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%
1113.65716065713945725345690625715755712340.23
2114.35732455715895724170.21
单位质量响应值RSD%判断
5028.475008.020.29数据可信
供试品溶液-js1M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%
5min1404040-40404071.30472.671.5271.3072.671.53
2405100-40510071.49171.49
3415616-41561673.34773.35
4416599-41659973.52073.52
5418897-41889773.92673.93
6410306-41030672.40972.41
10min1447713-44771379.01181.011.6279.1381.131.62
2451639-45163979.70479.82
3464751-46475182.01882.14
4464905-46490582.04582.17
5462291-46229181.58481.71
6462834-46283481.67981.80
15min1478708-47870884.48185.760.9784.7386.020.97
2481451-48145184.96585.22
3489278-48927886.34686.61
4488838-48883886.26986.53
5489773-48977386.43486.69
6487840-48784086.09286.35
20min1492404-49240486.89888.761.1787.2989.161.17
2500898-50089888.39788.79
3509392-50939289.89690.30
4505239-50523989.16389.57
5504647-50464789.05889.46
6505233-50523389.16289.56
30min1515338-51533890.94592.300.9791.4892.850.98
2519114-51911491.61292.15
3526873-52687392.98193.53
4527386-52738693.07193.62
5527426-52742693.07893.63
6522090-52209092.13792.69
45min1530165-53016593.56295.441.3494.2596.141.34
2539080-53908095.13595.83
3549992-54999297.06197.77
4548109-54810996.72897.44
5539127-53912795.14395.85
6538441-53844195.02295.72
60min1542386-54238695.71996.450.6096.5697.310.61
2545244-54524496.22397.08
3550528-55052897.15598.02
4550510-55051097.15298.02
5545335-54533596.23997.10
6545278-54527896.22997.09
极限1548788-54878896.84897.340.5697.8598.360.56
2550141-55014197.08798.10
3555019-55501997.94898.98
4555631-55563198.05699.09
5551253-55125397.28398.31
6548734-54873496.83997.86
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%
1113.65722165715015716285719825741495722950.19
2114.35878275820405849340.70
单位质量响应值RSD%判断
5037.815117.531.12数据可信
供试品溶液-js2M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%
5min1406182-40618270.84771.161.1470.8571.161.13
2407774-40777471.12571.12
3414127-41412772.23372.23
4403481-40348170.37670.38
5412976-41297672.03272.03
6403463-40346370.37370.37
10min1444641-44464177.55579.091.2877.6779.201.28
2453947-45394779.17879.30
3458219-45821979.92380.04
4453706-45370679.13679.25
5460544-46054480.32980.45
6449455-44945578.39578.51
15min1471256-47125682.19783.701.2982.4483.951.30
2479832-47983283.69383.94
3484899-48489984.57784.83
4481063-48106383.90884.16
5487688-48768885.06385.32
6474452-47445282.75583.00
20min1485915-48591584.75486.711.3885.1487.101.38
2497094-49709486.70487.09
3500887-50088787.36587.76
4504238-50423887.95088.34
5501915-50191587.54587.94
6492639-49263985.92786.31
30min1507826-50782688.57690.701.3689.1091.241.36
2520642-52064290.81191.35
3525139-52513991.59592.14
4522066-52206691.06091.60
5527631-52763192.03092.57
6516664-51666490.11790.65
45min1523180-52318091.25493.331.4291.9394.021.42
2532851-53285192.94193.63
3538316-53831693.89494.59
4536044-53604493.49894.18
5546371-54637195.29995.99
6533727-53372793.09393.77
60min1531137-53113792.64294.891.6993.4795.731.69
2542906-54290694.69495.54
3546319-54631995.29096.14
4551174-55117496.13796.98
5555986-55598696.97697.83
6536619-53661993.59894.43
极限1537691-53769193.78595.831.4994.7696.821.49
2548482-54848295.66796.67
3554777-55477796.76597.77
4549308-54930895.81196.81
5561430-56143097.92598.94
6544723-54472395.01196.00
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%
1113.65763705776925815855795705762045782840.40
2114.35784815837635811220.65
单位质量响应值RSD%判断
5090.535084.180.09数据可信
供试品溶液-js3M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%
5min1411301-41130171.59971.530.6071.6071.530.60
2407099-40709970.86770.87
3414685-41468572.18872.19
4411641-41164171.65871.66
5410446-41044671.45071.45
6410208-41020871.40871.41
10min1458511-45851179.81779.520.4979.9479.640.49
2455351-45535179.26779.39
3458392-45839279.79679.92
4459329-45932979.95980.08
5455346-45534679.26679.39
6453884-45388479.01279.13
15min1483270-48327084.12783.830.5884.3884.080.59
2480242-48024283.60083.85
3485039-48503984.43584.69
4483624-48362484.18984.44
5478867-47886783.36183.61
6478314-47831483.26483.51
20min1495877-49587786.32287.180.6986.7187.570.69
2504703-50470387.85888.25
3503082-50308287.57687.97
4503290-50329087.61288.01
5498517-49851786.78187.17
6499272-49927286.91387.30
30min1517507-51750790.08790.720.6390.6291.260.63
2521450-52145090.77391.31
3526932-52693291.72892.27
4520781-52078190.65791.20
5521502-52150290.78291.32
6518849-51884990.32190.85
45min1535372-53537293.19793.590.6393.8894.280.63
2537724-53772493.60694.29
3542502-54250294.43895.13
4535010-53501093.13493.82
5540775-54077594.13794.82
6534411-53441193.03093.71
60min1543908-54390894.68394.870.5895.5295.720.58
2548928-54892895.55796.40
3548081-54808195.40996.26
4545347-54534794.93395.78
5540619-54061994.11094.95
6543154-54315494.55295.39
极限1549692-54969295.69095.800.7696.6996.800.75
2553571-55357196.36597.37
3556462-55646296.86897.88
4544649-54464994.81295.82
5548477-54847795.47896.48
6548968-54896895.56496.56
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