依折麦布片项目信息
介质体积(ml)500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500
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%
110.913564093564153565463584903588823573480.35
210.873589853596003592920.13
单位质量响应值RSD%判断
32754.1733053.540.65数据可信
中间条件24月-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1175891-17589153.32451.5411.8353.3251.5411.83
2164470-16447049.86149.86
3138967-13896742.13042.13
4171370-17137051.95351.95
5167928-16792850.90950.91
6201390-20139061.05461.05
10min1244979-24497974.26881.347.4974.4381.507.46
2280786-28078685.12485.27
3292204-29220488.58588.71
4277401-27740184.09884.25
5242814-24281473.61273.76
6271743-27174382.38282.57
15min1258875-25887578.48188.347.9478.8688.747.92
2310760-31076094.21194.62
3319070-31907096.73097.12
4300855-30085591.20891.62
5272347-27234782.56582.94
6286366-28636686.81587.25
20min1264010-26401080.03890.777.5480.6691.437.51
2316898-31689896.07296.76
3325525-32552598.68799.37
4309387-30938793.79494.48
5286092-28609286.73287.35
6294536-29453689.29289.98
30min1272164-27216482.51092.435.9983.3793.365.98
2318409-31840996.53097.51
3322187-32218797.67598.65
4313689-31368995.09996.06
5299187-29918790.70291.58
6303607-30360792.04293.00
45min1280028-28002884.89493.844.9486.0095.054.95
2319526-31952696.86898.13
3321735-32173597.53898.81
4315407-31540795.61996.87
5307631-30763193.26294.42
6312808-31280894.83296.07
60min1285022-28502286.40894.294.2487.7795.784.25
2319115-31911596.74498.30
3320913-32091397.28998.85
4313828-31382895.14196.68
5311747-31174794.51095.94
6315423-31542395.62497.14
极限1332179-332179100.704102.161.41102.32103.931.42
2339052-339052102.788104.63
3335080-335080101.584103.44
4333585-333585101.130102.95
5336592-336592102.042103.76
6345310-345310104.685106.49
依折麦布片项目信息
介质体积(ml)500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500
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%
110.913319823325203321903328983322143323610.11
210.873381353382383381860.03
单位质量响应值RSD%判断
30463.8931111.871.49数据可信
中间条件24月-供试品溶液-2024012421批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148391-14839148.08349.7313.0048.0849.7312.99
2171698-17169855.63555.63
3158145-15814551.24351.24
4175888-17588856.99256.99
5145607-14560747.18147.18
6121167-12116739.26139.26
10min1277623-27762389.95790.578.1790.1090.728.17
2282208-28220891.44391.61
3307202-30720299.54299.70
4301659-30165997.74697.92
5249192-24919280.74580.89
6259173-25917383.97984.10
15min1302973-30297398.17197.614.6898.5998.034.69
2298680-29868096.78097.22
3322532-322532104.509104.96
4310366-310366100.567101.03
5285031-28503192.35892.74
6287798-28779893.25493.62
20min1308409-30840999.93399.443.10100.64100.153.11
2302238-30223897.93398.66
3322985-322985104.656105.42
4311032-311032100.783101.55
5297037-29703796.24896.91
6299636-29963697.09097.74
30min1310462-310462100.598100.642.19101.61101.652.20
2303200-30320098.24599.27
3322610-322610104.534105.61
4311314-311314100.874101.94
5305015-30501598.83399.78
6310933-310933100.751101.69
45min1310831-310831100.718100.941.81102.03102.261.82
2304766-30476698.752100.07
3321827-321827104.281105.67
4310336-310336100.557101.93
5309316-309316100.227101.47
6312085-312085101.124102.37
60min1310838-310838100.720100.741.79102.33102.361.80
2303699-30369998.407100.02
3320810-320810103.951105.66
4309089-309089100.153101.83
5309736-309736100.363101.91
6311292-311292100.867102.41
极限1320245-320245103.768103.741.47105.68105.661.45
2314361-314361101.861103.77
3325121-325121105.348107.37
4315220-315220102.140104.11
5325430-325430105.448107.30
6320500-320500103.851105.70
依折麦布片项目信息
