Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- CI Name
- CI Number
- Chemical Family
- Dye Type
- INCI Name
- Cosmetic Ingredients Functions
- Pharma & Nutraceuticals Functions
- CAS No.
- 128-80-3
- EC No.
- 204-909-5
- Technologies
- Product Families
Features & Benefits
Applications & Uses
- Markets
- Applications
- Applications
Use Statement : Externally applied Drugs and Cosmetics - GMP. Not to exceed by weight of total product:
- Contact lenses: 0.03%.
- Polyethylene terephthalate sutures: 0.75%.
- Polyglycolic acid sutures > size 8-0: 0.1%, size 8-0 and smaller: 0.5%.
- Poly (glycolic acid-co- trimethylene carbonate) sutures: 0.21%.
Properties
- Color
- Physical Form
- Microbiological Values
Value Units Test Method / Conditions Escherichia coli Absent in 10g - Pseudomonas Absent in 10g - Salmonella Absent in 10g - Staphylococcus aureus Absent in 10g - Total Viable Bacterial Count max. 1000 cfu/g - Total Yeast and Molds Count max. 500 cfu/g - - Specifications
Value Units Test Method / Conditions Arsenic Content max. 3 ppm - DSL Status Yes - - Lead Content max. 20 ppm - Mercury Content max. 1 ppm - Molecular Weight 418.5 - - Pure Dye Content min. 96 % -
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Regulatory
- TSCA Status : In Compliance
- DSL Status : Yes
- 21 CFR 74.1206 The color additive D&C Green No. 6 may be safely used for coloring externally applied drugs in amounts consistent with current good manufacturing practice.
- 21 CFR 74.2206 D&C Green No. 6 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.
- ANNEX IV (PART 1) - Field of Application Definition, as per EC directive 76/768/EEC for use of colors in cosmetics: 1- Coloring agents allowed in
all cosmetic products. - Permitted for Cosmetic and Toiletry applications in China and Korea
Storage & Handling
- Shelf Life
- 8 years (unopened container)
- Storage Instructions
- Store the product in original packaging with the original seal intact, in a dry environment, protected from heat and light.
- Store material sealed; recommended storage temperature between 60°F and 85°F (15°C and 30°C).
- Keep the original label intact and legible; keep container in good condition, protect from physical damage.
- Keep all opened containers tightly sealed in an area that is secure and clean.