MPI NutriPharma Pullulan Capsules 0#

Identification & Functionality

Chemical Name

Pullulan

Pharma & Nutraceuticals Functions

Capsule

CAS No.

9057-02-7

EC No.

232-945-1

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Modified & Controlled Release

Identification

• Body Color : Transparent
• Cap Color : Transparent

Composition

Ingredient	EEC	Color Index No.	Function	% Cap	% Body
Pullulan	-	-	Structure	qsp 100	qsp 100

Features & Benefits

Benefit Claims

Cost Effective

Labeling Claims

Allergen-free,

Clean Label,

Gluten-free,

Halal,

Irradiation-free,

Kosher,

Lactose-free,

Natural,

Non-GMO,

Plant-Based,

Preservative-free,

Sustainable,

Vegan

Applications & Uses

Markets

Food & Nutrition,

Healthcare & Pharma,

Printing & Packaging

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Food & Nutrition — Nutrition & Well Being

Nutraceuticals & Supplements

Printing & Packaging — Packaging

Healthcare Packaging

Properties

Physical Form

Capsules

Physico-Chemical Properties

	Value	Units	Test Method / Conditions
ldentification of Pullulan	Conform	—	TS.QC.C01
Disintegration Time	max. 15	Minutes	TS.QC.C01
Lubricant Content	max. 0.5	%	TS.QC.C01
Loss on Drying	10 - 14	%	TS.QC.C01
Sulphated Ash	max. 2	%	TS.QC.C01

Microbiological Values

	Value	Units	Test Method / Conditions
Total Bacteria Count	max. 500	cfu/g	TS.QC.C01
Total Yeast and Mold Count	max. 100	cfu/g	TS.QC.C01
Escherichia Coli	Absent	per 1g	TS.QC.C01
Staphylococcus Aureus	Absent	per 1g	TS.QC.C01
Salmonella	Absent	per 10g	TS.QC.C01
Pseudomonas Aeruginosa	Absent	per 1g	TS.QC.C01

Characteristics

	Value	Units	Test Method / Conditions
Weight	101 - 115	mg	—
Capsule Length (Closed)	21.2 - 22.2	mm	—
Body Length	18.2 - 19	mm	—
Cap Length	10.5 - 11.3	mm	—
External Diameter (Body)	7.3 - 7.4	mm	—
External Diameter (Cap)	7.61 - 7.71	mm	—
Volume	0.68	ml	—

Heavy Metals

	Value	Units	Test Method / Conditions
Heavy Metals Content	max. 10	ppm	TS.QC.C01
Arsenic Content	max. 1	ppm	TS.QC.C01
Cadmium Content	max. 1	ppm	TS.QC.C01
Lead Content	max. 1	ppm	TS.QC.C01
Mercury Content	max. 0.1	ppm	TS.QC.C01
Chromium Content	max. 2	ppm	TS.QC.C01

Regulatory & Compliance

Certifications & Compliance

GMP,

Halal,

Kosher,

NSF Approved,

Vegan

Compliant With

Current versions of Ph.Eur, USP, JP, EU Directive EC No. 231/2012