介质体积(ml)500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500
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%
110.913578973587143588183585073603693588610.26
210.873568233568693568460.01
单位质量响应值RSD%判断
32892.8532828.520.14数据可信
中间条件24月-供试品溶液-2024012521批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143070-14307043.43045.1019.3643.4345.1019.36
2122286-12228637.12037.12
3152980-15298046.43846.44
4190677-19067757.88157.88
5113718-11371834.52034.52
6168708-16870851.21251.21
10min1300331-30033191.16786.418.2591.3086.548.26
2248113-24811375.31675.43
3299780-29978091.00091.14
4308048-30804893.50993.68
5264887-26488780.40880.51
6286727-28672787.03787.19
15min1317182-31718296.28295.543.8796.6995.943.90
2299320-29932090.86091.20
3327170-32717099.31499.73
4328633-32863399.758100.21
5302593-30259391.85392.20
6313563-31356395.18395.60
20min1318416-31841696.65797.082.3497.3597.762.37
2312011-31201194.71295.32
3329171-32917199.921100.63
4328599-32859999.748100.50
5312979-31297995.00695.63
6317651-31765196.42497.12
30min1318211-31821196.59497.681.8397.5898.651.86
2317435-31743596.35997.25
3330388-330388100.291101.30
4327969-32796999.556100.61
5316800-31680096.16697.07
6319835-31983597.08798.08
45min1318330-31833096.63197.891.7997.9099.151.82
2318711-31871196.74697.93
3331651-331651100.674101.99
4327694-32769499.473100.82
5318495-31849596.68197.87
6319917-31991797.11298.39
60min1317039-31703996.23997.571.8397.8099.121.86
2318287-31828796.61798.09
3331266-331266100.557102.17
4325937-32593798.940100.59
5316812-31681296.17097.65
6319156-31915696.88198.45
极限1341086-341086103.538102.431.09105.39104.281.10
2333027-333027101.092102.86
3333513-333513101.239103.15
4341718-341718103.730105.68
5337157-337157102.346104.12
6338057-338057102.619104.48
依折麦布片项目信息
介质体积(ml)500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500
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%
110.913566293569073572483569133567523568900.07
210.873587113584043585580.07
单位质量响应值RSD%判断
32712.1932986.020.59数据可信
中间条件24月-供试品溶液-X013576批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1175998-17599853.44549.3120.1153.4449.3020.11
2208783-20878363.40063.40
3115534-11553435.08435.08
4168904-16890451.29051.29
5169177-16917751.37351.37
6135822-13582241.24541.24
10min1298509-29850990.64789.673.2090.8189.823.22
2306551-30655193.08993.28
3279024-27902484.73084.84
4294531-29453189.43989.59
5300940-30094091.38591.54
6292163-29216388.72088.84
15min1311205-31120594.50394.911.4594.9395.321.47
2319166-31916696.92097.39
3309632-30963294.02594.38
4306660-30666093.12293.54
5316163-31616396.00896.44
6312430-31243094.87595.26
20min1312242-31224294.81795.191.3095.5395.891.31
2319603-31960397.05397.81
3312032-31203294.75495.40
4307345-30734593.33094.03
5315188-31518895.71296.43
6314350-31435095.45896.13
30min1310351-31035194.24395.241.3595.2496.231.35
2319230-31923096.93997.99
3315388-31538895.77396.70
4307230-30723093.29594.28
5314937-31493795.63696.64
6314685-31468595.55996.52
45min1311371-31137194.55395.531.4595.8496.811.44
2320140-32014097.21698.56
3318228-31822896.63597.85
4307621-30762193.41494.68
5314791-31479195.59196.88
6315411-31541195.78097.03
60min1310784-31078494.37595.401.6195.9496.961.59
2318898-31889896.83998.47
3319618-31961897.05798.56
4306386-30638693.03994.58
5313415-31341595.17496.75
6315800-31580095.89897.43
极限1325565-32556598.86399.901.06100.71101.741.07
2332275-332275100.901102.83
3324117-32411798.423100.22
4331781-331781100.751102.57
5328557-32855799.772101.63
6331492-331492100.663102.49
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