普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.635124951269514075142951346513400.16
216.665113251146511390.02
单位质量响应值RSD%判断
3087.193069.570.41数据可信
中间条件36月-供试品溶液-2022100911批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min150653-5065398.13594.813.6598.1494.813.65
250290-5029097.43297.43
350582-5058297.99798.00
446712-4671290.50090.50
548146-4814693.27893.28
647242-4724291.52791.53
5min152247-52247101.22399.852.08101.2299.852.08
252461-52461101.638101.64
352767-52767102.231102.23
450403-5040397.65197.65
550880-5088098.57598.57
650483-5048397.80697.81
10min152176-52176101.086100.541.66101.09100.541.66
252709-52709102.118102.12
353028-53028102.736102.74
451172-5117299.14199.14
551163-5116399.12399.12
651130-5113099.05999.06
15min152234-52234101.198100.821.64101.20100.821.64
252766-52766102.229102.23
353246-53246103.159103.16
451169-5116999.13599.13
551526-5152699.82699.83
651294-5129499.37799.38
30min152205-52205101.142100.801.65101.14100.801.65
252625-52625101.956101.96
353359-53359103.378103.38
451270-5127099.33099.33
551460-5146099.69999.70
651239-5123999.27099.27
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.635110251163511495119551162511540.07
216.665100751091510490.12
单位质量响应值RSD%判断
3076.013064.170.28数据可信
中间条件36月-供试品溶液-2022101011批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min148122-4812293.48393.861.3593.4893.861.35
248298-4829893.82593.82
348432-4843294.08594.09
447179-4717991.65191.65
548839-4883994.87694.88
649016-4901695.22095.22
5min150826-5082698.73699.100.6898.7499.100.68
251257-5125799.57399.57
351387-5138799.82699.83
450689-5068998.47098.47
550616-5061698.32898.33
651319-5131999.69399.69
10min151101-5110199.270100.100.7899.27100.100.79
251742-51742100.515100.52
352125-52125101.259101.26
451437-5143799.92399.92
551093-5109399.25499.25
651675-51675100.385100.39
15min151198-5119899.458100.180.6199.46100.180.61
251694-51694100.422100.42
352103-52103101.217101.22
451522-51522100.088100.09
551371-5137199.79599.79
651535-51535100.113100.11
30min151222-5122299.505100.270.5299.51100.270.52
251601-51601100.241100.24
352022-52022101.059101.06
451705-51705100.443100.44
551465-5146599.97799.98
651685-51685100.404100.40
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.635119951150512975111251138511790.15
216.665123551061511480.25
单位质量响应值RSD%判断
3077.513070.110.18数据可信
中间条件36月-供试品溶液-2022101111批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min149830-4983096.68395.041.2696.6895.041.26
249074-4907495.21795.22
348324-4832493.76193.76
449587-4958796.21296.21
548565-4856594.22994.23
648531-4853194.16394.16
5min151663-51663100.24099.530.94100.2499.530.94
251520-5152099.96399.96
351368-5136899.66899.67
451816-51816100.537100.54
550698-5069898.36898.37
650719-5071998.40898.41
10min151690-51690100.292100.200.90100.29100.200.90
251765-51765100.438100.44
352036-52036100.964100.96
452165-52165101.214101.21
551231-5123199.40299.40
650971-5097198.89798.90
15min152004-52004100.902100.461.04100.90100.461.04
251972-51972100.840100.84
352088-52088101.065101.06
452329-52329101.532101.53
551385-5138599.70199.70
650888-5088898.73698.74
30min151977-51977100.849100.111.07100.85100.111.07
251831-51831100.566100.57
351920-51920100.739100.74
452004-52004100.902100.90
550684-5068498.34098.34
651156-5115699.25699.26
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