依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.261712501706151707431707441707241708150.15
210.261714191724291719240.42
单位质量响应值RSD%判断
16648.6416756.730.46数据可信
供试品溶液-2023121221批-依折麦布-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%
5min110645-106455.7174.5437.545.724.5437.55
211878-118786.3796.38
39862-98625.2975.30
44312-43122.3162.32
59336-93365.0145.01
64718-47182.5342.53
10min118440-184409.9039.1712.689.949.2012.74
219430-1943010.43510.47
318367-183679.8649.89
414567-145677.8237.84
517441-174419.3679.39
614256-142567.6567.67
15min119109-1910910.26310.054.8110.3510.134.91
219309-1930910.37010.46
318810-1881010.10210.19
418340-183409.8509.91
519599-1959910.52610.61
617101-171019.1849.24
20min118281-182819.81810.052.159.9610.182.19
218893-1889310.14710.30
318690-1869010.03810.18
418787-1878710.09010.20
519335-1933510.38410.52
618273-182739.8149.92
30min118597-185979.98810.021.0010.1910.211.04
218711-1871110.04910.26
318491-184919.93110.13
418733-1873310.06110.23
518971-1897110.18910.38
618473-184739.92110.08
45min117829-178299.5759.631.759.839.871.71
217976-179769.6549.92
318000-180009.6679.92
418454-184549.91110.13
517771-177719.5449.80
617511-175119.4059.62
60min118045-180459.6919.661.3110.009.951.38
218207-182079.77810.10
317778-177789.5489.85
418147-181479.74610.02
518096-180969.71910.02
617610-176109.4589.73
极限117288-172889.2859.582.069.659.932.00
217854-178549.5899.96
317750-177509.5339.89
418054-180549.69610.03
518373-183739.86710.23
617667-176679.4889.81
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.823198143194173195723195183194933195630.05
210.863210293226023218160.35
单位质量响应值RSD%判断
29534.4729633.150.24数据可信
供试品溶液-2023121221批-瑞舒伐他汀钙-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%
5min1184411-18441151.48937.3635.8751.4937.3635.87
2111637-11163731.17031.17
3193940-19394054.15054.15
478199-7819921.83421.83
5141976-14197639.64139.64
692732-9273225.89125.89
10min1267647-26764774.72966.4313.6675.0266.6413.72
2234144-23414465.37565.55
3280585-28058578.34178.64
4189392-18939252.88053.00
5229646-22964664.11964.34
6226218-22621863.16263.31
15min1296510-29651082.78878.946.2183.4979.526.31
2282404-28240478.84979.39
3308284-30828486.07586.81
4259050-25905072.32972.74
5272079-27207975.96776.54
6278128-27812877.65578.15
20min1300266-30026683.83784.553.8785.0085.573.92
2300464-30046483.89284.87
3322129-32212989.94191.16
4297951-29795183.19084.01
5287313-28731380.22081.22
6308891-30889186.24587.17
30min1323085-32308590.20889.683.8791.8391.173.88
2319479-31947989.20190.64
3335813-33581393.76295.48
4323330-32333090.27691.56
5298511-29851183.34784.79
6326962-32696291.29092.70
45min1322517-32251790.04989.895.5392.1891.885.46
2318993-31899389.06591.00
3340610-34061095.10197.34
4337015-33701594.09795.88
5290405-29040581.08382.99
6322179-32217989.95591.87
60min1327906-32790691.55491.494.1494.1893.984.12
2327823-32782391.53193.96
3341780-34178095.42898.19
4336523-33652393.96096.26
5302469-30246984.45286.81
6329627-32962792.03494.45
极限1331255-33125592.48994.261.2695.6397.251.27
2338181-33818194.42397.36
3343447-34344795.89399.19
4340745-34074595.13997.96
5335772-33577293.75096.58
6336148-33614893.85596.78
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.261709571701651701011702361701161703150.22
210.261726781748351737560.88
单位质量响应值RSD%判断
16599.9016935.281.42数据可信
供试品溶液-2023121221批-依折麦布-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%
5min113019-130196.9665.8320.446.975.8420.44
211287-112876.0396.04
310651-106515.6995.70
49208-92084.9274.93
57697-76974.1184.12
613545-135457.2477.25
10min118161-181619.7179.385.739.769.415.77
218394-183949.8419.87
318499-184999.8989.93
416398-163988.7738.80
516243-162438.6918.71
617440-174409.3319.37
15min118798-1879810.05810.043.4510.1510.123.46
219451-1945110.40710.50
319558-1955810.46410.55
418200-182009.7389.81
518620-186209.96210.03
617960-179609.6099.70
20min118818-1881810.06810.101.6310.2210.241.65
219217-1921710.28210.43
319241-1924110.29510.44
418463-184639.87810.01
518842-1884210.08110.21
618662-186629.98510.13
30min118223-182239.75010.043.049.9510.232.94
219202-1920210.27410.48
318836-1883610.07810.28
419026-1902610.18010.36
519363-1936310.36010.54
617926-179269.5919.79
45min118406-184069.8489.961.9110.1110.211.85
218909-1890910.11710.38
318645-186459.97610.23
419046-1904610.19010.43
518637-186379.97110.21
618056-180569.6619.91
60min117633-176339.4349.793.269.7510.103.15
218773-1877310.04410.36
318773-1877310.04410.36
418687-186879.99810.30
518420-184209.85510.15
617454-174549.3389.65
极限117460-174609.3429.682.879.7110.042.76
218067-180679.66610.04
318742-1874210.02810.40
418340-183409.81210.17
518415-184159.85310.20
617496-174969.3619.72
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.823185013178563178213177063176223179010.11
