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%
110.181766331766561764521760111762281763960.16
210.191778041786251782140.33
单位质量响应值RSD%判断
17327.7017489.110.66数据可信
供试品溶液-2022091403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%
5min12745-27451.4161.9530.741.421.9530.71
25100-51002.6302.63
32782-27821.4351.43
42844-28441.4671.47
55199-51992.6812.68
63985-39852.0552.06
10min18712-87124.4934.4911.554.504.5011.57
26939-69393.5793.59
38739-87394.5074.51
49306-93064.7994.81
59949-99495.1315.15
68556-85564.4124.42
15min110896-108965.6195.235.335.655.265.28
210161-101615.2405.27
39486-94864.8924.93
49775-97755.0415.08
510632-106325.4835.53
69854-98545.0825.12
20min111681-116816.0245.388.396.095.458.33
210287-102875.3055.37
39280-92804.7864.85
49783-97835.0455.11
511139-111395.7445.82
610478-104785.4045.47
30min110403-104035.3655.234.955.465.334.89
210278-102785.3005.39
310529-105295.4305.52
49322-93224.8074.90
510597-105975.4655.57
69767-97675.0375.13
45min110511-105115.4215.322.915.555.442.87
29878-98785.0945.22
310656-106565.4955.61
410262-102625.2925.41
510512-105125.4215.56
610065-100655.1915.31
60min110469-104695.3995.173.945.565.333.83
29952-99525.1325.28
310403-104035.3655.51
49382-93824.8384.99
59896-98965.1035.27
610078-100785.1975.35
极限110149-101495.2345.173.835.425.353.60
210161-101615.2405.42
310248-102485.2855.46
410198-101985.2595.43
59247-92474.7694.96
610157-101575.2385.42
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2500
标示量(mg)20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%
111.101548791549281550101544101546271547710.16
211.161562611569171565890.30
单位质量响应值RSD%判断
13943.3314031.270.45数据可信
供试品溶液-2022091403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%
5min198465-9846558.14862.987.9558.1562.987.95
2115776-11577668.37168.37
395456-9545656.37156.37
4104423-10442361.66661.67
5113412-11341266.97466.97
6112396-11239666.37566.37
10min1133429-13342978.79580.814.1979.1281.164.17
2128263-12826375.74576.12
3140000-14000082.67682.99
4142753-14275384.30284.64
5142153-14215383.94784.32
6134404-13440479.37179.74
15min1134384-13438479.35985.403.9880.1286.203.97
2149604-14960488.34789.15
3144315-14431585.22486.00
4148714-14871487.82288.63
5148342-14834287.60288.44
6142359-14235984.06984.88
20min1143612-14361284.80987.402.3586.0188.672.35
2150519-15051988.88890.18
3148632-14863287.77389.02
4150447-15044788.84590.14
5151068-15106889.21290.54
6143682-14368284.85086.13
30min1145735-14573586.06390.103.3687.7491.863.34
2152497-15249790.05691.84
3156671-15667192.52194.25
4155874-15587492.05093.84
5157676-15767693.11494.93
6147012-14701286.81788.56
45min1153964-15396490.92293.564.8693.0795.824.77
2152298-15229889.93892.22
3168313-16831399.396101.64
4164075-16407596.89399.20
5162931-16293196.21898.56
6149052-14905288.02190.25
60min1160116-16011694.55595.645.1797.2198.425.08
2153054-15305490.38593.17
3168960-16896099.778102.58
4167039-16703998.643101.49
5171043-171043101.008103.88
6151486-15148689.45992.18
极限1169310-16931099.98599.480.77103.17102.790.74
2166860-16686098.538101.83
3169359-169359100.014103.37
4166750-16675098.473101.86
5169508-169508100.102103.54
6168911-16891199.749102.97
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%
110.181763191763201762681763971763681763340.03
210.191786101795731790920.39
单位质量响应值RSD%判断
17321.6117575.271.03数据可信
供试品溶液-2022091403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%
5min15101-51012.6252.8017.942.622.8017.89
27277-72773.7443.74
34666-46662.4012.40
45162-51622.6562.66
54719-47192.4282.43
65713-57132.9402.94
10min19213-92134.7404.956.774.764.976.73
29416-94164.8454.87
310460-104605.3825.40
410348-103485.3245.34
58812-88124.5344.55
69478-94784.8774.89
15min19296-92964.7835.064.954.825.105.00
210129-101295.2125.26
310228-102285.2635.31
410206-102065.2515.30
59133-91334.6994.74
69974-99745.1325.18
20min19771-97715.0285.294.035.105.374.04
210594-105945.4515.53
310738-107385.5255.60
410579-105795.4435.52
510214-102145.2565.32
69834-98345.0605.13
30min110104-101045.1995.271.015.295.371.08
210350-103505.3265.43
310339-103395.3205.42
410220-102205.2595.36
510137-101375.2165.31
610276-102765.2875.39
45min110092-100925.1935.202.075.325.322.02
210392-103925.3475.48
310222-102225.2605.39
49766-97665.0255.16
