Synthetic Glycerin

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GMP Solution

ICH-Q7 GMP Manufactured Product

Synthetic Glycerin

USP, EP, Parenteral Grade, GMP Excipient Grade
Product Code: GLYS-3151

Minimum Order Quantity: Please Inquire
Lead Time: Please Inquire

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Product Code: GLYS-3151

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.

CAS #: 56-81-5
Formula: C₃H₈O₃F.W.: 92.1 g/mol

Product Specifications

ANALYSIS

SPECIFICATIONS

Acidity or Alkalinity (EP)

Passes Test

Aldehydes (EP)

< = 10 ppm

Appearance and Color

Clear, Colorless, Viscous Liquid

Appearance of Solution (EP)

Clear, Colorless Solution

Assay, Anhydrous Basis (USP/EP)

99.0 - 101.%

Chloride (USP/EP)

< = 10 ppm

Color (USP)

Passes Test

Fatty Acids and Esters (USP/EP)

Passes Test

Halogenated Compounds (EP)

< = 35 ppm

Limit of Chlorinate Compounds (USP)

< = 30 ppm of Cl

Identification, IR (USP-A/EP-B)

Conforms to Reference Standard

Identification C (USP)

Conforms to Reference Standard

Identification A, Refractive Index, 20°C (EP)

1.470 - 1.475

Purity

> = 99.7%

Related Substances

Diethylene Glycol (USP-B/EP)

Ethylene Glycol (USP-B)

Any Individual Unspecified Impurity with RRT < RRT of Glycerin (EP)

Any Individual Unspecified Impurity with RRT > RRT of Glycerin (EP)

Any Individual Unspecified Impurity (USP)

Total Impurities (USP)

< = 0.1%

< = 0.5%

< = 0.1%

< = 1.0%

Residue on Ignition / Sulfated Ash (USP/EP)

< = 0.01%

Specific Gravity

Specific Gravity, 25°C (USP)

Specific Gravity, 20°C (EP-C)

> = 1.249

1.258 - 1.268

Sugars (EP)

Passes Test

Sulfate (USP)

< = 20 ppm

Water, KF (USP/EP)

< = 2.0%

Printable Version

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-3151 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-3151 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

(Please contact us for more specific information about your package size and Chain of Custody.)

Country of Origin:

India

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.