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)5补液体积(ml)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%
111.484905764908794908434903584903884906090.05
211.384938734940304939520.03
单位质量响应值RSD%判断
42735.9843405.271.10数据可信
供试品溶液-2024040921批-瑞舒伐他汀钙-pH7.0磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1449490-44949089.18287.173.8189.1887.173.81
2440005-44000587.30087.30
3455869-45586990.44790.45
4419340-41934083.20083.20
5418541-41854183.04183.04
6452966-45296689.87189.87
10min1493766-49376697.96696.521.2798.4697.011.27
2482327-48232795.69796.18
3494505-49450598.11398.62
4483273-48327395.88496.35
5480061-48006195.24795.71
6485018-48501896.23196.73
15min1500874-50087499.37698.581.89100.4299.601.88
2483318-48331895.89396.91
3507786-507786100.748101.80
4492549-49254997.72598.72
5505346-505346100.264101.25
6491404-49140497.49898.53
20min1499793-49979399.16298.761.94100.75100.331.92
2483382-48338295.90697.46
3508320-508320100.854102.46
4494147-49414798.04299.58
5508099-508099100.810102.36
6492966-49296697.80799.38
30min1498714-49871498.94898.511.90101.09100.621.89
2481861-48186195.60497.69
3507342-507342100.660102.83
4493108-49310897.83699.92
5505379-505379100.270102.38
6492502-49250297.71599.83
45min1497299-49729998.66798.381.97101.36101.051.95
2482638-48263895.75898.37
3507036-507036100.599103.33
4491415-49141597.500100.13
5506766-506766100.545103.21
6490042-49004297.22799.89
60min1493879-49387997.98998.151.95101.23101.361.93
2480107-48010795.25698.40
3504615-504615100.119103.40
4491097-49109797.437100.60
5506259-506259100.445103.67
6492130-49213097.642100.84
极限1493151-49315197.84497.751.72101.63101.501.71
2479473-47947395.13098.80
3500585-50058599.319103.16
4489604-48960497.140100.85
5502948-50294899.788103.57
6490260-49026097.271101.01
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)5补液体积(ml)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%
111.074438244432194438264430974434374434810.08
211.194435004434954434980.01
单位质量响应值RSD%判断
40061.5239633.420.76数据可信
供试品溶液-2024040921批-依折麦布-pH7.0磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1150240-15024033.93428.8327.4333.9328.8327.43
2185709-18570941.94641.95
3114597-11459725.88425.88
4100506-10050622.70122.70
591323-9132320.62720.63
6123499-12349927.89427.89
10min1388351-38835187.71678.0116.0387.9078.1616.04
2412325-41232593.13193.36
3329210-32921074.35874.50
4357890-35789080.83680.96
5254048-25404857.38157.50
6330321-33032174.60974.76
15min1436351-43635198.55896.193.1099.2396.783.17
2430634-43063497.26698.02
3432367-43236797.65898.21
4433845-43384597.99298.57
5401340-40134090.65091.08
6420569-42056994.99395.56
20min1435008-43500898.25497.781.1599.4898.911.15
2428591-42859196.80598.10
3440714-44071499.543100.64
4435450-43545098.35499.47
5428982-42898296.89397.83
6428729-42872996.83697.93
30min1433788-43378897.97997.631.1199.7599.301.08
2426681-42668196.37398.20
3440133-44013399.412101.06
4433832-43383297.98999.65
5430641-43064197.26898.74
6428465-42846596.77698.41
45min1432086-43208697.59497.461.1699.9199.671.12
2426874-42687496.41798.78
3439813-43981399.340101.54
4432334-43233497.65099.86
5431978-43197897.57099.59
6425780-42578096.17098.34
60min1429437-42943796.99697.261.0699.85100.020.99
2425008-42500895.99698.90
3438307-43830798.999101.76
4431448-43144897.450100.20
5431873-43187397.546100.10
6427633-42763396.58999.30
极限1428745-42874596.84096.840.82100.23100.140.78
2424202-42420295.81499.25
3434472-43447298.133101.44
4430088-43008897.143100.44
5428891-42889196.87399.97
6426188-42618896.26299.51
