非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.133805693806653801123807473799183804020.10
211.113798263798363798310.01
单位质量响应值RSD%判断
34178.0834188.210.03数据可信
中间条件6月-供试品溶液-2025082921批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1261047-26104768.67570.9714.1668.6870.9714.16
2286088-28608875.26375.26
3294798-29479877.55577.55
4288671-28867175.94375.94
5292192-29219276.86976.87
6195852-19585251.52451.52
10min1330114-33011486.84586.872.0286.9686.992.04
2333058-33305887.62087.75
3334511-33451188.00288.13
4333857-33385787.83087.96
5332716-33271687.53087.66
6316966-31696683.38683.47
15min1343191-34319190.28690.600.6890.5490.860.70
2346197-34619791.07691.35
3347560-34756091.43591.71
4344591-34459190.65490.93
5343912-34391290.47590.75
6340876-34087689.67789.90
20min1349725-34972592.00591.870.4492.4192.290.45
2348826-34882691.76892.19
3351925-35192592.58393.01
4349203-34920391.86792.29
5347746-34774691.48491.91
6347945-34794591.53691.91
30min1354149-35414993.16893.310.3893.7393.880.40
2354535-35453593.27093.85
3357113-35711393.94894.53
4355188-35518893.44294.02
5353839-35383993.08793.66
6353318-35331892.95093.48
45min1360796-36079694.91794.410.5795.6495.130.56
2358656-35865694.35495.09
3359591-35959194.60095.34
4360158-36015894.74995.48
5355050-35505093.40694.14
6358955-35895594.43395.11
60min1358321-35832194.26694.540.4795.1495.420.48
2359519-35951994.58195.47
3362481-36248195.36096.26
4359269-35926994.51595.41
5357563-35756394.06794.95
6358946-35894694.43095.27
极限1359532-35953294.58594.650.5495.6295.690.53
2359885-35988594.67795.72
3362794-36279495.44396.50
4358012-35801294.18595.23
5357581-35758194.07195.12
6360897-36089794.94495.94
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.133801263797633800783801263798173799820.05
211.113794553792993793770.03
单位质量响应值RSD%判断
34140.3434147.340.02数据可信
中间条件6月-供试品溶液-2025082921批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1283401-28340174.64268.9215.3674.6468.9115.36
2288647-28864776.02476.02
3288065-28806575.87175.87
4283628-28362874.70274.70
5191073-19107350.32550.32
6235127-23512761.92861.93
10min1331817-33181787.39485.542.4887.5285.662.50
2327586-32758686.28086.41
3330662-33066287.09087.22
4328108-32810886.41786.54
5310892-31089281.88381.97
6319570-31957084.16884.27
15min1342590-34259090.23189.990.4590.5090.250.47
2342644-34264490.24690.52
3341381-34138189.91390.18
4342632-34263290.24290.51
5338766-33876689.22489.44
6342060-34206090.09290.34
20min1349867-34986792.14891.440.5592.5791.850.55
2348176-34817691.70392.12
3346322-34632291.21491.64
4346794-34679491.33991.76
5347643-34764391.56291.93
6344273-34427390.67591.07
30min1354936-35493693.48392.910.4694.0693.470.45
2351781-35178192.65293.23
3351237-35123792.50993.08
4352239-35223992.77393.34
5354622-35462293.40093.92
6351766-35176692.64893.19
45min1356443-35644393.88093.660.6294.6194.370.60
2355145-35514593.53894.27
3355444-35544493.61794.34
4352323-35232392.79593.52
5359076-35907694.57395.25
6355133-35513393.53594.23
60min1359129-35912994.58794.380.5795.4795.260.55
2356941-35694194.01194.90
3356222-35622293.82294.71
4358258-35825894.35895.24
5361969-36196995.33596.17
6357621-35762194.19095.05
极限1358664-35866494.46594.190.6195.5195.220.60
2358794-35879494.49995.54
3355769-35576993.70294.74
4358096-35809694.31595.35
5360106-36010694.84595.84
6354330-35433093.32394.34
