拉莫三嗪分散片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.285850305852125854515852455854585852790.04
211.345845875846965846420.02
单位质量响应值RSD%判断
51886.4451555.730.46数据可信
中间条件36月-供试品溶液-2022101711批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1569200-56920098.75197.741.6098.7597.741.60
2556284-55628496.51096.51
3554350-55435096.17496.17
4565578-56557898.12298.12
5577486-577486100.188100.19
6557366-55736696.69796.70
10min1589236-589236102.227100.741.56102.39100.901.56
2569977-56997798.88599.05
3583738-583738101.273101.43
4578334-578334100.335100.50
5591332-591332102.590102.76
6571213-57121399.10099.26
15min1590632-590632102.469100.991.56102.80101.321.56
2571931-57193199.22499.55
3584778-584778101.453101.78
4578775-578775100.412100.74
5593691-593691102.999103.34
6572998-57299899.40999.74
20min1588767-588767102.145100.841.48102.65101.341.48
2571782-57178299.19899.69
3583545-583545101.239101.74
4577805-577805100.243100.74
5592767-592767102.839103.35
6572914-57291499.39599.89
30min1588005-588005102.013100.861.40102.69101.531.40
2572310-57231099.29099.95
3583161-583161101.173101.84
4577414-577414100.176100.84
5592942-592942102.870103.55
6574402-57440299.653100.31
45min1586827-586827101.809100.701.32102.65101.541.32
2572274-57227499.284100.11
3582233-582233101.012101.85
4575547-57554799.852100.68
5591350-591350102.593103.45
6574485-57448599.667100.49
60min1586065-586065101.676100.531.33102.69101.531.33
2570957-57095799.055100.04
3581985-581985100.969101.97
4574213-57421399.620100.62
5589941-589941102.349103.37
6573418-57341899.482100.47
极限1584810-584810101.459100.371.28102.64101.541.28
2571336-57133699.121100.27
3580603-580603100.729101.90
4572814-57281499.378100.54
5588953-588953102.177103.37
6572685-57268599.355100.51
拉莫三嗪分散片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.285851815849085847605848625845155848450.05
211.345833705830535832120.04
单位质量响应值RSD%判断
51847.9651429.630.58数据可信
中间条件36月-供试品溶液-2022101811批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1568460-56846098.78097.821.4998.7897.821.49
2562075-56207597.67097.67
3554940-55494096.43196.43
4572037-57203799.40199.40
5551194-55119495.78095.78
6568860-56886098.84998.85
10min1575723-575723100.04299.381.45100.2199.551.45
2572243-57224399.43799.60
3561675-56167597.60197.76
4580260-580260100.830101.00
5562177-56217797.68897.85
6579527-579527100.703100.87
15min1574468-57446899.82499.371.50100.1699.701.49
2571554-57155499.31899.65
3561531-56153197.57697.90
4579851-579851100.759101.09
5562212-56221297.69498.02
6581510-581510101.048101.38
20min1572782-57278299.53199.211.48100.0399.701.48
2570293-57029399.09899.59
3560536-56053697.40397.89
4578871-578871100.589101.09
5562111-56211197.67798.16
6581053-581053100.968101.47
30min1572531-57253199.48799.021.47100.1599.681.47
2568496-56849698.78699.45
3559245-55924597.17997.83
4577533-577533100.356101.03
5561426-56142697.55898.21
6579725-579725100.737101.41
45min1569943-56994399.03898.741.4299.8799.571.42
2567116-56711698.54699.37
3558108-55810896.98197.79
4576055-576055100.100100.94
5560291-56029197.36098.17
6577935-577935100.426101.26
60min1569680-56968098.99298.671.4799.9999.661.47
2566746-56674698.48299.47
3557309-55730996.84297.81
4575158-57515899.944100.95
5559699-55969997.25898.23
6578282-578282100.487101.49
极限1568798-56879898.83998.431.54100.0099.581.54
2565212-56521298.21699.37
3555524-55552496.53297.67
4573392-57339299.637100.81
5557751-55775196.91998.05
6577843-577843100.410101.58
拉莫三嗪分散片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.285832535834855836105833145834755834270.03
211.345827645828205827920.01
单位质量响应值RSD%判断
51722.2551392.590.46数据可信
中间条件36月-供试品溶液-2022101911批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1570924-57092499.36499.290.4699.3699.290.46
2572070-57207099.56399.56
3571848-57184899.52599.52
4568460-56846098.93598.94
5566296-56629698.55998.56
6573304-57330499.77899.78
10min1580456-580456101.023100.740.71101.19100.910.71
2576523-576523100.338100.50
3583558-583558101.563101.73
4577354-577354100.483100.65
5572640-57264099.66399.83
6582504-582504101.379101.55
15min1581256-581256101.162100.690.83101.50101.020.83
2576371-576371100.312100.65
3585029-585029101.819102.15
4576276-576276100.295100.63
5571525-57152599.46999.80
6580766-580766101.077101.41
20min1582236-582236101.333100.590.93101.84101.090.92
2575534-575534100.166100.67
3585108-585108101.833102.34
4574940-574940100.063100.56
5570553-57055399.29999.80
6579431-579431100.845101.35
30min1583474-583474101.548100.471.00102.22101.141.00
2574541-57454199.994100.66
3583572-583572101.565102.24
4573761-57376199.858100.52
5569217-56921799.06799.73
6579105-579105100.788101.46
45min1578140-578140100.620100.160.99101.46101.000.98
2573342-57334299.785100.62
3583949-583949101.631102.47
4572716-57271699.676100.51
5567403-56740398.75199.58
6577495-577495100.508101.35
60min1578497-578497100.682100.050.98101.69101.060.97
2572714-57271499.676100.68
3582202-582202101.327102.34
4570891-57089199.358100.36
5567140-56714098.70599.70
6577908-577908100.580101.59
极限1575643-575643100.18599.630.87101.36100.800.87
2569498-56949899.116100.28
3579366-579366100.833102.02
4569472-56947299.111100.28
5565928-56592898.49599.65
6574765-574765100.033101.21
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