瑞舒伐他汀钙依折麦布片项目信息
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5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.444871524843854868934877234876854867680.29
211.414846814849354848080.04
单位质量响应值RSD%判断
42549.6542489.750.10数据可信
长期12月-供试品溶液-2024040821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%
5min1411135-41113582.62490.047.0382.6290.047.03
2446069-44606989.64489.64
3413085-41308583.01683.02
4480543-48054396.57296.57
5483858-48385897.23897.24
6453572-45357291.15291.15
10min1486774-48677497.82498.902.0197.9699.042.01
2484496-48449697.36797.52
3492343-49234398.94499.08
4498182-498182100.117100.28
5508459-508459102.182102.34
6482374-48237496.94097.09
15min1502004-502004100.88599.722.02101.19100.042.02
2483626-48362697.19297.50
3500191-500191100.521100.82
4496445-49644599.768100.10
5509564-509564102.404102.74
6485523-48552397.57397.89
20min1505032-505032101.49499.721.93101.96100.201.92
2484025-48402597.27297.75
3500811-500811100.645101.12
4495737-49573799.626100.12
5506064-506064101.701102.20
6485607-48560797.59098.07
30min1510417-510417102.57699.712.31103.21100.362.30
2485896-48589697.64898.28
3497955-497955100.071100.71
4489901-48990198.45399.11
5508747-508747102.240102.91
6484067-48406797.28097.92
45min1510336-510336102.56099.562.33103.37100.372.33
2482195-48219596.90497.70
3498353-498353100.151100.96
4492239-49223998.92399.75
5505803-505803101.649102.49
6483534-48353497.17397.97
60min1508400-508400102.17199.632.21103.15100.612.20
2484798-48479897.42798.39
3498307-498307100.142101.11
4493520-49352099.180100.17
5507150-507150101.919102.93
6482422-48242296.95097.91
极限1509967-509967102.48599.412.39103.64100.562.38
2483142-48314297.09598.22
3496009-49600999.680100.82
4492216-49221698.918100.07
5505943-505943101.677102.86
6480736-48073696.61197.74
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院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%
111.324458474430254451694421424457274443820.39
211.444432434446584439500.23
单位质量响应值RSD%判断
39256.3638806.820.82数据可信
长期12月-供试品溶液-2024040821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%
5min1164198-16419837.76845.3527.8537.7745.3527.85
2192834-19283444.35444.35
3144270-14427033.18433.18
4287529-28752966.13666.14
5235830-23583054.24454.24
6158397-15839736.43336.43
10min1401019-40101992.24093.034.9992.3093.105.01
2379565-37956587.30587.38
3395520-39552090.97591.03
4432812-43281299.55399.66
5424428-42442897.62497.71
6393407-39340790.48990.55
15min1433927-43392799.80998.881.78100.0399.111.79
2425545-42554597.88198.10
3432950-43295099.58499.79
4437468-437468100.624100.90
5432866-43286699.56599.82
6416482-41648295.79796.01
20min1434378-43437899.91398.901.55100.3099.301.56
2426883-42688398.18998.57
3433413-43341399.691100.06
4436785-436785100.467100.91
5429999-42999998.90699.32
6418406-41840696.23996.61
30min1433971-43397199.81998.751.40100.3799.311.40
2428135-42813598.47799.02
3431357-43135799.21899.76
4432220-43222099.416100.03
5432452-43245299.470100.05
6417796-41779696.09996.63
45min1433727-43372799.76398.561.41100.4899.281.41
2427938-42793898.43299.14
3430838-43083899.09999.80
4432126-43212699.395100.17
5429377-42937798.76399.51
6416959-41695995.90696.60
60min1428977-42897798.67198.441.4399.5599.331.45
2427590-42759098.35299.23
3430755-43075599.08099.95
4433744-43374499.767100.71
5430611-43061199.04699.96
6416242-41624295.74196.59
极限1431488-43148899.24898.311.52100.2999.361.53
2426063-42606398.00099.04
3428951-42895198.66599.70
4433109-43310999.621100.73
5429667-42966798.82999.91
6415150-41515095.49096.50
