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%
110.181764401763621766651762701767501764970.12
210.191806021798241802130.31
单位质量响应值RSD%判断
17337.6217685.281.41数据可信
供试品溶液-2022091401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%
5min114156-141567.2586.409.897.266.409.90
212984-129846.6576.66
313077-130776.7056.70
411448-114485.8705.87
510712-107125.4925.49
612536-125366.4276.43
10min118486-184869.4789.092.429.529.122.46
217607-176079.0279.06
317532-175328.9899.03
417361-173618.9018.93
517406-174068.9248.95
617953-179539.2059.24
15min118184-181849.3239.012.689.429.092.69
217842-178429.1489.23
316985-169858.7088.80
417360-173608.9018.98
517150-171508.7938.87
617863-178639.1599.25
20min117942-179429.1998.932.449.349.072.44
217642-176429.0459.18
317141-171418.7888.92
416982-169828.7078.84
517022-170228.7278.86
617811-178119.1329.27
30min117123-171238.7798.541.918.988.731.94
216825-168258.6268.81
316405-164058.4118.60
416435-164358.4268.61
516333-163338.3748.55
616853-168538.6418.83
45min116915-169158.6738.503.938.928.733.88
216827-168278.6278.86
316286-162868.3508.58
416603-166038.5138.74
515455-154557.9248.15
617351-173518.8969.13
60min116651-166518.5378.362.558.838.642.53
216121-161218.2658.55
315798-157988.1008.38
416208-162088.3108.58
516148-161488.2798.55
616950-169508.6918.98
极限116815-168158.6218.362.338.968.682.35
216479-164798.4498.78
316021-160218.2148.54
416067-160678.2388.56
515836-158368.1198.43
616566-165668.4948.83
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5000
标示量(mg)10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%
111.101588631591161587471588331590791589280.11
211.161622891621071621980.08
单位质量响应值RSD%判断
14317.8414533.871.06数据可信
供试品溶液-2022091401批-阿托伐他汀钙-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%
5min165340-6534037.41533.4724.2437.4133.4724.25
276327-7632743.70643.71
362560-6256035.82335.82
446336-4633626.53326.53
537178-3717821.28921.29
662970-6297036.05836.06
10min1123406-12340670.66471.405.7670.8771.585.79
2129526-12952674.16974.41
3133286-13328676.32276.52
4123055-12305570.46370.61
5112343-11234364.32964.45
6126504-12650472.43872.64
15min1144275-14427582.61483.264.1183.2183.844.15
2149019-14901985.33185.99
3151894-15189486.97787.60
4146385-14638583.82284.36
5134460-13446076.99477.47
6146414-14641483.83984.44
20min1154063-15406388.21988.103.9089.2889.143.94
2155695-15569589.15390.28
3162085-16208592.81293.92
4153292-15329287.77788.78
5143471-14347182.15483.06
6154513-15451388.47789.55
30min1157524-15752490.20189.453.7391.7590.983.76
2158523-15852390.77392.40
3163130-16313093.41195.03
4157154-15715489.98991.48
5145610-14561083.37984.74
6155348-15534888.95590.51
45min1164687-16468794.30293.764.3596.3595.794.37
2166645-16664595.42397.55
3170771-17077197.78699.93
4164143-16414393.99195.98
5150029-15002985.90987.73
6166154-16615495.14297.20
60min1167505-16750595.91695.313.4698.4997.863.48
2164136-16413693.98796.65
3172471-17247198.760101.44
4168227-16822796.32998.84
5156158-15615889.41891.72
6170140-17014097.425100.01
极限1169496-16949697.05697.081.84100.16100.161.91
2167734-16773496.04799.23
3173489-17348999.342102.58
4169530-16953097.075100.12
5164783-16478394.35797.15
6172216-17221698.614101.74
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%
110.181764651765461764801763361765031764660.05
210.191771291776281773780.20
单位质量响应值RSD%判断
17334.5817407.070.30数据可信
供试品溶液-2022091403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%
5min114427-144277.4567.3111.017.467.3211.01
214123-141237.2997.30
313877-138777.1727.17
411335-113355.8585.86
515630-156308.0788.08
615509-155098.0158.02
10min118464-184649.5439.661.179.589.701.18
218886-188869.7619.80
318800-188009.7169.76
418733-187339.6829.71
518849-188499.7419.79
618358-183589.4889.53
15min118199-181999.4069.472.009.509.561.96
218442-184429.5319.63
318438-184389.5299.62
418561-185619.5939.68
518617-186179.6229.72
617631-176319.1129.21
20min117820-178209.2109.212.449.369.362.40
217603-176039.0989.25
318288-182889.4529.60
418200-182009.4069.55
517871-178719.2369.39
617094-170948.8348.98
30min117174-171748.8769.033.049.079.232.96
217653-176539.1239.32
318041-180419.3249.52
417931-179319.2679.46
517466-174669.0279.23
616606-166068.5828.78
45min116131-161318.3378.642.858.588.892.78
216473-164738.5148.76
317071-170718.8239.07
