精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.293251523255613264553262853264883259880.19
210.343236573208193222380.63
单位质量响应值RSD%判断
31680.0831164.221.17数据可信
长期12月-供试品溶液-2023091921批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109551-10955159.49668.0211.7359.5068.0211.73
2123832-12383267.25267.25
3147168-14716879.92679.93
4109683-10968359.56859.57
5125673-12567368.25268.25
6135578-13557873.63173.63
10min1187442-187442101.79899.851.94101.9099.961.94
2178544-17854496.96697.08
3185551-185551100.771100.90
4185643-185643100.821100.92
5180262-18026297.89998.01
6185672-185672100.837100.96
15min1184583-184583100.24699.820.99100.51100.100.99
2181928-18192898.80499.08
3183101-18310199.44199.74
4184229-184229100.053100.32
5182201-18220198.95299.23
6186792-186792101.445101.74
20min1185942-185942100.984100.591.84101.42101.041.83
2182694-18269499.22099.66
3183389-18338999.597100.06
4191101-191101103.786104.22
5181796-18179698.73299.17
6186410-186410101.238101.70
30min1185610-185610100.804100.501.42101.41101.121.41
2183769-18376999.804100.41
3183207-18320799.498100.13
4189408-189408102.866103.47
5182120-18212098.90899.51
6186208-186208101.128101.76
极限1185553-185553100.773100.561.18101.54101.341.17
2184498-184498100.200100.97
3183032-18303299.403100.20
4187235-187235101.686102.46
5182628-18262899.18499.96
6187973-187973102.087102.88
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.293238513238663239373239923233463237980.09
210.343235753218003226880.39
单位质量响应值RSD%判断
31467.2531207.740.59数据可信
长期12月-供试品溶液-2023092021批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111948-11194860.95984.4717.0960.9684.4817.09
2172910-17291094.15594.16
3174403-17440394.96894.97
4133285-13328572.57872.58
5175919-17591995.79495.79
6162315-16231588.38688.39
10min1171623-17162393.45497.832.6993.5697.972.71
2182345-18234599.29399.45
3184345-184345100.382100.54
4177897-17789796.87196.99
5183722-183722100.043100.20
6177968-17796896.90997.06
15min1179881-17988197.95199.591.2798.2199.901.29
2181521-18152198.84499.17
3185521-185521101.022101.35
4183014-18301499.65799.94
5185659-185659101.097101.42
6181756-18175698.97299.28
20min1182029-18202999.12199.850.7799.54100.320.78
2182346-18234699.29399.78
3185549-185549101.038101.53
4184344-184344100.381100.83
5183680-183680100.020100.51
6182294-18229499.26599.74
30min1183802-183802100.086100.080.78100.67100.720.77
2181855-18185599.02699.68
3185660-185660101.098101.76
4185182-185182100.838101.45
5183312-18331299.819100.48
6182941-18294199.617100.26
极限1184294-184294100.354100.300.77101.11101.100.76
2182181-18218199.204100.02
3185634-185634101.084101.91
4185886-185886101.221102.00
5183235-18323599.777100.61
6183910-183910100.145100.95
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.293228333226843222723220013217693223120.14
210.343232253231713231980.02
单位质量响应值RSD%判断
31322.8431257.060.15数据可信
长期12月-供试品溶液-2023092022批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1153612-15361283.77386.114.1983.7786.114.19
2153027-15302783.45383.45
3167707-16770791.45991.46
4156392-15639285.28985.29
5164573-16457389.75089.75
6152118-15211882.95882.96
10min1186677-186677101.805101.282.98101.94101.432.98
2175719-17571995.82995.97
3190139-190139103.693103.85
4183287-18328799.956100.10
5190127-190127103.686103.84
6188365-188365102.725102.86
15min1187717-187717102.372102.232.20102.68102.542.20
2180839-18083998.62198.92
3191103-191103104.218104.54
4184455-184455100.593100.90
5191309-191309104.331104.65
6189322-189322103.247103.56
20min1187750-187750102.390102.491.78102.87102.981.78
2183519-183519100.082100.55
3191182-191182104.261104.76
4184359-184359100.540101.02
5190982-190982104.152104.65
6189844-189844103.532104.01
30min1188431-188431102.761102.711.44103.41103.361.44
2186522-186522101.720102.35
3190808-190808104.057104.73
4183885-183885100.282100.93
5190749-190749104.025104.70
6189590-189590103.393104.05
极限1188081-188081102.570103.071.31103.39103.901.30
2189284-189284103.226104.03
3190401-190401103.835104.68
4184515-184515100.626101.44
5191235-191235104.290105.13
6190496-190496103.887104.71
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.293243713244343244913242363242493243560.04
210.343220833218973219900.05
单位质量响应值RSD%判断
31521.4831140.230.87数据可信
长期12月-供试品溶液-716277批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190882-9088249.50049.2312.0349.5049.2312.03
268712-6871237.42537.42
395799-9579952.17852.18
494732-9473251.59751.60
594205-9420551.31051.31
697969-9796953.36053.36
10min1161702-16170288.07286.304.5888.1586.384.59
2143805-14380578.32578.39
3162809-16280988.67588.76
4161101-16110187.74587.83
5159474-15947486.85986.94
6161767-16176788.10888.20
15min1186431-186431101.541101.561.98101.77101.781.98
2183818-183818100.118100.31
3192568-192568104.884105.12
4184382-184382100.425100.66
5188833-188833102.850103.08
6182737-18273799.52999.77
20min1188871-188871102.870102.192.19103.27102.582.19
2185751-185751101.171101.53
3193788-193788105.548105.96
4183831-183831100.125100.52
5190241-190241103.616104.02
6183212-18321299.788100.19
30min1188331-188331102.576102.082.05103.15102.642.05
2185268-185268100.908101.44
3192947-192947105.090105.68
4184159-184159100.304100.87
5190496-190496103.755104.33
6183281-18328199.826100.39
极限1188549-188549102.695101.852.08103.44102.592.08
2185063-185063100.796101.49
3192419-192419104.803105.56
4183723-183723100.066100.80
5189879-189879103.419104.17
6182408-18240899.350100.08
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