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RSF-703-230921对照品来源原料对照品使用方法直接使用
对照品含量(%)100.7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%
1 10.722460732463242461002460152462192461460.06
2 10.812487642495522491580.23
单位质量响应值RSD%判断
22961.3823048.840.27数据可信
供试品溶液-24111801批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133342-13334250.53547.5216.3950.5347.5216.39
2123222-12322246.70046.70
3140386-14038653.20453.20
4146395-14639555.48255.48
5120326-12032645.60245.60
688644-8864433.59533.59
10min1193336-19333673.27268.4812.8373.8369.0012.85
2188041-18804171.26571.78
3187586-18758671.09371.68
4197179-19717974.72875.34
5183544-18354469.56170.07
6134394-13439450.93451.31
15min1201088-20108876.21077.939.9277.5979.229.93
2209384-20938479.35480.66
3211298-21129880.07981.46
4213685-21368580.98482.43
5229692-22969287.05088.33
6168668-16866863.92364.86
20min1213220-21322080.80882.116.0983.0384.266.21
2215319-21531981.60383.80
3221494-22149483.94386.21
4229861-22986187.11489.46
5226874-22687485.98288.23
6193144-19314473.19974.85
30min1222100-22210084.17383.124.0087.2986.184.20
2222149-22214984.19287.29
3221473-22147383.93587.14
4226656-22665685.90089.21
5221645-22164584.00187.20
6201898-20189876.51778.98
45min1219524-21952483.19784.273.7087.2588.263.89
2227109-22710986.07190.11
3223385-22338584.66088.80
4232102-23210287.96492.23
5224122-22412284.93989.07
6207940-20794078.80782.12
60min1221056-22105683.77784.602.7088.7689.522.94
2225822-22582285.58490.57
3223022-22302284.52289.60
4229570-22957087.00492.25
5227245-22724586.12391.20
6212621-21262180.58184.77
极限1210940-21094079.94483.273.1185.8589.133.20
2222139-22213984.18890.13
3218688-21868882.88088.90
4225943-22594385.62991.84
5227651-22765186.27792.31
6212879-21287980.67885.76
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RSF-703-230921对照品来源原料对照品使用方法直接使用
对照品含量(%)100.7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%
1 10.722459282458792459052464602458562460060.11
2 10.812483422487602485510.12
单位质量响应值RSD%判断
22948.3222992.690.14数据可信
供试品溶液-24111801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%
5min1145472-14547255.21562.6511.8655.2162.6511.87
2141796-14179653.82053.82
3161054-16105461.12961.13
4170510-17051064.71864.72
5192433-19243373.03973.04
6179041-17904167.95667.96
10min1194278-19427873.74081.948.4274.3582.638.44
2191000-19100072.49573.09
3224762-22476285.31085.99
4228632-22863286.77987.50
5231092-23109287.71388.52
6225509-22550985.59386.35
15min1207736-20773678.84888.266.9480.2889.876.98
2216715-21671582.25683.66
3244611-24461192.84494.47
4239027-23902790.72492.41
5244935-24493592.96794.75
6242254-24225491.94993.66
20min1214044-21404481.24290.066.1883.5592.656.23
2226079-22607985.81088.13
3246265-24626593.47296.13
4237086-23708689.98892.68
5250042-25004294.90597.72
6250155-25015594.94897.68
30min1233653-23365388.68591.943.4991.9095.523.62
2230479-23047987.48090.75
3250794-25079495.19198.89
4242413-24241392.01095.70
5246446-24644693.54097.41
6249531-24953194.71198.49
45min1229629-22962987.15790.783.7291.3595.393.80
2230597-23059787.52591.77
3252595-25259595.874100.63
4235424-23542489.35794.07
5243865-24386592.56197.47
6242907-24290792.19797.03
60min1225610-22561085.63292.134.2790.8097.754.31
2241026-24102691.48396.70
3253615-25361596.261102.08
4237218-23721890.03895.74
5250057-25005794.911100.85
6248924-24892494.481100.34
极限1263307-26330799.94092.924.07106.0699.563.62
2237829-23782990.27096.50
3249008-24900894.513101.40
4240317-24031791.21497.92
5237972-23797290.32497.32
6240388-24038891.24198.15
