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Intended For Use As A Parenteral Excipient 

• Synthetic Parenteral Glycerin (Glycerol) is a fully synthetic, parenteral grade, suitable for use in insulin manufacturing and other critical cGMP manufacturing applications and pharmaceutical preparations.

General Product Description:

Synthetic Glycerin is produced at our cGMP platform in India and then shipped to and fully retested and packaged at our sites in Rensselaer, NY and Bangor PA, USA.

• Synthetic Glycerin is a Clear Liquid product.

• Molecular Formula: C3 H8 O3

• Molecular Weight: 92.09 g/mol

• CAS Number: 56-81-5

• There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

• Synthetic Glycerin GLYS-3150 at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.

• Synthetic Gycerin manufactured at our cGMP platform in India and any raw materials used in the manufacture of Synthetic Glycerin at BioSpectra are not subject to genetic modification.

• Synthetic Gycerin is further purified at our site in Canada, Dextran Products apart of the BioSpectra Organization.

• Synonyms: Glycerol, Glycerolum, Glicerol, Glyzerin, 1,2,3-Propantriol, Glycerinester, Pfl.

GMP Compliance:

• Bio Excipient Grade Synthetic Glycerin, GLYS-3150 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Synthetic Glycerin is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

• The recommended retest period for Synthetic Glycerin is two years from the date of manufacture.

Storage and Shipping Conditions:

• Ship and store in ambient temperature.

Package Sizes:

• 6x1L, 4x 3.78L, 10L, 200L and 1000 liter

Country of Origin:

• India