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)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%
19.943141993151073141653142473147433144920.14
29.863136073152483144280.37
单位质量响应值RSD%判断
31639.0331889.250.56数据可信
供试品溶液-317273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%
5min1130314-13031435.00433.1221.7135.0033.1221.71
2142777-14277738.35138.35
3139909-13990937.58137.58
470140-7014018.84018.84
5128608-12860834.54534.55
6128117-12811734.41334.41
10min1254540-25454068.37266.2114.4268.4366.2614.42
2282686-28268675.93276.00
3264049-26404970.92670.99
4178998-17899848.08048.11
5244133-24413365.57665.63
6254479-25447968.35568.41
15min1333908-33390889.69187.908.2689.8688.078.28
2354666-35466695.26695.46
3342515-34251592.00392.18
4276092-27609274.16174.27
5327901-32790188.07788.24
6328422-32842288.21788.39
20min1374255-374255100.52899.353.29100.8599.663.32
2380942-380942102.324102.67
3370552-37055299.53499.87
4346165-34616592.98393.22
5372143-37214399.961100.27
6375178-375178100.776101.09
30min1376619-376619101.163101.921.29101.65102.391.28
2380849-380849102.299102.82
3371142-37114299.692100.19
4380428-380428102.186102.58
5382681-382681102.792103.27
6384809-384809103.363103.85
极限1376209-376209101.053101.761.25101.71102.401.23
2379793-379793102.016102.71
3370655-37065599.561100.23
4380858-380858102.302102.86
5381819-381819102.560103.21
6383599-383599103.038103.70
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)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%
19.943140903128393145853140613127523136650.27
29.863139273142583140920.08
单位质量响应值RSD%判断
31555.8431855.170.67数据可信
供试品溶液-320179批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1122531-12253132.97432.897.5432.9732.897.54
2137969-13796937.12837.13
3112826-11282630.36230.36
4113412-11341230.52030.52
5125246-12524633.70533.70
6121315-12131532.64732.65
10min1255314-25531468.70767.793.4768.7667.843.46
2258416-25841669.54269.60
3255354-25535468.71868.77
4248631-24863166.90866.96
5235610-23561063.40463.46
6258070-25807069.44969.50
15min1333372-33337289.71390.792.5889.8890.962.58
2346982-34698293.37593.55
3341579-34157991.92192.09
4337264-33726490.76090.92
5322413-32241386.76486.93
6342680-34268092.21892.39
20min1371953-371953100.095101.951.54100.41102.261.54
2387106-387106104.173104.51
3375281-375281100.991101.31
4383070-383070103.087103.40
5374614-374614100.811101.12
6380966-380966102.521102.84
30min1376936-376936101.436103.691.56101.92104.181.55
2389505-389505104.819105.33
3378858-378858101.954102.44
4391670-391670105.401105.89
5387473-387473104.272104.75
6387346-387346104.238104.73
极限1376164-376164101.229103.541.52101.88104.201.51
2388694-388694104.600105.28
3379268-379268102.064102.72
4391350-391350105.315105.98
5386612-386612104.040104.69
6386365-386365103.974104.64
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)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%
19.943153033152993151073145363149803150450.11
29.863144343137273140800.16
单位质量响应值RSD%判断
31694.6731853.960.36数据可信
供试品溶液-715967批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1127775-12777534.31033.8411.6234.3133.8411.62
2141387-14138737.96537.97
3133787-13378735.92535.92
4128793-12879334.58434.58
598387-9838726.41926.42
6125975-12597533.82733.83
10min1238391-23839164.01365.132.0064.0765.182.00
2245027-24502765.79565.86
3250007-25000767.13267.19
4244227-24422765.58065.64
5240647-24064764.61964.66
6236932-23693263.62163.68
15min1327045-32704587.81889.641.9487.9889.811.94
2333339-33333989.50889.68
3336443-33644390.34290.51
4333257-33325789.48689.65
5344905-34490592.61492.77
6328040-32804088.08588.25
20min1380225-380225102.098101.540.90102.41101.860.90
2378008-378008101.503101.83
3377983-377983101.496101.82
4374031-374031100.435100.75
5383395-383395102.949103.26
6375209-375209100.751101.06
30min1391964-391964105.250103.581.64105.73104.061.64
2392228-392228105.321105.81
3379664-379664101.948102.44
4380640-380640102.210102.69
5390183-390183104.772105.25
6379716-379716101.962102.44
极限1389572-389572104.608103.271.48105.26103.931.48
2391179-391179105.040105.71
3379808-379808101.986102.65
4379102-379102101.797102.45
5388392-388392104.291104.94
6379497-379497101.903102.55
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)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%
19.943124483131293129333125133123493126740.11
29.863128653125393127020.08
单位质量响应值RSD%判断
31456.1431714.200.58数据可信
供试品溶液-715967批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1131355-13135535.48335.315.0135.4835.315.00
2136222-13622236.79836.80
3140042-14004237.83037.83
4128589-12858934.73634.74
5122851-12285133.18633.19
6125270-12527033.83933.84
10min1268154-26815472.43768.883.5772.5068.943.57
2257918-25791869.67269.73
3258166-25816669.73969.80
4255912-25591269.13069.19
5242028-24202865.37965.43
6247776-24777666.93266.99
15min1343849-34384992.88491.882.5693.0692.052.56
2339450-33945091.69691.87
3338239-33823991.36991.55
4346817-34681793.68693.86
5324285-32428587.60087.76
6348182-34818294.05594.22
20min1379798-379798102.595102.401.17102.93102.731.18
2380618-380618102.817103.15
3381510-381510103.058103.39
4379487-379487102.511102.84
5370375-370375100.050100.36
6382723-382723103.385103.71
30min1382126-382126103.224103.370.72103.73103.870.72
2384631-384631103.901104.40
3386440-386440104.390104.89
4380846-380846102.878103.38
5378732-378732102.307102.78
6383257-383257103.530104.03
极限1381997-381997103.189102.930.68103.87103.600.69
2382935-382935103.443104.12
3382667-382667103.370104.05
4379291-379291102.458103.13
5376551-376551101.718102.37
6382708-382708103.381104.05
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