拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.205712345707655711755712165707655710310.05
211.265700215700155700180.01
单位质量响应值RSD%判断
50984.9150623.270.51数据可信
长期36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211568753569310569032100.50100.710.9599.71%~101.71%
256429856435156432499.67
3578075578632578354102.15
4574833574428574630101.49
5569450569726569588100.60
656555456511056533299.85
2024030221156364156341156352699.53100.261.1399.08%~101.45%
256478756468056473499.74
3578613578972578792102.23
456569856560556565299.91
556220356118256169299.21
6571598571766571682100.97
20240303211567675567565567620100.2599.390.8998.47%~100.32%
2566364566342566353100.03
356566856508356537699.86
455835355794355814898.58
556403056374656388899.59
655514855515755515298.05
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.205703545708815708215708115702015706140.06
211.265701075693955697510.09
单位质量响应值RSD%判断
50947.6850599.560.49数据可信
中间条件36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211571627571546571586101.0298.302.7595.47%~101.14%
2567878567878567878100.36
355497255521855509598.10
454458654443254450996.23
553245953261353253694.11
6566425565345565885100.01
2024030221154912554842754877696.9899.061.8897.11%~101.00%
256038756017256028099.02
3565695566221565958100.02
455085755167755126797.42
5577376578014577695102.09
655848555963455906098.80
20240303211567819569133568476100.47100.040.8399.17%~100.91%
2568173568532568352100.44
356340556284956312799.52
4565736566546566141100.05
5571114572696571905101.07
655837255872055854698.71
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.201139164113903511388891138912114024311392490.05
211.261135086113467311348800.03
单位质量响应值RSD%判断
101718.66100788.630.65数据可信
长期36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111196551122338112099699.34100.511.1399.32%~101.69%
2114509111452351145163101.49
3113350811324521132980100.41
411195951118772111918499.18
5113466511356731135169100.60
6115186611505191151192102.02
2024030221111230821123173112312899.5399.471.1198.32%~100.62%
2113328811329951133142100.42
3113081811322371131528100.28
410978251099636109873097.37
511237941124352112407399.62
611238921123547112372099.59
20240303211115376311523011153032102.1899.871.5598.25%~101.48%
2113648311358611136172100.69
3113311811312151132166100.33
411116591113841111275098.61
511228201122368112259499.49
611035381105947110474297.90
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.201138104113901111391941137584113967011387130.08
211.261137292113921711382540.12
单位质量响应值RSD%判断
101670.80101088.280.41数据可信
中间条件36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111127461112514111263098.48101.081.4399.56%~102.59%
2114756911480641147816101.59
3114285511432581143056101.17
4115307811529471153012102.05
5115855211589011158726102.56
6113575811373691136564100.60
2024030221111281241127488112780699.8299.611.4198.14%~101.08%
210992941097236109826597.21
311201441120742112044399.17
4113841211403861139399100.85
511239851124507112424699.51
6114132011436841142502101.12
2024030321111303991128734112956699.9899.721.4398.23%~101.22%
2114025011381421139196100.83
3114689411454101146152101.45
411295481129877112971299.99
511045611105118110484097.79
611099531111234111059498.30
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.205694095686935691415698365705165695190.13
211.265685095681345683220.05
单位质量响应值RSD%判断
50849.9150472.650.53数据可信
长期36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211573927573213573570101.59101.720.64101.05%~102.40%
2570182570012570097100.98
3580080580584580332102.79
4576589576209576399102.09
5573707574452574080101.68
6571418571541571480101.22
20240302211567404567802567603100.53100.901.0799.77%~102.03%
2568239567471567855100.58
3579212579739579476102.64
4567984567965567974100.60
556177356165656171499.49
6573965572897573431101.57
20240303211568418569301568860100.7699.830.8898.91%~100.75%
2567683567866567774100.56
3566085565669565877100.23
455883355927655905499.02
556386656382956384899.87
655671155620355645798.56
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.205710135704725703005703725701335704580.06
211.265689375678985684180.13
单位质量响应值RSD%判断
50933.7550481.170.64数据可信
中间条件36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211577495577296577396102.18100.782.3298.34%~103.22%
2578274577515577894102.26
3576387576180576284101.98
455780555753455767098.69
554783054882754832897.03
6579467579394579430102.54
2024030221155000554960154980397.2999.691.9597.65%~101.72%
256337756369356353599.72
3568532569925569228100.73
455475555473955474798.17
5580916580741580828102.78
656258256115256186799.43
20240303211572131572113572122101.24100.640.7099.91%~101.37%
2569242569635569438100.77
3565778565087565432100.06
4567900568422568161100.54
5574153573509573831101.54
656360956310756335899.69
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.201138902113891711389071137602113882511386310.06
211.261135636113330511344700.15
单位质量响应值RSD%判断
101663.48100752.220.64数据可信
长期36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211112828911277381128014100.01101.051.0299.97%~102.13%
2115177911515491151664102.11
3113788211379311137906100.89
411243471125542112494499.74
5114388511440151143950101.42
6115262411514471152036102.14
20240302211112843111279201128176100.0399.911.1698.69%~101.12%
2114086211396511140256101.10
3113676211349441135853100.71
411019931103501110274797.77
5112850411273801127942100.00
611261221125774112594899.83
20240303211116808211674221167752103.53100.651.6598.91%~102.39%
2113951011401351139822101.06
3113485611351211134988100.63
411273561128046112770199.98
5113004811298901129969100.18
611110471111335111119198.52
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.201137686113724611381001137802113691111375490.05
211.261136711113591811363140.05
单位质量响应值RSD%判断
101566.88100915.990.46数据可信
中间条件36月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111237911123364112357899.58101.841.35100.41%~103.28%
2115314111517171152429102.14
3114989511502081150052101.93
4116210511641861163146103.09
5116569811642141164956103.25
6114133911393021140320101.07
20240302211113476511359001135332100.63100.371.3598.96%~101.79%
211108261109873111035098.41
311226021120572112158799.41
4114566811460611145864101.56
5113076911299581130364100.18
6115194711508121151380102.05
20240303211113363311341241133878100.50100.641.0499.55%~101.74%
2114236111442881143324101.33
3115020711499881150098101.93
4114086911424941141682101.19
511186901119222111895699.17
611252621125642112545299.75
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