Synthetic Glycerin

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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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

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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

USP COMPENDIA

ANALYSIS

SPECIFICATIONS

Assay (Dried Basis)

99.0 to 101.0%

Chloride

≤ 10ppm

Color

Passes Test

Fatty acid and Esters

Passes Test

Identification

Identification A IR
Identification B Diethylene glycol
Identification B ethylene glycol
Identification C by GC

Conforms with reference standard
≤ 0.025%¹
≤ 0.025%¹
Passes Test

Limit of Chlorinate Compounds

≤ 30ppm of Cl

Related Compounds

Any Individual Impurity
Total Impurities

≤ 0.1%
≤ 0.5%¹

Residue of Ignition

≤ 0.01%

Specific gravity (at 25.0°C)

≥ 1.249

Sulfate

≤ 20ppm

Water Content

≤ 2.0%¹

¹Stringent specification

EP COMPENDIA

ANALYSIS

SPECIFICATIONS

Aldehydes

≤ 10ppm

Acidity or alkalinity

Passes Test

Appearance

Clear, colorless, or almost colorless viscous liquid

Appearance of solution

Solution is clear, colorless

Assay (Dried Basis)

99.0 to 101.0%¹

Chlorides

≤ 10ppm

Esters

Passes Test

Halogenated compounds

≤ 35ppm

Identification

Identification A, Refractive Index
Identification B, IR
Identification C, Relative density

1.470 – 1.475
Conforms with reference standard
1.258 - 1.268

Related substances

Impurity A
Any other Individual impurity
Total impurities

≤ 0.025%²
≤ 0.1%
≤ 0.5%

Sugars

Passes Test

Sulfated Ash

≤ 0.01%

Water

≤ 2.0%

¹USP Specification
²Stringent specification

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.