HSO技術知識庫>LICO 690 使用者如何確保歐洲藥典讀值符合歐洲藥典第2.2.2章“液體色度”之規定？
HSO技術知識庫>LICO 690使用者如何確保歐洲藥典讀值符合歐洲藥典第2.2.2章“液體色度”之規定？
How can a LICO 690 user be sure that European Pharmacopoeia readings comply with European Pharmacopoeia, chapter 2.2.2. "Degree of coloration of liquids" requirements?
LICO 690使用者如何確保歐洲藥典讀值符合歐洲藥典第2.2.2章“液體色度”之規定？
Document ID : TE12644
Published Date : 23/11/2020
Source : Hach UK
Question
How can a LICO 690 user be sure that European Pharmacopoeia readings comply with European Pharmacopoeia, chapter 2.2.2. "Degree of coloration of liquids" requirements?
Summary
The Validation report LICO 690 Pharm. Eur. provides full information on how a LICO 690 complies with European Pharmacopoeia, chapter 2.2.2. "Degree of coloration of liquids" requirements? LICO 690歐洲藥典驗證報告提供有關 LICO 690 如何符合歐洲藥典第2.2.2章“液體色度”規定之完整資訊
Answer
The validation is based on the instrumental and objective colour evaluation of optically clear tinted liquids as specified in the European Pharmacopoeia, chapter 2.2.2. "Degree of coloration of liquids" (http://www.pheur.org/). Even today, many pharmaceutical products are still assessed by visual methods to detect colour changes during production, storage or ageing.
The visual subjective comparison with color reference solutions according to the Ph.Eur.- specifications often involves problems if one product is judged by several persons. Human colour perception is considerably influenced by surroundings, light and mental state of the person. Moreover, no method is defined to check colour reference solutions for colour fastness and constancy. Usually the user has to depend on the standards being replaced in regular intervals and stored orderly at any time.
This method was elaborated to develop a suitable measuring procedure on the basis of existing national and international regulations and standards that should enable objective instrumental colour comparisons to be made.
此驗證是根據歐洲藥典第2.2.2章“液體的著色程度”所規定之光學透明有色液體的儀器的客觀色度評估（http://www.pheur.org/）。
即使是在今天，許多藥製品還是透過目視方法評估來偵測關於製造、儲存或老化過程中的顏色變化。
根據歐洲藥典規範顏色參考溶液，如果一個產品由多人主觀目視比較來判斷，通常會有一些問題。因為人類對色彩的感知會相當程度地受到周圍環境、光線和人員精神狀態的影響。此外，沒有定義的方法來檢查顏色參考溶液的色牢度和穩定度。使用者通常必須仰賴定期更換並且隨時有序儲存的標準品。
LICO 690儀器測試方法目的在根據現有的國家和國際法規標準來發展適合的測量程序，以進行客觀的儀器色度比較。
Attachments附件 :
Validation LICO 690 PhEur V02_E.pdf
Validation report LICO 690 - Pharm. Eur V2016-02
(VALIDATION OF AN INSTRUMENTAL MEASURING PROCEDURE ACCORDING TO THE EUROPEAN PHARMACOPOEIA CHAPTER 2.2.2) 根據歐洲藥典第 2.2.2 章對儀器測量程序進行驗證 (17 pages)
LICO 690使用者如何確保歐洲藥典讀值符合歐洲藥典第2.2.2章“液體色度”之規定？
Document ID : TE12644
Published Date : 23/11/2020
Source : Hach UK
Question
How can a LICO 690 user be sure that European Pharmacopoeia readings comply with European Pharmacopoeia, chapter 2.2.2. "Degree of coloration of liquids" requirements?
Summary
The Validation report LICO 690 Pharm. Eur. provides full information on how a LICO 690 complies with European Pharmacopoeia, chapter 2.2.2. "Degree of coloration of liquids" requirements? LICO 690歐洲藥典驗證報告提供有關 LICO 690 如何符合歐洲藥典第2.2.2章“液體色度”規定之完整資訊
Answer
The validation is based on the instrumental and objective colour evaluation of optically clear tinted liquids as specified in the European Pharmacopoeia, chapter 2.2.2. "Degree of coloration of liquids" (http://www.pheur.org/). Even today, many pharmaceutical products are still assessed by visual methods to detect colour changes during production, storage or ageing.
The visual subjective comparison with color reference solutions according to the Ph.Eur.- specifications often involves problems if one product is judged by several persons. Human colour perception is considerably influenced by surroundings, light and mental state of the person. Moreover, no method is defined to check colour reference solutions for colour fastness and constancy. Usually the user has to depend on the standards being replaced in regular intervals and stored orderly at any time.
This method was elaborated to develop a suitable measuring procedure on the basis of existing national and international regulations and standards that should enable objective instrumental colour comparisons to be made.
此驗證是根據歐洲藥典第2.2.2章“液體的著色程度”所規定之光學透明有色液體的儀器的客觀色度評估（http://www.pheur.org/）。
即使是在今天，許多藥製品還是透過目視方法評估來偵測關於製造、儲存或老化過程中的顏色變化。
根據歐洲藥典規範顏色參考溶液，如果一個產品由多人主觀目視比較來判斷，通常會有一些問題。因為人類對色彩的感知會相當程度地受到周圍環境、光線和人員精神狀態的影響。此外，沒有定義的方法來檢查顏色參考溶液的色牢度和穩定度。使用者通常必須仰賴定期更換並且隨時有序儲存的標準品。
LICO 690儀器測試方法目的在根據現有的國家和國際法規標準來發展適合的測量程序，以進行客觀的儀器色度比較。
Attachments附件 :
Validation LICO 690 PhEur V02_E.pdf
Validation report LICO 690 - Pharm. Eur V2016-02
(VALIDATION OF AN INSTRUMENTAL MEASURING PROCEDURE ACCORDING TO THE EUROPEAN PHARMACOPOEIA CHAPTER 2.2.2) 根據歐洲藥典第 2.2.2 章對儀器測量程序進行驗證 (17 pages)
儀器資訊 :
