YY 0206-1995Pharmaceutical excipients - Disodium edetate (English PDF)
药用辅料 乙二胺四乙酸二钠
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY 0206-1995 in 30 minutes.
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.
Found what you need?
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
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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Similar standards
How to Download YY 0206-1995
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY 0017-2026 — Implants for osteosynthesis - Metallic bone plates
YY 0018-2026 — Implants for osteosynthesis - Metallic bone screws
YY 0118-2026 — Joint replacement implants - Hip joint prostheses - Fundamental requirements
Secure payment via Stripe
Payments accepted
YY 0206-1995
$149.00