氢溴酸替格列汀片项目信息
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MAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.572210332204602213812213222209602210310.17
214.622205112209022207060.13
单位质量响应值RSD%判断
15170.2815096.170.35数据可信
供试品溶液-24031301批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1150081-15008157.48851.6917.3157.4951.6917.30
2146545-14654556.13356.13
392927-9292735.59535.60
4148686-14868656.95356.95
5121446-12144646.51946.52
6149966-14996657.44457.44
10min1247526-24752694.81388.2011.7294.9188.2811.73
2242519-24251992.89592.99
3181857-18185769.65969.72
4247124-24712494.65994.75
5214479-21447982.15582.23
6247994-24799494.99395.09
15min1271154-271154103.864100.985.01104.12101.215.03
2268646-268646102.903103.15
3238005-23800591.16691.34
4273020-273020104.579104.83
5261189-261189100.047100.26
6269725-269725103.317103.57
20min1269246-269246103.133102.961.01103.56103.361.04
2269185-269185103.110103.53
3264289-264289101.234101.56
4272711-272711104.460104.89
5268144-268144102.711103.09
6269198-269198103.115103.54
30min1270102-270102103.461102.840.91104.06103.410.94
2268414-268414102.814103.41
3264862-264862101.454101.95
4271744-271744104.090104.69
5266808-266808102.199102.75
6268897-268897102.999103.60
45min1269596-269596103.267102.630.66104.04103.380.69
2267832-267832102.591103.35
3265221-265221101.591102.26
4270089-270089103.456104.23
5267458-267458102.448103.17
6267449-267449102.445103.21
60min1269339-269339103.169102.670.84104.11103.590.88
2267497-267497102.463103.40
3264354-264354101.259102.09
4271143-271143103.860104.81
5267716-267716102.547103.44
6268194-268194102.730103.67
极限1269320-269320103.161102.691.02104.28103.781.03
2266944-266944102.251103.36
3263552-263552100.952101.96
4271023-271023103.814104.93
5270191-270191103.495104.56
6267532-267532102.477103.59
氢溴酸替格列汀片项目信息
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MAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.574440324436744397294436444434944429150.41
214.624423814409674416740.23
单位质量响应值RSD%判断
30399.1130210.260.45数据可信
供试品溶液-24031302批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1187406-18740635.84737.0820.5635.8537.0820.55
2211451-21145140.44740.45
3225959-22595943.22243.22
4116566-11656622.29722.30
5211113-21111340.38240.38
6210759-21075940.31440.31
10min1377338-37733872.17873.1616.6072.2473.2216.60
2414280-41428079.24479.31
3425348-42534881.36181.43
4257154-25715449.18949.23
5412277-41227778.86178.93
6408397-40839778.11978.19
15min1491075-49107593.93393.2512.8794.1193.4412.88
2520219-52021999.50899.71
3521582-52158299.76999.98
4361560-36156069.16069.28
5514474-51447498.40998.61
6516248-51624898.74898.95
20min1520722-52072299.60498.387.6199.9498.727.64
2534134-534134102.170102.54
3533721-533721102.091102.46
4435196-43519683.24583.48
5533915-533915102.128102.49
6528263-528263101.047101.41
30min1523659-523659100.166101.031.43100.67101.531.48
2535518-535518102.434102.97
3532581-532581101.873102.42
4515530-51553098.61198.98
5533514-533514102.051102.58
6528130-528130101.021101.55
45min1521802-52180299.811101.131.00100.48101.801.03
2535018-535018102.339103.05
3532405-532405101.839102.55
4524260-524260100.281100.82
5532140-532140101.788102.49
6526566-526566100.722101.42
60min1518248-51824899.131100.981.0699.97101.821.09
2533472-533472102.043102.92
3531573-531573101.680102.56
4525377-525377100.495101.20
5531390-531390101.645102.52
6527438-527438100.889101.76
极限1521309-52130999.717100.680.99100.72101.691.04
2531926-531926101.747102.79
3530188-530188101.415102.47
4518963-51896399.268100.14
5529309-529309101.247102.29
6526504-526504100.710101.75
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