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%
110.181753151753821752741754081756921754140.10
210.191748401751481749940.13
单位质量响应值RSD%判断
17231.2417173.110.24数据可信
供试品溶液-2022092001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%
5min13704-37041.9331.9916.521.931.9916.54
24301-43012.2452.24
33753-37531.9591.96
44429-44292.3112.31
52669-26691.3931.39
64011-40112.0932.09
10min19758-97585.0935.456.105.105.466.12
210413-104135.4345.45
310644-106445.5555.57
411549-115496.0276.04
59906-99065.1705.18
610377-103775.4165.43
15min111849-118496.1845.896.566.225.936.54
211651-116516.0806.12
311845-118456.1826.22
411727-117276.1206.17
510316-103165.3845.42
610367-103675.4105.45
20min111975-119756.2506.195.416.326.265.36
212126-121266.3286.40
312830-128306.6966.77
411598-115986.0536.13
511799-117996.1586.22
610882-108825.6795.75
30min111758-117586.1366.141.576.246.241.64
211955-119556.2396.35
311925-119256.2236.34
411805-118056.1616.27
511651-116516.0806.18
611459-114595.9806.08
45min110910-109105.6945.761.105.845.901.07
211039-110395.7615.91
310963-109635.7215.87
411259-112595.8766.02
511002-110025.7425.88
610996-109965.7395.88
60min111053-110535.7685.642.705.945.822.56
211073-110735.7795.96
310685-106855.5765.76
410356-103565.4055.59
511023-110235.7535.92
610642-106425.5545.72
极限111224-112245.8585.851.506.066.061.38
210971-109715.7265.94
311164-111645.8266.04
411280-112805.8876.10
511477-114775.9906.19
611146-111465.8176.02
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%
111.103094913096663098613093263101733097030.11
211.163087793091023089400.08
单位质量响应值RSD%判断
27901.1727682.800.56数据可信
供试品溶液-2022092001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%
5min1167751-16775149.85850.057.4449.8650.057.44
2175401-17540152.13152.13
3188716-18871656.08956.09
4166696-16669649.54449.54
5153887-15388745.73745.74
6157958-15795846.94746.95
10min1216634-21663464.38667.6310.0764.6667.9110.03
2207814-20781461.76562.05
3251110-25111074.63374.94
4199908-19990859.41559.69
5254719-25471975.70675.96
6235170-23517069.89570.16
15min1227284-22728467.55271.4410.2168.1972.1010.17
2217832-21783264.74265.38
3265924-26592479.03679.76
4213169-21316963.35763.96
5270002-27000280.24880.92
6248069-24806973.72974.38
20min1228171-22817167.81573.4910.9368.8374.5410.88
2224983-22498366.86867.86
3280283-28028383.30484.47
4218965-21896565.07966.04
5276152-27615282.07683.20
6255068-25506875.80976.87
30min1242569-24256972.09577.3411.3373.4878.8011.27
2233037-23303769.26270.63
3294962-29496287.66689.29
4226682-22668267.37368.69
5283863-28386384.36885.94
6280217-28021783.28484.76
45min1245842-24584273.06779.5712.4174.8581.4612.32
2235539-23553970.00571.75
3307716-30771691.45793.57
4233603-23360369.43071.12
5285611-28561184.88786.93
6297980-29798088.56390.51
60min1264732-26473278.68283.5812.3880.8785.9112.29
2249750-24975074.22976.37
3326385-32638597.00699.63
4240760-24076071.55773.64
5293382-29338287.19789.71
6312288-31228892.81695.25
极限1333327-33332799.06998.911.31101.70101.701.49
2325471-32547196.73499.28
3337453-337453100.295103.46
4332016-33201698.679101.16
5336916-336916100.136103.14
6331555-33155598.542101.49
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%
110.181782331782661782331781151780651781820.05
210.191753891756121755000.09
单位质量响应值RSD%判断
17503.1417222.771.15数据可信
供试品溶液-2022092001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%
5min14753-47532.4582.2711.032.462.2711.00
24635-46352.3972.40
34582-45822.3692.37
43480-34801.7991.80
54207-42072.1752.18
64668-46682.4142.41
10min110617-106175.4905.384.475.505.394.47
210014-100145.1785.19
310430-104305.3935.41
49681-96815.0065.02
510739-107395.5535.57
610899-108995.6365.65
15min110936-109365.6556.025.215.706.065.18
211157-111575.7695.81
311515-115155.9546.00
411537-115375.9666.00
512507-125076.4676.51
612216-122166.3176.36
20min111604-116046.0006.063.266.086.143.28
211293-112935.8395.91
311880-118806.1436.22
411339-113395.8635.93
512242-122426.3306.41
612018-120186.2146.29
30min110745-107455.5565.883.175.665.993.15
211466-114665.9296.04
311747-117476.0746.18
411461-114615.9266.03
511645-116456.0216.14
611218-112185.8015.91
45min110605-106055.4845.613.925.625.753.91
210767-107675.5675.71
