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%
110.904705994709644707164713644709064709100.07
210.934703894709804706840.09
单位质量响应值RSD%判断
43202.7543063.490.23数据可信
中间条件6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%
5min1367024-36702472.71077.4414.4372.7177.4414.44
2361273-36127371.57171.57
3369177-36917773.13773.14
4455556-45555690.24990.25
5465940-46594092.30692.31
6326297-32629764.64264.64
10min1498960-49896098.84897.154.0398.9797.284.03
2453610-45361089.86389.98
3500962-50096299.24499.37
4491013-49101397.27397.42
5510391-510391101.112101.27
6487560-48756096.58996.70
15min1508973-508973100.83198.812.44101.1299.102.45
2479829-47982995.05895.33
3505433-505433100.130100.42
4491620-49162097.39397.71
5511687-511687101.369101.69
6495051-49505198.07398.34
20min1510837-510837101.20099.082.04101.6599.532.04
2488237-48823796.72397.15
3505005-505005100.045100.50
4491466-49146697.36397.84
5511240-511240101.280101.77
6493954-49395497.85698.29
30min1510003-510003101.03599.331.66101.6699.961.66
2500478-50047899.14899.74
3504495-50449599.944100.57
4489957-48995797.06497.70
5509798-509798100.995101.65
6493754-49375497.81698.41
45min1509424-509424100.92199.401.64101.71100.181.64
2503473-50347399.742100.50
3504012-50401299.848100.64
4490290-49029097.13097.93
5509867-509867101.008101.84
6493295-49329597.72598.48
60min1508218-508218100.68299.181.62101.64100.131.62
2502537-50253799.556100.48
3502839-50283999.616100.57
4488878-48887896.85097.81
5508470-508470100.732101.73
6492760-49276097.61998.54
极限1507345-507345100.50998.871.74101.6499.991.74
2500387-50038799.130100.22
3502036-50203699.457100.58
4486550-48655096.38997.51
5507486-507486100.537101.70
6490726-49072697.21698.30
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%
110.914287274290374286764289284289104288560.04
210.894290594292184291380.03
单位质量响应值RSD%判断
39308.5239406.610.18数据可信
中间条件6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%
5min1189122-18912243.24741.9519.5043.2541.9619.49
2182670-18267041.77241.77
3182555-18255541.74541.75
4230984-23098452.82052.82
5194988-19498844.58844.59
6120464-12046427.54727.55
10min1421607-42160796.41092.345.2996.4892.415.30
2410313-41031393.82893.90
3393172-39317289.90889.98
4422023-42202396.50596.59
5409943-40994393.74393.82
6365886-36588683.66883.71
15min1438268-438268100.22098.451.79100.4598.671.81
2425662-42566297.33797.56
3425000-42500097.18697.41
4436233-43623399.755100.00
5437523-437523100.050100.28
6420479-42047996.15296.34
20min1440069-440069100.63299.211.20101.0399.601.21
2428139-42813997.90498.29
3431535-43153598.68099.06
4435636-43563699.618100.03
5439085-439085100.407100.80
6428629-42862998.01698.36
30min1439574-439574100.51999.470.91101.09100.020.92
2429403-42940398.19398.74
3435720-43572099.637100.18
4435081-43508199.491100.07
5438609-438609100.298100.86
6431554-43155498.68599.19
45min1439119-439119100.41599.480.86101.15100.200.87
2429449-42944998.20398.92
3436076-43607699.719100.43
4434952-43495299.462100.21
5438484-438484100.269101.00
6432111-43211198.81299.49
60min1438050-438050100.17099.250.82101.07100.140.83
2428638-42863898.01898.90
3434651-43465199.393100.27
4433822-43382299.203100.12
5437403-437403100.022100.92
6431622-43162298.70099.54
极限1436936-43693699.91598.980.88100.98100.030.89
2427103-42710397.66798.71
3434376-43437699.330100.37
4432118-43211898.81499.89
5436413-43641399.796100.86
6430196-43019698.37499.38
