
单位质量响应值RSD%判断
41878.5141846.910.06数据可信
加速3月-供试品溶液-2024031021批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1374585-37458576.46086.9811.9576.4686.9811.95
2394984-39498480.62480.62
3470737-47073796.08696.09
4373372-37337276.21276.21
5486055-48605599.21399.21
6457067-45706793.29693.30
10min1502954-502954102.662100.272.34102.79100.412.33
2490416-490416100.103100.24
3491786-491786100.383100.54
4481254-48125498.23398.36
5504878-504878103.055103.22
6476029-47602997.16697.32
15min1506097-506097103.304101.492.15103.60101.802.14
2494228-494228100.881101.18
3492132-492132100.453100.78
4502729-502729102.616102.91
5508246-508246103.742104.08
6479790-47979097.93498.25
20min1505704-505704103.224101.572.28103.69102.052.26
2494032-494032100.841101.31
3491780-491780100.381100.88
4507045-507045103.497103.96
5507751-507751103.641104.15
6479310-47931097.83698.32
30min1504787-504787103.036101.552.38103.68102.202.37
2492118-492118100.450101.09
3491563-491563100.337101.00
4510149-510149104.131104.77
5507057-507057103.500104.18
6479294-47929497.83398.48
45min1505581-505581103.199101.462.51104.01102.282.49
2492902-492902100.610101.42
3490678-490678100.157100.99
4509714-509714104.042104.85
5506265-506265103.338104.19
6477123-47712397.39098.20
60min1501898-501898102.447101.242.34103.43102.222.32
2493096-493096100.650101.62
3489607-48960799.938100.93
4509063-509063103.909104.89
5504645-504645103.007104.03
6477561-47756197.47998.45
极限1501930-501930102.453100.962.53103.61102.122.51
2492355-492355100.499101.64
3488409-48840999.693100.86
4508117-508117103.716104.87
5502893-502893102.650103.85
6473883-47388396.72897.86
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.694110674111714110344112214113734111730.04
210.734122824122024122420.02
单位质量响应值RSD%判断
38463.3338419.570.09数据可信
加速3月-供试品溶液-2024031021批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114534-11453426.81545.7832.6826.8145.7832.69
2131078-13107830.68830.69
3264137-26413761.84061.84
4178169-17816941.71341.71
5253956-25395659.45759.46
6231258-23125854.14354.14
10min1367181-36718185.96590.117.2986.0190.197.31
2344050-34405080.55080.60
3426778-42677899.918100.02
4388366-38836690.92590.99
5398556-39855693.31193.41
6384466-38446690.01290.10
15min1410942-41094296.21198.243.5996.4098.473.61
2394685-39468592.40592.59
3436597-436597102.217102.49
4429045-429045100.449100.67
5427184-427184100.013100.27
6419294-41929498.16698.41
20min1420781-42078198.51499.582.6498.8699.972.67
2406027-40602795.06095.40
3436369-436369102.164102.60
4434657-434657101.763102.15
5430424-430424100.772101.19
6423827-42382799.22799.63
30min1426080-42608099.755100.221.97100.27100.781.99
2414619-41461997.07297.57
3436242-436242102.134102.74
4437239-437239102.367102.93
5429950-429950100.661101.25
6424276-42427699.33299.90
45min1430307-430307100.744100.521.56101.42101.241.58
2419673-41967398.25598.91
3435542-435542101.970102.75
4437013-437013102.315103.04
5429969-429969100.665101.42
6423689-42368999.19599.93
60min1429619-429619100.583100.411.44101.43101.301.45
2420550-42055098.46099.28
3434370-434370101.696102.65
4436490-436490102.192103.09
5428806-428806100.393101.32
6423374-42337499.121100.02
极限1430129-430129100.703100.241.42101.72101.301.44
2420475-42047598.44399.43
3433516-433516101.496102.62
4435641-435641101.993103.06
5426904-42690499.948101.04
6422190-42219098.84499.91
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.314727884723624724244722504723384724320.05