210.863230063248223239140.40
单位质量响应值RSD%判断
29380.8729826.341.07数据可信
供试品溶液-2023121221批-瑞舒伐他汀钙-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%
5min1135250-13525037.74033.9829.7037.7433.9829.69
2121895-12189534.01334.01
3186901-18690152.15252.15
490760-9076025.32525.33
594775-9477526.44626.45
6101126-10112628.21828.22
10min1235370-23537065.67763.7511.3965.8963.9411.44
2228744-22874463.82864.02
3275746-27574676.94377.23
4217512-21751260.69460.83
5202570-20257056.52456.67
6210949-21094958.86259.02
15min1274508-27450876.59877.286.6177.1777.826.67
2273033-27303376.18676.73
3309753-30975386.43287.15
4282844-28284478.92479.40
5263801-26380173.61074.07
6257770-25777071.92772.41
20min1298181-29818183.20384.883.3784.2085.863.45
2300985-30098583.98684.95
3322968-32296890.12091.32
4308925-30892586.20187.12
5296154-29615482.63883.51
6297997-29799783.15284.04
30min1316020-31602088.18191.052.2289.6492.492.26
2327250-32725091.31592.75
3335011-33501193.48095.18
4330919-33091992.33893.73
5329315-32931591.89193.22
6319289-31928989.09390.44
45min1335373-33537393.58194.531.3795.5396.481.40
2337465-33746594.16596.11
3342439-34243995.55397.77
4345140-34514096.30698.21
5332571-33257192.79994.64
6339636-33963694.77196.61
60min1330000-33000092.08294.602.0994.5597.082.14
2339249-33924994.66397.13
3348972-34897297.376100.12
4345408-34540896.38198.82
5334537-33453793.34895.70
6336081-33608193.77996.15
极限1332305-33230592.72594.352.2595.7197.352.30
2330288-33028892.16295.15
3351684-35168498.132101.42
4339612-33961294.76497.74
5335743-33574393.68496.56
6339136-33913694.63197.52
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.261736401743771751451751751751161746910.39
210.261757311757151757230.01
单位质量响应值RSD%判断
17026.4117127.000.42数据可信
供试品溶液-2023121421批-依折麦布-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%
5min112707-127076.6756.273.666.676.273.62
211868-118686.2346.23
311888-118886.2456.24
412083-120836.3476.35
511622-116226.1056.11
611458-114586.0196.02
10min117532-175329.2109.433.009.259.472.98
217612-176129.2529.29
318071-180719.4939.53
417950-179509.4299.46
518969-189699.96410.00
617627-176279.2599.29
15min118422-184229.67710.032.859.7710.122.83
219426-1942610.20410.29
318879-188799.91710.00
418574-185749.7579.84
519517-1951710.25210.34
619743-1974310.37110.46
20min118851-188519.9029.881.5310.0410.021.50
218812-188129.88210.02
318246-182469.5859.73
418958-189589.95910.10
518938-189389.94810.09
619047-1904710.00510.15
30min118186-181869.5539.671.459.759.871.41
218157-181579.5389.74
318204-182049.5639.76
418645-186459.7949.99
518774-187749.86210.06
618502-185029.7199.92
45min117845-178459.3749.591.629.629.841.58
218018-180189.4659.72
318324-183249.6269.87
418472-184729.7039.95
518234-182349.5789.83
618652-186529.79810.05
60min117268-172689.0719.492.489.379.792.43
218073-180739.4949.80
318043-180439.4789.78
418027-180279.4709.78
518400-184009.6669.97
618561-185619.75010.06
极限117600-176009.2459.381.639.609.741.58
217561-175619.2259.58
317690-176909.2939.65
417987-179879.4499.81
517947-179479.4289.79
618319-183199.6239.98
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.823238423259313268723270173267063260740.41
210.863268613285803277200.38
单位质量响应值RSD%判断
30136.2330176.800.10数据可信
供试品溶液-2023121421批-瑞舒伐他汀钙-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%
5min197840-9784026.79940.6321.5326.8040.6221.53
2168482-16848246.14846.15
3168687-16868746.20446.20
4180307-18030749.38749.39
5122136-12213633.45433.45
6152464-15246441.76141.76
10min1204929-20492956.13162.8214.6456.2863.0414.61
2173774-17377447.59747.85
3257245-25724570.46170.72
4260069-26006971.23471.51
5240409-24040965.84966.03
6239689-23968965.65265.88
15min1255752-25575270.05274.527.9770.5175.108.00
2236215-23621564.70065.22
3283893-28389377.76078.41
4292837-29283780.20980.88
5277811-27781176.09476.65
6285981-28598178.33178.93
20min1282425-28242577.35779.395.9878.2180.386.02
2260815-26081571.43872.32
3297902-29790281.59782.68
4312517-31251785.60086.72
5290680-29068079.61980.59
6294644-29464480.70481.74
30min1304091-30409183.29284.304.3284.5785.734.39
2286256-28625678.40779.68
3312807-31280785.67987.21
4327126-32712689.60191.19
5306421-30642183.93085.35
6309914-30991484.88786.37
45min1319925-31992587.62988.263.6189.3790.163.65
2309639-30963984.81286.52
3318349-31834987.19789.21
4340218-34021893.18795.28
5313405-31340585.84387.73
6331857-33185790.89792.85
60min1320118-32011887.68289.202.1989.9191.592.27
2320980-32098087.91890.10
3320532-32053287.79590.29
4335961-33596192.02194.63
5322960-32296088.46090.82
6333478-33347891.34193.80
极限1329981-32998190.38391.341.7893.1094.221.80
2333301-33330191.29393.96
3324824-32482488.97191.95
4342467-34246793.80396.92
5336024-33602492.03894.89
6334221-33422191.54594.51
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