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%
19.863168633161693161623167643163573164630.11
29.923160243162953161600.07
单位质量响应值RSD%判断
32095.6431870.970.50数据可信
加速6月-供试品溶液-2023092121批-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1191206-19120651.00885.3519.9951.0185.3519.99
2364305-36430597.18597.18
3346872-34687292.53492.53
4333236-33323688.89788.90
5338882-33888290.40390.40
6345173-34517392.08192.08
10min1367353-36735397.99899.151.5498.0899.291.55
2374768-37476899.976100.14
3364215-36421597.16197.31
4377887-377887100.808100.96
5368566-36856698.32198.47
6377225-377225100.631100.78
15min1371656-37165699.14699.241.3899.3999.541.38
2372647-37264799.41099.74
3364128-36412897.13897.45
4378199-378199100.891101.21
5368862-36886298.40098.71
6376477-376477100.432100.75
20min1370394-37039498.80999.181.4399.2299.651.43
2373162-37316299.547100.04
3363641-36364197.00897.49
4378295-378295100.917101.40
5368994-36899498.43698.91
6376261-376261100.374100.86
30min1369645-36964598.60998.921.4499.1999.561.44
2371368-37136899.06999.73
3362907-36290796.81297.45
4378246-378246100.904101.56
5368053-36805398.18598.83
6374548-37454899.917100.57
极限1369057-36905798.45298.921.3899.2099.721.38
2372351-37235199.331100.16
3363310-36331096.91997.72
4377190-377190100.622101.44
5367914-36791498.14798.95
6375091-375091100.062100.88
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)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%
19.863196523199893198723198233193723197420.08
29.923162723164563163640.05
单位质量响应值RSD%判断
32428.1931891.531.18数据可信
加速6月-供试品溶液-2023092221批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1279977-27997774.28388.619.2874.2888.619.28
2357809-35780994.93394.93
3348351-34835192.42492.42
4321097-32109785.19385.19
5332091-33209188.11088.11
6364518-36451896.71396.71
10min1355908-35590894.42996.601.7494.5596.751.75
2368101-36810197.66497.82
3371942-37194298.68398.84
4363827-36382796.53096.67
5357457-35745794.84094.99
6367408-36740897.48097.64
15min1366042-36604297.11897.331.0397.4097.641.03
2369207-36920797.95798.28
3372279-37227998.77299.09
4365549-36554996.98797.29
5361087-36108795.80396.11
6366962-36696297.36297.69
20min1367200-36720097.42597.270.8597.8797.740.85
2369347-36934797.99498.48
3370679-37067998.34898.83
4365021-36502196.84797.31
5362323-36232396.13196.60
6365060-36506096.85797.34
30min1372830-37283098.91997.840.9599.5298.470.94
2370236-37023698.23098.88
3372288-37228898.77599.42
4366779-36677997.31397.94
5365507-36550796.97697.60
6364851-36485196.80297.45
极限1377198-377198100.07798.541.04100.8599.341.02
2373608-37360899.12599.94
3370544-37054498.31299.12
4369395-36939598.00798.80
5371793-37179398.64399.43
6365873-36587397.07397.88
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)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%
19.863154213153383151123149623143723150410.14
29.923154593158653156620.10
单位质量响应值RSD%判断
31951.4231820.770.29数据可信
加速6月-供试品溶液-2023092321批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1301822-30182280.76188.215.1680.7688.215.16
2347453-34745392.97192.97
3346287-34628792.65992.66
4321319-32131985.97885.98
5329313-32931388.11788.12
6331691-33169188.75388.75
10min1376027-376027100.61799.031.25100.7599.171.24
2373024-37302499.81399.97
3369028-36902898.74498.90
4369967-36996798.99599.14
5362298-36229896.94397.09
6370145-37014599.04399.19
15min1376604-376604100.77199.201.26101.0799.521.26
2374642-374642100.246100.57
3368035-36803598.47898.80
4372277-37227799.61399.92
5363934-36393497.38197.69
6368947-36894798.72299.04
20min1376468-376468100.73599.341.21101.2199.821.21
2375245-375245100.408100.90
3368873-36887398.70399.19
4373042-37304299.818100.29
5364583-36458397.55598.03
6369248-36924898.80399.28
30min1375439-375439100.45999.241.18101.1099.881.18
2375274-375274100.415101.07
3368140-36814098.50699.15
4373246-37324699.873100.51
5364908-36490897.64298.27
6368256-36825698.53799.18
极限1375200-375200100.39599.571.10101.20100.381.10
2378152-378152101.185102.01
3369290-36929098.81499.63
4373131-37313199.842100.65
5367503-36750398.33699.13
6369429-36942998.85199.66
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%
19.863153463148023153333152133150133151410.08
29.923139433141483140460.05
单位质量响应值RSD%判断
31961.5631657.860.68数据可信
加速6月-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%
5min1151701-15170140.69037.3812.1340.6937.3812.13
2137470-13747036.87336.87
3141804-14180438.03638.04
4150298-15029840.31440.31
5106653-10665328.60728.61
6148122-14812239.73039.73
10min1298739-29873980.13074.515.8080.2074.575.80
2253488-25348867.99268.05
3283307-28330775.99076.05
4289052-28905277.53177.60
5274107-27410773.52373.57
6267949-26794971.87171.94
15min1364581-36458197.79094.493.3397.9994.683.33
2331602-33160288.94489.12
3354721-35472195.14595.34
4356741-35674195.68795.88
5359449-35944996.41496.58
6346668-34666892.98593.17
20min1376037-376037100.863100.080.70101.23100.420.71
2370057-37005799.25999.58
3376021-376021100.859101.21
4373684-373684100.232100.59
5370733-37073399.44099.77
6372101-37210199.807100.15
30min1373662-373662100.22699.650.76100.76100.160.76
2371616-37161699.677100.17
3374856-374856100.546101.06
4370762-37076299.44899.97
5371455-37145599.634100.13
6366768-36676898.37798.88
极限1374109-374109100.34699.680.51101.05100.360.53
2370314-37031499.32899.98
3373837-373837100.273100.96
4371454-37145499.634100.32
5369765-36976599.18199.84
6370334-37033499.333100.00
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