非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 11.133810723799343798233806533797103802380.16
2 11.113791013790743790880.01
单位质量响应值RSD%判断
34163.3434121.330.09数据可信
加速6月-供试品溶液-2025083121批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1277921-27792173.20272.682.2373.2072.682.23
2280523-28052373.88773.89
3271627-27162771.54471.54
4270929-27092971.36071.36
5284884-28488475.03675.04
6269646-26964671.02271.02
10min1331187-33118787.23287.250.5487.3587.370.54
2333632-33363287.87688.00
3329678-32967886.83486.95
4333056-33305687.72487.84
5330763-33076387.12087.25
6329235-32923586.71886.84
15min1343790-34379090.55190.820.5290.8291.080.52
2346632-34663291.30091.57
3343973-34397390.60090.86
4347417-34741791.50791.77
5343307-34330790.42490.69
6343630-34363090.50990.77
20min1349541-34954192.06692.340.4892.4892.760.48
2352380-35238092.81493.24
3350542-35054292.33092.74
4352881-35288192.94693.36
5348975-34897591.91792.34
6349269-34926991.99592.41
30min1356291-35629193.84494.040.4494.4294.610.44
2357936-35793694.27794.85
3356858-35685893.99394.56
4359680-35968094.73795.31
5355234-35523493.56694.14
6356232-35623293.82994.40
45min1360030-36003094.82995.280.7395.5696.010.72
2363720-36372095.80196.53
3361395-36139595.18895.91
4364021-36402195.88096.61
5357518-35751894.16794.90
6363867-36386795.83996.56
60min1361668-36166895.26095.460.5096.1596.350.50
2365096-36509696.16397.06
3361964-36196495.33896.22
4364147-36414795.91396.80
5360535-36053594.96295.85
6361244-36124495.14996.03
极限1363942-36394295.85995.780.6096.9096.820.60
2365219-36521996.19697.25
3363926-36392695.85596.90
4366049-36604996.41497.46
5359862-35986294.78595.83
6362779-36277995.55396.59
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 11.133780083779853783363781403772013779340.12
2 11.113780983778013779500.06
单位质量响应值RSD%判断
33956.3334018.900.14数据可信
加速6月-供试品溶液-2025083121批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1273414-27341472.34352.6440.4272.3452.6440.42
2222119-22211958.77158.77
3107718-10771828.50128.50
4239796-23979663.44863.45
5262371-26237169.42169.42
688339-8833923.37423.37
10min1328450-32845086.90583.445.5987.0383.535.63
2323877-32387785.69585.79
3300517-30051779.51479.56
4322848-32284885.42385.53
5329797-32979787.26187.38
6286653-28665375.84675.88
15min1343176-34317690.80189.641.2891.0789.861.32
2339797-33979789.90790.15
3335124-33512488.67188.85
4340958-34095890.21490.46
5341663-34166390.40190.66
6331956-33195687.83288.00
20min1347190-34719091.86391.750.4892.2892.120.51
2346084-34608491.57191.96
3346892-34689291.78492.11
4347077-34707791.83392.23
5349150-34915092.38292.79
6344100-34410091.04691.36
30min1354249-35424993.73193.720.3994.3094.250.42
2353991-35399193.66394.21
3354470-35447093.78994.27
4355396-35539694.03494.59
5355342-35534294.02094.59
6351687-35168793.05393.52
45min1358566-35856694.87394.740.9095.6095.420.89
2352590-35259093.29293.99
3360898-36089895.49096.13
4356606-35660694.35595.06
5361359-36135995.61296.33
6358321-35832194.80895.43
60min1361744-36174495.71495.670.3696.6096.510.37
2360789-36078995.46196.32
3363019-36301996.05196.85
4360347-36034795.34496.21
5363161-36316196.08996.97
6360322-36032295.33896.11
极限1360683-36068395.43395.640.5196.4896.640.50
2359432-35943295.10296.12
3363402-36340296.15397.11
4360568-36056895.40396.43
5364027-36402796.31897.36
6360663-36066395.42896.36
