氟伐他汀钠片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.911458831145957014541571451576145357214555410.24
211.151482944148787314854080.24
单位质量响应值RSD%判断
133413.47133220.450.11数据可信
供试品溶液-包衣片23121101批-pH6.8磷酸盐缓冲液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1242596-24259616.13416.633.0216.1316.633.03
2254053-25405316.89616.90
3247489-24748916.46016.46
4250043-25004316.63016.63
5262635-26263517.46717.47
6243197-24319716.17416.17
480min1456436-45643630.35631.763.9530.3831.783.95
2482663-48266332.10032.13
3460540-46054030.62930.65
4483776-48377632.17432.20
5508423-50842333.81433.84
6473101-47310131.46431.49
720min1656349-65634943.65245.844.4643.7245.914.46
2695417-69541746.25046.32
3649553-64955343.20043.27
4710811-71081147.27447.35
5728407-72840748.44448.52
6694737-69473746.20546.28
960min1864285-86428557.48160.686.9757.6260.836.96
2929797-92979761.83861.98
3835508-83550855.56755.70
4879075-87907558.46458.61
5999554-99955466.47766.63
6966535-96653564.28164.42
1200min11213583-121358380.71185.848.6980.9386.078.68
21285795-128579585.51485.75
31141485-114148575.91676.14
41263045-126304584.00184.23
51433451-143345195.33495.58
61406925-140692593.57093.81
1440min11411451-141145193.87194.922.7194.2195.282.73
21440509-144050995.80396.17
31372857-137285791.30491.64
41401164-140116493.18793.54
51468041-146804197.63598.03
61469018-146901897.69998.08
极限11418138-141813894.31695.321.9294.8095.831.94
21441438-144143895.86596.37
31404314-140431493.39693.87
41407226-140722693.59094.09
51459721-145972197.08197.62
61468915-146891597.69398.22
氟伐他汀钠片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.911484240147561814811051480322147135214785270.35
211.151516791152089915188450.20
单位质量响应值RSD%判断
135520.35136219.280.37数据可信
供试品溶液-包衣片23121102批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1277969-27796918.14016.2010.9118.1416.2010.92
2224852-22485214.67314.67
3266599-26659917.39817.40
4250473-25047316.34516.35
5207239-20723913.52413.52
6262664-26266417.14117.14
480min1551808-55180836.01031.829.9736.0431.849.97
2449481-44948129.33229.35
3511747-51174733.39533.42
4502962-50296232.82232.85
5414475-41447527.04827.07
6494746-49474632.28632.31
720min1814934-81493453.18147.148.6553.2647.218.65
2677964-67796444.24244.31
3738653-73865348.20348.28
4752739-75273949.12249.20
5634704-63470441.41941.48
6714760-71476046.64346.72
960min11150647-115064775.08866.327.7575.2566.477.75
2982798-98279864.13564.27
31022060-102206066.69766.85
41045679-104567968.23868.39
5919518-91951860.00560.13
6977349-97734963.77963.92
1200min11474366-147436696.21392.782.7696.4993.022.77
21384865-138486590.37390.60
31453694-145369494.86495.11
41411648-141164892.12192.37
51373603-137360389.63889.85
61432051-143205193.45293.69
1440min11484234-148423496.85796.391.6197.2896.771.60
21455261-145526194.96795.33
31475251-147525196.27196.66
41444418-144441894.25994.65
51504299-150429998.16798.51
61499063-149906397.82598.21
极限11484717-148471796.88996.972.2697.4597.502.24
21469842-146984295.91896.42
31470297-147029795.94896.48
41452731-145273194.80295.33
51489360-148936097.19297.69
61549048-1549048101.087101.61
氟伐他汀钠片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.911467409146438014597051464108146270814636620.20
211.151511164151222415116940.05
单位质量响应值RSD%判断
134157.84135577.940.75数据可信
供试品溶液-包衣片23121102-2批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1253466-25346616.66416.873.4616.6616.873.47
2255225-25522516.77916.78
3273885-27388518.00618.01
4253331-25333116.65516.65
5248170-24817016.31616.32
6255629-25562916.80616.81
480min1449595-44959529.55831.206.7329.5831.236.73
2475795-47579531.28131.31
3536169-53616935.25035.28
4473426-47342631.12531.15
5456561-45656130.01630.04
6455997-45599729.97930.00
720min1623830-62383041.01344.065.4941.0844.135.49
2659491-65949143.35743.43
3736064-73606448.39248.47
4674278-67427844.32944.40
5668620-66862043.95844.03
6658929-65892943.32043.39
960min1773720-77372050.86755.105.2351.0055.245.23
2808630-80863053.16253.30
3903296-90329659.38659.54
4851931-85193156.00956.15
5842517-84251755.39055.53
6848456-84845655.78155.92
1200min1899396-89939659.13066.466.9159.3466.686.90
2957561-95756162.95463.17
31093204-109320471.87172.11
41035357-103535768.06868.29
51042538-104253868.54068.76
61037463-103746368.20768.43
1440min11080807-108080771.05682.037.4871.3582.357.47
21197398-119739878.72179.03
31314280-131428086.40686.75
41280435-128043584.18084.50
51288467-128846784.70985.03
61325140-132514087.12087.44
极限11202681-120268179.06985.153.8879.4785.593.89
21274567-127456783.79584.22
31339701-133970188.07788.56
41312645-131264586.29886.75
51322553-132255386.94987.40
61318517-131851786.68487.14
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