依折麦布阿托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DSMF-387-240606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(%)99.75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%
110.181764091769231768311765601771351767720.17
210.191788301793471790880.21
单位质量响应值RSD%判断
17364.6417574.880.86数据可信
供试品溶液-2022091401批-依折麦布-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%
5min12949-29491.5161.9513.041.521.9513.02
23907-39072.0082.01
34279-42792.1992.20
43796-37961.9511.95
53550-35501.8241.82
64238-42382.1782.18
10min110916-109165.6104.967.215.624.977.18
29442-94424.8524.86
39761-97615.0165.03
49316-93164.7884.80
59620-96204.9444.95
68846-88464.5464.56
15min111610-116105.9665.813.096.015.853.06
210930-109305.6175.66
311814-118146.0716.11
411295-112955.8055.84
511130-111305.7205.76
611013-110135.6605.70
20min111860-118606.0955.825.916.175.895.85
211622-116225.9736.04
311859-118596.0946.17
411327-113275.8215.89
511202-112025.7575.83
610076-100765.1785.25
30min111543-115435.9325.782.956.045.882.97
211235-112355.7745.88
311691-116916.0086.12
410792-107925.5465.65
511164-111645.7375.84
611024-110245.6655.76
45min111002-110025.6545.621.685.795.761.70
211052-110525.6805.81
311204-112045.7585.90
410785-107855.5425.68
510864-108645.5835.72
610712-107125.5055.63
60min110961-109615.6335.285.095.805.455.00
210452-104525.3715.54
310409-104095.3495.52
410176-101765.2305.39
510340-103405.3145.48
69361-93614.8114.97
极限110940-109405.6225.521.795.825.721.73
210825-108255.5635.76
310747-107475.5235.73
410541-105415.4175.61
510503-105035.3985.59
610944-109445.6245.81
依折麦布阿托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%
111.101559681562331564471562001563501562400.12
211.161582351583701583020.07
单位质量响应值RSD%判断
14075.6814184.770.55数据可信
供试品溶液-2022091401批-阿托伐他汀钙-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%
5min188312-8831251.62559.5315.6951.6259.5315.69
2106544-10654462.28362.28
3116070-11607067.85167.85
490783-9078353.06953.07
5123765-12376572.34972.35
685557-8555750.01450.01
10min1133438-13343878.00483.057.5678.2983.387.54
2125536-12553673.38573.73
3147745-14774586.36886.74
4152737-15273789.28689.58
5151089-15108988.32288.72
6141860-14186082.92783.21
15min1139261-13926181.40886.887.6982.1387.687.67
2131714-13171476.99677.75
3153208-15320889.56190.42
4162965-16296595.26596.06
5155823-15582391.09091.98
6148785-14878586.97587.71
20min1145433-14543385.01688.247.1886.1989.527.16
2133227-13322777.88179.06
3151877-15187788.78390.14
4163494-16349495.57496.89
5160089-16008993.58394.98
6151570-15157088.60389.83
30min1156657-15665791.57791.636.4093.2293.396.39
2138378-13837880.89282.51
3159383-15938393.17195.02
4161943-16194394.66796.52
5168146-16814698.293100.21
6155956-15595691.16792.88
45min1162640-16264095.07595.026.4897.2397.306.46
2142357-14235783.21885.28
3163671-16367195.67798.04
4167490-16749097.910100.29
5172816-172816101.023103.49
6166355-16635597.24699.47
60min1165494-16549496.74395.175.8199.4297.975.80
2144417-14441784.42286.95
3162928-16292895.24398.14
4167233-16723397.760100.68
5171566-171566100.293103.32
6165132-16513296.53199.29
极限1174997-174997102.298102.061.51105.52105.391.60
2171813-171813100.437103.43
3174637-174637102.088105.51
4172709-172709100.961104.42
5179351-179351104.843108.43
6174060-174060101.751105.05
