氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163214623217373221533218573219403218300.08
214.143221353215283218320.14
单位质量响应值RSD%判断
22728.1122760.400.11数据可信
供试品溶液-1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1174747-17474744.58341.057.1444.5841.057.14
2156298-15629839.87639.88
3141795-14179536.17636.18
4168456-16845642.97842.98
5165377-16537742.19342.19
6158771-15877140.50740.51
10min1323365-32336582.50079.283.5082.5779.353.50
2310831-31083179.30379.37
3297164-29716475.81675.88
4318677-31867781.30481.38
5316066-31606680.63880.71
6298355-29835576.12076.19
15min1376952-37695296.17293.862.9696.3894.062.96
2369792-36979294.34594.54
3370907-37090794.63094.82
4372249-37224994.97295.18
5371104-37110494.68094.88
6346288-34628888.34988.54
20min1376869-37686996.15194.953.0496.5295.313.04
2371397-37139794.75595.11
3380385-38038597.04897.39
4372283-37228394.98195.35
5381489-38148997.33097.69
6350660-35066089.46489.81
30min1377356-37735696.27594.942.9496.8195.462.94
2371501-37150194.78195.30
3379085-37908596.71697.22
4372921-37292195.14495.67
5380901-38090197.18097.70
6351087-35108789.57390.06
45min1374764-37476495.61495.173.5796.3195.853.56
2370934-37093494.63795.31
3378401-37840196.54297.21
4372616-37261695.06695.75
5391216-39121699.811100.50
6350317-35031789.37790.02
极限1375813-37581395.88294.552.8596.7395.382.84
2369603-36960394.29795.13
3377575-37757596.33197.16
4371581-37158194.80295.64
5378611-37861196.59597.45
6350280-35028089.36790.16
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163221813212583214923216763217283216670.11
214.143208333205283206800.07
单位质量响应值RSD%判断
22716.6022678.930.12数据可信
供试品溶液-1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1175979-17597944.99043.613.5144.9943.613.51
2165491-16549142.30842.31
3168949-16894943.19243.19
4167192-16719242.74342.74
5165927-16592742.42042.42
6179954-17995446.00646.01
10min1319444-31944481.66782.042.0181.7482.112.00
2316776-31677680.98581.06
3316800-31680080.99181.06
4316350-31635080.87680.95
5323031-32303182.58482.65
6332941-33294185.11885.19
15min1377748-37774896.57395.712.4496.7895.922.44
2366067-36606793.58693.79
3362341-36234192.63492.84
4372378-37237895.20095.41
5385697-38569798.60598.81
6381996-38199697.65997.88
20min1383311-38331197.99596.751.7298.3797.121.72
2372705-37270595.28395.64
3372224-37222495.16095.52
4373156-37315695.39995.76
5387079-38707998.95899.33
6382119-38211997.69098.07
30min1382606-38260697.81596.921.9998.3597.451.99
2372761-37276195.29895.82
3372027-37202795.11095.63
4372567-37256795.24895.77
5386678-38667898.85699.39
6388041-38804199.20499.75
45min1386426-38642698.79196.612.0199.4997.302.01
2372566-37256695.24895.93
3370404-37040494.69595.37
4370969-37096994.84095.52
5386624-38662498.84299.54
6380360-38036097.24097.95
极限1380441-38044197.26196.402.0198.1297.252.01
2371538-37153894.98595.82
3370134-37013494.62695.46
4370872-37087294.81595.66
5389229-38922999.508100.37
6380177-38017797.19498.07
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.163214193208953211493213833211263211940.07
214.143213813218103215960.10
单位质量响应值RSD%判断
22683.1922743.710.19数据可信
供试品溶液-1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189752-18975248.47746.588.4448.4846.588.45
2180544-18054446.12546.12
3179716-17971645.91345.91
4157248-15724840.17340.17
5204444-20444452.23152.23
6182300-18230046.57446.57
10min1354506-35450690.56885.283.6390.6585.363.63
2327108-32710883.56983.65
3330109-33010984.33584.41
4328266-32826683.86583.93
5341501-34150187.24687.33
6321394-32139482.10982.19
15min1391789-391789100.09398.662.79100.3298.872.79
2386548-38654898.75498.97
3386477-38647798.73698.95
4393099-393099100.428100.63
5393871-393871100.625100.86
6365194-36519493.29993.51
20min1392095-392095100.17198.922.70100.5799.302.69
2391088-39108899.914100.29
3388724-38872499.31099.69
4395622-395622101.072101.45
5389013-38901399.38499.78
6366538-36653893.64294.01
30min1391644-391644100.05698.682.67100.6299.232.67
2388889-38888999.35299.90
3387713-38771399.05299.60
4395013-395013100.917101.46
5388389-38838999.22599.79
6365990-36599093.50294.03
45min1391220-39122099.94898.732.76100.6899.442.75
2391424-391424100.000100.71
3387801-38780199.07499.79
4394686-394686100.833101.54
5388180-38818099.17199.90
6365334-36533493.33594.02
极限1390394-39039499.73798.782.98100.6499.662.97
2390171-39017199.680100.56
3395305-395305100.991101.87
4393128-393128100.435101.31
5386964-38696498.86199.76
6363890-36389092.96693.80