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.133795283791743795253796133797963795270.06
211.113793003796083794540.06
单位质量响应值RSD%判断
34099.4634154.280.12数据可信
中间条件6月-供试品溶液-2025083021批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1253963-25396366.92268.1017.3066.9268.1017.30
2298981-29898178.78578.78
3209751-20975155.27255.27
4299744-29974478.98678.99
5200253-20025352.76952.77
6287856-28785675.85375.85
10min1321527-32152784.72686.403.4284.8486.513.44
2336160-33616088.58288.71
3312913-31291382.45682.55
4342581-34258190.27490.41
5320789-32078984.53184.62
6333271-33327187.82187.95
15min1339976-33997689.58790.691.5589.8490.941.57
2346030-34603091.18391.46
3338675-33867589.24589.47
4353565-35356593.16893.45
5342562-34256290.26990.50
6344052-34405290.66190.93
20min1348787-34878791.90992.491.3092.3192.901.32
2351829-35182992.71193.14
3345831-34583191.13091.51
4359367-35936794.69795.13
5350096-35009692.25492.63
6350065-35006592.24692.67
30min1354139-35413993.32093.871.1593.8794.441.16
2356836-35683694.03094.62
3354810-35481093.49694.03
4363507-36350795.78896.38
5356779-35677994.01594.55
6351389-35138992.59593.17
45min1357669-35766994.25094.991.1694.9695.711.16
2360917-36091795.10695.85
3358740-35874094.53295.22
4368289-36828997.04897.80
5360533-36053395.00495.69
6356712-35671293.99894.73
60min1356931-35693194.05595.051.2294.9295.921.23
2359700-35970094.78595.69
3361503-36150395.26096.10
4369069-36906997.25498.17
5358915-35891594.57895.43
6358073-35807394.35695.24
极限1362923-36292395.63495.151.1196.6696.181.11
2359235-35923594.66295.72
3361328-36132895.21496.22
4367815-36781596.92398.00
5358604-35860494.49695.50
6356547-35654793.95495.00
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.133789143788863800943798243799683795370.16
211.113789323789953789640.02
单位质量响应值RSD%判断
34100.3634110.170.03数据可信
中间条件6月-供试品溶液-2025083021批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1290517-29051776.60370.1312.9576.6070.1312.94
2286209-28620975.46775.47
3206257-20625754.38554.39
4296504-29650478.18278.18
5246099-24609964.89164.89
6270286-27028671.26871.27
10min1335940-33594088.58087.901.9288.7188.021.93
2336280-33628088.67088.80
3321580-32158084.79384.88
4340249-34024989.71689.85
5332177-33217787.58887.70
6333918-33391888.04788.17
15min1349538-34953892.16591.670.9292.4491.940.93
2351089-35108992.57492.85
3342628-34262890.34390.58
4349824-34982492.24192.52
5345459-34545991.09091.34
6347471-34747191.62091.89
20min1353417-35341793.18892.780.7493.6293.200.76
2353831-35383193.29793.73
3347416-34741691.60691.99
4353447-35344793.19693.63
5349947-34994792.27392.68
6353128-35312893.11293.53
30min1364324-36432496.06494.880.9596.6595.460.97
2360451-36045195.04395.63
3354161-35416193.38493.92
4361833-36183395.40796.00
5359622-35962294.82495.38
6358667-35866794.57395.15
45min1363036-36303695.72595.440.6296.4796.170.64
2363363-36336395.81196.55
3359611-35961194.82195.51
4365213-36521396.29997.05
5360608-36060895.08495.80
6359955-35995594.91295.64
60min1363260-36326095.78495.730.6996.6996.620.70
2364752-36475296.17797.08
3359718-35971894.85095.70
4366476-36647696.63297.54
5360884-36088495.15796.03
6363298-36329895.79496.68
极限1363491-36349195.84495.250.5296.9196.300.54
2362185-36218595.50096.56
3358272-35827294.46895.48
4362507-36250795.58596.65
5360436-36043695.03996.07
6360570-36057095.07496.12
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