依折麦布阿托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DSMF-387-240606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(%)99.75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%
110.181768411767331767181770061768161768230.07
210.191806061807131806600.05
单位质量响应值RSD%判断
17369.6517729.151.45数据可信
供试品溶液-2022091401批-依折麦布-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%
5min15672-56722.9022.709.522.902.709.51
25582-55822.8562.86
34668-46682.3882.39
45498-54982.8132.81
55635-56352.8832.88
64598-45982.3522.35
10min18913-89134.5604.5710.094.584.5810.07
28259-82594.2254.24
37664-76643.9213.93
49274-92744.7454.76
510277-102775.2585.27
69188-91884.7014.71
15min110335-103355.2875.0910.175.335.1310.13
29740-97404.9835.02
38702-87024.4524.49
49594-95944.9084.95
511718-117185.9956.04
69610-96104.9174.96
20min110568-105685.4075.583.595.485.653.60
211475-114755.8715.94
310487-104875.3655.43
411077-110775.6675.74
511155-111555.7075.79
610661-106615.4545.52
30min110974-109745.6145.502.665.725.602.65
210294-102945.2675.37
310609-106095.4285.52
410769-107695.5105.61
511111-111115.6845.79
610738-107385.4945.59
45min110216-102165.2275.412.975.365.542.98
210698-106985.4735.60
310204-102045.2205.34
410661-106615.4545.59
511007-110075.6315.77
610711-107115.4805.61
60min110493-104935.3685.371.885.535.531.91
210530-105305.3875.55
310237-102375.2375.39
410581-105815.4135.57
510812-108125.5325.70
610363-103635.3025.46
极限110514-105145.3795.432.445.575.622.46
210757-107575.5035.69
310143-101435.1895.37
410674-106745.4615.65
510855-108555.5545.76
610749-107495.4995.69
依折麦布阿托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%
111.101562711558691562201559131560651560680.12
211.161593941596921595430.14
单位质量响应值RSD%判断
14060.1814295.971.18数据可信
供试品溶液-2022091401批-阿托伐他汀钙-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%
5min1115420-11542067.24761.1616.4467.2561.1616.44
2131896-13189676.84776.85
3101193-10119358.95858.96
491298-9129853.19353.19
5106351-10635161.96361.96
683723-8372348.78048.78
10min1139025-13902581.00088.065.2181.3788.405.21
2163616-16361695.32895.75
3151406-15140688.21488.54
4151645-15164588.35388.65
5152306-15230688.73889.08
6148837-14883786.71786.99
15min1147559-14755985.97291.414.8886.8092.244.89
2169219-16921998.59299.55
3156141-15614190.97291.79
4160557-16055793.54594.33
5157275-15727591.63392.47
6150648-15064887.77288.52
20min1143431-14343183.56791.495.4384.8792.835.42
2169348-16934898.667100.17
3159808-15980893.10994.43
4159689-15968993.04094.35
5156209-15620991.01292.36
6153735-15373589.57190.81
30min1148162-14816286.32491.993.3588.0993.843.36
2163575-16357595.30497.36
3161182-16118293.90995.75
4158236-15823692.19394.02
5157140-15714091.55493.41
6159053-15905392.66994.41
45min1146742-14674285.49693.854.9287.7496.204.88
2169135-16913598.543101.13
3161233-16123393.93996.30
4158737-15873792.48594.82
5164344-16434495.75298.11
6166280-16628096.88099.13
60min1160740-16074093.65296.702.9296.3799.582.94
2172118-172118100.281103.41
3162157-16215794.47897.36
4162250-16225094.53297.38
5170167-17016799.144102.04
6168440-16844098.138100.93
极限1173782-173782101.251102.111.34104.49105.521.36
2177426-177426103.374107.06
3171514-17151499.929103.34
4176109-176109102.606105.98
5175035-175035101.981105.42
6177651-177651103.505106.84
