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%
19.943267873238293251783255143249793252570.33
29.863239373238663239020.02
单位质量响应值RSD%判断
32722.0332850.100.28数据可信
供试品溶液-686292批-pH1.2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%
5min187663-8766345.62643.644.4445.6343.644.44
277311-7731140.23840.24
383955-8395543.69643.70
486053-8605344.78844.79
582208-8220842.78742.79
685885-8588544.70044.70
10min1157306-15730681.87382.012.6381.9582.082.63
2159010-15901082.75982.83
3150119-15011978.13278.20
4162809-16280984.73784.81
5158294-15829482.38782.46
6157846-15784682.15482.23
15min1191255-19125599.54299.701.1699.7599.911.16
2190344-19034499.06899.27
3188014-18801497.85598.06
4192596-192596100.240100.46
5192857-192857100.376100.58
6194339-194339101.147101.36
20min1194391-194391101.174101.401.32101.55101.781.32
2191154-19115499.48999.86
3195318-195318101.657102.02
4193843-193843100.889101.27
5195235-195235101.613101.99
6199043-199043103.595103.98
30min1194199-194199101.074101.311.33101.62101.861.32
2191042-19104299.43199.97
3194827-194827101.401101.94
4193658-193658100.793101.34
5195271-195271101.632102.18
6198953-198953103.548104.10
极限1193483-193483100.702101.051.33101.42101.761.33
2190589-19058999.19599.90
3194592-194592101.279101.98
4193196-193196100.552101.27
5194611-194611101.289102.00
6198472-198472103.298104.02
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%
19.943235383237503232683234873237163235520.07
29.863226883226763226820.01
单位质量响应值RSD%判断
32550.5032726.370.39数据可信
供试品溶液-321605批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min181524-8152442.62339.6819.8742.6239.6819.86
245342-4534223.70623.71
382536-8253643.15243.15
478996-7899641.30141.30
584465-8446544.16044.16
682528-8252843.14843.15
10min1145089-14508975.85677.147.3075.9377.207.31
2126925-12692566.35966.40
3154800-15480080.93381.00
4153694-15369480.35580.42
5154761-15476180.91380.99
6149947-14994778.39678.47
15min1186739-18673997.63198.062.9197.8398.252.93
2177712-17771292.91293.06
3194097-194097101.478101.69
4189267-18926798.95399.16
5189886-18988699.27799.49
6187604-18760498.08498.29
20min1190673-19067399.688100.952.02100.05101.312.04
2187239-18723997.89398.20
3198156-198156103.601103.98
4196048-196048102.498102.87
5192384-192384100.583100.96
6194042-194042101.450101.82
30min1190556-19055699.627100.862.09100.15101.382.11
2186783-18678397.65498.12
3198080-198080103.561104.11
4195745-195745102.340102.88
5191867-191867100.312100.85
6194403-194403101.638102.17
极限1189998-18999899.335100.542.05100.03101.232.06
2186240-18624097.37198.00
3197295-197295103.150103.87
4195290-195290102.102102.81
5191778-191778100.266100.97
6193211-193211101.015101.72
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%
19.943222673225323221853224083222213223230.05
29.863225623226323225970.02
单位质量响应值RSD%判断
32426.8632717.750.64数据可信
供试品溶液-716277批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180887-8088742.37643.066.4742.3843.066.47
292274-9227448.34248.34
378309-7830941.02541.03
482948-8294843.45643.46
581123-8112342.50042.50
677600-7760040.65440.65
10min1153567-15356780.45279.874.2080.5279.944.20
2164640-16464086.25386.33
3150750-15075078.97779.04
4149242-14924278.18778.26
5146550-14655076.77676.85
6149931-14993178.54878.62
15min1188515-18851598.76199.702.0998.9799.912.09
2197744-197744103.596103.82
3189798-18979899.43399.63
4188194-18819498.59398.80
5186465-18646597.68797.89
6191183-191183100.159100.36
20min1193774-193774101.516102.780.97101.89103.150.97
2198559-198559104.023104.42
3197527-197527103.483103.85
4195003-195003102.160102.53
5194870-194870102.091102.45
6197366-197366103.398103.76
30min1193333-193333101.285102.550.93101.82103.100.93
2197802-197802103.627104.20
3197410-197410103.421103.96
4194667-194667101.984102.52
5194570-194570101.933102.47
6196733-196733103.067103.60
极限1193385-193385101.313102.300.94102.02103.010.94
2197381-197381103.406104.15
3196795-196795103.099103.81
4194225-194225101.753102.46
5193342-193342101.290101.99
6196495-196495102.942103.65
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%
19.943231563240353234353238973237363236520.11
29.863221963223803222880.05
单位质量响应值RSD%判断
32560.5632686.410.28数据可信
供试品溶液-716277批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min177420-7742040.49542.587.9840.5042.587.98
285943-8594344.95344.95
385726-8572644.84044.84
485094-8509444.50944.51
569864-6986436.54336.54
684336-8433644.11344.11
10min1154041-15404180.57380.736.2580.6480.806.25
2166054-16605486.85686.93
3158535-15853582.92383.00
4151383-15138379.18279.26
5137517-13751771.93071.99
6158476-15847682.89382.97
15min1185478-18547897.01698.442.8197.2298.642.82
2196260-196260102.656102.88
3190020-19002099.39299.60
4187010-18701097.81898.02
5180497-18049794.41194.59
6189924-18992499.34299.55
20min1193311-193311101.113101.591.02101.48101.961.03
2197328-197328103.215103.61
3195628-195628102.325102.70
4192496-192496100.687101.06
5192240-192240100.553100.89
6194320-194320101.641102.02
30min1192748-192748100.819101.421.04101.35101.961.05
2197207-197207103.151103.71
3195137-195137102.068102.62
4192231-192231100.548101.09
5192014-192014100.435100.94
6194084-194084101.518102.06
极限1191801-191801100.324101.120.92101.02101.830.94
2195908-195908102.472103.21
3194942-194942101.966102.69
4191996-191996100.426101.13
5191794-191794100.320100.99
6193498-193498101.211101.93
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