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166437596445016441306437076430246438240.09
214.146460526444726452620.18
单位质量响应值RSD%判断
45467.8045633.800.26数据可信
供试品溶液-2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1211949-21194927.00027.153.3727.0027.153.36
2199740-19974025.44525.45
3212646-21264627.08927.09
4219101-21910127.91227.91
5218278-21827827.80727.81
6216840-21684027.62427.62
10min1476727-47672760.73161.732.5260.7861.782.52
2472466-47246660.18860.23
3472510-47251060.19460.24
4498634-49863463.52263.57
5489970-48997062.41862.46
6497226-49722663.34263.39
15min1661069-66106984.21586.162.2384.3686.312.23
2671455-67145585.53885.68
3659519-65951984.01784.16
4685759-68575987.36087.51
5682449-68244986.93887.09
6697899-69789988.90689.06
20min1744946-74494694.90096.401.9395.1996.701.93
2758178-75817896.58596.87
3736566-73656693.83294.12
4762399-76239997.12397.42
5760050-76005096.82497.12
6778359-77835999.15699.46
30min1760581-76058196.89197.911.7997.3498.361.78
2766484-76648497.64398.09
3753796-75379696.02796.47
4767790-76779097.81098.27
5768792-76879297.93898.39
6794037-794037101.154101.62
45min1760121-76012196.83397.781.9197.4498.391.91
2766374-76637497.62998.24
3751872-75187295.78296.38
4764737-76473797.42198.04
5767024-76702497.71298.33
6795151-795151101.295101.93
极限1758808-75880896.66697.691.8997.4398.471.89
2764923-76492397.44598.22
3753375-75337595.97496.74
4764630-76463097.40798.19
5764636-76463697.40898.19
6794819-794819101.253102.06
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166446196445856453856446736439936446510.08
214.146452726457606455160.06
单位质量响应值RSD%判断
45526.2045651.770.20数据可信
供试品溶液-2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1230954-23095429.39729.658.2229.4029.658.21
2234297-23429729.82229.82
3250516-25051631.88731.89
4219008-21900827.87627.88
5257155-25715532.73232.73
6205842-20584226.20126.20
10min1511151-51115165.06266.373.4265.1166.423.42
2528407-52840767.25867.31
3538477-53847768.54068.59
4510587-51058764.99065.04
5542601-54260169.06569.12
6497529-49752963.32863.37
15min1697635-69763588.79889.481.6588.9689.641.66
2709847-70984790.35390.51
3722492-72249291.96292.13
4692466-69246688.14088.29
5702804-70280489.45689.63
6692818-69281888.18588.33
20min1749203-74920395.36297.281.6595.6797.581.65
2768513-76851397.82098.13
3782682-78268299.62399.94
4756584-75658496.30196.60
5755611-75561196.17896.50
6772904-77290498.37998.67
30min1748231-74823195.23897.571.4995.7098.041.49
2768009-76800997.75698.23
3782348-78234899.581100.07
4763456-76345697.17697.64
5764057-76405797.25397.73
6772993-77299398.39098.85
45min1748523-74852395.27597.401.4295.9098.041.42
2766549-76654997.57098.21
3781070-78107099.418100.07
4762428-76242897.04597.67
5761653-76165396.94797.59
6771257-77125798.16998.79
极限1746126-74612694.97097.301.4995.7598.091.49
2767985-76798597.75398.55
3779091-77909199.16699.98
4761436-76143696.91997.70
5760008-76000896.73797.54
6771840-77184098.24399.03
氢溴酸提格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.166442236451716447466456336439046447350.11
214.146449956453856451900.05
单位质量响应值RSD%判断
45532.1345628.710.15数据可信
供试品溶液-2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1249590-24959031.77530.295.5731.7730.295.56
2233020-23302029.66529.67
3238485-23848530.36130.36
4229783-22978329.25329.25
5256415-25641532.64432.64
6220417-22041728.06128.06
10min1535940-53594068.23065.844.1368.2865.894.13
2516164-51616465.71265.76
3519694-51969466.16166.21
4488229-48822962.15662.20
5544339-54433969.29969.35
6498823-49882363.50463.55
15min1707199-70719990.03288.563.0690.2088.723.06
2700632-70063289.19689.36
3697517-69751788.80088.96
4655728-65572883.48083.63
5717902-71790291.39591.56
6694640-69464088.43388.59
20min1751761-75176195.70596.071.3596.0296.381.36
2746901-74690195.08795.39
3749389-74938995.40395.71
4744966-74496694.84095.13
5767012-76701297.64797.97
6767898-76789897.76098.06
30min1751939-75193995.72896.511.3096.2096.981.29
2747479-74747995.16095.63
3749563-74956395.42695.89
4761706-76170696.97297.42
5766686-76668697.60698.09
6771143-77114398.17398.64
45min1750849-75084995.58996.551.4796.2397.181.47
2747834-74783495.20695.83
3749975-74997595.47896.11
4759080-75908096.63797.25
5766316-76631697.55898.21
6776252-77625298.82399.45
极限1749965-74996595.47796.101.3096.2796.881.29
2746231-74623195.00195.78
3745401-74540194.89695.68
4754955-75495596.11296.88
5762516-76251697.07597.88
6769958-76995898.02298.81
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