比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.071843571844491848411854561846521847510.24
211.051851991858171855080.24
单位质量响应值RSD%判断
16689.3416788.050.42数据可信
供试品溶液-2025073121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107545-10754557.59457.603.4757.5957.603.47
2108608-10860858.16358.16
3108645-10864558.18358.18
4100418-10041853.77753.78
5111414-11141459.66659.67
6108758-10875858.24358.24
10min1148948-14894879.76678.572.7779.8678.662.77
2147616-14761679.05379.15
3148025-14802579.27279.37
4138478-13847874.15974.25
5148669-14866979.61779.72
6148539-14853979.54779.64
15min1168748-16874890.37088.332.3390.6088.562.33
2165725-16572588.75188.98
3166327-16632789.07389.30
4157512-15751284.35284.57
5165180-16518088.45988.69
6166136-16613688.97189.20
20min1178155-17815595.40793.242.2095.7993.612.21
2175119-17511993.78294.16
3176018-17601894.26394.64
4166927-16692789.39489.75
5173629-17362992.98493.36
6174761-17476193.59093.97
30min1186476-18647699.86497.971.96100.4098.501.96
2184190-18419098.63999.17
3184196-18419698.64399.18
4176120-17612094.31894.82
5184161-18416198.62499.16
6182443-18244397.70498.24
45min1189812-189812101.650100.232.03102.36100.932.03
2187989-187989100.674101.37
3188779-188779101.097101.80
4180251-18025196.53097.19
5190516-190516102.027102.73
6185631-18563199.411100.11
60min1190469-190469102.002101.051.69102.88101.911.70
2188838-188838101.128101.99
3189718-189718101.600102.47
4183872-18387298.46999.29
5192899-192899103.303104.17
6186308-18630899.774100.64
极限1191002-191002102.287101.281.86103.33102.311.86
2188791-188791101.103102.14
3189987-189987101.744102.78
4184418-18441898.76199.75
5194299-194299104.053105.09
6186209-18620999.721100.75
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.071854661855981853041859991852431855220.17
211.051855201856811856000.07
单位质量响应值RSD%判断
16758.9916796.380.16数据可信
供试品溶液-2025073121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115115-11511561.50459.781.7461.5059.781.73
2110872-11087259.23759.24
3109393-10939358.44758.45
4111392-11139259.51559.51
5112790-11279060.26260.26
6111771-11177159.71759.72
10min1155613-15561383.14181.112.0783.2481.212.06
2153526-15352682.02682.12
3150091-15009180.19180.29
4154410-15441082.49882.60
5147710-14771078.91979.02
6149572-14957279.91480.01
15min1174012-17401292.97190.831.8093.2191.071.80
2172573-17257392.20392.44
3168481-16848190.01690.25
4171255-17125591.49891.74
5166613-16661389.01889.25
6167090-16709089.27389.51
20min1183683-18368398.13895.922.0598.5396.312.05
2182212-18221297.35397.74
3177007-17700794.57294.95
4182630-18263097.57697.97
5175746-17574693.89894.28
6175941-17594194.00294.38
30min1190819-190819101.95199.962.23102.51100.502.23
2192513-192513102.856103.41
3184347-18434798.49399.03
4188743-188743100.842101.39
5183227-18322797.89598.43
6182852-18285297.69498.23
45min1194633-194633103.989101.521.99104.72102.241.98
2193575-193575103.424104.15
3187641-187641100.253100.96
4191719-191719102.432103.15
5186497-18649799.642100.34
6186033-18603399.394100.10
60min1195162-195162104.272102.082.11105.17102.962.10
2195807-195807104.616105.51
3188528-188528100.727101.60
4192459-192459102.827103.72
5188358-188358100.636101.50
6186006-18600699.380100.25
极限1194888-194888104.125102.081.77105.20103.131.76
2193673-193673103.476104.55
3188588-188588100.759101.80
4192731-192731102.973104.03
5190481-190481101.771102.80