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%
110.904708374705214705024705944704864705880.04
210.934688174683494685830.08
单位质量响应值RSD%判断
43173.2142871.270.50数据可信
中间条件6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%
5min1391776-39177677.81478.4213.0277.8178.4213.03
2483269-48326995.98795.99
3353458-35345870.20470.20
4422161-42216183.84983.85
5373109-37310974.10774.11
6345314-34531468.58668.59
10min1495362-49536298.38998.411.8698.5298.541.87
2508295-508295100.957101.12
3485156-48515696.36296.48
4486074-48607496.54496.68
5503315-50331599.968100.09
6494501-49450198.21898.33
15min1501163-50116399.54199.971.2499.83100.271.24
2508735-508735101.045101.37
3509327-509327101.162101.44
4493590-49359098.03798.34
5507355-507355100.771101.06
6499880-49988099.28699.56
20min1500667-50066799.442100.071.5199.90100.531.51
2508225-508225100.944101.44
3514764-514764102.242102.69
4492929-49292997.90598.37
5506267-506267100.555101.01
6500030-50003099.31699.76
30min1499711-49971199.25299.931.7399.88100.561.72
2507362-507362100.772101.44
3517108-517108102.708103.32
4492482-49248297.81798.44
5505025-505025100.308100.93
6497154-49715498.74599.35
45min1499623-49962399.23599.831.72100.03100.621.72
2506517-506517100.604101.44
3516552-516552102.597103.39
4491707-49170797.66398.45
5504237-504237100.151100.94
6496975-49697598.70999.48
60min1497816-49781698.87699.561.7499.83100.521.73
2505392-505392100.381101.38
3515466-515466102.382103.34
4490339-49033997.39198.34
5502423-50242399.791100.75
6496066-49606698.52899.47
极限1496018-49601898.51999.271.7799.64100.401.76
2504655-504655100.234101.40
3514056-514056102.102103.23
4488993-48899397.12498.24
5500816-50081699.472100.60
6494394-49439498.19699.30
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%
110.914285844283024284164283154282564283750.04
210.894269184266934268060.04
单位质量响应值RSD%判断
39264.4439192.470.13数据可信
中间条件6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%
5min1191065-19106543.83541.6128.5443.8441.6128.54
2247714-24771456.83256.83
3173021-17302139.69539.70
4227753-22775352.25252.25
5133323-13332330.58830.59
6115288-11528826.45026.45
10min1420017-42001796.36392.085.0796.4492.145.08
2401087-40108792.02092.11
3407515-40751593.49493.56
4424438-42443897.37797.46
5376717-37671786.42886.48
6378205-37820586.77086.81
15min1433724-43372499.50798.161.7799.7498.391.79
2425112-42511297.53297.78
3431087-43108798.90299.12
4437845-437845100.453100.70
5420811-42081196.54596.74
6418659-41865996.05196.24
20min1433782-43378299.52199.290.8199.9299.670.82
2430856-43085698.84999.26
3435673-43567399.954100.34
4437165-437165100.297100.71
5431449-43144998.98599.34
6427631-42763198.10998.46
30min1432914-43291499.32299.590.8099.89100.140.81
2430452-43045298.75799.33
3438146-438146100.522101.08
4436763-436763100.205100.79
5436312-436312100.101100.62
6429970-42997098.64699.16
45min1433097-43309799.36399.660.81100.09100.380.80
2430218-43021898.70399.44
3437812-437812100.445101.17
4436206-436206100.077100.83
5438142-438142100.521101.21
6430830-43083098.84399.52
60min1431212-43121298.93199.390.8299.83100.270.82
2429001-42900198.42499.33
3437018-437018100.263101.15
4435118-43511899.827100.74
5436830-436830100.220101.08
6430070-43007098.66999.51
极限1429907-42990798.63299.140.8299.69100.180.81
2428300-42830098.26399.33
3435987-435987100.027101.08
4433964-43396499.562100.65
5435672-43567299.954100.98
6428776-42877698.37299.38
