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)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.904663704697074689844681874677354681970.28
210.934692594704944698760.19
单位质量响应值RSD%判断
42953.8542989.570.06数据可信
长期6月-供试品溶液-2024030821批-舒伐他汀钙-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%
5min1484487-48448796.34174.4119.1596.3474.4119.15
2295428-29542858.74658.75
3333075-33307566.23266.23
4381203-38120375.80375.80
5322850-32285064.19964.20
6428253-42825385.15885.16
10min1512080-512080101.82898.822.91101.9998.942.92
2502202-50220299.86399.96
3504834-504834100.387100.50
4499469-49946999.32099.45
5470457-47045793.55193.66
6492680-49268097.97098.11
15min1513137-513137102.038100.601.46102.37100.891.47
2510785-510785101.570101.83
3507769-507769100.970101.25
4503758-503758100.173100.46
5492292-49229297.89398.16
6507631-507631100.943101.25
20min1510731-510731101.559100.620.99102.06101.081.00
2511245-511245101.662102.10
3507658-507658100.948101.39
4506024-506024100.623101.08
5498429-49842999.11399.54
6502078-50207899.839100.31
30min1507775-507775100.971100.430.81101.64101.060.81
2511467-511467101.706102.31
3505621-505621100.543101.16
4501227-50122799.669100.30
5501133-50113399.651100.24
6503132-503132100.048100.69
45min1508724-508724101.160100.590.74102.00101.380.75
2510361-510361101.486102.26
3508348-508348101.085101.87
4503735-503735100.168100.96
5501478-50147899.719100.48
6502474-50247499.917100.72
60min1507588-507588100.934100.420.83101.94101.380.83
2510658-510658101.545102.49
3506235-506235100.665101.62
4500675-50067599.560100.52
5499804-49980499.386100.31
6505052-505052100.430101.40
极限1508909-508909101.197100.090.65102.37101.210.66
2503719-503719100.165101.28
3503773-503773100.176101.29
4502731-50273199.968101.09
5499111-49911199.249100.34
6501749-50174999.773100.91
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)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.914284824279834291704266454263404277240.29
210.894286594303184294880.28
单位质量响应值RSD%判断
39204.7739438.750.43数据可信
长期6月-供试品溶液-2024030821批-依折麦布瑞-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%
5min1242741-24274155.55938.2928.6455.5638.2928.63
2102270-10227023.40823.41
3136385-13638531.21631.22
4182549-18254941.78241.78
5156672-15667235.86035.86
6183048-18304841.89741.90
10min1423603-42360396.95589.745.4697.0589.815.47
2359539-35953982.29282.33
3399979-39997991.54891.60
4383338-38333887.74087.81
5386221-38622188.39988.46
6399841-39984191.51791.59
15min1439492-439492100.59298.292.16100.8598.512.17
2415975-41597595.21095.39
3432558-43255899.00599.21
4433244-43324499.16299.38
5420156-42015696.16796.37
6435281-43528199.62899.85
20min1435855-43585599.76099.051.26100.1899.431.28
2425252-42525297.33397.67
3436810-43681099.978100.35
4435717-43571799.728100.11
5426292-42629297.57197.94
6436648-43664899.941100.33
30min1437864-437864100.22099.760.92100.81100.300.94
2431919-43191998.85999.36
3440073-440073100.725101.26
4432078-43207898.89599.44
5432852-43285299.07299.60
6440298-440298100.777101.33
45min1437808-437808100.20799.630.75100.96100.340.77
2430966-43096698.64199.30
3438483-438483100.361101.07
4432705-43270599.03999.75
5433674-43367499.26199.96
6438205-438205100.298101.02
60min1436732-43673299.96199.350.70100.88100.230.70
2433246-43324699.16399.99
3437712-437712100.185101.06
4430869-43086998.61999.50
5430601-43060198.55799.42
6435338-43533899.641100.53
极限1436557-43655799.92099.230.96101.01100.270.97
2428865-42886598.16099.15
3438225-438225100.302101.34
4432261-43226198.93799.98
5428803-42880398.14699.17
6436473-43647399.901100.96
