请帮忙翻译氧氟沙星片的认证
\u95ee\uff1a\u95ee\uff1a \u8dea\u6c42\u5916\u8d38\u9ad8\u624b\u5e2e\u5fd9 \u7ffb\u8bd1\u6210\u82f1\u6587 \u524d\u9762\u60a8\u8981\u6c42\u4ea7\u54c1\u8981\u901a\u8fc7REACH\u8ba4\u8bc1\uff0c\u56e0\u4e3a\u6211\u54a8\u8be2\u4e86\u68c0\u6d4bIn front of you products through the REACH certification, because the reply I consulted the detection mechanism obtained is REACH divided into SVHC-168 and Pb Cd AZO two, you need to confirm the need to do. A test report I had provided, we only do cloth AZO test, and AZO is a member of the REACH regulation, so the report is displayed on the REACH.
In addition, your company now required before the production of products to do the test. After so much cargo completed still need to send samples to detect?
\u5728\u8fd9\u5219\u901a\u8baf\u548c\u9644\u4ef6\u4e2d\u7684\u4fe1\u606f\u5c5e\u4e8e\u673a\u5bc6\u6587\u4ef6\uff0c\u4ec5\u4f9b\u6709\u6253\u7b97\u7684\u6536\u4fe1\u4eba\u4f7f\u7528\u3002\u5728\u6ca1\u7ecf\u8fc7\u53d1\u4fe1\u4eba\u7684\u540c\u610f\u4efb\u4f55\u5f62\u5f0f\u7684\u516c\u5f00\u548c\u4f20\u64ad\u662f\u4e0d\u5141\u8bb8\u7684\u3002\u5982\u679c\u4f60\u5bf9\u6b64\u6ca1\u6709\u6253\u7b97\uff0c\u8bf7\u901a\u77e5\u53d1\u4fe1\u4eba\u5e76\u5728\u672a\u4f7f\u7528\uff0c\u4fdd\u5b58\u6216\u516c\u5f00\u4efb\u4f55\u5185\u5bb9\u7684\u524d\u63d0\u4e0b\u5b8c\u5168\u5220\u9664\u6240\u6709\u7684\u901a\u8baf\u3002
\u8fd9\u5219\u901a\u8baf\u4ec5\u4f9b\u53c2\u8003\uff0c\u4e0d\u80fd\u88ab\u7528\u4f5c\u7533\u8bf7\u6216\u7533\u8bf7\u8bf7\u6c42\u6216\u534f\u8bae\u53ca\u4ea4\u6613\u7684\u8ba4\u8bc1\u3002\u6240\u6709\u7684\u6570\u636e\u6216\u8fd9\u91cc\u5176\u4ed6\u4fe1\u606f\u4e0d\u80fd\u4fdd\u8bc1\u5b8c\u5168\u7684\u6b63\u786e\u4e14\u672a\u53d7\u4efb\u4f55\u6539\u52a8\u3002\u8fd9\u91cc\u7684\u4efb\u4f55\u8bc4\u4ef7\u548c\u6ce8\u91ca\u5e76\u975e\u53cd\u6620PT. GLOBAL PUTRA INDONESIA MARITIME\u7684\u4fe1\u606f\uff0cWAN HAI LINES LTD.\u516c\u53f8\u4e2d\u4ecb\u6216\u5176\u5b83\u7684\u9644\u5c5e\u4f01\u4e1a\u3002
\u7f51\u7edc\u901a\u8baf\u4e0d\u80fd\u4fdd\u8bc1\u6ca1\u6709\u75c5\u6bd2\u3002\u6536\u4fe1\u4eba\u6709\u8d23\u4efb\u786e\u4fdd\u901a\u8baf\u6ca1\u6709\u75c5\u6bd2\uff0c\u800c\u53d1\u4fe1\u4eba\u5bf9\u4f20\u8f93\u5de5\u7a0b\u4e2d\u7531\u75c5\u6bd2\u5bfc\u81f4\u7684\uff08\u6587\u4ef6\uff09\u635f\u574f\u4e0d\u8d1f\u4efb\u4f55\u8d23\u4efb\u3002
Yangfushaxing Pian
Ofloxacin Tablets
This product containing ofloxacin (C18H20FN3O4) should be marked volume 90.0% ~ 110.0%.
