盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.191977921985481983391980671981001981690.15
211.132014412002902008660.41
单位质量响应值RSD%判断
17709.4718047.261.34数据可信
长期18月-供试品溶液-2022082801批-40mg规格-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169549-6954935.01133.1325.1935.0133.1225.19
263930-6393032.18232.18
373218-7321836.85836.86
490807-9080745.71245.71
555286-5528627.83127.83
642039-4203921.16221.16
10min1135430-13543068.17565.188.7368.2365.238.74
2137315-13731569.12469.18
3134141-13414167.52667.59
4139768-13976870.35970.43
5115213-11521357.99858.04
6114981-11498157.88157.92
15min1156608-15660878.83675.866.4379.0176.026.44
2154358-15435877.70377.87
3161046-16104681.07081.24
4154917-15491777.98578.18
5137446-13744669.19069.33
6139751-13975170.35070.48
20min1167967-16796784.55481.895.7884.8682.195.79
2165692-16569283.40983.71
3174475-17447587.83088.14
4164867-16486782.99383.32
5149022-14902275.01775.28
6154086-15408677.56677.82
30min1180002-18000290.61288.343.8391.0688.763.84
2183212-18321292.22892.67
3178675-17867589.94490.40
4175741-17574188.46788.93
5165246-16524683.18483.57
6170018-17001885.58685.96
45min1189461-18946195.37494.103.4995.9794.683.51
2188301-18830194.79095.38
3191786-19178696.54497.15
4193888-19388897.60298.21
5177018-17701889.11089.63
6181139-18113991.18591.71
60min1194043-19404397.68196.333.4598.4397.063.45
2202558-202558101.967102.72
3192257-19225796.78197.55
4188758-18875895.02095.79
5184013-18401392.63193.30
6186563-18656393.91594.59
极限1200103-200103100.73198.191.76101.6599.081.79
2196706-19670699.02199.94
3196453-19645398.89499.82
4194457-19445797.88998.82
5191234-19123496.26697.09
6191364-19136496.33297.16
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.191984991990761991131986232014941993610.62
211.131988151998731993440.38
单位质量响应值RSD%判断
17816.0017910.510.38数据可信
长期18月-供试品溶液-2022082801批-40mg规格-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183799-8379942.21635.4226.7542.2235.4226.75
288880-8888044.77644.78
336086-3608618.17918.18
470623-7062335.57935.58
577101-7710138.84238.84
665390-6539032.94232.94
10min1143254-14325472.16967.457.7272.2467.517.73
2144898-14489872.99773.07
3116837-11683758.86058.89
4134641-13464167.83067.89
5135398-13539868.21168.28
6128337-12833764.65464.71
15min1161440-16144081.33077.495.0781.5277.665.08
2162077-16207781.65181.85
3141227-14122771.14771.28
4154697-15469777.93378.11
5153826-15382677.49577.67
6149650-14965075.39175.55
20min1171261-17126186.27883.453.7686.6083.743.79
2172260-17226086.78187.11
3155915-15591578.54778.79
4165250-16525083.25083.55
5167847-16784784.55884.87
6161302-16130281.26181.55
30min1182506-18250691.94389.922.5392.4190.362.55
2184628-18462893.01293.49
3175481-17548188.40488.78
4179041-17904190.19790.64
5176800-17680089.06889.52
6172498-17249886.90187.32
45min1189457-18945795.44594.031.8996.0794.631.91
2189851-18985195.64396.28
3183218-18321892.30292.83
4189519-18951995.47696.07
5186090-18609093.74994.35
6181806-18180691.59092.16
60min1192095-19209596.77496.401.5597.5697.151.58
2195015-19501598.24599.04
3189461-18946195.44796.13
4194122-19412297.79598.55
5190245-19024595.84296.59
6187166-18716694.29195.01
极限1194199-19419997.83498.330.8398.7899.240.84
2195337-19533798.40799.36
3193327-19332797.39498.23
4197903-19790399.700100.61
5194409-19440997.94098.85
6195933-19593398.70799.59
