替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
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%
1111.95540045577425516115507375532445534680.50
2112.95503965518925511440.20
单位质量响应值RSD%判断
4946.094881.700.93数据可信
供试品溶液-2409136批-shui(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1147764-14776426.63221.1440.3426.6321.1440.34
247618-476188.5828.58
3105059-10505918.93518.93
4187950-18795033.87433.87
5101378-10137818.27118.27
6113984-11398420.54320.54
10min1191424-19142434.50133.289.3934.5433.319.41
2173753-17375331.31631.33
3165337-16533729.79929.83
4214549-21454938.66838.72
5186246-18624633.56733.60
6176517-17651731.81431.85
15min1202079-20207936.42134.219.3936.5234.309.42
2175514-17551431.63331.70
3176088-17608831.73731.82
4218551-21855139.39039.51
5191631-19163134.53834.62
6175142-17514231.56631.65
20min1199662-19966235.98534.438.7336.1534.588.76
2176983-17698331.89832.02
3176785-17678531.86232.00
4219066-21906639.48339.67
5193568-19356834.88735.03
6179978-17997832.43832.58
30min1197359-19735935.57034.649.7535.7934.849.77
2177693-17769332.02632.20
3179540-17954032.35932.55
4226272-22627240.78141.03
5193977-19397734.96135.16
6178263-17826332.12932.32
45min1202909-20290936.57136.459.7336.8536.719.75
2187858-18785833.85834.08
3186378-18637833.59133.83
4238913-23891343.06043.38
5205878-20587837.10637.37
6191360-19136034.48934.74
60min1214521-21452138.66338.839.3639.0139.169.37
2200548-20054836.14536.43
3197784-19778435.64735.94
4253187-25318745.63246.02
5218925-21892539.45739.78
6207778-20777837.44837.75
90min1240807-24080743.40143.789.2743.8144.179.28
2224415-22441540.44740.79
3221223-22122339.87140.23
4283041-28304151.01351.48
5251152-25115245.26545.65
6236851-23685142.68843.06
极限1389402-38940270.18272.674.0970.6673.134.11
2384994-38499469.38869.80
3413178-41317874.46874.89
4428708-42870877.26777.82
5395098-39509871.20971.67
6407699-40769973.48073.92
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
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%
1111.95512545489525494875483425481975492460.23
2112.95517555493305505420.32
单位质量响应值RSD%判断
4908.364876.370.47数据可信
供试品溶液-2409136批-pH1.2(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1134780-13478024.39823.5822.9524.4023.5822.96
2102161-10216118.49318.49
3164012-16401229.68929.69
4167273-16727330.28030.28
5102070-10207018.47718.48
6111390-11139020.16420.16
10min1210197-21019738.05041.6710.4038.0941.7110.40
2251921-25192145.60245.63
3242509-24250943.89943.95
4257869-25786946.67946.73
5199183-19918336.05636.09
6219534-21953439.74039.77
15min1246286-24628644.58248.645.7244.6948.755.72
2286393-28639351.84251.95
3267580-26758048.43748.56
4285973-28597351.76651.89
5262470-26247047.51247.60
6263628-26362847.72247.82
20min1271986-27198649.23553.524.7449.4153.714.75
2309163-30916355.96456.16
3292216-29221652.89753.10
4309688-30968856.05956.27
5291557-29155752.77752.95
6299330-29933054.18454.36
30min1317353-31735357.44760.533.5157.7160.803.52
2347050-34705062.82363.11
3330677-33067759.85960.15
4347626-34762662.92763.23
5327682-32768259.31759.57
6335776-33577660.78261.05
45min1356313-35631364.49967.363.4264.8667.743.43
2381391-38139169.03969.43
3372391-37239167.41067.80
4391251-39125170.82471.24
5362467-36246765.61365.97
6368967-36896766.79067.16
60min1384096-38409669.52972.003.4869.9972.493.49
2407445-40744573.75574.26
3399498-39949872.31772.82
4418974-41897475.84276.37
5383730-38373069.46269.93
6392718-39271871.08971.57
90min1416746-41674675.43977.863.7576.0278.473.75
2441143-44114379.85580.48
3433349-43334978.44479.07
4454839-45483982.33482.99
5412526-41252674.67575.26
6422171-42217176.42177.02
极限1498804-49880490.29390.421.1991.0091.171.21
2499920-49992090.49591.26
3497164-49716489.99690.75
4510906-51090692.48493.28
5494164-49416489.45390.16
6496235-49623589.82890.56