510024-100245.1585.28
610089-100895.1915.32
60min110347-103475.3245.342.445.485.502.47
210747-107475.5305.70
310542-105425.4245.59
410431-104315.3675.53
510195-101955.2465.40
610033-100335.1625.32
极限110316-103165.3085.442.495.495.632.49
210811-108115.5635.76
310851-108515.5835.78
410461-104615.3835.57
510780-107805.5475.73
610272-102725.2855.47
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2500
标示量(mg)20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%
111.101548011547101547901548201547911547820.03
211.161567321575241571280.36
单位质量响应值RSD%判断
13944.3214079.570.69数据可信
供试品溶液-2022091403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%
5min159593-5959335.13151.8127.7035.1351.8127.70
2118054-11805469.59469.59
377202-7720245.51145.51
470883-7088341.78641.79
584770-8477049.97349.97
6116863-11686368.89268.89
10min1116547-11654768.70679.078.2568.9079.368.30
2135314-13531479.76980.16
3134914-13491479.53379.79
4127747-12774775.30875.54
5142172-14217283.81284.09
6148093-14809387.30287.69
15min1129413-12941376.29083.625.9376.8784.345.99
2142585-14258584.05584.89
3143396-14339684.53385.23
4134942-13494279.55080.20
5149016-14901687.84788.59
6151680-15168089.41790.28
20min1132270-13227077.97584.855.3378.9886.045.37
2141989-14198983.70485.00
3145366-14536685.69586.86
4139804-13980482.41683.51
5153092-15309290.24991.48
6151056-15105689.04990.41
30min1139243-13924382.08586.033.9383.5287.704.00
2146154-14615486.15987.92
3149114-14911487.90489.54
4138702-13870281.76683.32
5150502-15050288.72390.46
6151914-15191489.55591.41
45min1151431-15143189.27088.332.4491.1690.472.39
2146909-14690986.60488.84
3144099-14409984.94887.08
4150755-15075588.87290.88
5154037-15403790.80693.03
6151796-15179689.48591.84
60min1153120-15312090.26691.463.7492.6594.093.70
2160822-16082294.80697.53
3144454-14445485.15787.76
4157687-15768792.95895.46
5157991-15799193.13795.87
6156757-15675792.41095.26
极限1164022-16402296.69397.831.9099.58100.971.95
2163623-16362396.45899.71
3163763-16376396.54099.61
4164721-16472197.105100.12
5171291-171291100.978104.23
6168300-16830099.215102.58
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%
110.181774921781491783111782291780921780550.19
210.191776231789471782850.53
单位质量响应值RSD%判断
17490.6717496.070.03数据可信
供试品溶液-2022091801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%
5min13939-39392.0212.1311.322.022.1311.35
25006-50062.5692.57
33943-39432.0242.02
44407-44072.2622.26
53841-38411.9711.97
63797-37971.9491.95
10min110940-109405.6145.637.855.635.647.88
211873-118736.0936.11
311548-115485.9265.94
411224-112245.7605.77
510845-108455.5665.58
69396-93964.8224.83
15min112068-120686.1935.926.596.245.966.59
211768-117686.0396.09
312335-123356.3306.37
411205-112055.7505.79
511645-116455.9766.02
610198-101985.2345.27
20min111763-117636.0375.932.296.116.012.31
211411-114115.8565.94
311548-115485.9266.01
411826-118266.0696.15
511678-116785.9936.07
611112-111125.7035.77
30min112285-122856.3055.835.256.415.945.19
211458-114585.8805.99
311123-111235.7085.82
411764-117646.0376.15
510884-108845.5865.69
610677-106775.4795.58
45min111588-115885.9475.696.396.095.836.33
211354-113545.8275.97
311624-116245.9656.11
411325-113255.8125.96
510913-109135.6005.74
69742-97425.0005.13
60min110595-105955.4375.612.735.625.782.52
210750-107505.5175.70
310961-109615.6255.80
410979-109795.6345.81
510796-107965.5405.71
611457-114575.8806.04
极限111088-110885.6905.772.605.905.982.47
210970-109705.6305.84
310970-109705.6305.84
411672-116725.9906.20
511254-112545.7755.98
611508-115085.9066.10
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2500
标示量(mg)20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%
111.103111023124343124133120663117863119600.18
211.163115813136483126140.47
单位质量响应值RSD%判断
28104.5028012.010.24数据可信
供试品溶液-2022091801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%
5min1183247-18324753.94643.5929.9753.9543.5929.98
2173783-17378351.16051.16
3180833-18083353.23553.24
473185-7318521.54521.54
5161981-16198147.68547.69
6115371-11537133.96433.96
10min1264130-26413077.75778.375.8978.0678.615.94
2283362-28336283.41883.70
3271522-27152279.93380.23
4237006-23700669.77269.89
5268405-26840579.01579.28
6272879-27287980.33280.52
15min1277334-27733481.64482.704.8482.3883.384.88
2295942-29594287.12287.87
