美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23204539
204539+0
204615
204615+0
204672
204672+0
204359
204359+0
204492
204492+0
2045350.06
219.28206268
206268+0
203749
203749+0
2050080.87
单位质量响应值RSD%判断
10636.2510633.200.03数据可信
长期12月-供试品溶液-2023082421批-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192869.8
86137+8416*0.8
-92869.845.76047.562.9545.7647.562.95
293740.8
88312+6786*0.8
-93740.846.19046.19
396557.2
91266+6614*0.8
-96557.247.57747.58
4100531.4
95025+6883*0.8
-100531.449.53649.54
597227
91723+6880*0.8
-9722747.90747.91
698181.2
92646+6919*0.8
-98181.248.37848.38
10min1143835.4
135369+10583*0.8
-143835.470.87373.042.1171.3873.562.11
2148878.6
139789+11362*0.8
-148878.673.35873.87
3147727.6
138706+11277*0.8
-147727.672.79173.32
4152085.8
142653+11791*0.8
-152085.874.93875.49
5145815.6
136834+11227*0.8
-145815.671.84972.38
6151022.2
141743+11599*0.8
-151022.274.41474.95
15min1166865.4
155639+14033*0.8
-166865.482.22183.931.5183.5285.271.51
2169273.6
157516+14697*0.8
-169273.683.40784.74
3173056
161036+15025*0.8
-17305685.27186.61
4172654.4
160536+15148*0.8
-172654.485.07386.46
5168254.2
156555+14624*0.8
-168254.282.90584.24
6171894.8
159634+15326*0.8
-171894.884.69986.06
20min1179470.8
165798+17091*0.8
-179470.888.43289.052.1390.6491.322.10
2173742.4
159516+17783*0.8
-173742.485.60987.86
3182810.8
168318+18116*0.8
-182810.890.07892.36
4183377.4
168627+18438*0.8
-183377.490.35792.69
5184230.4
169564+18333*0.8
-184230.490.77793.03
6180698.8
166362+17921*0.8
-180698.889.03791.34
30min1186420.4
163294+28908*0.8
-186420.491.85692.451.6195.0595.711.55
2188977
164561+30520*0.8
-18897793.11696.32
3191749
167141+30760*0.8
-19174994.48297.77
4185670
161686+29980*0.8
-18567091.48694.82
5189534.8
165190+30431*0.8
-189534.893.39196.65
6183403
159771+29540*0.8
-18340390.36993.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1186054.8
156466+36986*0.8
-186054.891.67692.581.9795.8996.881.91
2184231.8
153715+38146*0.8
-184231.890.77895.02
3190451.2
159012+39299*0.8
-190451.293.84298.18
4188714.2
157563+38939*0.8
-188714.292.98697.34
5193541.4
161887+39568*0.8
-193541.495.36599.66
6184395.8
153891+38131*0.8
-184395.890.85995.16
60min1180087
140283+49755*0.8
-18008788.73690.611.5493.9795.931.50
2185537.2
143642+52369*0.8
-185537.291.42196.67
3185785
143641+52680*0.8
-18578591.54396.92
4187417.6
144772+53307*0.8
-187417.692.34897.73
5183120.6
141847+51592*0.8
-183120.690.23095.59
6181382
140186+51495*0.8
-18138289.37494.68
极限1180634
136702+54915*0.8
-18063489.00589.981.7995.2296.311.69
2186954
140998+57445*0.8
-18695492.11998.38
3185941.6
139308+58292*0.8
-185941.691.62098.02
4182586.8
137030+56946*0.8
-182586.889.96796.38
5181137.2
136258+56099*0.8
-181137.289.25395.61
6178444.6
134411+55042*0.8
-178444.687.92694.23
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23204131
204131+0
204474
204474+0
204413
204413+0
204262
204262+0
204116
204116+0
2042790.08
219.28203723
203723+0
204032
204032+0
2038780.11
单位质量响应值RSD%判断
10622.9310574.590.33数据可信
长期12月-供试品溶液-2023082421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194439.6
88882+6947*0.8
-94439.646.69246.170.8646.6946.170.86
292521.6
87108+6767*0.8
-92521.645.74445.74
394093.4
88595+6873*0.8
-94093.446.52146.52
493107.4
87565+6928*0.8
-93107.446.03346.03
593608.8
87808+7251*0.8
-93608.846.28146.28
692550.4
86932+7023*0.8
-92550.445.75845.76
10min1143580.4
134338+11553*0.8
-143580.470.98872.491.9071.5173.001.88
2148053
138305+12185*0.8
-14805373.19973.71
3143928.6
134483+11807*0.8
-143928.671.16071.68
4145296.2
135621+12094*0.8
-145296.271.83672.35
5150567
140751+12270*0.8
-15056774.44274.96
6148249.8
138573+12096*0.8
-148249.873.29673.80
15min1170403
158023+15475*0.8
-17040384.24984.351.6485.5685.661.63
2170780.2
158041+15924*0.8
-170780.284.43685.76
3170167.8
157411+15946*0.8
-170167.884.13385.44
4166248.8
153680+15711*0.8
-166248.882.19583.50
5175047.8
161955+16366*0.8
-175047.886.54687.89
6170938
158142+15995*0.8
-17093884.51485.84
20min1177357.4
162887+18088*0.8
-177357.487.68890.283.0789.9392.533.02
2185230.8
169610+19526*0.8
-185230.891.58093.84
3177299.8
162427+18591*0.8
-177299.887.65989.90
4181134
165706+19285*0.8
-18113489.55591.78
