依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.139687409687299693869693969696249691750.05
210.169720719724559722630.03
单位质量响应值RSD%判断
95673.7495695.180.02数据可信
供试品溶液-Z008150批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1287062-28706226.93337.8124.1326.9337.8124.14
2356531-35653133.45133.45
3312408-31240829.31129.31
4514221-51422148.24648.25
5496571-49657146.59046.59
6451419-45141942.35442.35
10min1498155-49815546.73955.9614.7946.7856.0214.81
2540036-54003650.66850.72
3514844-51484448.30548.35
4693154-69315465.03465.11
5678981-67898163.70563.78
6653327-65332761.29861.37
15min1611294-61129457.35464.1110.2057.4864.2610.22
2633749-63374959.46159.60
3616208-61620857.81557.94
4755915-75591570.92371.11
5748490-74849070.22670.41
6734085-73408568.87569.05
20min1677934-67793463.60668.737.4563.8269.007.48
2691867-69186764.91465.15
3679321-67932163.73763.96
4786056-78605673.75174.06
5781881-78188173.35973.66
6778433-77843373.03673.32
30min1750711-75071170.43574.225.1070.7674.605.14
2761721-76172171.46871.82
3751936-75193670.55070.88
4817884-81788476.73777.17
5828658-82865877.74878.17
6835581-83558178.39878.81
45min1815651-81565176.52878.792.9076.9779.292.95
2828019-82801977.68878.15
3813293-81329376.30676.76
4850361-85036179.78480.34
5858443-85844380.54381.10
6872658-87265881.87682.42
60min1851255-85125579.86881.111.9080.4481.741.95
2854467-85446780.17080.77
3847882-84788279.55280.13
4867627-86762781.40482.10
5874979-87497982.09482.78
6890448-89044883.54584.22
极限1874843-87484382.08182.651.2482.7883.421.27
2876483-87648382.23582.96
3871926-87192681.80882.52
4873786-87378681.98282.81
5889133-88913383.42284.25
6899151-89915184.36285.18
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162144222214532421464372146401214625821457280.05
210.132157606215344621555260.14
单位质量响应值RSD%判断
211193.70212786.380.54数据可信
供试品溶液-Z008150批-辛伐他汀-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1259926-25992610.98019.8041.6810.9819.8041.68
2328573-32857313.88013.88
3291420-29142012.31012.31
4681914-68191428.80628.81
5654893-65489327.66527.66
6594981-59498125.13425.13
10min1491212-49121220.75027.7323.9120.7727.7623.93
2536017-53601722.64322.67
3515986-51598621.79721.82
4817401-81740134.53034.58
5805867-80586734.04234.09
6771888-77188832.60732.65
15min1631979-63197926.69731.2614.1926.7531.3414.23
2658991-65899127.83827.90
3643332-64333227.17627.23
4844515-84451535.67535.78
5838425-83842535.41835.52
6822873-82287334.76134.86
20min1723031-72303130.54333.258.2430.6433.388.31
2734409-73440931.02431.13
3726654-72665430.69630.80
4845496-84549635.71635.88
5844988-84498835.69535.86
6848217-84821735.83135.99
30min1808853-80885334.16835.222.7234.3235.402.80
2822324-82232434.73834.90
3811998-81199834.30134.45
4841802-84180235.56035.78
5852779-85277936.02436.25
6864021-86402136.49936.71
45min1873939-87393936.91836.501.6737.1236.741.55
2878659-87865937.11737.33
3872645-87264536.86337.07
4842561-84256135.59235.88
5850640-85064035.93436.22
6865534-86553436.56336.84
60min1907503-90750338.33636.914.3938.6037.214.25
2911372-91137238.49938.78
3904331-90433138.20238.47
4828459-82845934.99735.34
5836619-83661935.34135.68
6853549-85354936.05736.39
极限1926968-92696839.15837.474.9439.4937.844.81
2926674-92667439.14639.49
3925169-92516939.08239.42
4834863-83486335.26735.67
5848956-84895635.86336.26
6858990-85899036.28636.68
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.139728509729659748929751719730809737920.12
