XXYYYY片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
111.442395862393272395112398772397572396120.09
211.302400032394012397020.18
单位质量响应值RSD%判断
20945.1021212.570.90数据可信
盐酸奥洛他定口崩片--供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105672-10567245.03043.912.8745.0343.912.87
2105297-10529744.87044.87
3101954-10195443.44643.45
499592-9959242.43942.44
599829-9982942.54042.54
6105888-10588845.12245.12
10min1112277-11227747.84546.692.6248.0946.942.62
2111730-11173047.61247.86
3107683-10768345.88746.13
4106424-10642445.35145.59
5106854-10685445.53445.77
6112441-11244147.91548.17
15min1114879-11487948.95447.812.6149.4748.322.61
2114509-11450948.79649.31
3110898-11089847.25747.75
4109135-10913546.50646.99
5108811-10881146.36846.86
6114963-11496348.98949.51
20min1116510-11651049.64948.422.6550.4449.192.66
2115747-11574749.32350.11
3111742-11174247.61748.38
4110643-11064347.14847.89
5110412-11041247.05047.80
6116745-11674549.74950.54
30min1118791-11879150.62149.182.7451.6850.212.73
2117513-11751350.07651.13
3113542-11354248.38449.41
4111393-11139347.46848.48
5112934-11293448.12549.13
6118242-11824250.38751.45
极限1120389-12038951.30249.632.8152.6550.952.80
2118790-11879050.62051.96
3114591-11459148.83150.12
4113266-11326648.26649.54
5112909-11290948.11449.39
6118913-11891350.67352.02
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
111.442392152392772382372387872386912388410.18
211.302401042408392404720.22
单位质量响应值RSD%判断
20877.7121280.711.36数据可信
盐酸奥洛他定口崩片--供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103159-10315943.96144.542.8843.9644.542.88
2102856-10285643.83243.83
3105983-10598345.16445.16
4104129-10412944.37444.37
5101198-10119843.12543.13
6109727-10972746.76046.76
10min1109750-10975046.77047.462.9647.0147.702.96
2109022-10902246.45946.70
3113741-11374148.47048.72
4111184-11118447.38147.63
5107859-10785945.96446.20
6116660-11666049.71449.97
15min1111455-11145547.49648.422.8748.0048.932.87
2111748-11174847.62148.12
3116140-11614049.49350.01
4113487-11348748.36248.87
5110176-11017646.95147.45
6118764-11876450.61151.15
20min1113061-11306148.18049.023.0248.9549.803.01
2112865-11286548.09748.86
3117426-11742650.04150.84
4115312-11531249.14049.92
5111061-11106147.32848.08
6120492-12049251.34752.16
30min1115148-11514849.07049.802.5250.1150.852.52
2115068-11506849.03650.07
3119461-11946150.90851.98
4117041-11704149.87750.93
5113346-11334648.30249.32
6121078-12107851.59752.70
极限1116319-11631949.56950.392.7150.8851.722.72
2116406-11640649.60650.91
3121309-12130951.69553.05
4117999-11799950.28551.61
5114599-11459948.83650.12
6122869-12286952.36053.75
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
111.442388082391262394162400992392602393420.21
211.302379522392962386240.40
单位质量响应值RSD%判断
20921.5021117.170.66数据可信
盐酸奥洛他定口崩片--供试品溶液-2025041621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189512-18951280.98482.021.3680.9882.021.36
2192144-19214482.10982.11
3190629-19062981.46281.46
4193461-19346182.67282.67
5196269-19626983.87283.87
6189664-18966481.04981.05
10min1206288-20628888.15387.671.4788.6088.131.47
2204659-20465987.45787.91
3202977-20297786.73887.19
4205715-20571587.90888.37
5210023-21002389.74990.22
6201306-20130686.02486.47
15min1211608-21160890.42690.101.4891.3791.041.48
2210820-21082090.09091.03
3206811-20681188.37789.31
