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%
1114.45689035597875647875657935643215647180.59
2114.85671335674165672740.04
单位质量响应值RSD%判断
4936.354941.410.08数据可信
供试品溶液-25052301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%
5min1237779-23777942.63735.3414.0942.6435.3414.10
2171764-17176430.79930.80
3202621-20262136.33236.33
4209451-20945137.55737.56
5200784-20078436.00336.00
6160193-16019328.72528.72
10min1322757-32275757.87455.056.7457.9555.116.75
2298241-29824153.47853.53
3304978-30497854.68654.75
4315504-31550456.57456.64
5328987-32898758.99159.05
6271587-27158748.69948.75
15min1378316-37831667.83764.925.9068.0065.075.91
2350481-35048162.84562.99
3349082-34908262.59562.75
4369837-36983766.31666.47
5391038-39103870.11870.28
6333524-33352459.80559.93
20min1424349-42434976.09172.115.1276.3772.365.12
2388290-38829069.62569.87
3390360-39036069.99670.25
4411752-41175273.83274.10
5423268-42326875.89776.17
6374770-37477067.20167.43
30min1458089-45808982.14180.963.6682.5581.343.68
2435614-43561478.11178.47
3451306-45130680.92581.30
4457970-45797082.12082.51
5475622-47562285.28585.69
6430405-43040577.17777.52
45min1507706-50770691.03889.443.4891.5889.953.49
2477071-47707185.54586.04
3500448-50044889.73690.24
4501673-50167389.95690.48
5524199-52419993.99594.54
6481559-48155986.34986.82
60min1530969-53096995.20994.373.3095.9195.043.31
2502961-50296190.18790.82
3530083-53008395.05095.71
4527391-52739194.56895.24
5553475-55347599.24599.95
6512861-51286191.96292.58
90min1555186-55518699.55299.242.63100.41100.062.64
2535691-53569196.05696.84
3559144-559144100.261101.08
4549516-54951698.53599.37
5577756-577756103.599104.46
6543494-54349497.45598.22
极限1566496-566496101.580101.962.18102.60102.942.19
2559251-559251100.280101.22
3576444-576444103.363104.35
4562933-562933100.941101.94
5589604-589604105.723106.76
6556842-55684299.848100.78
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%
1114.45660265657635654625656625657355657300.04
2114.85686815682795684800.06
单位质量响应值RSD%判断
4945.194951.920.10数据可信
供试品溶液-25052302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%
5min1187038-18703833.47340.6811.4833.4740.6811.48
2241152-24115243.15743.16
3265403-26540347.49747.50
4216344-21634438.71738.72
5229628-22962841.09541.09
6224229-22422940.12840.13
10min1310692-31069255.60259.876.3255.6659.946.33
2336489-33648960.21960.29
3372993-37299366.75166.83
4331854-33185459.38959.45
5321307-32130757.50257.57
6334063-33406359.78459.85
15min1366365-36636565.56569.204.1965.7169.374.20
2391255-39125570.02070.19
3414656-41465674.20774.40
4379183-37918367.85968.02
5380813-38081368.15168.32
6387828-38782869.40669.57
20min1404463-40446372.38376.053.2972.6476.343.30
2425030-42503076.06476.35
3445159-44515979.66679.98
4416400-41640074.52074.80
5425346-42534676.12176.40
6433453-43345377.57177.85
30min1453288-45328881.12184.612.6681.5085.022.67
2480579-48057986.00586.42
3490363-49036387.75688.20
4468426-46842683.83084.23
5469057-46905783.94384.35
6474892-47489284.98785.40
45min1500735-50073589.61292.812.1990.1393.362.20
2529532-52953294.76695.32
3531561-53156195.12995.72
4514279-51427992.03692.58
5514971-51497192.16092.70
6520396-52039693.13193.68
60min1529975-52997594.84597.661.7595.5198.361.77
2553798-55379899.10899.83
3557050-55705099.690100.44
4543112-54311297.19697.89
5543329-54332997.23597.93
6546902-54690297.87498.58
90min1556240-55624099.546102.281.59100.37103.141.60
2581651-581651104.093104.98
3579130-579130103.642104.56
4570976-570976102.183103.04
5568046-568046101.658102.52
6572905-572905102.528103.40
极限1568732-568732101.781104.031.30102.77105.071.32
2587678-587678105.172106.23
3587028-587028105.055106.15
4578222-578222103.479104.51
5578885-578885103.598104.63
6587315-587315105.107106.15
