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ZT-705-231101-1-D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)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%
19.873328843328183328353331593329033329200.05
29.823320063316233318140.09
单位质量响应值RSD%判断
33730.5033789.610.13数据可信
加速6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%
5min1183848-18384854.45749.9411.9054.4649.9411.90
2147783-14778343.77543.77
3179705-17970553.23053.23
4194815-19481557.70657.71
5156836-15683646.45646.46
6148691-14869144.04444.04
10min1286346-28634684.81885.575.0984.9885.725.08
2282326-28232683.62783.76
3267702-26770279.29679.46
4308095-30809591.26091.43
5285843-28584384.66984.81
6303051-30305189.76689.90
15min1314514-31451493.16292.783.1493.5893.193.14
2311959-31195992.40592.79
3294462-29446287.22287.62
4320450-32045094.92095.37
5316947-31694793.88294.28
6321030-32103095.09295.49
20min1320616-32061694.96993.872.6995.6794.562.68
2315509-31550993.45694.12
3300427-30042788.98989.65
4319638-31963894.67995.41
5321537-32153795.24295.92
6323654-32365495.86996.56
30min1323228-32322895.74394.652.6796.7395.622.66
2316790-31679093.83694.78
3304151-30415190.09291.02
4320868-32086895.04496.06
5323187-32318795.73196.69
6328992-32899297.45098.42
45min1325254-32525496.34395.103.0197.6196.353.00
2316623-31662393.78695.01
3305663-30566390.54091.74
4319920-31992094.76396.06
5324487-32448796.11697.36
6334415-33441599.056100.32
60min1324975-32497596.26095.343.2297.8296.873.20
2316132-31613293.64195.14
3305683-30568390.54692.01
4319393-31939394.60796.19
5332086-33208698.36799.90
6332850-33285098.593100.16
极限1330405-33040597.86998.710.6099.72100.540.58
2334789-33478999.167100.95
3332505-33250598.491100.23
4331786-33178698.278100.15
5335102-33510299.260101.09
6334926-33492699.208101.07
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ZT-705-231101-1-D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)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%
19.873333603319703319553320993317623322290.20
29.823333873330253332060.08
单位质量响应值RSD%判断
33660.4933931.360.57数据可信
加速6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%
5min1192004-19200456.81453.039.1556.8153.039.15
2165551-16555148.98648.99
3198206-19820658.64958.65
4189223-18922355.99155.99
5156889-15688946.42346.42
6173371-17337151.30051.30
10min1310240-31024091.80089.242.9991.9789.403.00
2291804-29180486.34486.49
3314438-31443893.04293.22
4300868-30086889.02689.19
5294184-29418487.04987.19
6297993-29799388.17688.33
15min1329836-32983697.59896.181.0498.0496.611.04
2326169-32616996.51396.92
3326462-32646296.60097.05
4322716-32271695.49195.93
5325031-32503196.17696.58
6320088-32008894.71495.13
20min1333260-33326098.61197.481.3099.3598.201.29
2334245-33424598.90399.60
3329430-32943097.47898.22
4325673-32567396.36697.09
5330675-33067597.84698.54
6323319-32331995.67096.37
30min1335944-33594499.40598.301.50100.4499.311.48
2339106-339106100.341101.33
3331348-33134898.04599.08
4326851-32685196.71597.73
5333351-33335198.63899.62
6326660-32666096.65897.65
45min1337144-33714499.76098.881.32101.09100.191.30
2340555-340555100.770102.06
3333050-33305098.54999.88
4327938-32793897.03698.34
5334677-33467799.030100.31
6331750-33175098.16499.44
60min1336756-33675699.64698.931.15101.28100.531.14
2340301-340301100.695102.29
3332950-33295098.519100.15
4329096-32909697.37998.97
5334333-33433398.929100.50
6332680-33268098.439100.01
极限1337891-33789199.98199.740.77101.91101.630.76
2341716-341716101.113103.01
3334849-33484999.081101.00
4335578-33557899.297101.18
5335120-33512099.161101.03
6337261-33726199.795101.66