4212131-21213190.65091.60
5215576-21557692.12293.09
6208055-20805588.90889.84
20min1215121-21512191.92891.431.3993.3792.871.39
2212695-21269590.89192.33
3210299-21029989.86791.29
4215815-21581592.22493.68
5218260-21826093.26994.75
6211539-21153990.39791.82
30min1219462-21946293.78393.081.4295.7495.031.42
2216798-21679892.64494.59
3214723-21472391.75893.68
4221041-22104194.45796.42
5220857-22085794.37996.37
6213971-21397191.43693.36
极限1224367-22436795.87994.602.0598.3597.072.03
2222116-22211694.91797.38
3217404-21740492.90395.34
4224514-22451495.94298.43
5225552-22555296.38598.90
6214289-21428991.57294.00
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
111.442392582398072400262388132402212396250.25
211.302395672384072389870.35
单位质量响应值RSD%判断
20946.2421149.290.69数据可信
盐酸奥洛他定口崩片--供试品溶液-2025041621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1209831-20983189.54688.620.7689.5588.620.76
2209277-20927789.31089.31
3206584-20658488.16088.16
4207354-20735488.48988.49
5205785-20578587.81987.82
6207159-20715988.40688.41
10min1215840-21584092.11092.841.2492.6193.341.23
2221518-22151894.53495.03
3216968-21696892.59293.08
4216004-21600492.18092.67
5220232-22023293.98594.47
6214800-21480091.66792.16
15min1219062-21906293.48594.441.1894.4995.441.17
2225802-22580296.36297.38
3219463-21946393.65794.66
4219693-21969393.75594.76
5222837-22283795.09696.11
6220892-22089294.26695.27
20min1220306-22030694.01695.071.0995.5496.601.09
2227184-22718496.95298.51
3221167-22116794.38495.91
4223213-22321395.25796.78
5222952-22295295.14696.68
6221781-22178194.64696.17
30min1221280-22128094.43296.051.4296.4898.111.40
2230177-23017798.229100.32
3222979-22297995.15797.21
4226194-22619496.52998.58
5226339-22633996.59198.66
6223422-22342295.34697.40
极限1223194-22319495.24996.661.1097.8299.261.10
2229933-22993398.125100.77
3224531-22453195.81998.40
4227131-22713196.92999.52
5228343-22834397.446100.05
6225925-22592596.41498.99
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
111.442399102404632398092392532394482397770.20
211.302396622394102395360.08
单位质量响应值RSD%判断
20959.5321197.880.80数据可信
盐酸奥洛他定口崩片--供试品溶液-2025041621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1206640-20664088.05687.421.6188.0687.421.61
2206704-20670488.08388.08
3207404-20740488.38188.38
4198896-19889684.75684.76
5203982-20398286.92386.92
6207214-20721488.30088.30
10min1218314-21831493.03091.672.2293.5292.162.21
2218611-21861193.15793.65
3215727-21572791.92892.42
4205750-20575087.67688.15
5215824-21582491.96992.45
6216547-21654792.27792.77
15min1222104-22210494.64593.671.9895.6594.661.98
2224322-22432295.59196.60
3222055-22205594.62595.63
4211885-21188590.29191.25
5218849-21884993.25894.25
6219640-21964093.59594.60
20min1222114-22211494.65094.081.5496.1895.601.55
2223927-22392795.42296.96
3222495-22249594.81296.34
4214287-21428791.31492.77
5220241-22024193.85295.36
6221608-22160894.43495.96
30min1229303-22930397.71395.762.1599.7797.802.14
2228719-22871997.46499.53
3225076-22507695.91297.97
4215895-21589592.00093.97
5225341-22534196.02598.06
6223996-22399695.45297.50
极限1228173-22817397.23295.741.8199.8398.311.81
2228566-22856697.399100.01
3224744-22474495.77098.36
4217310-21731092.60395.08
5225095-22509595.92098.49
6224088-22408895.49198.07
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