211.344730864734324732590.06
单位质量响应值RSD%判断
41771.1841733.600.07数据可信
加速3月-供试品溶液-CLB05410批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1428212-42821287.63780.5317.5587.6480.5317.55
2275146-27514656.31156.31
3421020-42102086.16586.17
4444933-44493391.05991.06
5344767-34476770.55970.56
6446839-44683991.44991.45
10min1463652-46365294.89095.473.1695.0495.603.18
2443666-44366690.80090.89
3473381-47338196.88197.02
4482759-48275998.80198.95
5456718-45671893.47193.59
6478714-47871497.97398.13
15min1468925-46892595.96998.541.8396.2798.831.84
2479690-47969098.17298.42
3485804-48580499.42499.73
4492514-492514100.797101.11
5474417-47441797.09397.37
6487470-48747099.765100.08
20min1467272-46727295.63199.261.8996.1099.721.87
2489395-489395100.159100.57
3487234-48723499.716100.19
4493494-493494100.998101.48
5485278-48527899.31699.75
6487257-48725799.721100.20
30min1466224-46622495.41699.002.1296.0499.622.11
2490502-490502100.385100.96
3487042-48704299.677100.31
4493322-493322100.962101.62
5476989-47698997.62098.22
6488231-48823199.920100.57
45min1465053-46505395.17799.082.4495.9699.872.42
2496782-496782101.670102.41
3486975-48697599.663100.47
4493059-493059100.908101.73
5475568-47556897.32998.09
6487364-48736499.743100.56
60min1466400-46640095.45398.842.0396.3999.792.02
2489845-489845100.251101.16
3486156-48615699.496100.46
4491932-491932100.678101.67
5476088-47608897.43598.36
6487204-48720499.710100.69
极限1465507-46550795.27098.672.0396.3799.792.02
2489874-489874100.257101.34
3485020-48502099.263100.40
4490427-490427100.370101.53
5475382-47538297.29198.38
6486438-48643899.553100.70
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.694105354103534104224104554105154104560.02
210.734110544109914110220.02
单位质量响应值RSD%判断
38396.2638305.870.17数据可信
加速3月-供试品溶液-CLB05410批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1218261-21826151.22045.5811.3851.2245.5811.38
2156718-15671836.77836.78
3186149-18614943.68443.68
4204757-20475748.05148.05
5189185-18918544.39744.40
6210191-21019149.32649.33
10min1403616-40361694.71891.024.2794.8091.104.27
2369429-36942986.69686.76
3368844-36884486.55886.63
4392955-39295592.21692.30
5407436-40743695.61595.69
6384874-38487490.32090.40
15min1442403-442403103.821102.471.34104.06102.691.34
2438138-438138102.820103.03
3429165-429165100.714100.93
4443872-443872104.165104.40
5432606-432606101.522101.75
6433580-433580101.750101.98
20min1441551-441551103.621103.181.17104.04103.581.17
2443927-443927104.178104.56
3433797-433797101.801102.19
4445792-445792104.616105.02
5439325-439325103.098103.50
6433554-433554101.744102.15
30min1439921-439921103.238102.801.30103.83103.371.30
2442920-442920103.942104.49
3433514-433514101.735102.29
4445851-445851104.630105.21
5431860-431860101.346101.92
6434168-434168101.888102.46
45min1438755-438755102.965102.881.56103.73103.621.55
2447459-447459105.007105.73
3433488-433488101.729102.45
4445613-445613104.574105.33
5431158-431158101.182101.93
6433829-433829101.809102.55
60min1440095-440095103.279102.631.28104.21103.551.28
2442044-442044103.736104.64
3432488-432488101.494102.39
4444600-444600104.336105.27
5431452-431452101.251102.16
6433399-433399101.708102.62
极限1439442-439442103.126102.401.23104.23103.481.23
2441579-441579103.627104.70
3431940-431940101.365102.43
4442244-442244103.783104.89
5429990-429990100.908101.99
6432815-432815101.571102.65
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.314741714745974747594747274746884745880.06
211.344749284748734749000.01
