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对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74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%
111.181921101925181925001924161923871923860.09
211.251922011919891920950.08
单位质量响应值RSD%判断
17208.0517075.110.55数据可信
供试品溶液-24122701批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106473-10647355.75857.055.2355.7657.055.23
2113541-11354159.45959.46
3115717-11571760.59960.60
4112405-11240558.86458.86
5103084-10308453.98353.98
6102423-10242353.63753.64
10min1141255-14125573.97374.623.1274.0774.723.12
2147809-14780977.40577.50
3147854-14785477.42877.53
4141673-14167374.19274.29
5137153-13715371.82571.91
6139204-13920472.89972.99
15min1159370-15937083.45984.922.7083.6885.142.69
2163628-16362885.68985.92
3163524-16352485.63585.86
4169555-16955588.79389.01
5157732-15773282.60182.81
6159113-15911383.32583.54
20min1169186-16918688.60089.331.0388.9589.691.04
2173204-17320490.70491.07
3171910-17191090.02690.40
4170849-17084989.47189.84
5168553-16855388.26888.62
6169794-16979488.91889.27
30min1180079-18007994.30494.840.8294.8195.350.83
2183347-18334796.01596.54
3181334-18133494.96195.48
4181563-18156395.08195.60
5178968-17896893.72294.22
6181353-18135394.97195.47
45min1186623-18662397.73198.490.7398.3999.160.72
2190082-19008299.542100.22
3187398-18739898.13798.82
4187808-18780898.35299.03
5187152-18715298.00898.66
6189383-18938399.17699.83
60min1191296-191296100.178100.310.69101.00101.140.69
2193657-193657101.415102.26
3190278-19027899.645100.49
4191140-191140100.097100.94
5190371-19037199.694100.51
6192510-192510100.814101.64
极限1193233-193233101.193101.390.71102.18102.390.72
2195200-195200102.223103.24
3193604-193604101.387102.40
4194039-194039101.615102.62
5191188-191188100.122101.10
6194412-194412101.810102.80
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对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74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%
111.181924821923101925811924141924931924560.06
211.251950381950461950420.01
单位质量响应值RSD%判断
17214.3117337.070.51数据可信
供试品溶液-24122701批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157651-5765129.95634.3511.8929.9634.3511.89
266080-6608034.33634.34
368892-6889235.79735.80
471149-7114936.97036.97
556345-5634529.27829.28
676539-7653939.77139.77
10min186977-8697745.19552.438.8045.2452.498.81
2103142-10314253.59453.65
3104565-10456554.33454.39
4105942-10594255.04955.11
593687-9368748.68148.73
6111100-11110057.72957.80
15min1107743-10774355.98563.627.1256.1163.767.13
2125722-12572265.32765.47
3127298-12729866.14666.30
4127002-12700265.99266.15
5116131-11613160.34360.47
6130719-13071967.92468.09
20min1122464-12246463.63471.396.1063.8571.646.11
2140709-14070973.11573.37
3142856-14285674.23074.49
4141453-14145373.50173.76
5132532-13253268.86669.10
6144270-14427074.96575.24
30min1142609-14260974.10281.464.8174.4381.834.82
2160476-16047683.38683.76
3162783-16278384.58584.97
4160129-16012983.20583.59
5154063-15406380.05480.40
6160564-16056483.43283.83
45min1161388-16138883.86090.213.7084.3190.723.71
2176946-17694691.94492.46
3179770-17977093.41193.94
4175755-17575591.32591.85
5172811-17281189.79590.27
6175041-17504190.95491.49
60min1172892-17289289.83795.633.0890.4396.283.10
2187232-18723297.28997.96
3188689-18868998.04698.73
4184498-18449895.86896.54
5185159-18515996.21196.84
6185715-18571596.50097.19
极限1180587-18058793.83698.892.6994.5799.702.71
2193483-193483100.537101.37
3195146-195146101.401102.25
4190345-19034598.90699.74
5190471-19047198.97299.76
6191827-19182799.676100.53
