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%
110.783403493403813401533395823408363402600.14
210.803390273404633397450.30
单位质量响应值RSD%判断
31564.0131457.870.24数据可信
长期24月-供试品溶液-2023091921批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108416-10841629.35534.0017.9229.3634.0017.91
2162962-16296244.12444.12
398129-9812926.57026.57
4123544-12354433.45133.45
5134528-13452836.42536.43
6125844-12584434.07434.07
10min1167239-16723945.28247.384.3745.3347.444.38
2181480-18148049.13849.21
3164145-16414544.44544.49
4175876-17587647.62147.68
5182573-18257349.43449.49
6178600-17860048.35848.42
15min1175283-17528347.46048.681.9547.5848.821.97
2181911-18191149.25549.41
3175756-17575647.58847.71
4180536-18053648.88349.02
5183900-18390049.79349.94
6181308-18130849.09249.23
20min1176694-17669447.84248.901.4948.0549.121.50
2181222-18122249.06849.31
3178062-17806248.21348.41
4182106-18210649.30849.52
5183785-18378549.76249.99
6181778-18177849.21949.44
30min1178418-17841848.30949.161.2448.5949.461.25
2181411-18141149.12049.44
3179781-17978148.67848.96
4181949-18194949.26549.56
5183418-18341849.66349.97
6184490-18449049.95350.25
极限1179693-17969348.65449.100.8149.0249.480.83
2181125-18112549.04249.44
3179676-17967648.65049.01
4182672-18267249.46149.84
5183126-18312649.58449.98
6181688-18168849.19549.58
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%
110.783390933385873392263392143391403390520.08
210.803391703390913391300.02
单位质量响应值RSD%判断
31451.9531400.930.12数据可信
长期24月-供试品溶液-2023092021批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128725-12872534.94841.6310.5034.9541.6310.49
2140627-14062738.17938.18
3164475-16447544.65444.65
4167500-16750045.47545.47
5167439-16743945.45845.46
6151356-15135641.09241.09
10min1182083-18208349.43449.990.6749.4950.060.67
2185621-18562150.39450.46
3184559-18455950.10650.18
4183987-18398749.95150.03
5183632-18363249.85449.93
6184869-18486950.19050.26
15min1185089-18508950.25050.270.4550.3950.420.44
2186199-18619950.55150.70
3185217-18521750.28550.44
4185130-18513050.26150.42
5183744-18374449.88550.04
6185646-18564650.40150.55
20min1185860-18586050.45950.300.5750.6850.530.56
2186405-18640550.60750.84
3184969-18496950.21750.46
4185300-18530050.30750.55
5183349-18334949.77850.02
6185676-18567650.40950.65
30min1184450-18445050.07750.210.5950.3950.530.59
2186209-18620950.55450.87
3184839-18483950.18250.51
4185212-18521250.28350.61
5183167-18316749.72850.05
6185843-18584350.45550.77
极限1185362-18536250.32450.200.5250.7250.600.52
2185666-18566650.40750.81
3184300-18430050.03650.44
4185825-18582550.45050.86
5183292-18329249.76250.17
6184964-18496450.21650.62
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%
110.783392993390543399883395093403703396440.16
210.803386633381563384100.11
单位质量响应值RSD%判断
31506.8631334.260.39数据可信
长期24月-供试品溶液-2023092022批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127673-12767334.66935.389.6334.6735.389.64
2138497-13849737.60837.61
3127242-12724234.55234.55
4133813-13381336.33636.34
5108912-10891229.57429.57
6145583-14558339.53239.53
10min1167396-16739645.45548.385.2745.5148.445.28
2188876-18887651.28851.35
3185684-18568450.42150.48
4177652-17765248.24048.30
5166681-16668145.26145.31
6182773-18277349.63149.70
15min1175651-17565147.69749.772.7347.8349.912.74
2189445-18944551.44351.59
3187396-18739650.88651.03