单位质量响应值RSD%判断
41961.8041878.310.15数据可信
加速3月-供试品溶液-2024030821批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1365237-36523774.45090.8511.2074.4590.8511.20
2429899-42989987.63087.63
3485716-48571699.00899.01
4419937-41993785.60085.60
5494178-494178100.733100.73
6479112-47911297.66297.66
10min1510178-510178103.994102.631.47104.12102.781.47
2496104-496104101.126101.27
3499075-499075101.731101.90
4507925-507925103.535103.68
5512026-512026104.371104.54
6495575-495575101.018101.18
15min1517587-517587105.505103.441.83105.80103.761.81
2502605-502605102.451102.77
3499971-499971101.914102.25
4515179-515179105.014105.33
5513975-513975104.768105.11
6495483-495483100.999101.33
20min1517583-517583105.504103.272.02105.98103.772.01
2502706-502706102.471102.96
3499261-499261101.769102.27
4517190-517190105.424105.91
5510711-510711104.103104.62
6492348-492348100.360100.86
30min1518160-518160105.622103.231.97106.27103.901.96
2501353-501353102.196102.85
3498461-498461101.606102.28
4517031-517031105.391106.06
5509369-509369103.830104.52
6494256-494256100.749101.42
45min1516107-516107105.203102.852.10106.03103.682.09
2499398-499398101.797102.62
3495956-495956101.095101.94
4516203-516203105.223106.06
5508310-508310103.614104.48
6491294-491294100.145100.98
60min1514700-514700104.916102.731.92105.92103.741.91
2499779-499779101.875102.87
3495448-495448100.992102.00
4513751-513751104.723105.74
5508407-508407103.633104.67
6491831-491831100.255101.26
极限1513254-513254104.622102.261.96105.80103.441.94
2497381-497381101.386102.55
3492258-492258100.342101.52
4510614-510614104.083105.27
5506536-506536103.252104.46
6490100-49010099.902101.07
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.694114724119604121894123454119284119790.09
210.734122744121624122180.02
单位质量响应值RSD%判断
38538.7338417.330.23数据可信
加速3月-供试品溶液-2024030821批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190604-19060444.58258.2423.2844.5858.2423.28
2210100-21010049.14249.14
3323123-32312375.57975.58
4192440-19244045.01245.01
5289492-28949267.71267.71
6288183-28818367.40667.41
10min1405609-40560994.87296.624.1894.9596.724.19
2431443-431443100.915101.00
3422732-42273298.87799.00
4382259-38225989.41089.49
5419231-41923198.05898.17
6417125-41712597.56697.68
15min1428216-428216100.160100.991.12100.39101.251.13
2437957-437957102.438102.69
3436574-436574102.115102.41
4427032-42703299.883100.11
5427611-427611100.018100.29
6433134-433134101.310101.59
20min1432188-432188101.089101.461.19101.49101.891.18
2437745-437745102.389102.81
3438137-438137102.480102.94
4438475-438475102.559102.95
5425931-42593199.625100.07
6430287-430287100.644101.09
30min1434357-434357101.596101.591.33102.16102.181.32
2436637-436637102.130102.72
3438006-438006102.450103.08
4440808-440808103.105103.67
5424384-42438499.26499.87
6431685-431685100.971101.58
45min1433510-433510101.398101.331.27102.14102.091.26
2435009-435009101.749102.51
3436963-436963102.206103.01
4439793-439793102.868103.60
5424466-42446699.283100.06
6429476-429476100.455101.23
60min1432423-432423101.144101.181.24102.05102.111.23
2435060-435060101.761102.69
3436244-436244102.038103.01
4438437-438437102.551103.46
5423607-42360799.082100.02
6429621-429621100.488101.44
极限1432116-432116101.072100.791.19102.15101.891.17
2433432-433432101.380102.48
3434961-434961101.738102.88
4435058-435058101.760102.84
5422008-42200898.70899.81
6427879-427879100.081101.20
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