替普瑞酮颗粒项目信息
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%
1 112.65502485511385512195498275506795506220.11
2 110.85505835520445513140.19
单位质量响应值RSD%判断
4890.074975.761.23数据可信
供试品溶液-25070101批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1496674-49667489.17488.660.6889.1788.660.69
2496909-49690989.21689.22
3496686-49668689.17689.18
4490383-49038388.04488.04
5492485-49248588.42288.42
6489743-48974387.93087.93
10min1510380-51038091.63590.970.6691.7891.120.66
2509791-50979191.52991.68
3508493-50849391.29691.44
4505250-50525090.71490.86
5503400-50340090.38290.53
6502684-50268490.25390.40
15min1514408-51440892.35891.290.8292.6691.590.82
2511434-51143491.82492.13
3509339-50933991.44891.75
4507376-50737691.09591.39
5503685-50368590.43390.73
6504440-50444090.56890.87
20min1514704-51470492.41191.510.7892.8791.970.78
2513247-51324792.15092.60
3510157-51015791.59592.05
4509513-50951391.47991.93
5504430-50443090.56791.02
6506199-50619990.88491.33
30min1514528-51452892.38091.680.8392.9992.280.83
2515930-51593092.63193.24
3512249-51224991.97092.58
4508496-50849691.29791.90
5505915-50591590.83391.43
6506552-50655290.94891.55
45min1515721-51572192.59491.910.8093.3692.670.80
2515870-51587092.62093.38
3513152-51315292.13292.89
4513038-51303892.11292.87
5506928-50692891.01591.77
6506818-50681890.99591.75
60min1515495-51549592.55391.710.9393.4792.620.93
2515944-51594492.63493.55
3513520-51352092.19993.11
4508479-50847991.29392.20
5505724-50572490.79991.70
6505731-50573190.80091.70
90min1516111-51611192.66491.790.9493.7492.850.94
2517052-51705292.83393.90
3512900-51290092.08793.15
4508695-50869591.33292.39
5506055-50605590.85891.91
6506668-50666890.96892.02
120min1-0.0000.00-1.231.220.81
2-0.0001.23
3-0.0001.22
4-0.0001.21
5-0.0001.21
6-0.0001.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.231.220.81
2-0.0001.23
3-0.0001.22
4-0.0001.21
5-0.0001.21
6-0.0001.21
替普瑞酮颗粒项目信息
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%
1 112.65504965514625499875500565505375505080.11
2 110.85520935509055514990.16
单位质量响应值RSD%判断
4889.064977.431.27数据可信
供试品溶液-25070102批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1502215-50221590.16389.040.9690.1689.040.96
2489321-48932187.84887.85
3492268-49226888.37788.38
4495224-49522488.90888.91
5499409-49940989.65989.66
6497456-49745689.30989.31
10min1517497-51749792.90792.150.5493.0692.300.54
2515381-51538192.52792.67
3511114-51111491.76191.91
4513786-51378692.24192.39
5511145-51114591.76691.92
6510912-51091291.72591.87
15min1520512-52051293.44892.510.6193.7592.820.61
2516279-51627992.68892.99
3513300-51330092.15392.45
4516401-51640192.71093.01
5513653-51365392.21792.52
6511736-51173691.87392.17
20min1519491-51949193.26592.590.5593.7393.050.55
2519206-51920693.21493.67
3514026-51402692.28492.74
4514680-51468092.40192.86
5513492-51349292.18892.64
6513601-51360192.20792.66
30min1520551-52055193.45592.750.5494.0793.360.54
2517287-51728792.86993.48
3516674-51667492.75993.37
4518207-51820793.03493.64
5513183-51318392.13292.74
6513851-51385192.25292.86
45min1519007-51900793.17892.720.5393.9593.490.52
2516204-51620492.67593.44
3516758-51675892.77493.54
4519820-51982093.32494.09
5514229-51422992.32093.08
6512831-51283192.06992.83
60min1519982-51998293.35392.830.4794.2893.750.47
2518424-51842493.07393.99
3517218-51721892.85793.77
4518571-51857193.10094.02
5514155-51415592.30793.22
6514213-51421392.31793.23
90min1521220-52122093.57593.030.5694.6694.100.56
2519105-51910593.19694.27
3520922-52092293.52294.59
4518155-51815593.02594.10
5514693-51469392.40393.47
6514860-51486092.43393.50
120min1-0.0000.00-1.241.230.62
2-0.0001.23
3-0.0001.23
4-0.0001.23
5-0.0001.22
6-0.0001.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.241.230.62
2-0.0001.23
3-0.0001.23
4-0.0001.23
5-0.0001.22
6-0.0001.22
替普瑞酮颗粒项目信息
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%
1 112.65603405630775593855635165611145614860.32
2 110.85580415572285576340.11
单位质量响应值RSD%判断
4986.555032.800.66数据可信
供试品溶液-25070101批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1465978-46597882.37681.512.0982.3881.522.09