417344-173448.9649.21
516963-169638.7679.02
616333-163338.4418.69
60min116596-165968.5778.712.488.879.012.45
216752-167528.6588.95
317202-172028.8909.19
417238-172388.9099.20
517169-171698.8739.18
616200-162008.3728.66
极限116599-165998.5798.582.868.928.932.81
216490-164908.5228.87
316962-169628.7669.12
416121-161218.3328.67
517335-173358.9599.31
616141-161418.3428.68
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5000
标示量(mg)10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%
111.101589381587691587451588501587251588050.06
211.161593581598661596120.23
单位质量响应值RSD%判断
14306.7614302.150.03数据可信
供试品溶液-2022091403批-阿托伐他汀钙-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%
5min167985-6798539.25749.3511.3139.2649.3611.31
283554-8355448.24848.25
386355-8635549.86549.87
487848-8784850.72750.73
596765-9676555.87655.88
690291-9029152.13852.14
10min1130069-13006975.10778.532.7975.3378.802.80
2138725-13872580.10680.37
3136672-13667278.92079.20
4139593-13959380.60780.89
5138191-13819179.79780.11
6132705-13270576.63076.92
15min1151969-15196987.75387.742.1188.3988.462.09
2155120-15512089.57390.29
3152513-15251388.06888.78
4154038-15403888.94889.68
5152147-15214787.85688.61
6145926-14592684.26484.98
20min1159682-15968292.20790.662.0893.3391.862.04
2159505-15950592.10593.32
3159058-15905891.84793.05
4158008-15800891.24192.46
5153552-15355288.66789.91
6152243-15224387.91289.10
30min1164199-16419994.81693.472.5196.4595.172.47
2166663-16666396.23897.96
3163185-16318594.23095.94
4163127-16312794.19695.93
5158263-15826391.38893.12
6155751-15575189.93791.61
45min1161038-16103892.99093.010.9195.1595.230.92
2161973-16197393.53095.79
3161486-16148693.24995.49
4162812-16281294.01596.27
5160553-16055392.71094.95
6158561-15856191.56093.73
60min1167559-16755996.75695.101.3999.4397.841.35
2165956-16595695.83098.61
3166183-16618395.96198.72
4162895-16289594.06396.84
5164068-16406894.74097.50
6161477-16147793.24495.92
极限1168471-16847197.28295.391.87100.5098.661.80
2168823-16882397.486100.79
3163447-16344794.38197.67
4160818-16081892.86396.16
5165550-16555095.59698.88
6164088-16408894.75197.95
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%
110.181767141768851769971774151774201770860.19
210.191783671787481785580.16
单位质量响应值RSD%判断
17395.4817522.870.52数据可信
供试品溶液-2022091402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%
5min114411-144117.4106.709.257.416.709.25
214377-143777.3937.39
312499-124996.4276.43
413143-131436.7586.76
512456-124566.4056.40
611323-113235.8225.82
10min118265-182659.3929.461.599.439.501.59
218730-187309.6319.67
317990-179909.2519.29
418686-186869.6089.65
518475-184759.5009.54
618189-181899.3539.39
15min118898-188989.7179.402.569.819.492.57
218668-186689.5999.69
317552-175529.0259.11
418179-181799.3489.44
518287-182879.4039.49
618126-181269.3219.40
20min118028-180289.2709.073.519.429.213.46
218196-181969.3579.50
317332-173328.9129.05
417826-178269.1669.31
516521-165218.4958.64
617895-178959.2029.34
30min117665-176659.0838.951.889.289.141.86
217239-172398.8649.06
316943-169438.7128.90
417649-176499.0759.27
517737-177379.1209.31
617175-171758.8319.02
45min117618-176189.0598.932.129.319.182.10
217568-175689.0349.28
316866-168668.6738.91
417814-178149.1609.40
517356-173568.9259.16
617017-170178.7508.99
60min117482-174828.9898.792.709.299.082.67
217407-174078.9519.25
316396-163968.4318.71
416690-166908.5828.88
517500-175008.9999.29
617121-171218.8049.09
极限117529-175299.0148.652.179.369.002.13
216598-165988.5358.88
316525-165258.4978.83
416714-167148.5948.94
516898-168988.6899.03
616723-167238.5998.93
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5000
标示量(mg)10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%
111.101584251586611589241586411589271587160.14
211.161600561603391601980.13
单位质量响应值RSD%判断
14298.7414354.660.28数据可信
供试品溶液-2022091402批-阿托伐他汀钙-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%
5min188033-8803350.75543.8418.6450.7643.8418.64
288115-8811550.80350.80
378258-7825845.12045.12
457151-5715132.95032.95
585126-8512649.07949.08
659598-5959834.36134.36
10min1123706-12370671.32272.5510.6071.6072.7910.61
2136393-13639378.63778.92
3134243-13424377.39877.65
4123682-12368271.30971.49
5135646-13564678.20678.48
6101306-10130658.40858.60
15min1150185-15018586.58983.347.8387.2783.997.86