6185977-18597799.364100.40
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.071859131860301860181860501855051859030.13
211.051861681862331862000.03
单位质量响应值RSD%判断
16793.4116850.680.25数据可信
供试品溶液-2025080121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111640-11164059.49055.363.7959.4955.363.79
2103146-10314654.96454.96
3102094-10209454.40354.40
4100432-10043253.51853.52
5102835-10283554.79854.80
6103136-10313654.95854.96
10min1151208-15120880.57575.953.1180.6776.043.11
2142819-14281976.10576.20
3140133-14013374.67374.76
4139160-13916074.15574.24
5140855-14085575.05875.15
6141004-14100475.13775.23
15min1165580-16558088.23384.982.5788.4785.202.57
2162082-16208286.36986.59
3158364-15836484.38884.60
4153413-15341381.75081.96
5159189-15918984.82885.04
6158272-15827284.33984.56
20min1173341-17334192.36989.912.1992.7590.272.20
2172787-17278792.07492.44
3167261-16726189.12989.48
4163823-16382387.29787.65
5168514-16851489.79790.15
6166675-16667588.81789.17
30min1179222-17922295.50393.932.3196.0494.452.31
2182464-18246497.23097.75
3174645-17464593.06493.57
4170781-17078191.00591.50
5175770-17577093.66394.17
6174795-17479593.14493.65
45min1182696-18269697.35496.462.3898.0597.132.38
2188299-188299100.340101.02
3179220-17922095.50296.16
4175443-17544393.48994.14
5180931-18093196.41397.08
6179508-17950895.65596.32
60min1184744-18474498.44597.212.3099.3098.042.30
2189406-189406100.929101.77
3180320-18032096.08896.91
4177332-17733294.49695.30
5182142-18214297.05997.88
6180605-18060596.24097.06
极限1185721-18572198.96697.902.5499.9998.892.53
2192014-192014102.319103.33
3181571-18157196.75497.73
4178623-17862395.18496.14
5182669-18266997.34098.33
6181730-18173096.83997.82
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.071862611854231859131862311865771860810.24
211.051865511866121865820.03
单位质量响应值RSD%判断
16809.4916885.250.32数据可信
供试品溶液-2025080121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101053-10105353.76854.883.5153.7754.883.50
2106317-10631756.56956.57
398086-9808652.18952.19
4101613-10161354.06654.07
5103987-10398755.32955.33
6107846-10784657.38257.38
10min1138940-13894073.92675.153.6474.0275.243.64
2147241-14724178.34378.44
3134541-13454171.58671.67
4138045-13804573.45073.54
5141450-14145075.26275.35
6147201-14720178.32278.42
15min1157117-15711783.59884.643.0283.8184.863.02
2165150-16515087.87288.10
3152185-15218580.97481.18
4157025-15702583.54983.76
5159199-15919984.70684.92
6163819-16381987.16487.39
20min1166787-16678788.74389.913.1289.1090.273.12
2176642-17664293.98794.36
3161838-16183886.11086.45
4166545-16654588.61488.97
5168880-16888089.85790.22
6173210-17321092.16192.53
30min1173387-17338792.25593.752.7592.7594.262.76
2183357-18335797.55998.09
3169983-16998390.44490.93
4174479-17447992.83693.34
5175735-17573593.50494.01
6180255-18025595.90996.43
45min1178696-17869695.07996.302.1095.7396.972.10
2186293-18629399.12299.81
3175897-17589793.59094.23
4179488-17948895.50196.16
5181430-18143096.53497.20
6184158-18415897.98698.67
60min1180369-18036995.97097.651.8196.7898.471.82
2188512-188512100.302101.16
3181520-18152096.58297.37
4181261-18126196.44497.26
5182737-18273797.23098.05
6186750-18675099.365100.21
极限1180969-18096996.28997.892.0997.2698.882.09
2189280-189280100.711101.73
3179589-17958995.55596.51
4182132-18213296.90897.88
5184231-18423198.02599.01
6187663-18766399.851100.86