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 11.133770253771753779303774913773453773930.10
2 11.113791013798093794550.14
单位质量响应值RSD%判断
33907.7334154.370.52数据可信
加速6月-供试品溶液-BXK0LE1批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1157194-15719441.54039.214.9041.5439.204.90
2138633-13863336.63536.63
3147628-14762839.01239.01
4146442-14644238.69838.70
5143796-14379637.99938.00
6156474-15647441.34941.35
10min1315177-31517783.28878.313.9683.3678.383.96
2283431-28343174.89874.96
3287477-28747775.96876.03
4304764-30476480.53680.60
5293335-29333577.51677.58
6293837-29383777.64877.72
15min1360366-36036695.22994.981.8295.4495.181.82
2356109-35610994.10494.29
3352086-35208693.04193.23
4368957-36895797.49997.70
5354276-35427693.62093.81
6364810-36481096.40396.60
20min1362561-36256195.80996.601.1496.1896.951.14
2361615-36161595.55995.90
3364508-36450896.32496.67
4372573-37257398.45598.82
5363719-36371996.11596.46
6368259-36825997.31597.67
30min1365176-36517696.50097.190.9897.0397.710.98
2364399-36439996.29596.80
3364890-36489096.42496.93
4373458-37345898.68999.21
5369169-36916997.55598.06
6369668-36966897.68798.21
45min1366212-36621296.77497.280.9497.4697.950.94
2363546-36354696.06996.73
3367756-36775697.18297.85
4373847-37384798.79199.48
5369222-36922297.56998.24
6368126-36812697.28097.96
60min1361342-36134295.48796.831.2296.3497.661.21
2363297-36329796.00496.83
3363672-36367296.10396.93
4372773-37277398.50899.36
5370398-37039897.88098.71
6366960-36696096.97197.82
极限1362615-36261595.82396.700.8196.8397.700.81
2363661-36366196.10097.08
3364560-36456096.33797.33
4370781-37078197.98199.00
5366840-36684096.94097.94
6367040-36704096.99398.00
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 11.133790593788043782543789933793833788990.11
2 11.113798293792603795440.11
单位质量响应值RSD%判断
34043.0434162.380.25数据可信
加速6月-供试品溶液-BXK0LE1批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154854-15485440.83539.393.1540.8339.393.15
2147200-14720038.81638.82
3155357-15535740.96740.97
4148461-14846139.14939.15
5143852-14385237.93437.93
6146442-14644238.61738.62
10min1310542-31054281.88982.492.8481.9682.562.84
2316978-31697883.58783.65
3315406-31540683.17283.24
4308371-30837181.31781.38
5299697-29969779.03079.09
6325988-32598885.96286.03
15min1364750-36475096.18496.870.7596.3997.070.75
2364414-36441496.09596.30
3368460-36846097.16297.37
4366566-36656696.66396.86
5368099-36809997.06797.26
6371787-37178798.04098.25
20min1367470-36747096.90197.580.7497.2797.940.74
2366884-36688496.74797.11
3370812-37081297.78398.15
4370947-37094797.81898.18
5369706-36970697.49197.85
6374420-37442098.73499.10
30min1371146-37114697.87197.410.6698.4097.940.65
2365949-36594996.50097.03
3370158-37015897.61098.14
4369201-36920197.35897.88
5372474-37247498.22198.74
6367408-36740896.88597.42
45min1370624-37062497.73397.650.8398.4298.340.83
2365044-36504496.26296.95
3370431-37043197.68298.38
4369163-36916397.34898.03
5373342-37334298.45099.13
6373237-37323798.42299.12
60min1367292-36729296.85497.370.7397.7198.220.72
2365147-36514796.28997.14
3369349-36934997.39798.25
4369749-36974997.50298.35
5371755-37175598.03198.88
6372170-37217098.14199.00
极限1368958-36895897.29496.820.4398.3197.840.43
2365065-36506596.26797.27
3367339-36733996.86797.89
4367499-36749996.90997.92
5368632-36863297.20898.22
6365575-36557596.40297.43
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