YY 0206-1995Pharmaceutical excipients - Disodium edetate (English PDF)
药用辅料 乙二胺四乙酸二钠
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 11, 1995
Implementation date
August 1, 1995
Scope
YY 0206-1995 is the English-translated version of 药用辅料 乙二胺四乙酸二钠.
YY 0206 is the pharmaceutical excipient standard for disodium edetate, the chelating agent added to formulations to bind trace metal ions that would otherwise catalyse oxidation, and used as a stabiliser and preservative adjunct across injectables, ophthalmics and topicals. It specifies the technical requirements, the test methods, the inspection rules and the packaging, labelling, storage and transport. An excipient standard governs a material that is not the active ingredient and is therefore easy to treat as a commodity, which is exactly why its identity, purity and heavy metal limits are specified: the impurity profile of the excipient becomes the impurity profile of the product. For a manufacturer or a supplier of EDTA disodium for pharmaceutical use in China, this is the material specification.
Document preview — YY 0206-1995
National Standard of the People's Republic of China
- Classification
- C21
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
Foreword
This document was issued on 11 March 1995 by the National Medical Products Administration and takes effect on 1 August 1995.
It is a YY standard without the /T suffix: compliance is mandatory in China.
It is classified under Chinese classification C21.
1 Scope
YY 0206 is the pharmaceutical excipient standard for disodium edetate, the chelating agent added to formulations to bind trace metal ions that would otherwise catalyse oxidation, and used as a stabiliser and preservative adjunct across injectables, ophthalmics and topicals. It specifies the technical requirements, the test methods, the inspection rules and the packaging, labelling, storage and transport. An excipient standard governs a material that is not the active ingredient and is therefore easy to treat as a commodity, which is exactly why its identity, purity and heavy metal limits are specified: the impurity profile of the excipient becomes the impurity profile of the product. For a manufacturer or a supplier of EDTA disodium for pharmaceutical use in China, this is the material specification.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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YY 0206-1995
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