瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所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5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002516892514812517682515832515692516180.05
211.152567582569042568310.05
单位质量响应值RSD%判断
22874.3623034.170.50数据可信
供试品溶液-506376批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228299-22829984.73479.773.7084.7379.773.70
2212171-21217178.74878.75
3206263-20626376.55576.56
4218553-21855381.11781.12
5208572-20857277.41277.41
6215653-21565380.04180.04
10min1252426-25242693.68991.402.9194.6392.292.90
2244524-24452490.75691.63
3233759-23375986.76187.61
4249612-24961292.64593.55
5252878-25287893.85794.72
6244401-24440190.71091.60
15min1255483-25548394.82492.042.9596.8193.942.94
2245997-24599791.30393.19
3235625-23562587.45389.27
4252691-25269193.78795.72
5252844-25284493.84495.75
6245237-24523791.02192.92
20min1249958-24995892.77391.752.3995.8194.682.39
2244551-24455190.76693.66
3237136-23713688.01490.80
4253757-25375794.18397.16
5251014-25101493.16596.11
6246830-24683091.61294.52
30min1246931-24693191.65089.332.2595.7293.282.26
2239596-23959688.92792.83
3233879-23387986.80590.57
4246409-24640991.45695.48
5241728-24172889.71893.70
6235573-23557387.43491.36
45min1242665-24266590.06687.772.1495.1592.712.16
2234704-23470487.11192.01
3227786-22778684.54489.27
4238744-23874488.61193.65
5238675-23867588.58593.56
6236333-23633387.71692.61
60min1241041-24104189.46387.202.6095.5593.122.58
2234203-23420386.92592.79
3225599-22559983.73289.40
4240063-24006389.10095.12
5238502-23850288.52194.48
6230295-23029585.47591.35
极限1242198-24219889.89389.802.3596.9796.682.25
2239908-23990889.04395.87
3242785-24278590.11196.71
4251576-25157693.374100.38
5241271-24127189.54996.49
6233985-23398586.84593.67
瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所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5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002525462521422518202522482525112522530.12
211.152580732580012580370.02
单位质量响应值RSD%判断
22932.0923142.330.65数据可信
供试品溶液-506376批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1211560-21156078.23973.833.9678.2473.823.96
2190143-19014370.31970.32
3193763-19376371.65871.66
4205436-20543675.97575.97
5196354-19635472.61672.62
6200487-20048774.14474.14
10min1245150-24515090.66284.225.0091.5385.044.98
2214655-21465579.38480.17
3217721-21772180.51881.31
4227201-22720184.02484.87
5235961-23596187.26388.07
6225647-22564783.44984.27
15min1254991-25499194.30187.315.8796.1889.075.83
2223000-22300082.47084.13
3225898-22589883.54285.23
4235096-23509686.94388.72
5251252-25125292.91894.69
6226332-22633283.70285.45
20min1252023-25202393.20388.164.0096.1390.894.02
2227460-22746084.12086.70
3231795-23179585.72388.34
4238605-23860588.24190.98
5247225-24722591.42994.24
6233220-23322086.25088.93
30min1252114-25211493.23789.402.9197.2093.112.97
2232101-23210185.83689.35
3239758-23975888.66892.24
4242134-24213489.54693.27
5246731-24673191.24695.07
6237655-23765587.89091.53
45min1254586-25458694.15189.512.9899.1594.213.03
2236046-23604687.29591.76
3238212-23821288.09692.65
4238430-23843088.17692.90
5246861-24686191.29496.13
6238158-23815888.07692.69
60min1249061-24906192.10888.832.8098.1594.532.84
2236032-23603287.29092.73
3233932-23393286.51392.05
4234543-23454386.73992.44
5247850-24785091.66097.51
6239808-23980888.68694.28
极限1250721-25072192.72288.932.6099.7995.612.64
2236584-23658487.49493.90
3238321-23832188.13694.63
4233334-23333486.29292.95
5244661-24466190.48197.35
6239238-23923888.47595.06
瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所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5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002541832541072541922544252538772541570.08
211.152526072530012528040.12
单位质量响应值RSD%判断
23105.1822673.001.34数据可信
供试品溶液-WK0055批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183452-18345268.28864.139.3668.2964.139.36
2162561-16256160.51260.51
3152788-15278856.87456.87
4181907-18190767.71367.71
5159592-15959259.40659.41
6193394-19339471.98971.99
10min1222426-22242682.79681.186.5483.5581.896.54
2223186-22318683.07983.75
3200614-20061474.67775.31
4210416-21041678.32579.08
5210372-21037278.30978.97
6241491-24149189.89390.69
15min1233370-23337086.87084.697.3688.5586.307.33
2233363-23336386.86788.46
3218395-21839581.29582.76
4210958-21095878.52780.15
5213534-21353479.48681.02
6255430-25543095.08196.88
20min1228456-22845685.04087.743.5487.6890.303.59
2234863-23486387.42589.99
3230551-23055185.82088.19
4238119-23811988.63791.13
5231103-23110386.02688.44
6251221-25122193.51496.37
30min1222763-22276382.92184.093.4586.5187.623.36
2233067-23306786.75790.29
3224291-22429183.49086.81
4212560-21256079.12382.60
5232033-23203386.37289.74
6230671-23067185.86589.76
45min1230853-23085385.93385.073.8090.4489.533.73
2227303-22730384.61189.11
3227000-22700084.49888.74
4213037-21303779.30183.66
5236000-23600087.84992.18
6237009-23700988.22493.07
60min1232701-23270186.62187.095.2092.0992.505.00
2231661-23166186.23391.67
3229867-22986785.56690.75
4215738-21573880.30685.55
5251748-25174893.71199.02
6242115-24211590.12595.95
极限1247966-24796692.30392.830.9798.7399.211.10
2247929-24792992.28998.68
3249177-24917792.75498.89
4246639-24663991.80997.94
5251967-25196793.792100.14
6252671-25267194.054100.88
瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所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5000
标示量(mg)20供试品稀释倍数10系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.002502282503852505882505922500032503590.11
211.152522422527182524800.14
单位质量响应值RSD%判断
22759.9122643.950.37数据可信
供试品溶液-24121703批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188963-8896333.38651.4521.0333.3951.4521.03
2144835-14483554.35354.35
3135993-13599351.03551.04
4150262-15026256.39056.39
5126752-12675247.56747.57
6175787-17578765.96965.97
10min1178464-17846466.97476.608.3367.3477.178.41
2220449-22044982.73083.33
3200585-20058575.27575.84
4209510-20951078.62479.25
5192859-19285972.37672.90
6222852-22285283.63184.36
15min1223363-22336383.82386.623.3484.9488.043.47
2239225-23922589.77691.30
3229434-22943486.10187.50
4231014-23101486.69488.19
5221745-22174583.21684.55
6240100-24010090.10491.77
20min1234492-23449288.00089.592.6090.0591.982.72
2241193-24119390.51493.04
3237853-23785389.26191.62
4234575-23457588.03190.49
5234239-23423987.90590.16
6250098-25009893.85696.52
30min1230301-23030186.42787.611.7689.4590.991.86
2231539-23153986.89190.42
3238717-23871789.58592.94
4233722-23372287.71191.15
5228581-22858185.78189.02
6237819-23781989.24892.95
45min1232929-23292987.41388.240.7391.4092.600.86
2233940-23394087.79292.28
3237504-23750489.13093.48
4236505-23650588.75593.17
5234376-23437687.95692.14
6235556-23555688.39993.10
60min1237075-23707588.96988.792.9893.9294.122.89
2246222-24622292.40297.87
3234434-23443487.97893.32
4225524-22552484.63490.04
5234821-23482188.12393.29
6241505-24150590.63196.31
极限1233416-23341687.59689.131.9293.5495.451.91
2244965-24496591.93098.42
3241266-24126690.54296.86
4235249-23524988.28494.63
5235203-23520388.26694.41
6234887-23488788.14894.83
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