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%
110.904683414681094683864682404683564682860.03
210.934680154680854680500.02
单位质量响应值RSD%判断
42962.0242822.510.23数据可信
加速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%
5min1363213-36321372.35985.0010.6872.3685.0010.68
2421960-42196084.06384.06
3466373-46637392.91192.91
4486936-48693697.00797.01
5393423-39342378.37878.38
6428102-42810285.28685.29
10min1500010-50001099.612100.110.7499.73100.260.74
2503510-503510100.309100.45
3508691-508691101.341101.50
4502916-502916100.191100.35
5502259-502259100.060100.19
6497820-49782099.17699.32
15min1505506-505506100.707100.880.97100.99101.180.96
2509077-509077101.418101.73
3512648-512648102.130102.45
4502281-502281100.064100.39
5509099-509099101.423101.72
6499506-49950699.51199.82
20min1504700-504700100.546100.750.98101.00101.220.98
2508639-508639101.331101.81
3511969-511969101.994102.49
4501583-50158399.925100.42
5508570-508570101.317101.78
6498796-49879699.37099.84
30min1504753-504753100.557100.620.92101.18101.270.92
2507590-507590101.122101.77
3511126-511126101.826102.49
4500475-50047599.704100.37
5507549-507549101.114101.75
6499054-49905499.421100.06
45min1504681-504681100.542100.520.91101.33101.340.91
2507156-507156101.035101.85
3510100-510100101.622102.46
4500196-50019699.649100.48
5507221-507221101.048101.85
6498118-49811899.235100.04
60min1503071-503071100.222100.220.99101.18101.200.99
2505913-505913100.788101.77
3509338-509338101.470102.47
4498722-49872299.355100.35
5505327-505327100.671101.64
6495877-49587798.78899.76
极限1502300-502300100.068100.110.93101.19101.260.92
2505032-505032100.612101.76
3508215-508215101.246102.42
4497395-49739599.091100.25
5505505-505505100.707101.85
6496707-49670798.954100.09
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%
110.914256684254514256064257784255094256020.04
210.894250704248764249730.04
单位质量响应值RSD%判断
39010.2739024.150.03数据可信
加速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%
5min1139703-13970332.22546.6522.9532.2246.6522.95
2188077-18807743.38343.38
3217782-21778250.23550.24
4279279-27927964.42164.42
5181050-18105041.76241.76
6207558-20755847.87747.88
10min1372706-37270685.97193.183.9286.0293.263.93
2406665-40666593.80493.88
3407127-40712793.91193.99
4407334-40733493.95994.07
5416179-41617995.99996.07
6413750-41375095.43995.52
15min1413638-41363895.41398.511.7595.6198.741.75
2429764-42976499.13399.36
3428117-42811798.75398.99
4425057-42505798.04798.31
5435626-435626100.485100.71
6430263-43026399.24899.49
20min1420181-42018196.92298.941.1597.2899.341.16
2430824-43082499.37799.77
3428661-42866198.87899.28
4429023-42902398.96299.39
5435206-435206100.388100.78
6429690-42969099.11699.52
30min1425826-42582698.22499.100.6798.7499.670.68
2429692-42969299.11699.68
3428083-42808398.74599.31
4430374-43037499.27399.87
5434483-434483100.221100.79
6429345-42934599.03699.61
45min1427427-42742798.59498.970.6099.2799.700.60
2429343-42934399.03599.76
3427040-42704098.50499.24
4428276-42827698.78999.55
5434039-434039100.119100.85
6428288-42828898.79299.53
60min1426421-42642198.36198.700.5799.2199.600.57
2428343-42834398.80599.69
3426493-42649398.37899.28
4426784-42678498.44599.37
5432654-43265499.799100.70
6426758-42675898.43999.34
极限1425704-42570498.19698.590.6199.2199.650.61
2427580-42758098.62999.68
3425807-42580798.22099.28
4425798-42579898.21899.30
5432476-43247699.758100.82
6427140-42714098.52799.59
