玛巴洛沙韦片项目信息
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.269990539994629991219990599986839990760.03
211.159961409962109961750.01
单位质量响应值RSD%判断
88727.8989343.050.49数据可信
供试品溶液-24121601批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1206243-20624320.97317.8112.0520.9717.8012.04
2161958-16195816.47016.47
3163733-16373316.65016.65
4173309-17330917.62417.62
5151042-15104215.36015.36
6194355-19435519.76419.76
10min1517183-51718352.59351.963.8652.6351.993.86
2482930-48293049.11049.14
3497565-49756550.59850.63
4539941-53994154.90754.94
5507621-50762151.62151.65
6520364-52036452.91652.95
15min1704370-70437071.62870.761.7971.7570.881.79
2686259-68625969.78669.90
3691993-69199370.36970.48
4716943-71694372.90773.03
5690021-69002170.16970.28
6685355-68535569.69469.82
20min1798692-79869281.22081.451.0081.4681.691.00
2796366-79636680.98381.21
3802518-80251881.60981.84
4812487-81248782.62382.87
5806077-80607781.97182.20
6789662-78966280.30280.54
30min1887184-88718490.21991.171.3790.6091.541.36
2884143-88414389.90990.27
3904031-90403191.93292.30
4897535-89753591.27191.65
5916510-91651093.20193.57
6889685-88968590.47390.84
45min1928342-92834294.40495.711.7494.9396.231.73
2928076-92807694.37794.89
3954674-95467497.08297.60
4938055-93805595.39295.92
5967343-96734398.37098.89
6930526-93052694.62695.15
60min1941550-94155095.74796.821.4996.4397.501.48
2941375-94137595.72996.40
3964923-96492398.12498.80
4948300-94830096.43497.12
5974423-97442399.09099.77
6942005-94200595.79396.47
极限1984022-984022100.066100.911.02100.91101.751.02
2980347-98034799.692100.52
31003003-1003003101.996102.84
4991870-991870100.864101.72
51005539-1005539102.254103.10
6989027-989027100.575101.41
玛巴洛沙韦片项目信息
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.269963729971109962369960279964149964320.05
211.151000557100097410007660.03
单位质量响应值RSD%判断
88493.0789754.801.01数据可信
供试品溶液-24121602批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1302143-30214330.69634.4433.6430.7034.4433.64
2388878-38887839.50839.51
3220554-22055422.40722.41
4443963-44396345.10445.10
5204755-20475520.80220.80
6473511-47351148.10648.11
10min1512865-51286552.10459.3422.5652.1659.4022.56
2611409-61140962.11562.18
3453860-45386046.10946.15
4752922-75292276.49276.57
5453632-45363246.08646.12
6719894-71989473.13773.22
15min1651129-65112966.15173.8914.8566.2974.0414.87
2728172-72817273.97874.15
3624813-62481363.47763.59
4886250-88625090.03890.24
5645691-64569165.59865.71
6827611-82761184.08084.28
20min1768850-76885078.11183.129.3078.3683.409.34
2798823-79882381.15681.45
3747426-74742675.93476.15
4939978-93997895.49695.85
5771666-77166678.39778.62
6882321-88232189.63889.98
30min1868341-86834188.21891.865.3988.6092.285.41
2855098-85509886.87387.30
3873802-87380288.77389.12
4984169-98416999.986100.50
5911950-91195092.64993.00
6931683-93168394.65395.14
45min1909978-90997892.44895.644.8792.9796.214.88
2877785-87778589.17889.75
3925923-92592394.06894.56
41004430-1004430102.044102.72
5972574-97257498.80899.31
6957639-95763997.29097.94
60min1926685-92668594.14696.764.8194.8397.504.82
2883912-88391289.80090.52
3939038-93903895.40196.05
41009881-1009881102.598103.45
5991384-991384100.719101.39
6963858-96385897.92298.73
极限1963244-96324497.860101.883.8598.70102.773.87
2962867-96286797.82198.69
3984729-984729100.043100.85
41054892-1054892107.171108.19
51035264-1035264105.177106.02
61015773-1015773103.196104.17
玛巴洛沙韦片项目信息
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.269985549987139993069989419985689988160.04
211.151000583100030510004440.02
单位质量响应值RSD%判断
88704.8089725.920.81数据可信
供试品溶液-24121603批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201821-20182120.48234.8030.6120.4834.8030.61
2450179-45017945.68845.69
3233793-23379323.72723.73
4336657-33665734.16734.17
5434630-43463044.11044.11
6400062-40006240.60240.60
10min1463025-46302546.99264.2018.2047.0364.2618.21
2752842-75284276.40476.48
3526669-52666953.45153.49
4636134-63613464.56064.62
5721051-72105173.17873.25
6695922-69592270.62870.70
15min1658488-65848866.82978.969.6066.9479.129.63
2859361-85936187.21587.42
3723115-72311573.38873.52
4782339-78233979.39879.56
5820863-82086383.30883.50
6823806-82380683.60783.79
20min1768429-76842977.98686.195.7178.2186.495.75
2905354-90535491.88392.23
3819856-81985683.20683.46
4859095-85909587.18887.48
5863598-86359887.64587.98
6879368-87936889.24589.57
30min1878525-87852589.16092.192.3189.5192.642.35
2940653-94065395.46595.97
3904107-90410791.75692.15
4913365-91336592.69693.14
5896673-89667391.00291.48
6917234-91723493.08893.56
45min1930708-93070894.45694.551.6294.9695.151.61
2953151-95315196.73397.39
3938191-93819195.21595.76
4931089-93108994.49495.09
5906679-90667992.01792.65
6930276-93027694.41295.04
60min1944722-94472295.87895.111.8596.5495.861.83
2955264-95526496.94897.77
3951873-95187396.60497.31
4932403-93240394.62895.38
5908262-90826292.17892.96
6930605-93060594.44595.23
极限1961707-96170797.60298.051.4598.4298.961.45
2983761-98376199.840100.82
3968534-96853498.29599.16
4973072-97307298.75599.67
5941761-94176195.57896.52
6967868-96786898.22799.17
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