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.191983311983331981501981021985001982830.09
211.131997142003972000560.25
单位质量响应值RSD%判断
17719.6617974.481.01数据可信
中间条件18月-供试品溶液-2022082601批-40mg规格-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159117-5911729.81027.809.5429.8127.809.54
247160-4716023.78123.78
358248-5824829.37229.37
450539-5053925.48525.48
560402-6040230.45830.46
655270-5527027.87027.87
10min1127312-12731264.19862.863.5564.2562.903.56
2116873-11687358.93458.97
3129755-12975565.43065.48
4123131-12313162.09062.13
5125929-12592963.50163.55
6124918-12491862.99163.04
15min1150893-15089376.08975.651.4876.2575.801.48
2149339-14933975.30675.44
3152188-15218876.74276.90
4149989-14998975.63375.78
5151720-15172076.50676.66
6146051-14605173.64873.80
20min1162166-16216681.77482.182.5282.0682.462.52
2159215-15921580.28680.55
3170962-17096286.20986.50
4162413-16241381.89882.17
5160893-16089381.13281.42
6162209-16220981.79582.07
30min1176588-17658889.04689.081.3789.4789.501.37
2174412-17441287.94988.35
3179173-17917390.35090.78
4176844-17684489.17589.58
5179449-17944990.48990.91
6173492-17349287.48587.90
45min1186974-18697494.28394.470.9894.8595.030.99
2186860-18686094.22694.77
3189229-18922995.42196.00
4187949-18794994.77595.33
5188887-18888795.24895.82
6184167-18416792.86893.42
60min1192272-19227296.95596.870.8497.6897.590.85
2191076-19107696.35297.05
3194040-19404097.84798.59
4193483-19348397.56698.28
5192144-19214496.89097.62
6189627-18962795.62196.33
极限1195298-19529898.48198.770.7999.3799.650.79
2195070-19507098.36699.23
3197567-19756799.625100.53
4196992-19699299.335100.21
5196827-19682799.252100.14
6193492-19349297.57098.44
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.191977681981051968851963491969071972030.37
211.131982802029272006041.64
单位质量响应值RSD%判断
17623.1518023.721.59数据可信
中间条件18月-供试品溶液-2022082601批-40mg规格-pH4.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151633-5163326.07327.1419.9326.0727.1419.93
260519-6051930.56030.56
356661-5666128.61228.61
460266-6026630.43230.43
560388-6038830.49430.49
633053-3305316.69116.69
10min1117144-11714459.15461.019.5659.2061.059.57
2130057-13005765.67465.73
3125874-12587463.56263.61
4125594-12559463.42163.47
5127243-12724364.25364.30
698955-9895549.96950.00
15min1146740-14674074.09975.672.9174.2475.822.93
2152740-15274077.12977.29
3151412-15141276.45876.61
4152667-15266777.09277.25
5153133-15313377.32777.48
6142394-14239471.90472.02
20min1160174-16017480.88382.121.2781.1582.401.28
2163790-16379082.70883.00
3164031-16403182.83083.11
4162181-16218181.89682.18
5165192-16519283.41683.70
6160414-16041481.00481.23
30min1173690-17369087.70889.031.3088.1189.441.31
2176623-17662389.18989.62
3177959-17795989.86390.28
4178729-17872990.25290.67
5177570-17757089.66790.09
6173319-17331987.52087.89
45min1186033-18603393.94094.060.5194.4994.620.52
2187591-18759194.72795.30
3187197-18719794.52895.10
4185256-18525693.54894.12
5186071-18607193.96094.53
6185482-18548293.66294.17
60min1190276-19027696.08397.091.1996.7997.801.19
2193798-19379897.86198.59
3196017-19601798.98299.71
4190172-19017296.03096.76
5192212-19221297.06197.79
6191132-19113296.51597.18
极限1194859-19485998.39798.841.1099.2699.711.09
2198872-198872100.424101.32
3196890-19689099.423100.31
4192771-19277197.34398.23
5194440-19444098.18699.08
6196559-19655999.256100.08
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