210.169816919839299828100.17
单位质量响应值RSD%判断
96129.5296733.270.45数据可信
供试品溶液-Z008150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%
5min1348366-34836632.43238.9225.8032.4338.9225.80
2322287-32228730.00430.00
3319264-31926429.72329.72
4519868-51986848.39948.40
5425951-42595139.65539.66
6572779-57277953.32553.32
10min1556400-55640051.80059.8917.4451.8559.9517.45
2549851-54985151.19051.24
3536343-53634349.93349.98
4756824-75682470.45970.54
5670247-67024762.39962.46
6790115-79011573.55873.65
15min1652862-65286260.78068.9212.7760.9269.0812.79
2659180-65918061.36861.50
3656685-65668561.13661.27
4832796-83279677.53277.73
5787064-78706473.27473.44
6852989-85298979.41279.62
20min1710012-71001266.10173.3310.1866.3473.6110.20
2715750-71575066.63566.87
3719362-71936266.97167.21
4859510-85951080.01980.35
5846555-84655578.81379.10
6874787-87478781.44181.78
30min1777013-77701372.33977.887.1272.6978.287.16
2783804-78380472.97173.32
3787494-78749473.31473.66
4885164-88516482.40782.87
5881132-88113282.03282.46
6904470-90447084.20584.68
45min1832162-83216277.47381.334.6777.9581.874.72
2836812-83681277.90678.38
3843160-84316078.49778.97
4901443-90144383.92384.52
5903196-90319684.08684.65
6925037-92503786.11986.74
60min1861098-86109880.16783.183.3280.7783.853.38
2866940-86694080.71181.31
3875078-87507881.46882.07
4909841-90984184.70585.44
5914930-91493085.17885.88
6933208-93320886.88087.64
极限1876189-87618981.57284.172.4082.3184.982.46
2886167-88616782.50183.24
3897393-89739383.54684.28
4911532-91153284.86285.74
5918982-91898285.55686.40
6934562-93456287.00687.91
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162153284215370721576952158189215379821553350.12
210.132173768217701021753890.11
单位质量响应值RSD%判断
212139.27214747.190.87数据可信
供试品溶液-Z008150批-辛伐他汀-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%
5min1817021-81702134.27920.7263.0234.2820.7263.01
2761058-76105831.93131.93
3751395-75139531.52631.53
4209892-2098928.8068.81
5174746-1747467.3327.33
6249464-24946410.46710.47
10min11331808-133180855.87833.7069.4255.9433.7469.41
21326198-132619855.64355.70
31277555-127755553.60253.65
4297345-29734512.47612.49
5269727-26972711.31711.33
6317236-31723613.31013.33
15min11568727-156872765.81840.1871.2965.9740.2771.28
21593664-159366466.86567.01
31579646-157964666.27666.42
4332642-33264213.95613.99
5323490-32349013.57313.60
6347616-34761614.58514.62
20min11710668-171066871.77443.7271.5772.0343.8871.56
21730174-173017472.59272.85
31727650-172765072.48672.74
4355936-35593614.93414.99
5354739-35473914.88414.94
6373299-37329915.66215.73
30min11849140-184914077.58347.2871.8077.9647.5171.80
21870634-187063478.48578.86
31876530-187653078.73379.11
4378728-37872815.89015.97
5385709-38570916.18316.26
6400743-40074316.81416.90
45min11941989-194198981.47949.7471.1181.9950.0571.10
21953317-195331781.95482.46
31969736-196973682.64383.15
4407500-40750017.09717.21
5412801-41280117.32017.43
6428121-42812117.96218.08
60min11973439-197343982.79951.0569.7683.4451.4469.77
21991387-199138783.55284.20
32009410-200941084.30884.95
4434508-43450818.23018.37
5436165-43616518.30018.43
6455533-45553319.11319.26
极限11987089-198708983.37151.8968.5284.1552.3768.54
22006315-200631584.17884.96
32036944-203694485.46386.25
4454903-45490319.08619.26
5457135-45713519.18019.34
6478100-47810020.05920.24
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.139761409787219798739798749790049787220.16