【Characters】 This product is white or slightly yellow plates or薄膜衣片, after removal of coating significantly to yellowish white.
】 【Identification (1) under the HPLC chromatogram recorded in the main peak for the sample solution should be consistent with the retention time of reference substance solution of the main peak of retention time consistent.
(2) check the appropriate fine chemicals, and 0.1mol / L hydrochloric acid dissolved and diluted into 1ml of each solution containing ofloxacin 6μg, filtration, the filtrate according to ultraviolet - visible spectrophotometry (Appendix Ⅳ A ) measured in the 294nm wavelength of maximum absorption.
】 【Check determination of the material taken for examination under reserve liquid products as a solution for the test materials; precise amount of check amount plus 0.1mol / L hydrochloric acid diluted 6μg each containing 1ml of the solution, as control solution. According to ofloxacin under related substances detected for the sample if any impurities chromatogram peaks may not be a single impurity peak area peak area is greater than the control solution (0.5%), the impurity peak areas and (no small the main peak in the control solution of 0.05 times the area of the peak is negligible) should be no larger than the main peak area of the control solution of 2-fold (1.0%).
Dissolution check the goods, according to dissolution test method (first method appendix Ⅹ C) to hydrochloric acid (9 → 1000) 900ml for the dissolution medium speed for 50 minutes to each, according to the operation, after 30 minutes, the check solution amount of filtration, the filtrate added precision check volume 2ml, buy 50ml量瓶, add diluted to scale dissolution medium, shaken, according to ultraviolet - visible spectrophotometry (Appendix Ⅳ A), in the determination of wavelength of 294nm absorbance ; another reference substance ofloxacin check amount that will be fine, plus the dissolution medium and dissolved in dilute 1ml into each containing 4.5μg about the solution, the same method to calculate the volume of each of the dissolution. Limit of 80% mark should be in order.
Other should be consistent with the tablet under the provisions of the relevant (Appendix Ⅰ A).
【照】 HPLC high-performance liquid chromatography (Appendix Ⅴ D) Determination.
Chromatographic conditions and system suitability test octadecyl silane bonded silica as the filler; to high sodium chlorate ammonium acetate solution (from ammonium acetate and 4.0g sodium 7.0g, adding water to make 1300 dissolved with phosphoric acid to adjust pH value of 2.2) - acetonitrile (85:15) as mobile phase; the detection wavelength was 294nm. Ofloxacin check amount, and 0.1mol / L hydrochloric acid and dissolved in dilute 1ml made about each of the solution containing 1mg, buy ultra-violet light (254nm) irradiation of more than four hours, check into the liquid chromatograph 10μl theoretical plate number calculated by the ofloxacin peak of not less than 5000, close to the pre-peak ofloxacin and ofloxacin peak impurity peak separation should meet the requirement.
Assay from 10 of the goods, precision that is scheduled to study a small amount of precision that check (about the equivalent of ofloxacin 0.1g), buy 100ml量瓶, the increase in 0.1mol / L hydrochloric acid dissolved and diluted to calibration, shake, filter, filtrate as continued access for goods store test fluid, the volume of check-precision 5ml, buy 50ml量瓶, the increase in 0.1mol / L hydrochloric acid solution to scale, shake, precision volume of 10μl were taken into the liquid chromatography to record chromatograms; another reference substance ofloxacin check amount that will be fine with 0.1mol / L hydrochloric acid and dissolved into quantitative dilution 1ml of each solution containing 0.12mg of ofloxacin with determination of by external standard method with peak area, that is too.
【Category】 with ofloxacin.
【Specification】 0.1g
【Storage】 shading, sealing preservation
绛旓細銆愯嵂鍝佸悕绉般戦氱敤鍚嶇О锛氱洂閰稿乏姘ф盁娌欐槦鐗 鍟嗗搧鍚嶇О锛氱洂閰稿乏姘ф盁娌欐槦鐗(涓夌簿)鑻辨枃鍚嶇О锛歀evofloxacin Hydrochloride Tablets 鎷奸煶鍏ㄧ爜锛歒anSuanZuoYangFuShaXingPian(SanJing)銆愪富瑕佹垚浠姐 鐩愰吀宸︽哀姘熸矙鏄熴傘愭垚 浠姐戝寲瀛﹀悕锛氾紙S锛-锛-锛-9-姘-2锛3-浜屾阿-3-鐢插熀-10-锛4-鐢插熀-1-鍝屽棯鍩猴級-7-姘-7H...
