Pharmactive Biotech Marigold P.E - 5% Lutein, 0.5% Zeaxanthin

Identification & Functionality

Active Component

Lutein,

Zeaxanthin

Ingredient Name

Marigold Extract

Country of Origin

China

Technologies

Food Ingredients,

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Nutraceuticals & Supplements

Phytochemicals & Plant Extracts,

Supplements & Functional Ingredients

Food Ingredients — Nutrition & Fortification

Functional Ingredients

Features & Benefits

Benefit Claims (Health)

Immune System Enhancer

Labeling Claims

BSE-free,

Irradiation-free,

Non-GMO,

TSE-free

Applications & Uses

Markets

Food & Nutrition

Applications

Food & Nutrition — Nutrition & Well Being

Nutraceuticals & Supplements

Properties

Physical Form

Powder

Appearance

Yellowish orange-red powder

Odor

Characteristic

Taste

Characteristic

Polycyclic Aromatic Hydrocarbons (PAH)

	Value	Units	Test Method / Conditions
BaP	max. 10	ppb	EU 1933/2015
Sum BaP, BaA, BbF, CHR	max. 50	ppb	EU 1933/2015

Microbiological Values

	Value	Units	Test Method / Conditions
Aerobic bacteria	max. 10 000	cfu/g	Eur. Pharm. (2.6.12) / (2.6.13) USP 37 <61>/<62>
Yeast & Molds Count	max. 100	cfu/g	Eur. Pharm. (2.6.12) / (2.6.13) USP 37 <61>/<62>
Enterobacteria	max. 100	cfu/g	Eur. Pharm. (2.6.12) / (2.6.13) USP 37 <61>/<62>
E. coli	Absent	—	Eur. Pharm. (2.6.12) / (2.6.13) USP 37 <61>/<62>
Salmonella spp.	Absent	—	Eur. Pharm. (2.6.12) / (2.6.13) USP 37 <61>/<62>

Assay

	Value	Units	Test Method / Conditions
Identification	Positive	—	HPLC / TLC
Lutein	min. 5	%	HPLC
Zeaxanthin	min. 0.5	%	HPLC
Bulk Density	min. 0.3	g/mL	Eur. Pharm. (2.9.34) / USP <616>
Ash Content	max. 10	%	Eur. Pharm. (2.4.16) / USP 37 <281>
Loss on drying	max. 8	%	Eur. Pharm. (2.8.17) / USP 37 <731>
Particle Size	240/60	μm/mesh	Eur. Pharm. (2.9.12) / USP 34 <786>

Residual Solvents

	Value	Units	Test Method / Conditions
Ethanol	max. 5 000	ppm	Eur. Pharm. (2.4.24) / USP 30 <467>

Heavy Metals

	Value	Units	Test Method / Conditions
Lead (Pb)	max. 3.0	ppm	Eur. Pharm. (2.4.27) / USP <233>
Arsenic (As)	max. 2.0	ppm	Eur. Pharm. (2.4.27) / USP <233>
Cadmium (Cd)	max. 1.0	ppm	Eur. Pharm. (2.4.27) / USP <233>
Mercury (Hg)	max. 0.1	ppm	Eur. Pharm. (2.4.27) / USP <233>

Toxicology Information

	Value	Units	Test Method / Conditions
B1	max. 5	ppb	HPLC
Sum B1, B2, G1, G2	max. 10	ppb	HPLC

Regulatory & Compliance

Certifications & Compliance

Regulation (EU) No. 1272/2008

Storage & Handling

Shelf Life

24 months

Storage Information

Shelf life: 24 months if sealed and stored at room temperature, sheltered from light and moisture.