Excipient
ICH-Q7 GMP Manufactured ProductSynthetic Glycerin, USP, EP, JP and Ch.P.,
Parenteral Grade, GMP Excipient Grade
Product Code: GLYS-3150
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 | |||
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ANALYSIS |
SPECIFICATIONS |
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99.0 to 101.0% | ||
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≤ 10ppm | ||
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Passes Test | ||
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Passes Test | ||
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Conforms with reference standard ≤ 0.025%1 ≤ 0.025%1 Passes Test |
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≤ 30ppm of Cl | ||
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≤ 0.1% ≤ 0.5%1 |
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≤ 0.01% |
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Specific gravity (at 25.0°C) |
≥ 1.249 |
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Sulfate |
≤ 20ppm |
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Water Content |
≤ 2.0%1 |
1Stringent specification
EP COMPENDIA | |||
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ANALYSIS |
SPECIFICATIONS |
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≤ 10ppm | ||
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Passes Test | ||
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Clear, colorless, or almost colorless viscous liquid | ||
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Solution is clear, colorless | ||
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99.0 to 101.0%1 | ||
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≤ 10ppm | ||
Esters | Passes Test | ||
Halogenated compounds | ≤ 35ppm | ||
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1.470 – 1.475 Conforms with reference standard 1.258 - 1.268 |
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≤ 0.025%2 |
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Sugars |
Passes Test |
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Sulfated Ash |
≤ 0.01% |
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Water |
≤ 2.0% |
1USP Specification
2Stringent specification
JP COMPENDIA |
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ANALYSIS |
SPECIFICATIONS |
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Passes Test | ||
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Passes Test | ||
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Passes Test | ||
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Clear, colorless, or almost colorless viscous liquid | ||
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≤ 0.3ppm2 | ||
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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 | ||
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≤ 0.025%2 ≤ 0.025%2 ≤ 0.1% ≤ 0.5% |
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≥1.470 |
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Residue on Ignition |
≤ 0.01% |
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Specific Gravity @20°C |
≥1.258 |
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Sulfate |
≤ 20ppm |
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Water |
≤ 2.0% |
1USP Specification
2Stringent specification
Ch.P. COMPENDIA |
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ANALYSIS |
SPECIFICATIONS |
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Passes Test | ||
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Passes Test | ||
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Passes Test | ||
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Clear, colorless, or almost colorless viscous liquid | ||
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≤ 0.3ppm | ||
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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 | ||
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Absent/per g ≤ 100CFU/g2 ≤ 100CFU/g |
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Readily carbonizable substances |
Passes Test |
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Refractive Index |
1.470 - 1.475 |
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Relative Density |
1.258 – 1.268 |
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≤ 0.025% |
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Residue of Ignition |
≤ 2mg |
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Specific gravity (at 25.0°C) |
≥ 1.249 |
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Sugars |
Passes Test |
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Sulfates |
≤ 20ppm |
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Water |
≤ 2.0% |
1USP Specification
2Stringent specification
ADDITIONAL ANALYSES | |||
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ANALYSIS |
SPECIFICATIONS |
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≤ 5ppm | ||
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≤ 5ppm | ||
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≤ 5ppm | ||
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≤ 5ppm | ||
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≤ 3000ppm | ||
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≤ 100CFU/g |
List of C of As files |
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No files available right now. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- C of As
- SDS
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.
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Synthetic Glycerin is a Clear Liquid product.
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Molecular Formula: C3 H8 O3
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Molecular Weight: 92.09 g/mol
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CAS Number: 56-81-5
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There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
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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.
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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.
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Synthetic Gycerin is further purified at our site in Canada, Dextran Products apart of the BioSpectra Organization.
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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