绛旓細閴翠簬鏈嵂鍙紩璧锋湭鎴愬勾鍔ㄧ墿鍏宠妭鐥呭彉,鏁呭瓡濡囩鐢,鍝轰钩鏈熷濂冲簲鐢ㄧ洂閰稿乏姘ф盁娌欐槦鐗囨椂搴旀殏鍋滃摵涔炽 銆愯嵂鐗╃浉浜掍綔鐢ㄣ戠洂閰稿乏姘ф盁娌欐槦鐗囦笌鍚晛鎴栭摑涔嬫姉閰稿墏銆佺～绯栭摑銆侀噾灞為槼绂诲瓙(濡傞搧)銆佸惈閿岀殑澶氱缁寸敓绱犲埗鍓傜瓑鑽墿鍚屾椂浣跨敤鏃跺皢骞叉壈鑳冭偁閬撳鐩愰吀宸姘ф盁娌欐槦鐗囩殑鍚告敹,浣胯鑽湪鍚勭郴缁熷唴鐨勬祿搴︽槑鏄鹃檷浣庛傚洜鑰,鏈嶇敤涓婅堪鑽墿...
绛旓細涔抽吀宸姘ф盁娌欐槦鍒嗘暎鐗囷紝閫傚簲鐥囦负鏈搧閫傜敤浜庢晱鎰熺粏鑿屾墍寮曡捣鐨勪笅鍒楄交銆佷腑搴︽劅鏌擄細鍛煎惛绯荤粺鎰熸煋锛氭ユф敮姘旂鐐庛佹參鎬ф敮姘旂鐐庛佹參鎬ф敮姘旂鐐庢ユф湡鍙戜綔銆佸讥婕х粏鏀皵绠＄値銆佹敮姘旂鎵╁紶鍚堝苟鎰熸煋銆佽偤鐐庛佸捊鍠夌値銆佹墎妗冧綋鐐庯紙鎵佹浣撳懆鍥磋創鑲匡級锛涙硨灏跨郴缁熸劅鏌擄細鑲剧泜鑲剧値銆佸鏉傛у翱璺劅鏌撶瓑锛涚敓娈栫郴缁熸劅鏌擄細鍓嶅垪鑵虹値...
绛旓細姘ф盁娌欐槦鐗囦笉鏄厫璐ラ吀锛岃姘熸矙鏄熸墠鏄互鍓嶇殑姘熷搶閰锛屾哀姘熸矙鏄熶笉鏄絾鏄晥鏋滈兘涓鏍凤紝閮芥槸娑堢値鑽紝娌荤枟鑲犵値鎷夎倸瀛愭晥鏋滄瘮杈冨ソ銆傝姘熸矙鏄燂紝瑗胯嵂鍚嶃傚父鐢ㄥ墏鍨嬩负鐗囧墏銆佽兌鍥婂墏銆佸鐢ㄥ埗鍓傘佹淮鐪煎墏銆佹爴鍓傘佹敞灏勫墏銆備负鍠硅閰被鎶楄弻鑽傜敤浜庢晱鎰熻弻鎵鑷寸殑灏胯矾鎰熸煋銆佹穻鐥呫佸墠鍒楄吅鐐庛佽偁閬撴劅鏌撳拰浼ゅ瘨鍙婂叾浠栨矙闂ㄨ弻鎰熸煋锛...
绛旓細浠庝互涓婂垎鏋愶紝鎴戜滑鍙互鐭ラ亾鐩愰吀宸姘ф盁娌欐槦鐗鍏锋湁鑹ソ鐨勬姉鑿屾姉鎰熸煋浣滅敤锛屾墍浠ョ洂閰稿乏姘ф盁娌欐槦鐗囦富瑕佺敤浜庢晱鎰熺粏鑿屽紩璧风殑鍛煎惛绯荤粺 娉屽翱绯荤粺 鐢熸畺绯荤粺 鐨偆杞粍缁囧強鑲犻亾鐨勪腑 閲嶅害鎰熸煋 涔熷彲鐢ㄤ簬璐ヨ鐥 绮掔粏鑳炲噺灏戝強鍏嶇柅鍔熻兘浣庝笅鎮ｈ呯殑鍚勭鎰熸煋 杩樺彲鐢ㄤ簬涔宠吅鐐 澶栦激 鐑т激鍙婃墜鏈悗浼ゅ彛鎰熸煋 鑵硅厰鎰熸煋(蹇呰鏃跺悎鐢ㄧ敳纭濆攽...
