非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813967415397005539681473959102394760739624650.24
29.853959246395462039569330.09
单位质量响应值RSD%判断
403921.00401719.090.39数据可信
供试品溶液-2024112321批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1332919-3329197.4386.518.387.446.518.36
2267592-2675925.9795.98
3299010-2990106.6816.68
4298290-2982906.6656.66
5271923-2719236.0756.08
6277278-2772786.1956.20
10min1584847-58484713.06712.194.0413.0812.204.04
2545212-54521212.18112.19
3524492-52449211.71911.73
4554086-55408612.38012.39
5534758-53475811.94811.96
6529892-52989211.83911.85
15min1662552-66255214.80314.431.8114.8514.471.80
2650944-65094414.54414.58
3639822-63982214.29514.34
4642769-64276914.36114.40
5649787-64978714.51814.56
6628200-62820014.03614.08
20min1703436-70343615.71715.432.0515.8015.502.06
2702066-70206615.68615.76
3699923-69992315.63815.71
4682043-68204315.23915.31
5689000-68900015.39415.47
6667455-66745514.91314.98
30min1748892-74889216.73215.984.1616.8516.094.15
2711768-71176815.90316.01
3720742-72074216.10316.21
4718820-71882016.06016.17
5731608-73160816.34616.45
6660827-66082714.76514.87
45min1762957-76295717.04616.254.0817.2016.404.08
2736757-73675716.46116.60
3721176-72117616.11316.26
4732234-73223416.36016.50
5738250-73825016.49416.64
6673832-67383215.05515.19
60min1762150-76215017.02816.184.5317.2216.364.51
2758197-75819716.94017.12
3726826-72682616.23916.42
4715288-71528815.98116.16
5708458-70845815.82916.01
6674712-67471215.07515.25
极限1780360-78036017.43516.385.2217.6616.605.19
2735384-73538416.43016.65
3729995-72999516.31016.53
4759115-75911516.96117.18
5728128-72812816.26816.48
6666991-66699114.90215.11
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813777707375142237462753746047374481337532530.38
29.853761250376474837629990.07
单位质量响应值RSD%判断
382594.60382030.360.11数据可信
供试品溶液-2024112321批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1290886-2908866.8486.807.326.856.807.32
2296742-2967426.9866.99
3290947-2909476.8496.85
4271107-2711076.3826.38
5262053-2620536.1696.17
6322438-3224387.5917.59
10min1556316-55631613.09613.103.8113.1113.113.81
2578297-57829713.61413.63
3533764-53376412.56512.58
4553572-55357213.03213.05
5533578-53357812.56112.57
6583158-58315813.72813.74
15min1664106-66410615.63415.591.1715.6815.631.15
2667259-66725915.70815.75
3650169-65016915.30615.35
4669810-66981015.76815.81
5655175-65517515.42315.47
6665965-66596515.67715.72
20min1725701-72570117.08416.761.6317.1616.841.63
2726042-72604217.09217.17
3703703-70370316.56616.64
4711689-71168916.75416.83
5707208-70720816.64816.72
6698033-69803316.43216.51
30min1760349-76034917.89917.742.6718.0217.862.65
2777212-77721218.29618.41
3742990-74299017.49117.60
4774760-77476018.23918.35
5737327-73732717.35717.47
6729472-72947217.17217.29
45min1798221-79822118.79118.690.9918.9518.840.99
2807672-80767219.01319.17
3787142-78714218.53018.68
4791375-79137518.63018.79
5788132-78813218.55318.70
6790652-79065218.61318.77
60min1794044-79404418.69318.635.1118.8918.835.05
2826495-82649519.45619.66
3812981-81298119.13819.33
4818464-81846419.26719.46
5779803-77980318.35718.55
6716723-71672316.87217.07
极限1826805-82680519.46419.201.7619.7019.441.75
2838673-83867319.74319.99
3810355-81035519.07719.31
4809097-80909719.04719.29
5799223-79922318.81419.05
6810725-81072519.08519.32