瑞舒伐他汀钙依折麦布片项目信息
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5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.444885224875574877464877164873544877790.10
211.414822244878914850580.83
单位质量响应值RSD%判断
42638.0242511.660.21数据可信
长期12月-供试品溶液-2024040921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%
5min1417588-41758883.81281.732.6883.8181.732.67
2396438-39643879.56779.57
3397113-39711379.70379.70
4421963-42196384.69084.69
5409506-40950682.19082.19
6400670-40067080.41680.42
10min1468266-46826693.98392.682.9294.1292.822.92
2444126-44412689.13889.27
3471490-47149094.63094.76
4470484-47048494.42894.57
5471522-47152294.63794.77
6444763-44476389.26689.40
15min1475956-47595695.52795.982.3995.8296.272.39
2459354-45935492.19592.48
3487300-48730097.80398.09
4491336-49133698.61498.91
5481771-48177196.69496.99
6473511-47351195.03695.32
20min1475064-47506495.34896.462.4695.8096.912.46
2463045-46304592.93593.37
3494661-49466199.28199.73
4492428-49242898.83399.30
5482239-48223996.78897.24
6476327-47632795.60196.04
30min1474137-47413795.16296.242.3095.7896.862.30
2464878-46487893.30393.89
3493385-49338599.02599.64
4489742-48974298.29498.92
5482861-48286196.91397.53
6472180-47218094.76995.37
45min1473186-47318694.97195.912.4995.7496.692.49
2460002-46000292.32593.07
3491081-49108198.56299.35
4489551-48955198.25599.05
5481844-48184496.70897.49
6471629-47162994.65895.42
60min1472407-47240794.81495.562.1595.7596.502.15
2460060-46006092.33693.24
3487460-48746097.83698.78
4485463-48546397.43598.39
5479942-47994296.32797.27
6471519-47151994.63695.55
极限1469085-46908594.14895.352.2595.2496.442.25
2461862-46186292.69893.75
3489266-48926698.19899.31
4485658-48565897.47498.59
5476183-47618395.57296.67
6468344-46834493.99995.07
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院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%
111.324469494462364466904469434463444466320.08
211.444433504453224443360.32
单位质量响应值RSD%判断
39455.1238840.561.12数据可信
长期12月-供试品溶液-2024040921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%
5min1115436-11543626.47421.1923.8126.4721.1923.81
2112956-11295625.90525.91
382258-8225818.86518.86
480573-8057318.47818.48
5103819-10381923.81023.81
659346-5934613.61013.61
10min1375385-37538586.09068.0915.8986.1368.1315.89
2270855-27085562.11762.16
3307539-30753970.53070.56
4279554-27955464.11264.14
5311686-31168671.48171.52
6236470-23647054.23154.25
15min1425081-42508197.48794.593.8897.6794.743.90
2400452-40045291.83991.99
3427564-42756498.05698.21
4417588-41758895.76895.91
5417848-41784895.82895.99
6386125-38612588.55388.67
20min1423513-42351397.12798.041.5597.4898.341.55
2421230-42123096.60496.90
3436160-436160100.028100.34
4433320-43332099.37699.67
5430044-43004498.62598.94
6420634-42063496.46796.73
30min1422749-42274996.95298.051.3697.4698.521.36
2423205-42320597.05797.52
3434781-43478199.711100.19
4432142-43214299.10699.57
5431041-43104198.85499.34
6421213-42121396.60097.02
45min1422852-42285296.97697.651.6197.6598.281.61
2418425-41842595.96096.58
3434468-43446899.640100.28
4430887-43088798.81899.45
5429571-42957198.51799.16
6418459-41845995.96896.55
60min1420633-42063396.46797.301.2697.3098.101.26
2417817-41781795.82196.60
3430821-43082198.80399.61
4427535-42753598.05098.84
5428536-42853698.27999.09
6420360-42036096.40497.15
极限1419729-41972996.25997.111.3197.2698.071.31
2419271-41927196.15497.10
3431331-43133198.92099.90
4427191-42719197.97198.93
5425935-42593597.68398.66
6417235-41723595.68796.59
瑞舒伐他汀钙依折麦布片项目信息
