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ASTM E2656-16
Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute- 발행일 : 2016-11-01
- 발행기관 : ASTM
상세정보
| 분야 | 14.01 : 보건정보학 |
|---|---|
| 적용범위 | 1.1 This practice establishes an approach to the real-time release testing (RTRT) of pharmaceutical water based on the total organic carbon (TOC) attribute using on-line total organic carbon (OLTOC) instrumentation that is in agreement with current regulatory thinking. 1.2 This practice is harmonized with or supports the concepts of relevant ASTM International Committee E55 on Manufacture of Pharmaceutical Products standards, ICH Harmonized Tripartite Guidelines, the U.S. FDA PAT Guidance, and U.S. FDA Pharmaceutical cGMPs. 1.3 This practice does not provide general guidance information for pharmaceutical procedures that are considered standard practice in the pharmaceutical industry. This practice provides specific guidance for non-standardized procedures. 1.4 This practice does not address the user’s various internal procedures for risk, change, or quality management systems. The overall project effort associated with this practice shall be proportional to the overall risk of failing the pharmaceutical water’s TOC concentration specification. 1.5 This practice does not purport to establish how to comply with pharmacopeias. The RTRT methodology selected must assure compliance with the user’s current required pharmacopeias. However, compliance with pharmacopeia TOC methods is not necessarily sufficient to meet current regulatory expectations for RTRT. 1.6 This practice does not purport to substitute for or replace compendial bioburden testing requirements. It is strictly applicable to the TOC attribute of water quality. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. |
| 국제분류(ICS)코드 |
11.120.10 : 약제
13.060.50 : 화학 물질에 대한 물의 시험 |
| 페이지수 | 8 |
| Edition | 16 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM E2656-25상세보기 | Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute | 2025-01-01 | 표준 |
| 2 | ASTM E2656-25 REDLINE상세보기 | Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute | 2025-01-01 | 표준 |
| 3 | ASTM E2656-16 REDLINE상세보기 | Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute | 2016-11-01 | 구판 |
| 4 | ASTM E2656-16상세보기 | Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute | 2016-11-01 | 구판 |
| 5 | ASTM E2656-10상세보기 | Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute | 2010-08-01 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- JIS K 0805:1988 - Continuous total organic carbon analyzer
- ISO 8245:1999 - Water quality — Guidelines for the determination of total organic carbon (TOC) and dissolved organic carbon (DOC)
- ASTM D7980-15 - Standard Guide for Ion-Chromatographic Analysis of Anions in Grab Samples of Ultrapure Water (UPW) in the Semiconductor Industry
- ASTM D5127-13(2018) - Standard Guide for Ultra-Pure Water Used in the Electronics and Semiconductor Industries
- ASTM D7573-18ae1 - Standard Test Method for Total Carbon and Organic Carbon in Water by High Temperature Catalytic Combustion and Infrared Detection
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