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ZT-705-231101-1-D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)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%
19.873333353332083331533331463329403331560.05
29.823329893330493330190.02
单位质量响应值RSD%判断
33754.4133912.320.34数据可信
加速6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%
5min1169302-16930250.04045.2210.8850.0445.2210.88
2140634-14063441.56741.57
3132729-13272939.23039.23
4158064-15806446.71946.72
5143391-14339142.38242.38
6173918-17391851.40551.40
10min1303782-30378289.78885.386.2989.9485.516.29
2264304-26430478.12078.24
3280969-28096983.04583.16
4303621-30362189.74189.88
5273891-27389180.95381.08
6306631-30663190.63090.78
15min1323064-32306495.48794.601.9995.9194.992.00
2312739-31273992.43692.79
3323065-32306595.48895.85
4316779-31677993.63094.04
5315011-31501193.10793.48
6329746-32974697.46297.89
20min1326104-32610496.38696.511.3097.0997.181.29
2330449-33044997.67098.31
3330225-33022597.60498.26
4319690-31969094.49095.18
5323679-32367995.66996.32
6328962-32896297.23197.95
30min1329502-32950297.39097.311.7098.3998.281.67
2336927-33692799.585100.51
3332127-33212798.16699.11
4320261-32026194.65995.63
5326528-32652896.51197.45
6330034-33003497.54798.56
45min1329865-32986597.49797.591.7298.7898.841.69
2338512-338512100.053101.28
3332555-33255598.29399.53
4321264-32126494.95596.21
5327884-32788496.91298.14
6330921-33092197.81099.11
60min1328784-32878497.17897.511.5298.7699.061.49
2337448-33744899.739101.27
3331667-33166798.03099.57
4322221-32222195.23896.78
5328214-32821497.01098.53
6331112-33111297.86699.46
极限1331159-33115997.88098.971.0699.75100.821.05
2339787-339787100.430102.26
3334109-33410998.752100.58
4333892-33389298.688100.52
5331758-33175898.05799.86
6338436-338436100.031101.92
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ZT-705-231101-1-D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)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%
19.873318343316503314273312983311453314710.09
29.823314153314333314240.01
单位质量响应值RSD%判断
33583.6933749.900.35数据可信
加速6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%
5min1126206-12620637.48736.2311.4037.4936.2311.40
2140248-14024841.65841.66
3103355-10335530.70030.70
4128252-12825238.09538.09
5126278-12627837.50837.51
6107503-10750331.93231.93
10min1253811-25381175.39075.543.1675.5075.653.17
2265574-26557478.88479.01
3243855-24385572.43272.52
4251913-25191374.82674.94
5261554-26155477.68977.80
6249171-24917174.01174.11
15min1299897-29989789.07988.990.5189.4289.330.51
2301244-30124489.47989.84
3297365-29736588.32688.64
4298247-29824788.58888.93
5300123-30012389.14689.49
6300755-30075589.33389.65
20min1309798-30979892.01993.041.2292.6393.641.20
2308101-30810191.51592.15
3314041-31404193.28093.85
4317126-31712694.19694.80
5312735-31273592.89293.50
6317512-31751294.31194.90
30min1317258-31725894.23595.461.6195.1296.341.58
2315336-31533693.66494.57
3323655-32365596.13596.99
4329176-32917697.77598.66
5318894-31889494.72195.61
6324021-32402196.24497.11
45min1318111-31811194.48996.021.5595.6597.181.53
2318740-31874094.67595.86
3325536-32553696.69497.84
4331585-33158598.49199.67
5321659-32165995.54396.72
6323881-32388196.20397.36
60min1319085-31908594.77896.131.5596.2397.591.53
2319406-31940694.87396.34
3326536-32653696.99198.42
4332125-33212598.651100.13
5321094-32109495.37596.84
6323586-32358696.11597.56
极限1319775-31977594.98396.381.4696.7298.121.44
2321210-32121095.40997.16
3327599-32759997.30799.03
4332340-33234098.715100.49
5321815-32181595.58997.34
6324031-32403196.24797.98
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