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DMAD-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(%)95.04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%
114.346548646552466549996554856543636549910.07
214.286549476548766549120.01
单位质量响应值RSD%判断
45675.8045862.180.29数据可信
加速6月-供试品溶液-2025011021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1219521-21952127.83228.958.5227.8328.958.52
2265758-26575833.69433.69
3227233-22723328.81028.81
4213202-21320227.03127.03
5214820-21482027.23627.24
6229423-22942329.08729.09
10min1465237-46523758.98561.413.9759.0361.463.97
2520306-52030665.96766.02
3488671-48867161.95662.00
4474321-47432160.13660.18
5479992-47999260.85560.90
6477633-47763360.55660.60
15min1650047-65004782.41684.212.3482.5684.362.34
2694139-69413988.00688.17
3665464-66546484.37084.52
4658811-65881183.52783.67
5656846-65684683.27883.42
6659911-65991183.66683.82
20min1742416-74241694.12795.391.8794.4195.681.87
2778560-77856098.70999.02
3750754-75075495.18495.48
4754822-75482295.70095.98
5748929-74892994.95295.24
6738958-73895893.68893.98
30min1770282-77028297.66097.771.0598.1098.221.06
2781724-78172499.11099.59
3772414-77241497.93098.38
4764742-76474296.95797.40
5777846-77784698.61999.06
6759930-75993096.34796.79
45min1770069-77006997.63397.681.1298.2398.291.13
2781854-78185499.12799.77
3771026-77102697.75498.37
4763014-76301496.73897.34
5777740-77774098.60599.21
6758948-75894896.22396.83
极限1768662-76866297.45497.501.1098.2298.271.10
2779878-77987898.87699.68
3768956-76895697.49198.27
4761622-76162296.56297.33
5776809-77680998.48799.26
6758099-75809996.11596.88
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DMAD-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(%)95.04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%
114.346543326546366546436522816510306533840.26
214.286515296514776515030.01
单位质量响应值RSD%判断
45563.7445623.460.10数据可信
加速6月-供试品溶液-2025011121批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1239416-23941630.47129.716.8430.4729.716.85
2231087-23108729.41129.41
3236354-23635430.08130.08
4257601-25760132.78532.79
5208878-20887826.58426.58
6227313-22731328.93028.93
10min1487793-48779362.08262.292.0462.1362.342.05
2480984-48098461.21661.26
3483759-48375961.56961.62
4504303-50430364.18364.24
5480575-48057561.16361.21
6499035-49903563.51363.56
15min1659281-65928183.90885.842.1784.0685.992.17
2662095-66209584.26684.42
3666061-66606184.77184.92
4681673-68167386.75886.92
5680016-68001686.54786.69
6697540-69754088.77788.93
20min1741161-74116194.32997.043.0994.6297.333.08
2747357-74735795.11795.41
3747100-74710095.08595.38
4761610-76161096.93197.24
5773302-77330298.41998.71
6804043-804043102.332102.63
30min1761198-76119896.879100.723.3697.33101.183.35
2772523-77252398.32098.77
3777834-77783498.99699.45
4825995-825995105.126105.59
5789930-789930100.536100.99
6821005-821005104.491104.96
45min1759733-75973396.69299.852.6297.31100.482.62
2772953-77295398.37598.99
3777719-77771998.98199.60
4787235-787235100.193100.84
5789185-789185100.441101.06
6820386-820386104.412105.06
极限1758244-75824496.50399.612.6497.28100.412.64
2770391-77039198.04998.83
3776329-77632998.80599.59
4785127-78512799.924100.73
5787048-787048100.169100.96
6818971-818971104.232105.05
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DMAD-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(%)95.04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%
114.346541626543736544546544666543136543540.02
214.286534166532796533480.02
单位质量响应值RSD%判断
45631.3845752.660.19数据可信
加速6月-供试品溶液-2025011221批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1223109-22310928.33427.907.1628.3327.907.16
2202015-20201525.65525.66
3205819-20581926.13826.14
4246321-24632131.28231.28
5218248-21824827.71727.72
6222717-22271728.28528.28
10min1471784-47178459.91560.103.8159.9660.153.81
2442053-44205356.14056.18
3468962-46896259.55759.60
4496163-49616363.01163.06
5480265-48026560.99261.04
6480380-48038061.00761.05
15min1650643-65064382.63083.582.4782.7883.732.47
2631282-63128280.17180.31
3660540-66054083.88784.03
4679967-67996786.35486.51
5661535-66153584.01384.16
6664858-66485884.43584.58
20min1747856-74785694.97695.562.2595.2695.842.26
2721927-72192791.68391.95
3759375-75937596.43996.72
4769946-76994697.78198.08
5751933-75193395.49495.78
6763580-76358096.97397.26
30min1764973-76497397.15097.781.0397.5998.231.03
2763623-76362396.97897.40
3771457-77145797.97398.42
4781041-78104199.19099.65
5761686-76168696.73297.18
6777054-77705498.68499.14
45min1763361-76336196.94597.701.0497.5598.311.04
2763598-76359896.97597.56
3769618-76961897.74098.35
4780261-78026199.09199.72
5761549-76154996.71597.32
6777483-77748398.73899.35
极限1761387-76138796.69497.441.0897.4698.211.09
2761974-76197496.76997.51
3767534-76753497.47598.24
4779394-77939498.98199.78
5758554-75855496.33497.10
6774631-77463198.37699.16
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DMAD-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(%)95.04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%
114.346520626530336516356521016512456520150.11
214.286533446536186534810.03
单位质量响应值RSD%判断
45468.2745761.970.46数据可信
加速6月-供试品溶液-H043批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1268926-26892634.21132.365.9734.2132.365.97
2265199-26519933.73733.74
3248897-24889731.66331.66
4226929-22692928.86828.87
5260425-26042533.12933.13
6255886-25588632.55232.55
10min1580630-58063073.86473.672.3873.9273.722.38
2591273-59127375.21775.27
3583727-58372774.25774.31
4552131-55213170.23870.29
5581398-58139873.96174.02
6585527-58552774.48674.54
15min1784842-78484299.84298.991.71100.0299.161.71
2780285-78028599.26299.44
3790378-790378100.546100.72
4752878-75287895.77695.94
5776160-77616098.73798.92
6784266-78426699.76999.95
20min1795962-795962101.256101.800.95101.60102.140.94
2800178-800178101.793102.14
3807002-807002102.661103.01
4810097-810097103.055103.38
5789148-789148100.390100.73
6799012-799012101.644101.99
30min1795318-795318101.175101.500.70101.69102.010.70
2798836-798836101.622102.14
3806476-806476102.594103.11
4799781-799781101.742102.24
5789505-789505100.435100.95
6797403-797403101.440101.95
45min1791215-791215100.653101.530.98101.34102.220.97
2800888-800888101.883102.57
3804651-804651102.362103.05
4798851-798851101.624102.29
5786716-786716100.080100.76
6806564-806564102.605103.29
极限1789993-789993100.497101.020.73101.35101.870.73
2796733-796733101.355102.21
3800883-800883101.882102.74
4797498-797498101.452102.29
5784854-78485499.843100.69
6794473-794473101.067101.92
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