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RSF-703-230921对照品来源原料对照品使用方法直接使用
对照品含量(%)100.7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%
1 10.722487852492332500412494092496702494280.19
2 10.812506562509852508200.10
单位质量响应值RSD%判断
23267.5423202.590.20数据可信
供试品溶液-24111801批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1216025-21602581.06081.4613.2781.0681.4613.27
2243125-24312591.22991.23
3229898-22989886.26686.27
4226541-22654185.00685.01
5225881-22588184.75984.76
6161079-16107960.44360.44
10min1266859-266859100.13591.9011.24101.0492.8011.24
2273401-273401102.590103.60
3249209-24920993.51294.47
4239279-23927989.78690.73
5245225-24522592.01792.96
6195508-19550873.36274.03
15min1260472-26047297.73892.617.1599.7594.537.23
2267604-267604100.415102.57
3245671-24567192.18594.18
4238162-23816289.36791.31
5251046-25104694.20196.17
6217801-21780181.72783.21
20min1256585-25658596.28091.804.1599.3894.764.30
2248624-24862493.29396.56
3248832-24883293.37196.39
4240525-24052590.25493.19
5246553-24655392.51595.53
6226795-22679585.10287.50
30min1248588-24858893.27993.514.1097.4597.494.26
2262592-26259298.534102.84
3249438-24943893.59897.66
4248616-24861693.29097.23
5254503-25450395.49999.54
6231517-23151786.87390.21
45min1251722-25172294.45594.844.7099.6699.864.76
2272175-272175102.130107.53
3246339-24633992.43597.53
4246393-24639392.45597.43
5260634-26063497.799102.90
6239299-23929989.79494.10
60min1265816-26581699.74493.634.05106.0099.704.13
2253340-25334095.062101.60
3250695-25069594.070100.20
4245184-24518492.00298.00
5246859-24685992.63098.82
6235315-23531588.29993.60
极限1256399-25639996.21094.261.09103.57101.361.13
2249617-24961793.665101.26
3249175-24917593.499100.67
4249275-24927593.537100.56
5251181-25118194.252101.47
6251519-25151994.379100.66
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RSF-703-230921对照品来源原料对照品使用方法直接使用
对照品含量(%)100.7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%
1 10.722525472515442516892516552510992517070.21
2 10.812493812502042497920.24
单位质量响应值RSD%判断
23480.1323107.491.14数据可信
供试品溶液-24111801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%
5min1220804-22080482.65085.876.1782.6585.876.18
2245141-24514191.75991.76
3212956-21295679.71279.71
4230318-23031886.21186.21
5247255-24725592.55192.55
6219924-21992482.32082.32
10min1252273-25227394.42994.591.8695.3595.541.89
2259272-25927297.04998.07
3244691-24469191.59192.48
4253349-25334994.83295.79
5254009-25400995.07996.11
6252599-25259994.55195.47
15min1269011-269011100.69497.154.64102.6699.164.60
2268156-268156100.374102.47
3241758-24175890.49392.40
4269765-269765100.976102.99
5260830-26083097.63299.72
6247776-24777692.74694.71
20min1252165-25216594.38893.321.7297.4796.401.76
2253644-25364494.94298.16
3246215-24621592.16195.07
4249711-24971193.47096.60
5251798-25179894.25197.42
6242328-24232890.70693.70
30min1286345-286345107.18297.135.96111.32101.255.75
2265272-26527299.295103.56
3259145-25914597.001100.93
4255505-25550595.63999.81
5248908-24890893.16997.39
6241798-24179890.50894.51
45min1248452-24845292.99993.441.7498.3298.641.71
2256991-25699196.195101.57
3251446-25144694.11999.13
4249922-24992293.54998.78
5245123-24512391.75397.00
6245871-24587192.03397.04
60min1253493-25349394.88692.442.29101.2498.682.30
2252124-25212494.373100.81
3241115-24111590.25296.31
4247824-24782492.76499.04
5247649-24764992.69898.97
6239568-23956889.67395.71
极限1243589-24358991.17893.091.6498.59100.361.52
2252474-25247494.504101.99
3254085-25408595.107102.17
4249225-24922593.288100.59
5247526-24752692.65299.95
6245348-24534891.83798.87
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