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SSB® 55 Pharma

SSB® 55 Pharma is the light-colored dewaxed Flake Shellac SSB® 55 Pharma FL is suitable for applications which require high purity raw materials. This special grade is manufactured from selected shellac raw materials (seed lac) by produced under the condition of the SSB® Flake Shellac refining process. This high quality product with excellent binding and film forming properties meets the requirements of international pharmacopeias (Ph.Eur. / USP ì JP – latest edition). SSB® 55 Pharma FL is physiologically harmless and biodegradable. It can be delivered as flakes, a fine powder and a ready to use solutions based on ethanol.

Brand: SSB (3 products)

Chemical Name: Shellac

Functions: Controlled Release Agent, Enteric Coating System, Film Former, Moisture Barrier Coating, Odor Masking Agent

Dosage Form: Capsules

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FDA IID, United States Pharmacopeia (USP)

Technical Data Sheet
Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name

Shellac

Pharma & Nutraceuticals Functions

Controlled Release Agent,

Enteric Coating System,

Film Former,

Moisture Barrier Coating,

Odor Masking Agent

CAS No.
9000-59-3
EC No.
232-549-9
Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Flavors & Taste Maskers,

Modified & Controlled Release,

Pharmaceutical Coatings

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Healthcare & Pharma — Pharmaceutical Manufacturing

Excipients & Coatings

Dosage Form

Capsules

Properties

Typical Properties
ValueUnitsTest Method / Conditions
Acid value60 - 80mg KOH/g-
Arsenic35ppm-
AshMax. 1.0%-
Heavy MetalMax. 10ppm-
Loss of drying2%-
WaxMax. 0.2%-
Microbiological Values
ValueUnitsTest Method / Conditions
E.coliNegative--
EnterobacteriaceaegMax. 100--
Ethanol-insoluble substancesMax. 2.0%-
Salmonellen(10g)Negative--
Staphlylococcus aureusNegative--
Total aerobic microbial count TAMCMax. 1000g-
Total yeast and mould count TYMCMax. 100g-

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

FDA IID,

United States Pharmacopeia (USP)

Grade

Pharma Grade

Packaging & Availability

Packaging

Solids: Fiber drums with inner PE bag, 25 kgs net.

Storage & Handling

Storage

The shelf life of this product will be 2 years if stored / transported at temperatures <20°C. Higher temperatures will speed up aging of the solid material and raise the risk of "blocking" especially under the influence of humidity. Because of reasons mentioned above we recommend refrigerated transport during the warm summer months.