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%
110.904681164680734682084681604681494681410.02
210.934680724682904681810.04
单位质量响应值RSD%判断
42948.7242834.490.19数据可信
加速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%
5min1416844-41684483.04582.9412.2683.0482.9412.26
2413112-41311282.30182.30
3351747-35174770.07670.08
4375861-37586174.88074.88
5443508-44350888.35788.36
6496699-49669998.95498.95
10min1492115-49211598.04098.462.9198.1898.602.92
2507654-507654101.136101.27
3474704-47470494.57294.69
4495608-49560898.73698.86
5482795-48279596.18496.33
6512520-512520102.106102.27
15min1498402-49840299.293100.381.7699.59100.681.76
2513467-513467102.294102.60
3494439-49443998.50398.78
4507694-507694101.144101.43
5495515-49551598.71899.03
6513576-513576102.316102.65
20min1507894-507894101.184100.771.24101.65101.241.24
2512107-512107102.023102.50
3496717-49671798.95799.40
4507948-507948101.195101.65
5499601-49960199.532100.00
6510695-510695101.742102.25
30min1498914-49891499.395100.341.28100.03100.981.29
2511183-511183101.839102.49
3496531-49653198.92099.52
4506433-506433100.893101.52
5498654-49865499.34399.98
6510255-510255101.654102.33
45min1498915-49891599.395100.111.26100.20100.921.27
2509289-509289101.462102.28
3494908-49490898.59799.37
4505770-505770100.761101.56
5497070-49707099.02899.83
6509084-509084101.421102.27
60min1497229-49722999.05999.891.28100.03100.861.29
2509073-509073101.419102.40
3494050-49405098.42699.36
4504656-504656100.539101.50
5496155-49615598.84599.81
6507344-507344101.074102.09
极限1496361-49636198.88699.641.25100.02100.781.25
2507702-507702101.146102.30
3492914-49291498.20099.30
4502420-502420100.093101.22
5495035-49503598.62299.76
6506285-506285100.863102.05
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%
110.914253694239354253764253424254304250900.16
210.894252974255104254040.04
单位质量响应值RSD%判断
38963.3439063.730.19数据可信
加速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%
5min1169307-16930739.05745.6520.4339.0645.6520.44
2178175-17817541.10341.10
3176156-17615640.63740.64
4198876-19887645.87945.88
5187013-18701343.14243.14
6277712-27771264.06564.07
10min1401443-40144392.60994.463.7992.6794.543.80
2414272-41427295.56895.64
3388562-38856289.63789.70
4399611-39961192.18692.26
5425889-42588998.24898.32
6427092-42709298.52698.63
15min1424690-42469097.97299.491.3698.1999.731.37
2431783-43178399.60899.84
3424854-42485498.00998.23
4430753-43075399.37099.60
5437653-437653100.962101.20
6437994-437994101.041101.31
20min1436291-436291100.648100.130.65101.03100.530.66
2431166-43116699.46599.86
3430753-43075399.37099.75
4433060-43306099.902100.30
5437465-437465100.919101.32
6435601-435601100.489100.93
30min1428206-42820698.78399.730.7099.33100.300.72
2430208-43020899.24499.80
3432195-43219599.703100.25
4431932-43193299.642100.20
5436443-436443100.683101.25
6435002-435002100.350100.96
45min1428220-42822098.78699.510.6499.50100.250.65
2428823-42882398.92599.65
3430737-43073799.367100.08
4431444-43144499.530100.26
5435108-435108100.375101.11
6433935-433935100.104100.88
60min1426741-42674198.44599.280.6499.32100.180.66
2428478-42847898.84599.74
3429811-42981199.153100.03
4430149-43014999.231100.13
5434260-434260100.179101.09
6432699-43269999.819100.76
极限1425940-42594098.26099.020.6199.30100.080.62
2427333-42733398.58199.64
3429209-42920999.014100.06
4428547-42854798.86199.92
5433015-43301599.892100.97
6431373-43137399.513100.62
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%