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813946882394691239444183948404394447239462180.05
29.853952157395470739534320.05
单位质量响应值RSD%判断
402264.83401363.650.16数据可信
供试品溶液-2024112421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1390169-3901698.7397.858.018.747.857.99
2316841-3168417.0977.10
3377412-3774128.4538.45
4348415-3484157.8047.80
5336481-3364817.5377.54
6332906-3329067.4577.46
10min1584905-58490513.10112.573.0713.1212.593.07
2549652-54965212.31112.33
3562270-56227012.59412.61
4577999-57799912.94612.96
5552791-55279112.38212.40
6540416-54041612.10412.12
15min1668906-66890614.98214.562.0815.0314.612.08
2647498-64749814.50314.55
3662232-66223214.83314.88
4639812-63981214.33114.38
5649594-64959414.55014.59
6632765-63276514.17314.22
20min1705337-70533715.79815.612.0515.8815.702.04
2702521-70252115.73515.81
3699019-69901915.65715.74
4707558-70755815.84815.93
5699546-69954615.66915.75
6668806-66880614.98015.06
30min1735533-73553316.47516.132.2516.5916.252.24
2728882-72888216.32616.44
3727801-72780116.30216.42
4729539-72953916.34116.45
5704718-70471815.78515.90
6695464-69546415.57715.69
45min1753260-75326016.87216.423.1617.0316.573.15
2725482-72548216.25016.40
3746028-74602816.71016.86
4747683-74768316.74716.90
5736072-73607216.48716.63
6690394-69039415.46415.61
60min1756331-75633116.94116.672.5917.1316.852.58
2738130-73813016.53316.72
3763492-76349217.10117.29
4760629-76062917.03717.22
5730799-73079916.36916.55
6715130-71513016.01816.20
极限1708715-70871515.87416.356.6116.1016.576.54
2774466-77446617.34717.57
3779819-77981917.46717.69
4704447-70444715.77916.00
5755145-75514516.91417.13
6656330-65633014.70114.91
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813746732374832137448383744500374365037456080.06
29.853799466379955237995090.01
单位质量响应值RSD%判断
381815.29385736.950.73数据可信
供试品溶液-2024112421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1274415-2744156.4367.1610.416.447.1610.39
2274625-2746256.4406.44
3328470-3284707.7037.70
4343791-3437918.0638.06
5281579-2815796.6046.60
6329202-3292027.7207.72
10min1535743-53574312.56413.013.1612.5813.023.17
2554151-55415112.99613.01
3568867-56886713.34113.36
4574537-57453713.47413.49
5532063-53206312.47812.49
6562640-56264013.19513.21
15min1635642-63564214.90715.192.9514.9515.242.95
2661922-66192215.52315.57
3651513-65151315.27915.33
4667007-66700715.64315.69
5615553-61555314.43614.48
6654883-65488315.35815.40
20min1718258-71825816.84416.342.6516.9216.422.64
2693052-69305216.25316.33
3701224-70122416.44516.53
4712931-71293116.72016.80
5689130-68913016.16116.24
6667008-66700815.64315.72
30min1733753-73375317.20817.114.0017.3217.223.99
2707297-70729716.58716.70
3763818-76381817.91318.03
4761873-76187317.86717.99
5717361-71736116.82316.93
6692703-69270316.24516.36
45min1793457-79345718.60817.503.7118.7617.653.68
2720074-72007416.88717.04
3734057-73405717.21517.37
4752415-75241517.64517.80
5721025-72102516.90917.06
6755730-75573017.72317.87
60min1810131-81013118.99918.424.4419.1918.614.40
2810547-81054719.00919.20
3805283-80528318.88519.08
4794197-79419718.62518.82
5721042-72104216.91017.10
6770832-77083218.07718.27
极限1781282-78128218.32218.2612.4718.5618.5012.34
2664145-66414515.57515.81
3805191-80519118.88319.12
4943605-94360522.12922.37
5700461-70046116.42716.65
6777908-77790818.24318.47
