Damp;C Black 2
KOELIN t
worlds local supplier for cosmetic colours

Inorganic Colourants for Pharma

KoelIN

Inorganic Colourants for Pharma

Koel's regulated, high - purity synthetic and natural colourants confirm to both US & EC colour specification and meet Directive 95/451EC. Natural colours are classified by the FDA as "exempt from certification" colours. Exempt colours are regulated by the code of Federal Regulations (CFR) Title 21 part 73.

KOELIN TiO2 ANATASE (Food Grade)

High Purity
High Dispersability
Pharmaceutical Grade

CONFIRMS TO:

IP/EP/USP/& E..; DIRECTIVES 95/94 (E 171)
FDA TITLES 21 CFR 73.575 / 21 CFR 73.1575 / 21 CFR 73.2575
FOOD - (FCC) V

FREE FROM:

Residual Solvents, Latex GMO, BSE, AOX Halogen, Animal Testing & VOC

CommonName IronOxide Red IronOxide Yellow IronOxide Black IronOxide Brown    
KoelinCode No Koelin/PH- 919 Koelin/PH- 929 Ko.sslin/PH- 999 Koelin/PH- 991
Colour Index No 77491 77492 77499 77491/92/99
E.E.0 No E -172 E -172 E - 172 E -172
CAS No 1309-37-1 51274-00-1 1309-38-2 1309-37-1/51274-00-1/1309-38-2
Identification Of Ferric Salt As PerUSP AsPer USP As PerUSP As PerUSP
WaterSoluble substance,percent by mass Max1.00 Max1.00 Max1.00 Max1.00
Acid insolublesubstances,percent by mass Max0.3 Max0.3 Max 0.3 Max0.3
Organic colours & lakes As PerUSP AsPer USP As PerUSP As PerUSP
Mercury(mg/kg) Max3.0 Max3.0 Max 3.0 Max3.0
Arsenic(mg/kg) Max3.0 Max3.0 Max 3.0 Max3.0
Lead (mg/kg) Max10.0 Max10.0 Max1D.0 Max10.0
Assay as Fe203on ignited basis 97.0%-100.5% 97.0%-100.5% 97.0%-100.5% 97.0%-100.5%
MicrobialLimit Test :            
A) TotalMicrobial Count NMT 50clu/g NMT50 clu/g NMT 50cfu/g NMT 50cfu/g
B) E.Coli   NMT 50ctu/g Absentin lOg Absentin lOg Absentin log  
C) Salmonella Absentin lOg Absentin lOg Absentin lOg Absentin 10g
D) Pseudomonas Absentin lOg Absentin lOg Absentin lOg Absentin 10g
E) S.aureus Absentin lOg Absentin 10g Absentin lOg Absentin lOg
F) Yeast &Mold NMT 50clu/g NMT50 cfu/g NMT 50cfu/g NMT 50cfu/g
NOTE:

Koel also offer pharma grade of Titanium Dioxide with the certificate of IP, BR USP, JP. Koel can offer various shades in Iron Oxides i.e 6 shades in Iron Oxide Red,3 shades of Iron Oxide Yellow & 2 shades of Iron Oxide Black.And also customised shade can be given as per the customers request.

APPLICATION OF INORGANIC COLOURS:

Pharmaceuticals:
- Coated And Compressed Tablets
- Gelatin Capsules (hard & Soft)

Colour Cosmetics & Personal Care Products:
- Nail Enamels
- Lip Products
- Eye Products

Nutraceuticals

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