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
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%
1111.95566165574105592595575215561825573980.22
2112.95514075509025511540.07
单位质量响应值RSD%判断
4981.224881.791.43数据可信
供试品溶液-2409136批-pH4.0(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183656-18365632.98426.5537.4132.9826.5537.41
294136-9413616.90716.91
376783-7678313.79013.79
4147785-14778526.54226.54
5159729-15972928.68728.69
6224851-22485140.38340.38
10min1260333-26033346.75540.1216.3146.8140.1716.32
2228783-22878341.08941.12
3170565-17056530.63330.66
4229879-22987941.28641.33
5190778-19077834.26334.31
6260039-26003946.70346.77
15min1274276-27427649.26044.769.7749.3944.889.80
2247505-24750544.45244.55
3234026-23402642.03142.10
4248929-24892944.70744.82
5213173-21317338.28638.39
6277563-27756349.85050.00
20min1289416-28941651.97947.669.1552.1947.849.17
2263466-26346647.31847.49
3250109-25010944.91945.06
4266730-26673047.90448.09
5228915-22891541.11341.28
6293592-29359252.72952.96
30min1320655-32065557.58952.958.2657.8953.218.28
2290669-29066952.20452.45
3280657-28065750.40650.62
4296838-29683853.31253.58
5258183-25818346.36946.61
6321791-32179157.79358.11
45min1357194-35719464.15159.637.2564.5559.987.27
2327113-32711358.74959.09
3319570-31957057.39457.70
4334342-33434260.04760.40
5295114-29511453.00253.32
6358670-35867064.41764.83
60min1386850-38685069.47864.806.8769.9865.256.90
2355872-35587263.91464.35
3346686-34668662.26462.66
4364918-36491865.53966.00
5322900-32290057.99258.40
6387558-38755869.60570.12
90min1433624-43362477.87872.806.3778.5073.366.40
2403505-40350572.46973.01
3388823-38882369.83270.33
4413258-41325874.22074.79
5364598-36459865.48165.98
6428372-42837276.93577.57
极限1516473-51647392.75892.290.8893.5192.970.90
2505767-50576790.83591.50
3515432-51543292.57193.19
4518075-51807593.04593.73
5511673-51167391.89692.50
6515848-51584892.64593.41
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
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%
1111.95556195563715553135549865555865555750.10
2112.95590765585715588240.07
单位质量响应值RSD%判断
4964.924949.730.22数据可信
供试品溶液-2409136批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189650-18965033.88020.5436.3133.8820.5436.31
299497-9949717.77517.77
387739-8773915.67415.67
470125-7012512.52712.53
5116065-11606520.73420.73
6126719-12671922.63822.64
10min1251814-25181444.98539.1913.0645.0439.2313.07
2219688-21968839.24639.28
3195814-19581434.98135.01
4221372-22137239.54739.57
5179000-17900031.97732.01
6248707-24870744.43044.47
15min1271470-27147048.49744.639.4448.6344.739.45
2256038-25603845.74045.83
3242224-24222443.27243.36
4248482-24848244.39044.48
5208479-20847937.24437.33
6272231-27223148.63348.74
20min1291733-29173352.11748.348.6152.3348.518.62
2274807-27480749.09349.26
3268908-26890848.03948.20
4268877-26887748.03448.19
5227980-22798040.72840.88
6291203-29120352.02252.21
30min1318353-31835356.87254.246.7757.1754.496.79
2306034-30603454.67154.92
3302653-30265354.06754.30
4306346-30634654.72754.97
5264999-26499947.34147.56
6323335-32333557.76258.04
45min1352063-35206362.89461.105.2963.2961.445.31
2341488-34148861.00561.35
3342217-34221761.13561.46
4350009-35000962.52762.86
5307530-30753054.93955.24
6358789-35878964.09664.47
60min1376414-37641467.24566.524.4267.7466.964.44
2370256-37025666.14466.59
3374637-37463766.92767.36
4384182-38418268.63269.07
5341293-34129360.97061.36
6387207-38720769.17369.66
90min1411101-41110173.44174.553.6174.0575.103.62
2418187-41818774.70775.26
3419908-41990875.01575.55
4433761-43376177.48978.04
5391438-39143869.92970.42
6429434-42943476.71677.31
极限1526468-52646894.05193.330.9894.7894.011.02
2516989-51698992.35893.04
3523615-52361593.54194.21
4525440-52544093.86794.55
5515078-51507892.01692.62
6526961-52696194.13994.86
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