依折麦布阿托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DSMF-387-240606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(%)99.75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%
110.181771071771721771811773031774061772340.07
210.191779801788931784360.37
单位质量响应值RSD%判断
17410.0217510.890.41数据可信
供试品溶液-2022091402批-依折麦布-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%
5min16230-62303.2032.7816.143.202.7816.06
26068-60683.1203.12
35580-55802.8692.87
45271-52712.7102.71
55558-55582.8582.86
63784-37841.9461.95
10min19993-99935.1384.964.635.164.974.63
29646-96464.9604.98
39218-92184.7404.76
48984-89844.6194.63
59901-99015.0915.11
610078-100785.1825.19
15min111029-110295.6715.596.635.725.636.65
211485-114855.9055.95
311081-110815.6975.74
49537-95374.9044.94
511446-114465.8855.93
610662-106625.4825.52
20min111855-118556.0955.794.366.175.864.35
211280-112805.8005.88
311583-115835.9566.03
410547-105475.4235.49
511474-114745.9005.98
610826-108265.5665.64
30min110850-108505.5795.713.015.695.823.02
211494-114945.9106.02
311108-111085.7115.82
411011-110115.6615.76
511494-114945.9106.02
610681-106815.4925.59
45min110565-105655.4325.491.745.575.631.75
210751-107515.5285.67
310687-106875.4955.63
410442-104425.3695.50
510989-109895.6505.79
610653-106535.4775.61
60min110728-107285.5165.572.355.695.742.26
210826-108265.5665.74
310503-105035.4005.57
410771-107715.5385.70
510924-109245.6175.79
611271-112715.7955.96
极限111010-110105.6615.582.035.865.781.93
210619-106195.4605.66
310557-105575.4285.63
410886-108865.5975.79
511004-110045.6585.86
611078-110785.6965.89
依折麦布阿托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%
111.101557801559711561311558531562011559870.12
211.161566901575121571010.37
单位质量响应值RSD%判断
14052.8814077.150.13数据可信
供试品溶液-2022091402批-阿托伐他汀钙-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%
5min1122898-12289872.17560.9917.2772.1760.9917.27
2115378-11537867.75867.76
391103-9110353.50253.50
4113914-11391466.89966.90
574757-7475743.90343.90
6105067-10506761.70361.70
10min1148154-14815487.00784.294.6287.4184.634.65
2143123-14312384.05284.43
3145241-14524185.29685.59
4142880-14288083.91084.28
5131380-13138077.15677.40
6150396-15039688.32488.67
15min1150868-15086888.60186.804.1589.4987.614.16
2143845-14384584.47685.32
3154037-15403790.46291.23
4146614-14661486.10286.94
5138187-13818781.15481.83
6153292-15329290.02490.86
20min1153838-15383890.34587.554.2191.7288.844.22
2146510-14651086.04187.35
3153488-15348890.13991.41
4145970-14597085.72487.04
5139225-13922581.76382.89
6155488-15548891.31492.65
30min1151535-15153588.99288.003.8490.8789.783.85
2146024-14602485.75687.55
3154823-15482390.92392.70
4147526-14752686.63888.43
5141919-14191983.34584.92
6157264-15726492.35794.20
45min1150682-15068288.49189.481.7490.8691.741.70
2148286-14828687.08489.35
3155888-15588891.54993.83
4152508-15250889.56491.84
5152664-15266489.65591.70
6154132-15413290.51892.87
60min1151178-15117888.78391.984.5891.6594.744.49
2152888-15288889.78792.54
3156281-15628191.78094.57
4153811-15381190.32993.10
5154756-15475690.88493.42
6170822-170822100.319103.18
极限1168710-16871099.07999.751.47102.44103.021.39
2167873-16787398.587101.84
3169874-16987499.762103.06
4174422-174422102.433105.71
5170482-170482100.120103.16
6167768-16776898.526101.94