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%
110.904702494702444700564699964697544700600.05
210.934705114703414704260.03
单位质量响应值RSD%判断
43124.7743039.890.14数据可信
中间条件6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%
5min1347824-34782468.98881.759.7768.9981.759.77
2416922-41692282.69282.69
3474502-47450294.11394.11
4414995-41499582.31082.31
5413754-41375482.06482.06
6405111-40511180.35080.35
10min1471467-47146793.51198.683.2593.6398.813.26
2492414-49241497.66697.80
3520546-520546103.245103.40
4505783-505783100.317100.45
5496094-49609498.39698.53
6498755-49875598.92399.06
15min1485110-48511096.217100.112.4196.49100.412.42
2502303-50230399.62799.93
3522332-522332103.600103.93
4510606-510606101.274101.58
5504218-504218100.007100.31
6503811-50381199.926100.22
20min1488464-48846496.882100.332.1897.31100.802.20
2505863-505863100.333100.80
3522295-522295103.592104.09
4510807-510807101.314101.79
5504918-504918100.146100.61
6502864-50286499.738100.20
30min1488916-48891696.972100.132.0997.56100.762.10
2504743-504743100.111100.74
3521252-521252103.385104.06
4509148-509148100.985101.63
5503156-50315699.796100.43
6501706-50170699.509100.14
45min1487692-48769296.72999.902.0997.48100.702.10
2503203-50320399.806100.61
3519817-519817103.101103.95
4508569-508569100.870101.68
5502128-50212899.592100.39
6500656-50065699.300100.10
60min1485946-48594696.38399.662.1497.30100.632.15
2502010-50201099.569100.54
3518833-518833102.906103.92
4507303-507303100.619101.60
5501040-50104099.376100.34
6499640-49964099.099100.06
极限1485991-48599196.39299.451.9997.47100.592.01
2501498-50149899.467100.60
3516711-516711102.485103.67
4505559-505559100.273101.42
5499758-49975899.122100.25
6499037-49903798.979100.11
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%
110.914288194287814286174285384284134286340.04
210.894286764284064285410.05
单位质量响应值RSD%判断
39288.1839351.790.12数据可信
中间条件6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%
5min1168076-16807638.47144.6513.7038.4744.6513.70
2213290-21329048.82048.82
3212778-21277848.70348.70
4168711-16871138.61638.62
5229705-22970552.57752.58
6177815-17781540.70040.70
10min1389356-38935689.12092.773.4389.1892.843.44
2412725-41272594.46994.55
3425043-42504397.28997.37
4389676-38967689.19389.26
5405028-40502892.70792.80
6409924-40992493.82893.90
15min1421391-42139196.45398.481.1696.6798.711.16
2430997-43099798.65298.89
3435939-43593999.783100.03
4429382-42938298.28298.49
5430196-43019698.46898.71
6433538-43353899.23399.46
20min1424852-42485297.24598.910.9197.6299.300.92
2433899-43389999.31699.72
3436280-43628099.861100.27
4432013-43201398.88499.26
5431744-43174498.82299.23
6434014-43401499.34299.73
30min1426346-42634697.58798.710.7398.1299.270.74
2432288-43228898.94799.52
3435546-43554699.693100.27
4430130-43013098.45398.99
5430261-43026198.48399.05
6432988-43298899.10799.66
45min1425426-42542697.37698.500.7298.0799.220.73
2430938-43093898.63899.37
3434384-43438499.427100.17
4429541-42954198.31899.02
5429246-42924698.25198.99
6432444-43244498.98399.70
60min1424059-42405997.06398.270.7597.9299.150.76
2430135-43013598.45499.35
3433660-43366099.261100.17
4428625-42862598.10998.98
5428368-42836898.05098.95
6431047-43104798.66399.55
极限1424646-42464697.19898.090.6198.2299.140.62
2429692-42969298.35399.41
3431691-43169198.81099.88
4427202-42720297.78398.82
5427355-42735597.81898.88
6430576-43057698.55599.60
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