5192188
175896+20365*0.8
-19218895.02097.32
6182377
166901+19345*0.8
-18237790.16992.43
30min1183062
159362+29625*0.8
-18306290.50893.272.5093.7396.532.44
2187218.4
162592+30783*0.8
-187218.492.56395.84
3183963.2
159876+30109*0.8
-183963.290.95394.17
4190999.8
165991+31261*0.8
-190999.894.43297.65
5191564.2
166445+31399*0.8
-191564.294.71298.07
6195081.4
169439+32053*0.8
-195081.496.45099.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1189153.6
158108+38807*0.8
-189153.693.52093.910.9097.7498.200.90
2188683.8
157103+39476*0.8
-188683.893.28797.59
3189719.2
158376+39179*0.8
-189719.293.79998.03
4188493
157185+39135*0.8
-18849393.19397.46
5190537.4
158811+39658*0.8
-190537.494.20498.61
6193075
160823+40315*0.8
-19307595.45899.79
60min1179954.6
139061+51117*0.8
-179954.688.97291.602.2394.2396.932.15
2183451.4
141513+52423*0.8
-183451.490.70096.04
3189348.8
146196+53941*0.8
-189348.893.61698.89
4183571.2
141656+52394*0.8
-183571.290.76096.06
5190982.2
147635+54184*0.8
-190982.294.42499.88
6184276.6
142447+52287*0.8
-184276.691.10896.50
极限1181617.4
136355+56578*0.8
-181617.489.79491.221.8596.0597.571.81
2184466.4
138324+57678*0.8
-184466.491.20297.55
3182896.8
137212+57106*0.8
-182896.890.42696.74
4180827.8
135331+56871*0.8
-180827.889.40395.71
5188145.2
140838+59134*0.8
-188145.293.02199.53
6189020.6
141543+59347*0.8
-189020.693.45499.86
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23203948
203948+0
204187
204187+0
203776
203776+0
204035
204035+0
203463
203463+0
2038820.14
219.28208479
208479+0
208518
208518+0
2084980.02
单位质量响应值RSD%判断
10602.2910814.211.40数据可信
长期12月-供试品溶液-2023082521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195850.2
90455+6744*0.8
-95850.246.90947.105.4646.9147.105.46
293938.4
88760+6473*0.8
-93938.445.97445.97
3105621
99549+7590*0.8
-10562151.69151.69
497791
92343+6810*0.8
-9779147.85947.86
594160.2
88865+6619*0.8
-94160.246.08246.08
690103.4
85081+6278*0.8
-90103.444.09744.10
10min1140932.4
132114+11023*0.8
-140932.468.97369.731.9269.4970.251.95
2142049.8
133273+10971*0.8
-142049.869.51970.03
3146733
137589+11430*0.8
-14673371.81172.39
4143095.8
134231+11081*0.8
-143095.870.03170.56
5143484
134672+11015*0.8
-14348470.22170.73
6138580
130192+10485*0.8
-13858067.82168.31
15min1160461
149553+13635*0.8
-16046178.53080.522.6379.8281.822.64
2165347.6
154006+14177*0.8
-165347.680.92182.20
3171323.8
159355+14961*0.8
-171323.883.84685.22
4167273.2
155750+14404*0.8
-167273.281.86483.17
5162632.4
151426+14008*0.8
-162632.479.59380.88
6160160.8
149004+13946*0.8
-160160.878.38379.63
20min1164550.8
149170+19226*0.8
-164550.880.53183.072.2082.6985.262.17
2172733.2
156642+20114*0.8
-172733.284.53686.72
3170608
154428+20225*0.8
-17060883.49685.80
4174745.2
158242+20629*0.8
-174745.285.52187.74
5167313.8
151725+19486*0.8
-167313.881.88484.06
6168484.2
152757+19659*0.8
-168484.282.45684.57
30min1182611.8
162355+25321*0.8
-182611.889.37089.381.4792.4392.501.50
2182467.4
162345+25153*0.8
-182467.489.30092.42
3186809.6
165788+26277*0.8
-186809.691.42594.66
4184225.8
163597+25786*0.8
-184225.890.16093.33
5180117.2
160170+24934*0.8
-180117.288.15091.24
6179535.4
159637+24873*0.8
-179535.487.86590.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1180509.4
148011+40623*0.8
-180509.488.34290.782.2192.3994.892.10
2181869.2
145978+44864*0.8
-181869.289.00793.12
3183617.8
150057+41951*0.8
-183617.889.86394.11
4189010.6
154733+42847*0.8
-189010.692.50296.67
5190555.6
156198+42947*0.8
-190555.693.25897.32
6187450
153262+42735*0.8
-18745091.73895.75
60min1181859.6
143054+48507*0.8
-181859.689.00292.012.1094.0397.132.04
2189972
149096+51095*0.8
-18997292.97398.08
3191186.6
149993+51492*0.8
-191186.693.56798.81
4187157.6
146964+50242*0.8
-187157.691.59596.79
5192339.4
151605+50918*0.8
-192339.494.13199.23
6185517
145473+50055*0.8
-18551790.79295.82
极限1181618.6
139593+52532*0.8
-181618.688.88491.982.1394.9098.122.05
2188882.6
144529+55442*0.8
-188882.692.43998.58
3186960.8
143728+54041*0.8
-186960.891.49997.78
4189695.8
145211+55606*0.8
-189695.892.83799.05
5193721
148949+55965*0.8
-19372194.807100.96
6186807.2
142536+55339*0.8
-186807.291.42497.46
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