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)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.904700974701364717494699494690574701980.21
210.934699204693314696260.09
单位质量响应值RSD%判断
43137.4342966.700.29数据可信
长期6月-供试品溶液-2024030921批-舒伐他汀钙-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%
5min1373217-37321774.07681.3911.6274.0881.3911.62
2394617-39461778.32478.32
3368261-36826173.09373.09
4399206-39920679.23579.23
5428132-42813284.97684.98
6497019-49701998.64998.65
10min1487991-48799196.85798.563.3596.9898.693.35
2484939-48493996.25196.38
3513058-513058101.832101.95
4473457-47345793.97294.10
5508419-508419100.911101.05
6511465-511465101.516101.68
15min1490720-49072097.39899.982.1697.68100.282.17
2498548-49854898.95299.24
3515829-515829102.382102.67
4493189-49318997.88898.18
5511762-511762101.575101.88
6512250-512250101.672102.01
20min1489433-48943397.143100.391.9497.59100.861.95
2500177-50017799.27599.73
3515069-515069102.231102.69
4504896-504896100.212100.66
5512971-512971101.815102.29
6512262-512262101.674102.18
30min1492576-49257697.767100.391.6998.38101.031.70
2498122-49812298.86799.49
3514473-514473102.113102.75
4508771-508771100.981101.60
5511790-511790101.580102.23
6509071-509071101.041101.71
45min1487492-48749296.75899.921.8997.53100.721.89
2495893-49589398.42599.21
3510120-510120101.249102.05
4509028-509028101.032101.82
5509776-509776101.181102.00
6508331-508331100.894101.73
60min1486460-48646096.55399.932.0697.49100.902.06
2496386-49638698.52399.47
3510187-510187101.262102.23
4509429-509429101.112102.07
5504439-504439100.121101.11
6514058-514058102.030103.04
极限1486140-48614096.48999.671.7197.58100.811.72
2498589-49858998.960100.07
3507278-507278100.685101.83
4506569-506569100.544101.67
5507615-507615100.752101.91
6506911-506911100.612101.79
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)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.914290644282884271874288394276984282150.19
210.894254264284874269560.51
单位质量响应值RSD%判断
39249.7739206.240.08数据可信
长期6月-供试品溶液-2024030921批-依折麦布瑞-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%
5min1151921-15192134.85546.7824.1934.8546.7824.19
2185732-18573242.61242.61
3175023-17502340.15540.16
4203605-20360546.71346.71
5212485-21248548.75048.75
6294552-29455267.57867.58
10min1385807-38580788.51592.044.2388.5792.124.24
2376422-37642286.36286.43
3415735-41573595.38195.45
4411972-41197294.51894.60
5399937-39993791.75791.84
6417189-41718995.71595.83
15min1427406-42740698.05998.681.0598.2698.911.07
2422715-42271596.98397.20
3431591-43159199.01999.24
4434012-43401299.57499.81
5430117-43011798.68198.92
6434787-43478799.752100.02
20min1434035-43403599.580100.330.8499.95100.730.85
2432516-43251699.23199.61
3437540-437540100.384100.77
4441830-441830101.368101.77
5440927-440927101.161101.56
6437099-437099100.283100.72
30min1438346-438346100.569100.430.56101.10101.000.57
2433593-43359399.478100.02
3438646-438646100.638101.20
4440978-440978101.173101.74
5438182-438182100.531101.10
6436821-436821100.219100.82
45min1435399-43539999.893100.251.10100.60100.981.10
2428757-42875798.36999.08
3437758-437758100.434101.16
4443339-443339101.714102.45
5438689-438689100.648101.38
6437801-437801100.444101.22
60min1431632-43163299.02899.911.1999.90100.801.20
2428763-42876398.37099.24
3437824-437824100.449101.34
4440301-440301101.017101.93
5432722-43272299.279100.18
6441510-441510101.295102.23
极限1432206-43220699.16099.650.66100.19100.720.67
2430492-43049298.76799.80
3436575-436575100.163101.22
4438087-438087100.509101.59
5433394-43339499.433100.50
6435360-43536099.884100.99