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)5补液体积(ml)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%
111.484927364926264930624931124930534929180.05
211.384918294919624918960.02
单位质量响应值RSD%判断
42937.1143224.600.48数据可信
供试品溶液-2024040921批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1419410-41941083.19087.233.8283.1987.223.82
2419114-41911483.13183.13
3456735-45673590.59390.59
4449555-44955589.16989.17
5440403-44040387.35487.35
6453321-45332189.91689.92
10min1483863-48386395.97496.611.2896.4497.091.29
2480377-48037795.28295.74
3495161-49516198.21598.72
4494459-49445998.07698.57
5483138-48313895.83096.32
6485313-48531396.26196.76
15min1493028-49302897.79298.641.9198.7999.661.89
2506069-506069100.378101.37
3508062-508062100.774101.82
4501339-50133999.440100.48
5483533-48353395.90896.93
6491667-49166797.52298.56
20min1494291-49429198.04298.862.1899.58100.432.16
2508667-508667100.894102.44
3512396-512396101.633103.24
4499930-49993099.161100.75
5483336-48333695.86997.42
6491996-49199697.58799.16
30min1492884-49288497.76398.511.8699.85100.631.85
2505823-505823100.330102.44
3507052-507052100.573102.75
4498943-49894398.965101.11
5482618-48261895.72797.81
6492474-49247497.68299.80
45min1490958-49095897.38198.302.01100.01100.971.99
2507550-507550100.672103.34
3505843-505843100.334103.07
4497639-49763998.706101.40
5481988-48198895.60298.22
6489636-48963697.11999.78
60min1491106-49110697.41198.091.98100.58101.301.97
2506334-506334100.431103.66
3504463-504463100.060103.35
4494203-49420398.025101.27
5479753-47975395.15998.30
6491183-49118397.426100.63
极限1479447-47944795.09897.741.7798.81101.501.73
2503240-50324099.817103.60
3501062-50106299.385103.23
4489234-48923497.039100.83
5493702-49370297.925101.60
6490013-49001397.194100.94
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)5补液体积(ml)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%
111.074425994422664428154426674426284425950.05
211.194418324417234417780.02
单位质量响应值RSD%判断
39981.4839479.710.90数据可信
供试品溶液-2024040921批-依折麦布
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1100488-10048822.76428.9327.3922.7628.9327.39
291352-9135220.69420.69
3114779-11477926.00126.00
4150372-15037234.06434.06
5185624-18562442.05042.05
6123627-12362728.00628.01
10min1358279-35827981.16378.2816.0681.2978.4416.08
2254078-25407857.55757.67
3329223-32922374.58074.72
4388759-38875988.06788.26
5412692-41269293.48993.72
6330430-33043074.85475.01
15min1434123-43412398.34496.513.0798.9297.113.14
2401810-40181091.02491.46
3432378-43237897.94998.51
4436512-43651298.88599.56
5430817-43081797.59598.35
6420630-42063095.28795.86
20min1435421-43542198.63898.181.4399.7699.311.41
2429620-42962097.32498.26
3444004-444004100.582101.69
4435033-43503398.55099.78
5428261-42826197.01698.31
6427953-42795396.94698.05
30min1433741-43374198.25797.941.0699.9399.621.04
2430956-43095697.62699.11
3439863-43986399.644101.31
4433831-43383198.278100.05
5427205-42720596.77798.61
6428365-42836597.04098.68
45min1431642-43164297.78297.681.12100.0099.901.07
2432508-43250897.978100.00
3438842-43884299.413101.63
4432161-43216197.899100.22
5426484-42648496.61398.99
6425538-42553896.39998.58
60min1431370-43137097.72097.481.09100.48100.251.03
2431695-43169597.794100.36
3438031-43803199.229102.00
4429518-42951897.301100.17
5424510-42451096.16699.07
6426826-42682696.69199.40
极限1424105-42410596.07497.120.8499.38100.430.84
2429069-42906997.199100.31
3434513-43451398.432101.75
4429874-42987497.381100.79
5428873-42887397.155100.60
6425920-42592096.48699.74
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