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Product Category

Excipient

ICH-Q7 GMP Manufactured Product

Synthetic Glycerin, USP, EP, JP and Ch.P.,
Parenteral Grade, GMP Excipient Grade

Product Code: GLYS-3150

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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

 

JP COMPENDIA

ANALYSIS

SPECIFICATIONS
Acidity or Alkalinity  
Passes Test
Acrolein, glucose, or other reducing substances  
Passes Test

Ammonium

  
Passes Test
Appearance  
Clear, colorless, or almost colorless viscous liquid
Arsenic  
≤ 0.3ppm2
Assay (Dried Basis)  
99.0 to 101.0%1
Calcium Passes Test
Chloride ≤ 10ppm

Color

 Passes Test

Fatty Acids or Esters

 Passes Test

Heavy Metals

 ≤ 2ppm2

Identification, IR

 Conforms with reference standard

Readily carbonizable substances

 Passes Test
Related Substances Diethylene glycol
Ethylene glycol
Any other individual impurity
Total impurities
≤ 0.025%2
≤ 0.025%2
≤ 0.1%
≤ 0.5%
Refractive Index @20°C  

≥1.470

Residue on Ignition

≤ 0.01%
Specific Gravity @20°C

≥1.258
Sulfate

≤ 20ppm
Water

≤ 2.0%

 

1USP Specification
2Stringent specification

 

Ch.P. COMPENDIA

ANALYSIS

SPECIFICATIONS
Acidity or Alkalinity  
Passes Test
Aldehydes and Related Substances  
Passes Test

Ammonium

  
Passes Test
Appearance  
Clear, colorless, or almost colorless viscous liquid
Arsenic  
≤ 0.3ppm
Assay (Dried Basis)  
99.0 to 101.0%1
Bacterial Endotoxin ≤ 10 EU/g
Calcium Passes Test
Chloride ≤ 6ppm

Color

 Passes Test

Fatty Acids or Esters

 Passes Test

Halogenated Compounds

 ≤ 30ppm

Heavy Metals

  ≤ 2ppm

Identification, IR

 Conforms with reference standard

Iron

 ≤ 0.5ppm
Microbial Limit Escherichia coli
TAMC
TYMC
Absent/per g
≤ 100CFU/g2
≤ 100CFU/g

Readily carbonizable substances

Passes Test

Refractive Index

1.470 - 1.475

Relative Density

1.258 – 1.268

Related Substances

 Diethylene glycol
Ethylene glycol
1,2-Propylene glycol
Any other individual impurity
Total impurities

≤ 0.025%
≤ 0.025%
≤ 0.1%
≤ 0.1%
≤ 0.5%

Residue of Ignition

≤ 2mg

Specific gravity (at 25.0°C)

≥ 1.249

Sugars

Passes Test

Sulfates

≤ 20ppm

Water

≤ 2.0%

 

1USP Specification
2Stringent specification

 

ADDITIONAL ANALYSES

ANALYSIS

SPECIFICATIONS
Dihydroxyacetone  
≤ 5ppm
Formaldehyde  
≤ 5ppm
Glyceraldehyde  
≤ 5ppm
Hydroxyacetone  
≤ 5ppm
Methanol  
≤ 3000ppm
Total Bioburden  
≤ 100CFU/g

 

Printable Version

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COAs and Tech Docs

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GLYS-3150

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-3150 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-3150 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