311284-112845.8355.98
410199-101995.2745.41
511318-113185.8526.00
610936-109365.6555.80
60min110453-104535.4055.513.335.585.683.17
210919-109195.6465.82
310907-109075.6405.82
410949-109495.6625.83
510051-100515.1975.38
610612-106125.4875.67
极限110966-109665.6705.741.835.875.941.83
211143-111435.7625.96
311296-112965.8416.05
410835-108355.6035.80
511352-113525.8706.08
610983-109835.6795.89
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%
111.103129743129123131713125293124963128160.10
211.163093143096523094830.08
单位质量响应值RSD%判断
28181.6227731.451.14数据可信
供试品溶液-2022092001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%
5min1198907-19890758.77350.2219.5358.7750.2219.53
2195459-19545957.75457.75
3196617-19661758.09658.10
4132766-13276639.22939.23
5169902-16990250.20250.20
6126077-12607737.25337.25
10min1252212-25221274.52370.255.3074.8570.525.35
2250366-25036673.97874.30
3239840-23984070.86771.19
4220380-22038065.11765.34
5236668-23666869.93070.21
6226943-22694367.05767.26
15min1270240-27024079.85075.135.8580.5975.805.90
2270001-27000179.77980.51
3259571-25957176.69777.41
4235742-23574269.65770.24
5250520-25052074.02374.69
6239502-23950270.76871.35
20min1276340-27634081.65277.755.1482.8478.845.19
2274354-27435481.06682.24
3268010-26801079.19180.33
4241806-24180671.44872.41
5266356-26635678.70279.78
6251964-25196474.45075.42
30min1281552-28155283.19280.265.2184.8381.775.25
2288235-28823585.16786.79
3274140-27414081.00282.58
4251562-25156274.33175.69
5276403-27640381.67183.19
6257775-25777576.16777.55
45min1286777-28677784.73683.014.0586.8484.984.07
2292916-29291686.55088.65
3271454-27145480.20982.24
4265217-26521778.36680.14
5291870-29187086.24188.21
6277453-27745381.98183.79
60min1291465-29146586.12185.724.9388.6988.144.87
2297568-29756887.92590.50
3277983-27798382.13884.62
4272126-27212680.40782.62
5312251-31225192.26394.71
6289180-28918085.44687.71
极限1330600-33060097.68598.651.84100.73101.551.87
2338673-338673100.070103.14
3329926-32992697.486100.42
4326832-32683296.57299.23
5343264-343264101.427104.39
6333849-33384998.645101.38
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%
110.181760601761141761001761121762611761290.05
210.191756121760771758440.19
单位质量响应值RSD%判断
17301.4717256.530.19数据可信
供试品溶液-2022092201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%
5min14699-46992.4412.687.812.442.687.86
25154-51542.6782.68
35828-58283.0283.03
45376-53762.7932.79
54935-49352.5642.56
64930-49302.5612.56
10min111365-113655.9055.316.025.925.336.02
210071-100715.2335.25
310203-102035.3015.32
49996-99965.1945.21
59509-95094.9414.95
610196-101965.2975.31
15min111800-118006.1315.984.356.186.024.29
212108-121086.2916.33
310819-108195.6215.67
411615-116156.0356.08
510983-109835.7065.75
611708-117086.0836.13
20min111850-118506.1576.092.466.246.172.47
212061-120616.2666.35
311404-114045.9256.00
411501-115015.9756.05
512035-120356.2536.33
611531-115315.9916.07
30min111894-118946.1805.923.366.296.033.27
211094-110945.7645.88
311089-110895.7615.87
411119-111195.7775.89
511854-118546.1596.27
611312-113125.8775.99
45min111243-112435.8415.752.215.995.902.15
210911-109115.6695.81
310654-106545.5355.68
411136-111365.7865.93
511262-112625.8515.99
611242-112425.8415.98
60min110630-106305.5235.562.495.705.732.42
210621-106215.5185.70
310248-102485.3245.50
411031-110315.7315.91
510792-107925.6075.78
610841-108415.6335.81
极限110973-109735.7015.701.365.915.911.33
210892-108925.6595.87
310862-108625.6435.85
410884-108845.6555.86
510937-109375.6825.89
611260-112605.8506.06
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%
111.103093113093443090993092543093223092660.04
211.163090323094863092590.11
单位质量响应值RSD%判断
27861.8027711.380.39数据可信
供试品溶液-2022092201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%
5min1197360-19736058.66953.0421.3658.6753.0421.36
2193318-19331857.46757.47
3210529-21052962.58462.58
4207624-20762461.72061.72
5119295-11929535.46335.46
6142423-14242342.33842.34
10min1272464-27246480.99577.544.8381.3277.834.80
2236522-23652270.31070.63
3265562-26556278.94379.29
4264563-26456378.64678.99
5266013-26601379.07779.27
6259880-25988077.25477.49
15min1285491-28549184.86780.606.6785.6481.326.62
2235434-23543469.98770.70