2152244-15224487.77688.50
3146948-14694884.72385.40
4145408-14540883.83584.41
5150495-15049586.76887.47
6122035-12203570.35970.87
20min1157132-15713290.59487.306.1991.7588.426.23
2156878-15687890.44891.65
3150907-15090787.00588.16
4152500-15250087.92488.97
5157951-15795191.06692.26
6133188-13318876.78977.70
30min1160295-16029592.41891.352.5494.0892.942.63
2159356-15935691.87693.59
3157766-15776690.96092.59
4159677-15967792.06193.59
5162623-16262393.76095.46
6150914-15091487.00988.34
45min1166142-16614295.78994.681.3697.9696.781.42
2165528-16552895.43597.65
3161535-16153593.13395.27
4166266-16626695.86097.91
5164449-16444994.81397.03
6161429-16142993.07294.89
60min1167684-16768496.67895.591.8899.3998.221.84
2167639-16763996.65299.40
3160238-16023892.38595.04
4163956-16395694.52997.11
5167981-16798196.84999.59
6167252-16725296.42998.76
极限1173752-173752100.17696.712.06103.4299.872.03
2165781-16578195.58198.87
3164741-16474194.98198.15
4169986-16998698.005101.11
5166245-16624595.84899.13
6165926-16592695.66498.53
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%
110.181764871765491765141765991767061765710.05
210.191763821768761766290.20
单位质量响应值RSD%判断
17344.8917333.560.05数据可信
供试品溶液-2022091402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%
5min111715-117156.0666.326.496.076.326.47
212244-122446.3396.34
311406-114065.9065.91
413691-136917.0897.09
512086-120866.2586.26
612052-120526.2406.24
10min117542-175429.0829.301.739.129.341.70
218014-180149.3279.36
318235-182359.4419.47
418105-181059.3749.41
517620-176209.1239.16
618264-182649.4569.49
15min117362-173628.9899.181.369.079.261.35
217962-179629.3009.39
317822-178229.2279.31
417490-174909.0569.15
517842-178429.2389.32
617869-178699.2529.34
20min117707-177079.1689.021.679.309.151.66
217099-170998.8538.99
317639-176399.1339.27
417551-175519.0879.23
517011-170118.8088.94
617487-174879.0549.19
30min116816-168168.7078.861.458.899.041.42
217453-174539.0369.22
317150-171508.8809.07
417179-171798.8959.09
517210-172108.9119.10
616817-168178.7078.90
45min116863-168638.7318.721.458.968.961.38
217280-172808.9479.18
316925-169258.7639.00
416715-167158.6548.90
516674-166748.6338.87
616616-166168.6038.84
60min116497-164978.5418.521.108.828.811.05
216737-167378.6668.95
316561-165618.5758.86
416245-162458.4118.70
516300-163008.4398.72
616434-164348.5098.79
极限116252-162528.4158.521.418.748.861.36
216656-166568.6248.96
316657-166578.6248.96
416166-161668.3708.71
516355-163558.4688.80
616684-166848.6388.97
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5000
标示量(mg)10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%
111.101581421582491583641583781583311582930.07
211.161582111584171583140.10
单位质量响应值RSD%判断
14260.6314185.840.38数据可信
供试品溶液-2022091402批-阿托伐他汀钙-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%
5min174138-7413843.05540.6032.3843.0640.6032.38
272160-7216041.90641.91
327908-2790816.20716.21
493615-9361554.36654.37
567363-6736339.12139.12
684258-8425848.93248.93
10min1128383-12838374.55873.4110.6374.8073.6410.69
2127562-12756274.08174.31
3100198-10019858.18958.28
4138229-13822980.27680.58
5130322-13032275.68475.90
6133744-13374477.67177.94
15min1145671-14567184.59884.794.3385.2585.424.42
2144985-14498584.19984.84
3134190-13419077.93078.34
4150906-15090687.63888.39
5150294-15029487.28287.92
6149990-14999087.10687.81
20min1150887-15088787.62789.463.0588.7590.563.15
2156190-15619090.70691.82
3146261-14626184.94085.79
4158608-15860892.11193.35
5154494-15449489.72190.84
6157774-15777491.62692.81
30min1157864-15786491.67993.441.4793.2995.041.54
2162748-16274894.51596.13
3158236-15823691.89593.21
4162914-16291494.61196.36
5162862-16286294.58196.20
6160808-16080893.38895.08
45min1163195-16319594.77595.510.8396.8997.630.80
2164607-16460795.59597.74
3164759-16475995.68397.51
4162679-16267994.47596.75
5165153-16515395.91298.06
6166406-16640696.63998.85
60min1165001-16500195.82395.281.0098.4797.930.95
2161673-16167393.89196.56
3164436-16443695.49597.86
4162427-16242794.32897.13
5165692-16569296.22598.90
6165144-16514495.90698.66
极限1168297-16829797.73796.820.92100.92100.000.92
2165560-16556096.14899.34
3165705-16570596.23299.12
4165296-16529695.99599.32
5168881-16888198.077101.29
6166573-16657396.736100.02
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