YY 0145-1993Pharmaceutical adjuvant - Ponceau 4R (English PDF)
药用辅料 胭脂红
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
November 29, 1993
Implementation date
May 1, 1994
Scope
YY 0145-1993 is the English-translated version of 药用辅料 胭脂红.
YY 0145-1993 is a mandatory Chinese medical device and pharmaceutical industry standard for Ponceau 4R, the red colourant known in Chinese practice as carmine, taken as a pharmaceutical excipient.
The standard states the technical requirements for the dye, the test methods that verify them, the inspection rules, and the packaging, labelling, transport and storage requirements.
The material in its scope is an azo dye made by diazotising an aminonaphthalene sulfonic acid and coupling it with a naphthol disulfonate, and it is added to medicines as a colouring agent.
It quotes GB 601, GB 602, GB 603 and GB 610.1, and with the Pharmacopoeia of the People's Republic of China. Its Chinese classification is C21. Issued on 29 November 1993, it has applied since 1 May 1994.
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Document preview — YY 0145-1993
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Scope
- Normative references
- About this standard
- Classification and status
1 Foreword
YY 0145-1993 was issued by NMPA on 29 November 1993 and has been in force since 1 May 1994.
2 Scope
This standard is a mandatory Chinese medical device and pharmaceutical industry standard for Ponceau 4R, the red colourant known in Chinese practice as carmine, taken as a pharmaceutical excipient. The standard states the technical requirements for the dye, the test methods that verify them, the inspection rules, and the packaging, labelling, transport and storage requirements. The material in its scope is an azo dye made by diazotising an aminonaphthalene sulfonic acid and coupling it with a naphthol disulfonate, and it is added to medicines as a colouring agent. It quotes GB 601, GB 602, GB 603 and GB 610.1, and with the Pharmacopoeia of the People's Republic of China. Its Chinese classification is C21.
3 Normative references
YY 0145-1993 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB 601
GB 602
GB 603
GB 610.1
4 About this standard
Issued by: NMPA
English translation: about 15 pages
5 Classification and status
Prefix YY: mandatory standard.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
GB 601 · GB 602 · GB 603 · GB 610.1
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