盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)2.5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%
110.782258612260532260452261862266172261520.13
210.712268742269772269260.04
单位质量响应值RSD%判断
20978.8521188.240.71数据可信
供试品溶液-2025041521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%
5min1105490-10549089.88484.053.7889.8884.053.78
296158-9615881.93281.93
395891-9589181.70581.70
498020-9802083.51983.52
5100140-10014085.32585.33
696150-9615081.92681.93
10min1114807-11480797.82290.034.5697.9790.174.56
2102689-10268987.49787.63
3102968-10296887.73587.87
4104190-10419088.77688.92
5107117-10711791.27091.41
6102230-10223087.10687.24
15min1112743-11274396.06491.133.0596.3891.423.05
2105000-10500089.46689.75
3104423-10442388.97589.26
4106469-10646990.71891.01
5108632-10863292.56192.86
6104459-10445989.00589.29
20min1113874-11387497.02792.262.9797.5092.712.97
2106212-10621290.49990.93
3105879-10587990.21590.65
4107718-10771891.78292.22
5110210-11021093.90694.35
6105809-10580990.15690.59
30min1115167-11516798.12993.452.9198.7694.042.91
2107707-10770791.77392.36
3107118-10711891.27191.85
4109004-10900492.87893.47
5111713-11171395.18695.79
6107309-10730991.43492.01
极限1116120-11612098.94194.222.8699.7494.972.86
2108624-10862492.55493.29
3108129-10812992.13292.87
4109834-10983493.58594.33
5112448-11244895.81296.58
6108303-10830392.28193.01
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)2.5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%
110.782272172272132270332271102271562271460.04
210.712253662255512254580.06
单位质量响应值RSD%判断
21071.0621051.170.07数据可信
供试品溶液-b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%
5min1105489-10548989.97686.253.0189.9886.253.02
2101540-10154086.60886.61
396658-9665882.44482.44
4103132-10313287.96687.97
5100361-10036185.60385.60
699558-9955884.91884.92
10min1108250-10825092.33191.412.2892.4891.552.28
2108647-10864792.67092.81
3103173-10317388.00188.14
4110100-11010093.90994.06
5106964-10696491.23591.38
6105855-10585590.28990.43
15min1111037-11103794.70993.472.1795.0193.762.17
2110915-11091594.60594.90
3105587-10558790.06090.34
4112255-11225595.74896.05
5108924-10892492.90693.20
6108772-10877292.77793.07
20min1112192-11219295.69494.711.8996.1695.171.89
2112455-11245595.91896.37
3107559-10755991.74292.18
4113380-11338096.70797.17
5110268-11026894.05394.50
6110405-11040594.17094.62
30min1114061-11406197.28896.002.2697.9196.612.26
2113876-11387697.13097.75
3108125-10812592.22592.81
4115362-11536298.39899.02
5111854-11185495.40596.01
6112024-11202495.55096.15
极限1114756-11475697.88196.842.0998.6697.612.09
2114648-11464897.78998.57
3109510-10951093.40694.15
4116437-11643799.315100.10
5112825-11282596.23497.00
6113033-11303396.41197.17
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)2.5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%
110.782269942270042268352270622269072269600.04
210.712264922267982266450.10
单位质量响应值RSD%判断
21053.8021162.000.37数据可信
供试品溶液-2025041521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%
5min1105466-10546689.75884.882.9789.7684.882.97
297129-9712982.66382.66
398057-9805783.45383.45
498993-9899384.24984.25
599807-9980784.94284.94
698957-9895784.21884.22
10min1111194-11119494.63391.272.7694.7891.422.76
2102425-10242587.17087.31
3106123-10612390.31790.46
4107202-10720291.23591.38
5109153-10915392.89693.04
6107380-10738091.38791.53
15min1111836-11183695.17991.922.0195.4992.212.02
2105147-10514789.48789.77
3107169-10716991.20791.50
4108029-10802991.93992.23
5107951-10795191.87392.17
6107874-10787491.80792.10
20min1114567-11456797.50494.082.5797.9794.532.57
2106656-10665690.77191.20
3108798-10879892.59493.04
4112578-11257895.81196.26
5109410-10941093.11593.56
6111282-11128294.70895.15
30min1115012-11501297.88294.531.9198.5195.141.92
2108694-10869492.50593.09
3109980-10998093.60094.20
4110831-11083194.32494.93
5111142-11114294.58995.19
6110812-11081294.30894.91
极限1115952-11595298.68295.361.8999.4796.121.89
2109818-10981893.46294.20
3110732-11073294.24094.99
4111923-11192395.25396.02
5112252-11225295.53396.30
6111604-11160494.98295.74
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)2.5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%