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%
1114.45686875696145683645689895666815684670.20
2114.85778885779685779280.01
单位质量响应值RSD%判断
4969.125034.220.93数据可信
供试品溶液-1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%
5min1193540-19354034.27042.6222.7934.2742.6222.79
2253093-25309344.81544.81
3218572-21857238.70238.70
4174190-17419030.84430.84
5310226-31022654.93154.93
6294649-29464952.17352.17
10min1332816-33281658.93161.004.0458.9961.074.05
2366505-36650564.89664.97
3328112-32811258.09858.16
4340638-34063860.31660.37
5347069-34706961.45561.55
6351891-35189162.30962.40
15min1365316-36531664.68668.123.1464.8468.303.16
2383535-38353567.91268.09
3388269-38826968.75068.91
4377807-37780766.89867.05
5396665-39666570.23770.43
6396824-39682470.26570.46
20min1403331-40333171.41774.282.1671.6874.562.17
2420070-42007074.38174.68
3423148-42314874.92675.20
4416055-41605573.67073.93
5428437-42843775.86376.17
6425811-42581175.39875.71
30min1454997-45499780.56682.561.8680.9582.971.87
2459097-45909781.29281.71
3466616-46661682.62383.02
4467421-46742182.76683.15
5479647-47964784.93085.37
6469913-46991383.20783.64
45min1505190-50519089.45390.161.0989.9790.711.09
2502348-50234888.95089.51
3509534-50953490.22290.76
4511993-51199390.65891.18
5518168-51816891.75192.33
6507835-50783589.92290.49
60min1533368-53336894.44394.761.1395.1195.461.13
2526894-52689493.29694.00
3536719-53671995.03695.72
4539234-53923495.48196.16
5543747-54374796.28097.01
6530959-53095994.01694.74
90min1560650-56065099.27399.360.90100.10100.220.89
2557438-55743898.70599.56
3559589-55958999.08699.93
4564123-56412399.888100.72
5569496-569496100.840101.73
6555656-55565698.38999.27
极限1570900-570900101.088100.570.84102.08101.600.83
2563078-56307899.703100.73
3566954-566954100.390101.40
4569642-569642100.866101.87
5574768-574768101.773102.83
6562578-56257899.615100.66
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%
1114.45737385725225717095737015723085727960.16
2114.85780655790305785480.12
单位质量响应值RSD%判断
5006.965039.620.46数据可信
供试品溶液-2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%
5min1203954-20395435.95745.6613.6635.9645.6613.66
2277738-27773848.96548.97
3234081-23408141.26941.27
4284645-28464550.18350.18
5298694-29869452.66052.66
6254861-25486144.93244.93
10min1346163-34616361.02964.053.9761.0964.123.97
2350648-35064861.82061.90
3384606-38460667.80667.88
4363908-36390864.15764.24
5360077-36007763.48263.57
6374286-37428665.98766.06
15min1394251-39425169.50771.093.9569.6771.283.95
2382038-38203867.35467.54
3395839-39583969.78769.97
4404303-40430371.27971.47
5423793-42379374.71574.91
6419236-41923673.91274.10
20min1425981-42598175.10175.762.7075.3876.072.70
2417769-41776973.65373.95
3420995-42099574.22274.52
4426584-42658475.20775.52
5448174-44817479.01379.33
6438957-43895777.38877.70
30min1475777-47577783.88084.501.7284.2884.931.72
2471831-47183183.18483.60
3475904-47590483.90284.32
4473045-47304583.39883.83
5488302-48830286.08886.54
6490975-49097586.55987.00
45min1519569-51956991.60092.711.1392.1493.281.13
2519701-51970191.62492.18
3527734-52773493.04093.60
4523336-52333692.26592.84
5532727-53272793.92094.51
6532104-53210493.81094.39
60min1548311-54831196.66897.681.0297.3698.401.03
2547639-54763996.54997.26
3555570-55557097.94798.66
4552362-55236297.38298.11
5561358-56135898.96899.72
6559064-55906498.56399.30
90min1577034-577034101.732102.181.03102.59103.071.03
2572630-572630100.955101.83
3585258-585258103.181104.06
4573868-573868101.173102.06
5586730-586730103.441104.36
6581982-581982102.604103.51
极限1583678-583678102.903103.081.12103.93104.131.12
2577331-577331101.784102.82
3591268-591268104.241105.29
4578520-578520101.994103.05
5593284-593284104.596105.68
6583996-583996102.959104.03
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