Biospectra Logo
Product Category

GMP Solution

ICH-Q7 GMP Manufactured Product

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

Product Code: GLYS-3151

minimum-quantity-image

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

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

List of C of As files
No files available right now.

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

minimum-quantity-image
formula-image

COAs and Tech Docs

formula-image

GLYS-3151

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:

India

 

Additional Packaging Information

https://www.biospectra.us/technical/packaging