3281609-28160982.90283.64
4257872-25787275.91576.42
5279555-27955582.29883.00
6293243-29324386.32786.96
20min1281234-28123482.79283.903.6783.9885.043.69
2297673-29767387.63188.86
3280811-28081182.66783.87
4271478-27147879.92080.85
5281352-28135282.82783.99
6297514-29751487.58588.70
30min1297677-29767787.63386.093.0989.2887.703.12
2305404-30540489.90791.63
3285608-28560884.08085.74
4282602-28260283.19584.57
5285900-28590084.16685.79
6297483-29748387.57689.18
45min1299806-29980688.25987.941.6090.3990.031.64
2307340-30734090.47792.70
3294381-29438186.66288.79
4296819-29681987.38089.22
5294737-29473786.76788.86
6299308-29930888.11390.20
60min1297291-29729187.51990.153.1390.1492.723.04
2317451-31745193.45496.17
3293957-29395786.53889.15
4309707-30970791.17493.49
5303564-30356489.36691.94
6315309-31530992.82395.40
极限1337616-33761699.39099.921.09102.50102.990.96
2337322-33732299.304102.54
3335846-33584698.869101.96
4345796-345796101.798104.63
5338088-33808899.529102.60
6341742-341742100.605103.70
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%
110.181759421764131766421766471766641764620.18
210.191744521744591744560.01
单位质量响应值RSD%判断
17334.1817120.310.88数据可信
供试品溶液-2022091801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%
5min14801-48012.5022.6117.152.502.6117.03
24104-41042.1392.14
34251-42512.2152.22
46111-61113.1853.18
54813-48132.5082.51
66011-60113.1333.13
10min110728-107285.5915.534.825.605.544.80
210281-102815.3585.37
310559-105595.5035.52
411481-114815.9836.00
510646-106465.5485.56
69963-99635.1925.21
15min112272-122726.3956.045.646.446.095.62
211256-112565.8665.91
310508-105085.4765.52
411983-119836.2456.30
511496-114965.9916.04
612066-120666.2886.33
20min112197-121976.3566.034.946.446.114.96
210761-107615.6085.68
311164-111645.8185.89
411608-116086.0496.14
511513-115136.0006.08
612217-122176.3676.45
30min111475-114755.9806.134.786.106.244.77
211565-115656.0276.13
311311-113115.8956.00
411968-119686.2376.36
511459-114595.9726.08
612820-128206.6816.80
45min111330-113305.9055.922.126.056.072.13
211267-112675.8726.01
310989-109895.7275.87
411381-113815.9316.09
511565-115656.0276.17
611677-116776.0856.24
60min110751-107515.6035.652.195.785.832.20
210940-109405.7015.87
310541-105415.4935.66
410986-109865.7255.91
510645-106455.5485.73
611179-111795.8266.01
极限111034-110345.7505.822.515.966.032.53
211206-112065.8406.04
310690-106905.5715.77
411320-113205.8996.12
511487-114875.9866.20
611307-113075.8936.11
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2500
标示量(mg)20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%
111.103069593077543080323080253080643077670.16
211.163048633049353048990.02
单位质量响应值RSD%判断
27726.7627320.701.05数据可信
供试品溶液-2022091801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%
5min1151603-15160345.49943.0819.0645.5043.0819.07
2139058-13905841.73441.73
3142694-14269442.82542.83
4190021-19002157.02957.03
5130775-13077539.24839.25
6107039-10703932.12532.12
10min1262642-26264278.82478.594.2279.0878.834.25
2276740-27674083.05683.29
3262256-26225678.70978.95
4269719-26971980.94881.27
5254341-25434176.33376.55
6245481-24548173.67473.85
15min1281560-28156084.50283.142.9485.1983.822.93
2291545-29154587.49988.19
3274031-27403182.24282.92
4271524-27152481.49082.26
5273176-27317681.98682.63
6270367-27036781.14381.73
20min1282901-28290184.90583.452.6986.0684.582.67
2290441-29044187.16788.35
3270135-27013581.07382.21
4272784-27278481.86883.09
5276982-27698283.12884.23
6274991-27499182.53183.57
30min1286976-28697686.12885.633.8387.7687.243.80
2306506-30650691.98993.65
3277778-27777883.36784.95
4278828-27882883.68285.36
5282964-28296484.92386.48
6278952-27895283.71985.22
45min1288041-28804186.44789.773.5488.5691.853.47
2306609-30660992.02094.19
3316752-31675295.06497.11
4294303-29430388.32790.47
5295865-29586588.79590.83
6293140-29314087.97789.94
60min1287684-28768486.34089.844.2688.9392.414.17
2314889-31488994.50597.19
3314677-31467794.44197.01
4292862-29286287.89490.52
5286860-28686086.09388.62
6299057-29905789.75392.20
极限1338788-338788101.677101.781.86104.75104.851.83
2349521-349521104.899108.11
3337511-337511101.294104.39
4331614-33161499.524102.64
5334798-334798100.480103.48
6342474-342474102.784105.73
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