依折麦布阿托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DSMF-387-240606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(%)99.75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%
110.181790211795011798131798091800201796330.22
210.191770671772841771760.09
单位质量响应值RSD%判断
17645.6817387.241.05数据可信
供试品溶液-2022091402批-依折麦布-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%
5min13570-35701.8302.5828.961.832.5828.99
26772-67723.4713.47
34043-40432.0722.07
43572-35721.8311.83
55992-59923.0713.07
66217-62173.1863.19
10min16323-63233.2414.4921.373.254.5121.37
210346-103465.3035.32
36848-68483.5103.52
410028-100285.1405.15
58380-83804.2954.31
610679-106795.4735.49
15min18015-80154.1084.8811.134.144.9211.19
210424-104245.3435.39
38706-87064.4624.49
410108-101085.1815.22
59156-91564.6934.73
610694-106945.4815.53
20min19148-91484.6895.186.754.745.246.87
210681-106815.4755.55
39538-95384.8894.94
49905-99055.0775.14
510437-104375.3495.42
610879-108795.5765.65
30min19267-92674.7505.186.904.835.277.01
210947-109475.6115.72
39481-94814.8594.94
410286-102865.2725.37
59797-97975.0215.12
610806-108065.5395.65
45min19728-97284.9865.132.885.095.263.01
210481-104815.3725.51
39950-99505.1005.21
410026-100265.1395.26
59722-97224.9835.11
610171-101715.2135.35
60min19835-98355.0415.202.745.175.362.89
210530-105305.3975.57
39909-99095.0795.22
410343-103435.3015.45
510307-103075.2835.44
69998-99985.1245.29
极限110694-106945.4815.373.095.645.553.10
210759-107595.5145.71
39928-99285.0895.26
410264-102645.2615.44
510532-105325.3985.58
610694-106945.4815.68
依折麦布阿托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%
111.101576871579991582611580841582881580640.16
211.161562371556791559580.26
单位质量响应值RSD%判断
14240.0013974.731.33数据可信
供试品溶液-2022091402批-阿托伐他汀钙-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%
5min197689-9768957.20364.8215.6157.2064.8215.61
2118129-11812969.17269.17
3123873-12387372.53572.54
482075-8207548.06048.06
5116024-11602467.93967.94
6126399-12639974.01474.01
10min1142000-14200083.15085.803.3783.4786.163.41
2147937-14793786.62687.01
3145079-14507984.95385.36
4141264-14126482.71982.99
5148223-14822386.79487.17
6154693-15469390.58290.99
15min1153385-15338589.81688.743.1390.6089.583.16
2151515-15151588.72189.59
3152081-15208189.05389.93
4144865-14486584.82785.55
5148532-14853286.97587.83
6158947-15894793.07393.99
20min1151746-15174688.85788.963.0890.1490.293.10
2152459-15245989.27490.63
3150500-15050088.12789.50
4147428-14742886.32887.53
5148748-14874887.10188.44
6160650-16065094.07095.50
30min1152312-15231289.18888.972.6390.9690.802.67
2152907-15290789.53691.39
3150210-15021087.95789.82
4147178-14717886.18287.86
5150064-15006487.87289.70
6158963-15896393.08395.04
45min1154320-15432090.36489.382.6292.6391.702.65
2152967-15296789.57291.92
3154212-15421290.30192.65
4147378-14737886.29988.46
5148711-14871187.07989.39
6158242-15824292.66095.13
60min1158239-15823992.65990.252.4095.4393.062.40
2153101-15310189.65092.50
3151824-15182488.90291.75
4148467-14846786.93789.57
5155806-15580691.23494.03
6157309-15730992.11495.10
极限1165958-16595897.17998.562.63100.46101.882.66
2168104-16810498.435101.78
3167879-16787998.303101.65
4162496-16249695.15198.27
5169697-16969799.368102.67
6175808-175808102.946106.44
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