ASTM-E2656 2010

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E2656-10 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

Published By	Publication Date	Number of Pages
ASTM	2010	8

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Categories: 11.120.10 - Medicaments, 13.060.50 - Examination of water for chemical substances, ASTM

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Description

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 US FDA PAT Guidance, and US 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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology Summary of Practice Significance and Use Procedure
3	FIG. 1
4	FIG. 2 TABLE 1
5	FIG. 3 FIG. 4
6	TABLE 2
8	REFERENCES

Additional information

Standard Title	E2656-10 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
Published Code	ASTM
Publication Date	2010
Pages Count	8
ICS Codes	11.120.10 - Medicaments 13.060.50 - Examination of water for chemical substances

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ASTM-E2656 2010

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