Hispanagar Pharmaceutical Agar

The Pharmaceutical Agar meets the specifications of the European Pharmacopeia and USP. The methods used are according to EP/NF or validated as appropriate to EP/NF. It is used in the pharmaceutical industry in various applications, such as barium sulfate suspending agent in radiology, as laxative and lubricant, and in preparations of emulsions, suspensions, capsules, etc.

Chemical Name: Agar

CAS Number: 9002-18-0

Functions: Gelling Agent, Laxative, Lubricant

Dosage Form: Capsules, Emulsions, Suspension

Labeling Claims: Natural, Naturally Derived, Non-Hazardous

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), National Formulary (NF), United States Pharmacopeia (USP)

Synonyms: Bengal gelatin, E 406

Technical Data Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family: Polysaccharides
Chemical Name: Agar
Ingredient Origin: Marine Origin,
Natural Origin
Pharma & Nutraceuticals Functions: Gelling Agent,
Laxative,
Lubricant
CAS No.: 9002-18-0
EC No.: 232-658-1
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Base Fluids, Glidants & Lubricants,
Emulsifiers & Stabilizers,
Other Excipients

Features & Benefits

Labeling Claims: Natural,
Naturally Derived,
Non-Hazardous

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Capsules,
Emulsions,
Suspension
Applications: Applications of farmeceutic agar in industry are usually such as a suspending agent for barium sulfate in radiology and in preparations of emulsions, suspensions, capsules, etc.

Properties

Physical Form

Typical Properties


	Value	Units	Test Method / Conditions
Acid Insoluble Ash	max. 0.5	%	-
Arsenic Content	max. 3	ppm	-
pH Value (1.5%)	6.0 - 7.5	-	-
Ash Content	max. 5	%	-
Cadmium Content	max. 1	ppm	-
Coliforms	Abscence	-	-
Colorimetry (at 1.5%)	max. 0.250	-	-
Gel Strength (at 1.5% at 20ºC)	750-1000	g/cm2	Nikan
Gelling Temperature (at 1.5%)	34-38	°C	-
Insoluble Matter	max. 1.0	%	-
Lead Content	max. 5	ppm	-
Melting Temperature (at 1.5%)	85 - 90	°C	-
Mercury Content	max. 1	ppm	-
Moisture Content	max. 20	%	-
Particle Size (throug M-60 US)	min. 95	%	ASTM
Swelling Rate	min. 10	ml	-
Turbidity (at 1.5%)	max. 35	NTU	-
Water Absorption	max. 75	ml	-

Microbiological Values


	Value	Units	Test Method / Conditions
Total Aerobic Microbial Count	max. 1000	CFU/g	Plate count
Yeast and Molds Count	max. 100	CFU/g	-

Regulatory & Compliance

Certifications & Compliance: European Pharmacopeia (Ph. Eur.),
National Formulary (NF),
United States Pharmacopeia (USP)
Grade: Pharma Grade

Safety & Health

Safety Information: Agar-agar is not considered a hazardous substance according to the OSHA or ECHA definition.

Packaging & Availability

Packaging Information: Packed in 25 kg net paper kraft paper with a polyethylene inner lining

Storage & Handling

Storage & Handling: Maintained closed in its original package, in a cool and dry place and at room temperature, the product doesn´t show changes in its properties during the four years following the manufacturing date.