绛旓細鑵规郴锛屼竴鑸冭檻鏄ユц偁鐐庯紝鍙互鏈嶇敤宸姘ф盁娌欐槦鐗鏉ユ秷鐐庯紝涓鑸槸姣忔鏈0.2g锛屾瘡澶2娆°傝吂娉伙紝搴斿鍠濆紑姘达紝鏀剧偣鐩愶紝浠ヨˉ鍏呬涪澶辩殑姘村垎銆佺數瑙ｈ川锛屼篃鍙互鍘昏嵂搴椾拱锛氬彛鏈嶈ˉ娑茬洂锛屽啿寮姘存湇鐢ㄣ傚鏋滄槸娑堝寲涓嶈壇寮曡捣鐨勮偁鐐庯紝鍙互鍔犳湇鍔╂秷鍖栫殑鑽紝濡傦細涔抽叾鐢熺墖銆
绛旓細宸姘ф盁娌欐槦:袥械胁芯褎谢芯泻褋邪褑懈薪 姘熷搶閰:袧袨袪肖袥袨袣小袗笑袠袧 鎴戞兂浣犺鐨勪經娲鹃吀搴旇鏄寚涓嬮潰杩欎釜锛氭盁鍝岄吀 銆愪腑鏂囧悕绉般戣姘熸矙鏄燂紱姘熷搶閰革紱1-涔欏熀-6-姘-4-姘т唬-1锛4-浜屾阿-7-锛1-鍛卞棯鍩猴級-3-鍠瑰晧缇ч吀 銆愯嫳鏂囧悕绉般憂orfloxacin Baccidal; Brazan;Floxacin;Norxacin;Horoxine h...
绛旓細鐩愰吀宸姘ф盁娌欐槦鍒嗘暎鐗囷紝閫傚簲鐥囦负閫傜敤浜庢晱鎰熻弻寮曡捣鐨勶細1銆佹硨灏跨敓娈栫郴缁熸劅鏌擄紝鍖呮嫭鍗曠函鎬с佸鏉傛у翱璺劅鏌撱佺粏鑿屾у墠鍒楄吅鐐庛佹穻鐥呭鐟熻弻灏块亾鐐庢垨瀹鐐(鍖呮嫭浜ч叾鏍墍鑷磋)2銆佸懠鍚搁亾鎰熸煋锛屽寘鎷晱鎰熼潻鍏伴槾鎬ф潌鑿屾墍鑷存敮姘旂鎰熸煋鎬ユу彂浣滃強鑲洪儴鎰熸煋銆3銆佽儍鑲犻亾鎰熸煋锛岀敱蹇楄春鑿屽睘銆佹矙闂ㄨ弻灞炪佷骇鑲犳瘨绱犲ぇ鑲犳潌鑿屻...
绛旓細1銆侀傚簲鐥囦笉鍚岋細宸姘ф盁娌欐槦鐗閫傚簲鐥囦负鏁忔劅缁嗚弻鎵寮曡捣鐨勪笅鍒楄交銆佷腑搴︽劅鏌擄紝濡傚懠鍚哥郴缁熸劅鏌撱佹硨灏跨郴缁熸劅鏌撱佺敓娈栫郴缁熸劅鏌撱佺毊鑲よ蒋缁勭粐鎰熸煋銆佽偁閬撴劅鏌撶瓑銆傝繕閫傜敤浜庡浼ゃ佺儳浼ゅ強鎵嬫湳鍚庝激鍙ｆ劅鏌撱佽吂鑵旀劅鏌撶瓑銆傜洂閰稿乏姘ф盁娌欐槦鐗囬傜敤浜庢晱鎰熻弻寮曡捣鐨勬硨灏跨敓娈栫郴缁熸劅鏌擄紝璐ヨ鐥囩瓑鍏ㄨ韩鎰熸煋銆2銆佽鏍间笉鍚岋細宸︽哀姘熸矙鏄熺墖...
