Synthetic Parenteral Glycerin, Meets USP/EP, GMP, Excipient

Temporarily Unavailable, Please Inquire for Lead Time.

GMP Solution

ICH Q7 GMP Manufactured Product

Synthetic Parenteral Glycerin

Meets USP/EP, GMP, Excipient
Product Code: GLYS-3151

Minimum Order Quantity: Please Inquire
Lead Time: Please Inquire

Product Inquiry COAs Spec Sheet

Click the button above for pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Product Code: GLYS-3151

Suitable for use as a cGMP parenteral excipient in pharmaceutical manufacturing processes and products.

Glycerin, Synthetic, USP, EP is a fully synthetic, Excipient Grade Product, manufactured, packaged, labeled, and tested in FDA registered and inspected cGMP facility in Bangor PA, USA. All operations are conducted in compliance with current Good Manufacturing Practices (cGMP) as defined by 21 CFR Parts 210 and 211 and ICH Q7 Guidance. This product is suitable for use in Insulin manufacturing and other critical pharmaceutical preparations.

CAS #: 56-81-5
Formula: C₃H₈O₃F.W.: 92.09 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)	< = 0.1 %
	Ethylene Glycol (USP-B)	< = 0.1 %
	Any Individual Unspecified Impurity with RRT < RRT of Glycerin (EP)	< = 0.1 %
	Any Individual Unspecified Impurity with RRT > RRT of Glycerin (EP)	< = 0.5%
	Any Individual Unspecified Impurity (USP)	< = 0.1%
	Total Impurities (USP)	< = 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

Key Product Features:

The manufacturing of Synthetic Parenteral Glycerin is performed at BioSpectra's Bangor, PA facility.
Appears as a clear, colorless, viscous liquid
Manufactured in accordance with ICH Q7
Is not subject to genetic modification
Manufactured in a hormone free and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Synonyms: Glycerol; Glycerine; 1,2,3-Propantriol; Proane-1,2,3-Trial; 1,2,3-Trihydroxypropane

Storage & Shipping:

Refer to SDS.

Package Sizes:

6x 1L, 4x 4L, 10L, 200L, 1,000L

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.