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对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74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%
111.181926921923021927641923081924091924950.12
211.251928871924561926720.16
单位质量响应值RSD%判断
17217.8017126.400.38数据可信
供试品溶液-24122701批-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%
5min193438-9343848.84452.263.9248.8452.263.92
298889-9888951.69451.69
3100810-10081052.69852.70
4102411-10241153.53553.54
599227-9922751.87151.87
6105028-10502854.90354.90
10min1126770-12677066.26968.802.4966.3568.882.49
2130695-13069568.32068.41
3131292-13129268.63268.72
4134449-13444970.28370.37
5130397-13039768.16568.25
6136029-13602971.10971.20
15min1144432-14443275.50176.533.6375.6976.733.62
2146232-14623276.44276.64
3153042-15304280.00280.20
4137922-13792272.09872.30
5145898-14589876.26876.47
6150918-15091878.89279.10
20min1155814-15581481.45182.171.2881.7782.501.28
2156263-15626381.68682.01
3156165-15616581.63581.97
4159093-15909383.16583.49
5155516-15551681.29681.62
6160336-16033683.81584.16
30min1168133-16813387.89188.841.0588.3489.301.04
2168096-16809687.87288.34
3169121-16912188.40788.88
4170642-17064289.20389.67
5172406-17240690.12590.59
6171251-17125189.52190.00
45min1179337-17933793.74893.380.8694.3593.990.86
2177512-17751292.79493.40
3179195-17919593.67494.29
4180391-18039194.29994.91
5176143-17614392.07892.69
6179163-17916393.65794.29
60min1189276-18927698.94396.581.3999.7097.351.37
2182638-18263895.47396.24
3184432-18443296.41197.19
4185411-18541196.92397.69
5182059-18205995.17195.94
6184710-18471096.55797.34
极限1190955-19095599.82198.621.07100.7499.541.06
2186392-18639297.43698.36
3188856-18885698.72499.66
4189709-18970999.170100.10
5186031-18603197.24798.17
6189948-18994899.295100.24
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对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74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%
111.181925201926861925791923551923391924960.08
211.251924851923851924350.04
单位质量响应值RSD%判断
17217.8917105.330.47数据可信
供试品溶液-24122701批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119492-11949262.50260.884.9762.5060.884.98
2115307-11530760.31360.31
3118479-11847961.97361.97
4114712-11471260.00260.00
5123712-12371264.71064.71
6106609-10660955.76455.76
10min1162035-16203584.75584.421.8884.8684.521.89
2159606-15960683.48583.59
3163593-16359385.57085.67
4160272-16027283.83383.93
5165652-16565286.64786.76
6157150-15715082.20082.29
15min1177999-17799993.10693.421.1693.3593.661.16
2176721-17672192.43792.68
3180734-18073494.53694.78
4179046-17904693.65393.89
5181028-18102894.69094.94
6176020-17602092.07092.30
20min1185689-18568997.12897.651.0897.5398.051.08
2184675-18467596.59896.99
3187688-18768898.17498.58
4189226-18922698.97899.37
5188377-18837798.53498.94
6184480-18448096.49696.88
30min1191773-191773100.310100.760.68100.87101.320.68
2191085-19108599.951100.51
3193796-193796101.369101.94
4193957-193957101.453102.01
5193610-193610101.271101.85
6191553-191553100.195100.74
45min1195092-195092102.046102.530.48102.78103.260.48
2195181-195181102.093102.81
3196337-196337102.698103.43
4197609-197609103.363104.09
5196260-196260102.657103.40
6195666-195666102.347103.06
60min1195113-195113102.057102.830.58102.96103.730.58
2196137-196137102.593103.48
3197536-197536103.325104.23
4198047-198047103.592104.49
5196969-196969103.028103.94
6195717-195717102.373103.26
极限1196631-196631102.851102.920.52103.92103.990.52
2195895-195895102.466103.53
3197489-197489103.300104.38
4198444-198444103.800104.87
5196107-196107102.577103.66
6195990-195990102.516103.57
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