110.904672494674334673124682914678624676290.10
210.934652894650434651660.04
单位质量响应值RSD%判断
42901.7442558.650.57数据可信
加速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%
5min1486243-48624397.23889.5710.0497.2489.5710.04
2400602-40060280.11280.11
3497522-49752299.49399.49
4386850-38685077.36177.36
5459285-45928591.84791.85
6456963-45696391.38391.38
10min1500958-500958100.181101.111.40100.34101.261.41
2499703-49970399.930100.06
3514090-514090102.807102.97
4505229-505229101.035101.16
5514569-514569102.902103.06
6499178-49917899.82599.98
15min1499796-49979699.948101.611.35100.28101.921.34
2505065-505065101.002101.30
3514417-514417102.872103.21
4512484-512484102.486102.78
5515264-515264103.041103.37
6501474-501474100.284100.60
20min1498091-49809199.607101.421.32100.10101.901.31
2504825-504825100.954101.42
3513119-513119102.612103.12
4511376-511376102.264102.73
5514027-514027102.794103.29
6501432-501432100.275100.76
30min1498233-49823399.636101.351.36100.30102.001.35
2505370-505370101.063101.70
3512676-512676102.524103.20
4511058-511058102.200102.84
5514031-514031102.795103.46
6499445-49944599.878100.53
45min1497455-49745599.480101.071.28100.31101.891.28
2504382-504382100.865101.67
3511340-511340102.257103.11
4509319-509319101.853102.66
5511748-511748102.338103.18
6498050-49805099.599100.42
60min1494570-49457098.903100.861.3399.90101.861.32
2503574-503574100.704101.68
3509679-509679101.925102.95
4508734-508734101.736102.71
5511105-511105102.210103.22
6498581-49858199.705100.69
极限1493429-49342998.675100.671.4599.83101.821.44
2502555-502555100.500101.64
3508467-508467101.682102.87
4509327-509327101.854103.00
5510479-510479102.085103.26
6496028-49602899.195100.35
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%
110.914247004246764245264254814251364249040.10
210.894228714226234227470.05
单位质量响应值RSD%判断
38946.2938819.740.24数据可信
加速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%
5min1338366-33836678.32049.1631.9978.3249.1631.99
2192946-19294644.66044.66
3216483-21648350.10850.11
4135269-13526931.31031.31
5207639-20763948.06148.06
6183525-18352542.47942.48
10min1428899-42889999.27594.034.0599.4194.114.07
2385631-38563189.26089.33
3397086-39708691.91191.99
4395999-39599991.66091.71
5420993-42099397.44597.52
6408785-40878594.61994.69
15min1430653-43065399.68199.721.4299.9899.961.42
2423443-42344398.01298.24
3425960-42596098.59498.83
4437126-437126101.179101.38
5438869-438869101.582101.82
6428805-42880599.25399.48
20min1429356-42935699.38199.921.1299.84100.321.11
2428259-42825999.12799.51
3427132-42713298.86699.27
4437542-437542101.275101.65
5438012-438012101.384101.80
6429812-42981299.48699.88
30min1429309-42930999.37099.831.13100.00100.411.12
2428479-42847999.17899.73
3426776-42677698.78399.35
4437155-437155101.186101.73
5437811-437811101.338101.92
6428360-42836099.15099.71
45min1428532-42853299.19099.611.0699.98100.341.05
2428510-42851099.18599.90
3425900-42590098.58199.31
4435903-435903100.896101.61
5436152-436152100.954101.70
6426996-42699698.83499.56
60min1426459-42645998.71099.371.1399.67100.281.12
2427044-42704498.84599.73
3424550-42455098.26899.16
4435308-435308100.758101.64
5435616-435616100.829101.75
6426953-42695398.82499.71
极限1428970-42897099.29199.341.21100.41100.401.20
2426282-42628298.66999.72
3423634-42363498.05699.11
4435886-435886100.892101.94
5434992-434992100.685101.77
6425211-42521198.42199.48
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