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SSB® 55 Pharma

1 of 3 products in this brand
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.

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
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Knowde Enhanced TDS

Identification & Functionality

Chemical Name
CAS No.
9000-59-3
EC No.
232-549-9

Applications & Uses

Dosage Form

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

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.