110.782266552266432267812267992268122267380.04
210.712267122273382270250.20
单位质量响应值RSD%判断
21033.2121197.480.56数据可信
供试品溶液-b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%
5min199143-9914384.34886.382.0984.3586.382.09
298836-9883684.08784.09
3103560-10356088.10688.11
4101481-10148186.33786.34
5102504-10250487.20787.21
6103638-10363888.17288.17
10min1104046-10404688.51991.702.3488.6691.842.34
2105524-10552489.77789.92
3110439-11043993.95894.10
4107995-10799591.87992.02
5108829-10882992.58892.73
6109877-10987793.48093.63
15min1106702-10670290.77994.743.4791.0795.033.47
2106998-10699891.03191.32
3112934-11293496.08196.38
4116483-11648399.10099.40
5111379-11137994.75895.06
6113626-11362696.66996.97
20min1107949-10794991.84094.752.3292.2895.202.32
2108393-10839392.21792.66
3113907-11390796.90897.37
4111986-11198695.27495.74
5112469-11246995.68596.14
6113503-11350396.56597.03
30min1109006-10900692.73996.282.3793.3396.892.37
2111066-11106694.49195.09
3115772-11577298.49599.12
4113471-11347196.53897.16
5113938-11393896.93597.55
6115724-11572498.45499.08
极限1110441-11044193.96097.592.8594.7198.362.84
2111348-11134894.73195.48
3119016-119016101.255102.04
4115490-11549098.25599.04
5115156-11515697.97198.75
6116803-11680399.372100.16
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)2.5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%
110.782266882262782262482264412262052263720.09
210.712261972263172262570.04
单位质量响应值RSD%判断
20999.2621125.770.43数据可信
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%
5min1106965-10696591.23090.883.3991.2390.883.38
2106218-10621890.59390.59
3108027-10802792.13692.14
499681-9968185.01885.02
5109946-10994693.77393.77
6108467-10846792.51192.51
10min1113674-11367496.95296.213.4197.1096.363.41
2112258-11225895.74595.90
3114611-11461197.75197.90
4105421-10542189.91390.05
5116158-11615899.07199.23
6114694-11469497.82297.98
15min1115589-11558998.58698.153.5098.9098.463.50
2114330-11433097.51297.82
3116981-11698199.773100.09
4107461-10746191.65391.94
5118702-118702101.241101.56
6117388-117388100.120100.44
20min1116882-11688299.68899.293.48100.1799.763.48
2115538-11553898.54299.02
3118447-118447101.023101.51
4108809-10880992.80393.25
5120209-120209102.526103.02
6118582-118582101.138101.62
30min1118557-118557101.117100.473.51101.76101.113.51
2117024-11702499.809100.45
3119804-119804102.181102.83
4109927-10992793.75694.36
5121376-121376103.521104.18
6120113-120113102.444103.10
极限1120093-120093102.427101.613.55103.24102.423.55
2118064-118064100.696101.50
3122019-122019104.070104.89
4111128-11112894.78195.54
5122468-122468104.453105.29
6121004-121004103.204104.03
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)2.5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%
110.782263982266102268472267602266692266570.08
210.712262482261772262120.03
单位质量响应值RSD%判断
21025.7021121.570.33数据可信
供试品溶液-b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%
5min1106403-10640390.70391.572.3590.7091.572.35
2112225-11222595.66695.67
3107773-10777391.87091.87
4104997-10499789.50489.50
5106284-10628490.60190.60
6106833-10683391.06991.07
10min1112602-11260295.98797.062.5896.1497.212.58
2119325-119325101.718101.88
3114564-11456497.65997.81
4110835-11083594.48194.63
5113158-11315896.46196.61
6112671-11267196.04696.20
15min1114804-11480497.86499.052.4998.1899.372.49
2121618-121618103.673104.00
3116784-11678499.55299.87
4113329-11332996.60796.91
5115754-11575498.67498.99
6114906-11490697.95198.26
20min1116162-11616299.022100.002.6299.50100.482.61
2122991-122991104.843105.34
3117853-117853100.463100.94
4113944-11394497.13197.60
5116824-11682499.586100.06
6116067-11606798.94199.42
30min1117552-117552100.207101.312.73100.85101.962.73
2124900-124900106.470107.15
3119831-119831102.149102.80
4115800-11580098.71399.34
5117711-117711100.342100.98
6117278-11727899.973100.61
极限1118181-118181100.743102.212.64101.55103.032.64
2125779-125779107.220108.07
3120904-120904103.064103.88
4116859-11685999.616100.41
5118940-118940101.390102.20
6118772-118772101.246102.05
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