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)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.904680504669264700974668414669514677730.30
210.934685194688274686730.05
单位质量响应值RSD%判断
42914.9542879.510.06数据可信
长期6月-供试品溶液-2024031021批-舒伐他汀钙-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%
5min1347483-34748369.21776.9910.6869.2276.9910.68
2430502-43050285.75485.75
3412706-41270682.20982.21
4423187-42318784.29784.30
5371666-37166674.03474.03
6333518-33351866.43566.44
10min1500547-50054799.70799.344.0299.8299.464.03
2506145-506145100.822100.97
3503117-503117100.219100.36
4519976-519976103.577103.72
5501895-50189599.976100.10
6460414-46041491.71391.82
15min1502885-502885100.173101.172.63100.45101.472.64
2519869-519869103.556103.87
3505842-505842100.762101.07
4520000-520000103.582103.90
5513945-513945102.376102.67
6484821-48482196.57496.84
20min1500730-50073099.743101.552.60100.19102.012.61
2525495-525495104.677105.16
3505700-505700100.733101.21
4521982-521982103.977104.46
5514047-514047102.396102.86
6490818-49081897.76998.19
30min1498264-49826499.252101.512.2799.87102.142.28
2525890-525890104.755105.41
3504495-504495100.493101.13
4519143-519143103.411104.07
5512531-512531102.094102.73
6497379-49737999.07699.66
45min1498923-49892399.384101.311.98100.16102.112.00
2522117-522117104.004104.84
3505805-505805100.754101.56
4516820-516820102.949103.78
5511453-511453101.879102.68
6496507-49650798.90299.65
60min1499209-49920999.440101.171.84100.39102.141.85
2519742-519742103.531104.54
3503876-503876100.370101.35
4516735-516735102.932103.93
5510619-510619101.713102.68
6497196-49719699.04099.96
极限1497652-49765299.130100.811.95100.24101.951.96
2518655-518655103.314104.49
3500784-50078499.754100.90
4514472-514472102.481103.66
5510644-510644101.718102.86
6494407-49440798.48499.57
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)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.914255244252324254114246124263184254190.15
210.894291834274624283220.29
单位质量响应值RSD%判断
38993.4939331.680.62数据可信
长期6月-供试品溶液-2024031021批-依折麦布瑞-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%
5min1125669-12566928.88134.9614.7528.8834.9614.75
2167103-16710338.40338.40
3163581-16358137.59337.59
4178985-17898541.13441.13
5124931-12493128.71128.71
6152490-15249035.04535.04
10min1384374-38437488.33588.427.0188.3888.487.01
2389108-38910889.42389.49
3413919-41391995.12595.19
4398223-39822391.51891.59
5334149-33414976.79376.84
6388595-38859589.30589.36
15min1417041-41704195.84296.763.4696.0496.973.47
2432967-43296799.50399.72
3433473-43347399.61999.84
4426052-42605297.91398.13
5394269-39426990.60990.78
6422447-42244797.08597.29
20min1425584-42558497.80698.592.2598.1698.962.26
2443445-443445101.911102.29
3434003-43400399.741100.13
4431889-43188999.25599.64
5415548-41554895.49995.83
6423442-42344297.31497.68
30min1423592-42359297.34898.911.8897.8799.441.89
2443290-443290101.875102.42
3432779-43277999.459100.01
4434584-43458499.874100.42
5421744-42174496.92397.41
6426311-42631197.97398.50
45min1428916-42891698.57299.201.5499.2599.891.55
2442722-442722101.744102.46
3433465-43346599.617100.34
4434040-43404099.749100.47
5425579-42557997.80598.45
6425106-42510697.69698.39
60min1428029-42802998.36899.221.3499.21100.081.35
2441619-441619101.491102.38
3431483-43148399.161100.05
4434956-43495699.960100.84
5428090-42809098.38299.19
6426172-42617297.94198.80
极限1426164-42616497.93998.811.4198.9599.841.41
2440800-440800101.303102.36
3429153-42915398.62699.68
4430733-43073398.989100.04
5429895-42989598.79799.77
6423009-42300997.21498.23
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