2456132-45613280.63680.64
3449214-44921479.41379.41
4454660-45466080.37680.38
5475799-47579984.11384.11
6464835-46483582.17482.17
10min1482657-48265785.32585.051.2585.4685.181.25
2476029-47602984.15384.29
3478255-47825584.54784.68
4475227-47522784.01184.15
5491397-49139786.87087.01
6482933-48293385.37485.51
15min1488864-48886486.42285.931.2686.7086.201.27
2478838-47883884.65084.92
3484612-48461285.67185.94
4479692-47969284.80185.07
5494256-49425687.37587.66
6490239-49023986.66586.94
20min1488273-48827386.31886.271.4486.7486.691.44
2481860-48186085.18485.60
3484688-48468885.68486.10
4481945-48194585.19985.61
5500284-50028488.44188.87
6491043-49104386.80787.23
30min1491546-49154686.89686.561.3387.4687.121.33
2482840-48284085.35785.91
3486261-48626185.96286.52
4483941-48394185.55286.11
5499621-49962188.32488.90
6493742-49374287.28587.85
45min1492543-49254387.07386.961.3087.7887.671.30
2483613-48361385.49486.19
3492111-49211186.99687.70
4487211-48721186.13086.83
5502299-50229988.79789.52
6493639-49363987.26687.98
60min1495689-49568987.62987.221.3888.4988.081.38
2488926-48892686.43387.28
3490548-49054886.72087.57
4485747-48574785.87186.71
5505171-50517189.30590.18
6494347-49434787.39188.25
90min1496237-49623787.72687.471.2488.7388.471.24
2489182-48918286.47887.46
3493184-49318487.18688.18
4489374-48937486.51287.50
5505751-50575189.40890.43
6494958-49495887.49988.50
120min1500838-50083888.53987.581.6189.6988.721.61
2487346-48734686.15487.28
3491559-49155986.89988.04
4487531-48753186.18787.32
5507244-50724489.67190.84
6497878-49787888.01689.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1501219-50121988.60687.711.6589.9089.001.65
2487205-48720586.12987.40
3492763-49276387.11188.39
4488146-48814686.29587.57
5508040-50804089.81291.13
6499633-49963388.32689.62
替普瑞酮颗粒项目信息
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%
1 112.65560245596205595195559575590645580370.34
2 110.85696185687465691820.11
单位质量响应值RSD%判断
4955.925137.022.54数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25070102批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1469678-46967882.45081.591.9882.4581.591.97
2446412-44641278.36678.37
3466229-46622981.84481.84
4466548-46654881.90081.90
5470549-47054982.60382.60
6469199-46919982.36682.37
10min1493555-49355586.64184.782.5386.7884.912.53
2476915-47691583.72083.85
3462205-46220581.13881.27
4481415-48141584.51084.65
5493701-49370186.66786.80
6489790-48979085.98086.12
15min1498639-49863987.53486.810.9387.8287.090.94
2488061-48806185.67785.95
3493580-49358086.64686.92
4490346-49034686.07886.36
5498699-49869987.54487.83
6497857-49785787.39787.68
20min1500882-50088287.92887.340.7788.3687.760.77
2492912-49291286.52886.94
3496960-49696087.23987.66
4493861-49386186.69587.12
5502624-50262488.23388.66
6497808-49780887.38887.81
30min1503274-50327488.34787.660.8788.9288.230.87
2495729-49572987.02387.58
3499073-49907387.61088.17
4493629-49362986.65487.22
5504906-50490688.63489.21
6499681-49968187.71788.29
45min1506922-50692288.98888.360.8189.7189.070.81
2500895-50089587.93088.63
3500811-50081187.91588.62
4497870-49787087.39988.11
5508164-50816489.20689.93
6505318-50531888.70689.42
60min1508273-50827389.22588.550.6790.0989.400.67
2503880-50388088.45489.30
3503122-50312288.32189.17
4499048-49904887.60688.46
5507653-50765389.11689.99
6504465-50446588.55789.42
90min1509865-50986589.50489.070.6890.5290.080.68
2507968-50796889.17190.17
3507547-50754789.09890.10
4501182-50118287.98088.98
5510989-51098989.70290.72
6506825-50682588.97189.98
120min1510008-51000889.53088.850.8190.7090.000.81
2508642-50864289.29090.43
3505565-50556588.75089.90
4501586-50158688.05189.20
5509956-50995689.52090.69
6500959-50095987.94189.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1509717-50971789.47888.680.8890.8089.980.88
2508324-50832489.23490.53
3503791-50379188.43889.74
4498360-49836087.48588.78
5508492-50849289.26390.58
6502228-50222888.16489.47
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