4182512-18251249.56049.70
5180137-18013748.91549.04
6184489-18448950.09750.25
20min1179432-17943248.72450.111.8248.9450.341.83
2188935-18893551.30451.54
3187370-18737050.87951.11
4184027-18402749.97150.19
5182893-18289349.66349.87
6184647-18464750.14050.37
30min1183037-18303749.70350.371.2250.0050.671.23
2188400-18840051.15951.48
3187852-18785251.01051.32
4185493-18549350.37050.68
5183243-18324349.75950.05
6184838-18483850.19250.51
极限1187288-18728850.85751.002.1651.2351.382.15
2188427-18842751.16651.57
3195441-19544153.07153.47
4186444-18644450.62851.02
5184273-18427350.03850.41
6184920-18492050.21450.61
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%
110.783395203395513388733401063396133395330.13
210.803394433391813393120.06
单位质量响应值RSD%判断
31496.5731417.780.18数据可信
长期24月-供试品溶液-716277批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184900-8490023.02724.546.8023.0324.546.80
297185-9718526.35926.36
398954-9895426.83926.84
486343-8634323.41823.42
589767-8976724.34724.35
685661-8566123.23423.23
10min1157185-15718542.63342.292.7342.6742.332.73
2157130-15713042.61842.66
3162672-16267244.12144.17
4151095-15109540.98141.02
5155746-15574642.24242.28
6151636-15163641.12841.17
15min1182212-18221249.42149.540.9449.5349.650.94
2186106-18610650.47750.59
3181746-18174649.29449.41
4182100-18210049.39049.50
5181584-18158449.25049.36
6182130-18213049.39849.51
20min1182888-18288849.60450.091.3249.8050.291.31
2188570-18857051.14551.34
3182339-18233949.45549.66
4186086-18608650.47150.66
5182903-18290349.60849.80
6185403-18540350.28650.48
30min1182257-18225749.43349.911.2749.7150.191.26
2187202-18720250.77451.06
3181576-18157649.24849.53
4186090-18609050.47350.75
5182268-18226849.43649.71
6184662-18466250.08550.36
极限1182124-18212449.39749.731.3349.7550.091.32
2186648-18664850.62450.99
3180553-18055348.97149.34
4185432-18543250.29450.65
5181301-18130149.17449.53
6184145-18414549.94550.30
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%
110.783391133394673390583391483387373391050.08
210.803396583391843394210.10
单位质量响应值RSD%判断
31456.8631427.870.07数据可信
长期24月-供试品溶液-715967批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169778-16977846.07041.467.1946.0741.467.18
2140307-14030738.07338.07
3159883-15988343.38543.38
4143155-14315538.84638.85
5154318-15431841.87541.87
6149318-14931840.51840.52
10min1299682-29968281.32072.745.9981.4072.815.99
2267757-26775772.65772.72
3261186-26118670.87470.95
4259895-25989570.52370.59
5264532-26453271.78271.85
6255344-25534469.28969.36
15min1368441-36844199.97893.433.72100.1993.623.72
2348038-34803894.44194.63
3339148-33914892.02992.22
4337332-33733291.53691.72
5339628-33962892.15992.35
6333226-33322690.42290.61
20min1375018-375018101.763100.890.71102.14101.230.71
2368052-36805299.872100.21
3371278-371278100.748101.09
4371457-371457100.796101.13
5370405-370405100.511100.85
6374500-374500101.622101.96
30min1373797-373797101.431101.161.07101.98101.681.06
2369030-369030100.138100.65
3373993-373993101.484102.00
4373227-373227101.277101.78
5367845-36784599.816100.33
6378872-378872102.808103.31
极限1372135-372135100.980100.901.14101.70101.581.13
2366818-36681899.537100.21
3372846-372846101.173101.85
4370986-370986100.668101.34
5369049-369049100.143100.82
6379162-379162102.887103.56
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