210.169839409860539849960.16
单位质量响应值RSD%判断
96616.1996948.430.25数据可信
供试品溶液-Z008150批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1268917-26891724.94533.4324.3824.9433.4224.39
2276358-27635825.63525.63
3297234-29723427.57127.57
4445846-44584641.35741.36
5427679-42767939.67239.67
6445998-44599841.37141.37
10min1508419-50841947.16154.8116.8247.2054.8616.83
2486278-48627845.10745.15
3508328-50832847.15347.20
4686952-68695263.72263.79
5661132-66113261.32761.39
6694058-69405864.38164.45
15min1639071-63907159.28066.5813.4359.4066.7313.44
2617851-61785157.31257.43
3633941-63394158.80458.93
4810647-81064775.19675.37
5793332-79333273.58973.76
6812064-81206475.32775.50
20min1707065-70706565.58772.6511.7065.8172.9111.72
2696267-69626764.58664.80
3696009-69600964.56264.78
4870162-87016280.71681.02
5858211-85821179.60879.90
6871587-87158780.84881.15
30min1768755-76875571.31077.468.8971.6477.848.92
2769006-76900671.33371.65
3764665-76466570.93071.26
4907494-90749484.17984.61
5894674-89467482.99083.41
6905763-90576384.01984.46
45min1823082-82308276.34980.796.1776.8081.306.22
2824711-82471176.50076.94
3818440-81844075.91876.37
4923145-92314585.63186.21
5913076-91307684.69785.26
6923237-92323785.63986.22
60min1852253-85225379.05582.434.6879.6383.084.74
2853143-85314379.13879.70
3847350-84735078.60079.18
4930436-93043686.30787.03
5920318-92031885.36986.07
6928600-92860086.13786.86
极限1872828-87282880.96483.573.5781.6784.363.63
2875158-87515881.18081.88
3868768-86876880.58781.29
4939370-93937087.13688.00
5920228-92022885.36086.21
6929462-92946286.21787.08
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162158454216496321672672166926216566821646560.17
210.132177926218181521798700.13
单位质量响应值RSD%判断
213056.69215189.540.71数据可信
供试品溶液-Z008150批-辛伐他汀-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1626449-62644926.20039.8134.0626.2039.8134.06
2644799-64479926.96726.97
3701850-70185029.35329.35
41269401-126940153.09053.09
51199420-119942050.16350.16
61269207-126920753.08253.08
10min11210756-121075650.63761.7621.2950.6861.8221.31
21156545-115654548.37048.41
31206349-120634950.45350.50
41780221-178022174.45474.54
51713588-171358871.66771.75
61792134-179213474.95275.04
15min11524778-152477863.77073.4315.5363.9073.6015.55
21481541-148154161.96262.09
31516746-151674663.43563.57
42021552-202155284.54784.76
51978241-197824182.73682.94
62012104-201210484.15284.37
20min11694240-169424070.85879.0412.2571.0979.3312.28
21668660-166866069.78870.02
31673600-167360069.99570.23
42113459-211345988.39188.74
52086243-208624387.25287.59
62102537-210253787.93488.29
30min11835441-183544176.76382.608.0477.1283.038.09
21834213-183421376.71277.06
31822295-182229576.21376.57
42136139-213613989.33989.84
52101462-210146287.88988.38
62120778-212077888.69789.20
45min11921025-192102580.34384.555.5080.8285.115.57
21929165-192916580.68381.16
31911092-191109279.92780.41
42130118-213011889.08789.74
52111308-211130888.30188.93
62126494-212649488.93689.58
60min11957325-195732581.86185.134.5982.4885.834.66
21958702-195870281.91882.53
31936745-193674581.00081.62
42134551-213455189.27390.07
52105941-210594188.07688.86
62119229-211922988.63289.43
极限11967577-196757782.29072.0348.5683.0472.8748.07
21978177-197817782.73383.48
322180-221800.9281.68
42146605-214660589.77790.72
52101441-210144187.88888.81
62117255-211725588.54989.49
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