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813744661374536637435793740065373908037425500.08
29.853787922378619737870600.04
单位质量响应值RSD%判断
381503.57384473.100.55数据可信
供试品溶液-2024112422批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1313527-3135277.3687.5013.137.377.5013.16
2323466-3234667.6017.60
3336535-3365357.9087.91
4362874-3628748.5278.53
5240580-2405805.6545.65
6337440-3374407.9307.93
10min1577190-57719013.56413.515.1313.5813.535.15
2576989-57698913.55913.58
3603920-60392014.19214.21
4599526-59952614.08914.11
5521362-52136212.25212.26
6571398-57139813.42813.45
15min1678921-67892115.95415.592.8316.0015.632.84
2664575-66457515.61715.66
3664381-66438115.61315.66
4684378-68437816.08316.13
5631569-63156914.84214.88
6656040-65604015.41715.46
20min1691600-69160016.25216.692.6816.3316.772.70
2721585-72158516.95717.04
3739642-73964217.38117.47
4711682-71168216.72416.81
5688889-68888916.18916.26
6707692-70769216.63116.71
30min1682190-68219016.03117.178.4416.1517.298.38
2739928-73992817.38817.51
3754442-75444217.72917.85
4814317-81431719.13619.26
5753471-75347117.70617.82
6638740-63874015.01015.13
45min1793483-79348318.64718.129.0718.8018.288.99
2701423-70142316.48316.64
3694995-69499516.33216.49
4791989-79198918.61218.78
5760915-76091517.88118.03
6883977-88397720.77320.93
60min1689118-68911816.19417.047.8616.3917.247.77
2672102-67210215.79415.99
3725939-72593917.05917.26
4794105-79410518.66118.87
5794747-79474718.67618.86
6675165-67516515.86616.06
极限1705178-70517816.57218.9113.8016.8019.1413.63
21016469-101646923.88724.12
3818252-81825219.22919.46
4745703-74570317.52417.77
5791538-79153818.60118.83
6749780-74978017.62017.85
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813834148383449338361063834877383140738342060.05
29.853939607393653539380710.06
单位质量响应值RSD%判断
390846.69399804.161.61数据可信
供试品溶液-2024112422批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1339079-3390797.7207.419.407.727.419.43
2372702-3727028.4868.49
3292587-2925876.6626.66
4339919-3399197.7407.74
5297797-2977976.7816.78
6311135-3111357.0847.08
10min1583832-58383213.29312.882.5013.3112.902.51
2582758-58275813.26913.29
3560205-56020512.75512.77
4561235-56123512.77912.80
5552366-55236612.57712.59
6553643-55364312.60612.62
15min1678078-67807815.43915.291.7315.4915.331.74
2690169-69016915.71415.76
3669313-66931315.24015.28
4669212-66921215.23715.28
5666102-66610215.16615.21
6656010-65601014.93714.98
20min1721859-72185916.43616.411.1316.5216.491.14
2735922-73592216.75616.84
3715957-71595716.30216.38
4720215-72021516.39916.48
5716901-71690116.32316.40
6712848-71284816.23116.31
30min1765288-76528817.42517.241.9517.5417.361.94
2776514-77651417.68017.80
3748968-74896817.05317.17
4739731-73973116.84316.96
5768619-76861917.50117.61
6745155-74515516.96617.08
45min1731129-73112916.64717.452.6416.8017.612.62
2786789-78678917.91418.07
3764972-76497217.41817.57
4760031-76003117.30517.46
5772611-77261117.59217.74
6783714-78371417.84418.00
60min1731553-73155316.65717.353.2216.8517.543.18
2752078-75207817.12417.32
3803668-80366818.29918.49
4755011-75501117.19117.38
5773870-77387017.62017.81
6755596-75559617.20417.39
极限1753630-75363017.15917.323.2517.3917.553.22
2783975-78397517.85018.09
3762920-76292017.37117.60
4768823-76882317.50517.74
5779343-77934317.74517.97
6715588-71558816.29316.52
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