地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031673091167315016740581672128167264616730150.05
210.151722306171951917209120.12
单位质量响应值RSD%判断
166801.10169547.981.16数据可信
供试品溶液-24111301批-pH6.8(内含0.5%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11640671-164067197.46795.531.6197.4795.531.61
21596706-159670694.85594.85
31574504-157450493.53693.54
41627293-162729396.67296.67
51586901-158690194.27294.27
61622009-162200996.35896.36
10min11666413-166641398.99696.441.92100.0897.501.91
21592369-159236994.59795.65
31585163-158516394.16995.21
41619387-161938796.20297.28
51632459-163245996.97998.03
61644528-164452897.69698.77
15min11673052-167305299.39095.872.32101.5798.002.30
21566121-156612193.03895.14
31582688-158268894.02296.11
41625507-162550796.56698.71
51612761-161276195.80997.93
61622290-162229096.37598.53
20min11640729-164072997.47094.532.06100.7697.732.05
21563805-156380592.90096.04
31566759-156675993.07696.21
41579781-157978193.84997.07
51572531-157253193.41996.61
61623772-162377296.46399.69
30min11624501-162450196.50693.681.60100.8897.931.58
21572680-157268093.42797.60
31565573-156557393.00597.17
41582225-158222593.99598.25
51561094-156109492.73996.97
61555486-155548692.40696.70
极限11636741-163674197.23394.052.41102.6899.342.36
21520325-152032590.31795.53
31567495-156749593.11998.32
41592851-159285194.62699.93
51589069-158906994.40199.66
61592032-159203294.57799.90
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031675318167665216758881675914167564916758840.03
210.151700220170943717048280.39
单位质量响应值RSD%判断
167087.14167963.350.37数据可信
供试品溶液-24111302批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11244995-124499574.24384.238.3974.2484.238.39
21573819-157381993.85293.85
31466137-146613787.43087.43
41430445-143044585.30285.30
51306708-130670877.92377.92
61453163-145316386.65786.66
10min11622694-162269496.76697.231.4797.5998.171.50
21630591-163059197.23798.28
31625982-162598296.96397.93
41651590-165159098.49099.44
51592210-159221094.94995.81
61660127-166012798.99999.96
15min11590111-159011194.82395.421.8996.7297.431.82
21552299-155229992.56994.69
31605551-160555195.74497.79
41592956-159295694.99397.04
51617453-161745396.45498.37
61642052-164205297.92199.98
20min11600725-160072595.45695.511.8398.4198.581.78
21580578-158057894.25597.41
31589262-158926294.77397.89
41572867-157286793.79596.89
51612036-161203696.13199.12
61653960-165396098.631101.78
30min11566885-156688593.43892.342.6597.4596.472.57
21565543-156554393.35897.56
31579664-157966494.20098.37
41561392-156139293.11197.25
51467308-146730887.50091.56
61549592-154959292.40796.65
极限11551030-155103092.49393.851.3997.5599.011.36
21564637-156463793.30498.54
31561885-156188593.14098.35
41567270-156727093.46198.64
51585622-158562294.55699.59
61611899-161189996.123101.40
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031695106169483816951301693863168947816936830.15
210.151748525175130917499170.12
单位质量响应值RSD%判断
168861.71172405.621.47数据可信
供试品溶液-24111303批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11442557-144255784.46681.684.6284.4781.684.62
21335163-133516378.17878.18
31495580-149558087.57087.57
41328856-132885677.80877.81
51392564-139256481.53981.54
61374934-137493480.50680.51
10min11651663-165166396.70995.880.9597.6596.780.97
21642059-164205996.14797.02
31653516-165351696.81897.79
41625817-162581795.19696.06
51638158-163815895.91996.82
61613586-161358694.48095.37
15min11682937-168293798.54195.262.23100.5597.242.20
21614499-161449994.53396.47
31630459-163045995.46897.52
41641219-164121996.09898.02
51572012-157201292.04694.02
61620631-162063194.89296.84
20min11657027-165702797.02494.791.68100.1397.821.64
21641896-164189696.13899.12
31589769-158976993.08596.19
41627067-162706795.26998.26
51598039-159803993.57096.56
61599879-159987993.67796.68
30min11607060-160706094.09893.161.8598.2897.241.81
21614482-161448294.53298.59
31613747-161374794.48998.63
41588402-158840293.00597.05
51536761-153676189.98294.02
61585601-158560192.84196.88
极限11612967-161296794.44492.661.9599.6897.781.92
21604992-160499293.97799.08
31613079-161307994.45099.64
41561042-156104291.40396.49
51553670-155367090.97296.01
61549491-154949190.72795.80
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