Product Category

GMP Solution

ICH-Q7 GMP Manufactured Product

Synthetic Glycerin, USP, EP,
Parenteral Grade, GMP Excipient Grade

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.

Product Specifications




Assay (Dried Basis)  
99.0 to 101.0%
≤ 10ppm
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


≤ 20ppm

Water Content

≤ 2.0%1

Stringent specification





≤ 10ppm
Acidity or alkalinity  
Passes Test
Clear, colorless, or almost colorless viscous liquid
Appearance of solution  
Solution is clear, colorless
Assay (Dried Basis)  
99.0 to 101.0%1
≤ 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%


Passes Test

Sulfated Ash

≤ 0.01%


≤ 2.0%


1USP Specification
2Stringent specification

Printable Version

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COAs and Tech Docs



CAS #: 56-81-5

Formula: C3H8O3

F.W.: 92.1 g/mol

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:



Additional Packaging Information