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.071865211872171868501872181871301869870.17
211.051869491866561868020.12
单位质量响应值RSD%判断
16891.3316905.160.06数据可信
供试品溶液-2025080122批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101795-10179553.99956.131.9154.0056.131.91
2106915-10691556.71556.72
3107044-10704456.78456.78
4106115-10611556.29156.29
5106113-10611356.29056.29
6106922-10692256.71956.72
10min1138135-13813573.27676.182.5273.3776.272.51
2147804-14780478.40678.50
3145755-14575577.31977.41
4142797-14279775.74975.84
5146030-14603077.46477.56
6141089-14108974.84374.94
15min1153559-15355981.45884.902.6381.6785.122.62
2163751-16375186.86587.09
3163950-16395086.97087.19
4158919-15891984.30284.52
5162872-16287286.39986.62
6157285-15728583.43583.65
20min1161599-16159985.72389.182.8886.0789.542.87
2172617-17261791.56891.94
3172805-17280591.66892.04
4165464-16546487.77488.13
5171636-17163691.04891.41
6164607-16460787.31987.68
30min1167800-16780089.01392.742.9189.5093.262.91
2179659-17965995.30495.83
3180436-18043695.71696.24
4172295-17229591.39791.90
5177375-17737594.09294.61
6171443-17144390.94591.45
45min1172438-17243891.47394.682.4392.1195.342.43
2183167-18316797.16497.85
3182394-18239496.75497.44
4176554-17655493.65794.32
5180949-18094995.98896.66
6175358-17535893.02293.68
60min1174854-17485492.75595.662.4693.5596.482.46
2185133-18513398.20799.05
3184325-18432597.77998.62
4177671-17767194.24995.06
5183270-18327097.21998.05
6176692-17669293.73094.54
极限1174995-17499592.82995.962.5493.7896.942.53
2186355-18635598.85699.86
3185059-18505998.16899.17
4178463-17846394.66995.64
5183063-18306397.10998.11
6177405-17740594.10895.07
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.071859551854051863841858891867931860850.29
211.051863161855381859270.30
单位质量响应值RSD%判断
16809.8516825.970.07数据可信
供试品溶液-2025080122批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103357-10335755.09056.042.7355.0956.042.73
2104389-10438955.64055.64
3107307-10730757.19557.19
4109212-10921258.21058.21
5101136-10113653.90653.91
6105425-10542556.19256.19
10min1141097-14109775.20575.872.8175.3075.962.81
2142643-14264376.02976.12
3148611-14861179.21079.31
4144975-14497577.27277.37
5138134-13813473.62673.72
6138568-13856873.85773.95
15min1157957-15795784.19285.152.3284.4185.372.32
2160291-16029185.43685.66
3165329-16532988.12188.35
4162203-16220386.45586.68
5154833-15483382.52782.74
6157883-15788384.15284.37
20min1165522-16552288.22489.592.2788.5889.952.27
2169575-16957590.38490.75
3172879-17287992.14592.52
4171262-17126291.28391.65
5162833-16283386.79187.14
6166402-16640288.69389.05
30min1171236-17123691.26993.002.0491.7793.512.04
2175451-17545193.51694.03
3179084-17908495.45295.98
4177120-17712094.40694.93
5169666-16966690.43390.93
6174287-17428792.89693.40
45min1173613-17361392.53694.431.9493.1995.101.94
2179191-17919195.50996.18
3181172-18117296.56597.25
4179716-17971695.78996.47
5172820-17282092.11492.76
6176490-17649094.07094.73
60min1174981-17498193.26595.131.7994.0895.951.79
2179673-17967395.76696.59
3182132-18213297.07797.92
4181287-18128796.62797.47
5174525-17452593.02293.82
6178233-17823394.99995.82
极限1175955-17595593.78595.741.7194.7596.721.72
2180858-18085896.39897.39
3183443-18344397.77698.79
4181963-18196396.98797.99
5176151-17615193.88994.84
6179376-17937695.60896.58
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