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5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.444871264845864854084862144845154855700.23
211.414842834862234852530.29
单位质量响应值RSD%判断
42444.9342528.750.14数据可信
长期12月-供试品溶液-2024041021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%
5min1382483-38248376.92590.797.7776.9390.797.77
2456863-45686391.88491.88
3460685-46068592.65392.65
4458642-45864292.24292.24
5482698-48269897.08097.08
6467074-46707493.93893.94
10min1452192-45219290.94598.113.7291.0798.263.73
2489489-48948998.44698.60
3494383-49438399.43099.58
4494956-49495699.54699.70
5503996-503996101.364101.53
6491833-49183398.91899.07
15min1481714-48171496.88299.351.4097.1699.661.41
2496950-49695099.947100.26
3493330-49333099.21999.54
4498529-498529100.264100.58
5501310-501310100.824101.15
6492128-49212898.97799.30
20min1485802-48580297.70599.561.2198.15100.041.22
2496150-49615099.786100.27
3493605-49360599.27499.76
4500572-500572100.675101.16
5502117-502117100.986101.48
6491930-49193098.93799.42
30min1482875-48287597.11699.381.5797.72100.021.58
2495647-49564799.685100.33
3492502-49250299.05299.70
4500955-500955100.752101.41
5503871-503871101.339102.01
6488914-48891498.33198.98
45min1483307-48330797.20399.211.3297.97100.021.33
2494944-49494499.543100.36
3493754-49375499.304100.12
4498439-498439100.246101.07
5500874-500874100.736101.57
6488424-48842498.23299.05
60min1480039-48003996.54698.741.2997.4799.721.31
2492120-49212098.97599.96
3493648-49364899.283100.26
4495490-49549099.653100.64
5497135-49713599.984100.99
6487256-48725697.99798.98
极限1479631-47963196.46498.671.4597.5599.811.46
2493265-49326599.206100.35
3487936-48793698.13499.28
4495562-49556299.668100.82
5499726-499726100.505101.68
6487439-48743998.03499.18
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院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%
111.324465154439854443714457154447704450710.24
211.444431084448154439620.28
单位质量响应值RSD%判断
39317.2338807.870.93数据可信
长期12月-供试品溶液-2024041021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%
5min168686-6868615.78636.6849.3615.7936.6849.36
297782-9778222.47422.47
3188950-18895043.42743.43
4112148-11214825.77525.78
5269875-26987562.02662.03
6220153-22015350.59950.60
10min1242020-24202055.62481.0321.2955.6581.0921.31
2294934-29493467.78667.82
3396736-39673691.18391.26
4333466-33346676.64276.68
5429663-42966398.75198.85
6418582-41858296.20496.29
15min1395922-39592290.99696.923.6191.1297.123.65
2410715-41071594.39694.55
3435153-435153100.013100.24
4429334-42933498.67598.85
5431811-43181199.24599.51
6427167-42716798.17798.42
20min1425128-42512897.70998.781.6397.9899.141.64
2422158-42215897.02697.33
3438828-438828100.857101.25
4437313-437313100.509100.84
5430504-43050498.94499.38
6424915-42491597.66098.07
30min1427195-42719598.18498.660.9898.6299.191.00
2425018-42501897.68398.15
3434741-43474199.918100.48
4432822-43282299.47799.98
5431117-43111799.08599.68
6424816-42481697.63798.21
45min1427173-42717398.17998.591.0998.7899.271.10
2423311-42331197.29197.92
3434442-43444299.849100.57
4434243-43424399.804100.47
5429513-42951398.71699.48
6425012-42501297.68298.42
60min1427620-42762098.28198.341.5099.0499.191.50
2420635-42063596.67697.47
3435597-435597100.115101.01
4433884-43388499.721100.56
5428901-42890198.57699.50
6420493-42049396.64397.54
极限1425229-42522997.73298.151.2698.6699.171.26
2421837-42183796.95297.91
3433113-43311399.544100.60
4433950-43395099.736100.74
5426487-42648798.02199.11
6421719-42171996.92597.98
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