3276738-27673882.26583.05
4271524-27152480.71581.50
5280189-28018983.29183.93
6277391-27739182.45983.12
20min1283607-28360784.30780.986.1485.5582.156.10
2238884-23888471.01372.11
3277881-27788182.60583.85
4276155-27615582.09283.32
5282009-28200983.83284.93
6275967-27596782.03683.16
30min1285965-28596585.00881.786.4586.7283.406.39
2242026-24202671.94773.44
3278882-27888282.90384.60
4278624-27862482.82684.51
5293062-29306287.11888.68
6272115-27211580.89182.47
45min1282879-28287984.09183.666.0686.2885.736.00
2250925-25092574.59276.48
3282621-28262184.01486.18
4289565-28956586.07888.22
5302665-30266589.97392.02
6279847-27984783.19085.22
60min1321127-32112795.46187.597.7698.1290.147.65
2259585-25958577.16679.47
3278661-27866182.83785.47
4304747-30474790.59293.21
5312296-31229692.83695.38
6291539-29153986.66589.16
极限1341897-341897101.635100.171.98104.82103.201.99
2333453-33345399.125101.86
3327478-32747897.349100.44
4341013-341013101.372104.50
5344908-344908102.530105.59
6333125-33312599.027102.00
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%
110.181768051774611780481783431784761778270.39
210.191755031759291757160.18
单位质量响应值RSD%判断
17468.2717243.960.92数据可信
供试品溶液-2022092201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%
5min15438-54382.8132.6918.982.812.6918.98
24915-49152.5422.54
35403-54032.7952.79
43380-33801.7481.75
56065-60653.1373.14
65988-59883.0973.10
10min110254-102545.3045.4210.505.325.4410.48
211037-110375.7095.72
310809-108095.5915.61
48362-83624.3254.34
511298-112985.8445.86
611135-111355.7605.78
15min110830-108305.6025.696.375.655.746.35
29957-99575.1515.20
310966-109665.6725.72
410753-107535.5625.60
511529-115295.9646.01
612000-120006.2076.26
20min110652-106525.5105.784.765.595.864.68
210746-107465.5595.63
310708-107085.5395.62
411837-118376.1236.19
511632-116326.0176.10
611471-114715.9346.02
30min110583-105835.4745.714.755.585.824.67
210746-107465.5595.66
310541-105415.4535.56
411587-115875.9946.09
511044-110445.7135.83
611770-117706.0886.20
45min110348-103485.3535.534.865.495.674.75
210177-101775.2645.40
310740-107405.5565.69
411226-112265.8075.94
510294-102945.3255.47
611413-114135.9046.05
60min110687-106875.5285.481.645.705.651.60
210746-107465.5595.72
310530-105305.4475.62
410287-102875.3215.49
510561-105615.4635.64
610728-107285.5495.73
极限110911-109115.6445.661.585.845.861.62
211084-110845.7335.93
310954-109545.6665.87
410630-106305.4995.69
511023-110235.7025.91
611097-110975.7405.95
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%
111.103092613101173109453112663116553106490.31
211.163084333093323088820.21
单位质量响应值RSD%判断
27986.4027677.600.79数据可信
供试品溶液-2022092201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%
5min1178442-17844252.96053.879.7752.9653.879.77
2164401-16440148.79348.79
3191257-19125756.76356.76
4157787-15778746.83046.83
5202451-20245160.08560.09
6194651-19465157.77057.77
10min1254691-25469175.59078.883.3575.8879.183.36
2264944-26494478.63378.90
3269827-26982780.08280.40
4256386-25638676.09376.35
5271411-27141180.55280.89
6277373-27737382.32282.64
15min1263381-26338178.16981.723.4778.8882.463.48
2272221-27222180.79281.50
3275349-27534981.72182.48
4269544-26954479.99880.68
5280812-28081283.34284.12
6290830-29083086.31587.09
20min1269680-26968080.03882.762.6281.1983.952.64
2279905-27990583.07384.23
3277995-27799582.50683.72
4272971-27297181.01582.14
5282035-28203583.70584.95
6290507-29050786.22087.48
30min1275118-27511881.65282.673.1483.2584.323.13
2268318-26831879.63481.25
3274996-27499681.61683.29
4277148-27714882.25583.83
5281609-28160983.57985.29
6294063-29406387.27589.01
45min1292813-29281386.90486.473.5688.9588.583.45
2285555-28555584.75086.81
3284434-28443484.41786.54
4307681-30768191.31793.35
5279481-27948182.94785.12
6298061-29806188.46190.68
60min1309090-30909091.73588.334.4694.2690.924.30
2287716-28771685.39187.92
3287819-28781985.42288.02
4318446-31844694.51297.05
5286747-28674785.10487.74
6295926-29592687.82890.54
极限1340328-340328101.00699.960.77104.05103.040.76
2334165-33416599.177102.18
3335646-33564699.616102.69
4338809-338809100.555103.62
5334037-33403799.139102.25
6337793-337793100.254103.45
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