Destab™ 9-4514S Calcium Carbonate 90SE (Bags)

Destab™ Calcium Carbonate 90SE - Ultra 250 is a white to off white free flowing, directly compressible powder, manufactured to contain 90% Calcium Carbonate, USP/Ph. Eur. and 9% Pregelatinized Corn Starch, NF/Ph. Eur.. Destab™ Calcium Carbonate 90SE - Ultra 250 was designed for tablet and capsule formulations where optimum tableting and free flowing characteristics are desired. This product has a lead content not more than 250 ppb.

Brand: Destab (7 products)

Certifications & Compliance: United States Pharmacopeia (USP), cGMP

Dosage Form: Capsules, Tablets

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family: Calcium Salts,
Carbonates
Ingredient Name: Calcium Carbonate
Pharma & Nutraceuticals Functions: Antacid
Ingredients: Pregelatinized Starch, Calcium Carbonate
Food Additive Number: E 170, INS 170, INS 170(i)
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors
Active Pharmaceutical Ingredients (APIs)

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
API Manufacturing,
Excipients & Coatings
Dosage Form: Capsules,
Tablets
Manufacturing Technology: Direct Compression
Food & Nutrition Applications: Nutraceuticals

Properties

Specifications


	Value	Units	Test Method / Conditions
Assay	873 - 954	mg/g	-
Identification for Calcium	Positive	-	-
Particle Size#20U.S. Std. Sieve	min. 98	%	-
Particle Size#60U.S. Std. Sieve	min. 60	%	-
Particle Size#100U.S. Std. Sieve	max. 57	%	-
Particle Size#200 U.S. Std. Sieve	max. 20	%	-
Bulk Density (tapped)	0.6 - 0.7	g/cc	-
Moisture (LOD)	max. 1.8	%	-
Lead	max. 250	ppb	-
Total Microbial Count	max. 1000	cfu/g	-
Yeast and Mold count	max. 100	cfu/g	-
E. Coli	Negative	-	-
Salmonella Spp.	Negative	-	-
Staph. Aureus	Negative	-	-
Identification for Carbonate	Positive	-	-
Identification for Starch	Positive	-	-

Regulatory & Compliance

Certifications & Compliance: United States Pharmacopeia (USP),
cGMP
Grade: Pharma Grade

Packaging & Availability

Packaging Type: Bags

Storage & Handling

Stability: Destab™ Calcium Carbonate 90SE - Ultra 250 is physically and chemically stable when stored in tightly closed containers in a dry location.