ICH-Q7 GMP Manufactured Product
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.
CAS #: 56-81-5
Formula: C3H8O3
F.W.: 92.1 g/mol
| USP COMPENDIA | |||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
99.0 to 101.0% | ||
|
≤ 10ppm | ||
|
Passes Test | ||
|
Passes Test | ||
|
Conforms with reference standard |
||
|
≤ 30ppm of Cl | ||
|
≤ 0.1% |
||
|
≤ 0.01% |
||
| Specific gravity (at 25.0°C) |
≥ 1.249 |
||
| Sulfate |
≤ 20ppm |
||
| Water Content |
≤ 2.0%1 |
||
1Stringent specification
| EP COMPENDIA | |||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
≤ 10ppm | ||
|
Passes Test | ||
|
Clear, colorless, or almost colorless viscous liquid | ||
|
Solution is clear, colorless | ||
|
99.0 to 101.0%1 | ||
|
≤ 10ppm | ||
| Esters | Passes Test | ||
| Halogenated compounds | ≤ 35ppm | ||
|
1.470 – 1.475 |
||
|
≤ 0.025%2 |
||
| Sugars |
Passes Test |
||
| Sulfated Ash |
≤ 0.01% |
||
| Water |
≤ 2.0% |
||
1USP Specification
2Stringent specification
|
JP COMPENDIA |
|||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
Clear, colorless, or almost colorless viscous liquid | ||
|
≤ 0.3ppm2 | ||
|
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 | ||
|
≤ 0.025%2 |
||
|
≥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 |
||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
Clear, colorless, or almost colorless viscous liquid | ||
|
≤ 0.3ppm | ||
|
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 | ||
|
Absent/per g |
||
|
Readily carbonizable substances |
Passes Test |
||
|
Refractive Index |
1.470 - 1.475 |
||
|
Relative Density |
1.258 – 1.268 |
||
|
≤ 0.025% |
||
|
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 |
||
|
≤ 5ppm | ||
|
≤ 5ppm | ||
|
≤ 5ppm | ||
|
≤ 5ppm | ||
|
≤ 3000ppm | ||
|
≤ 100CFU/g | ||
Printable Version
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.
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.
The recommended retest period for Synthetic Glycerin is two years from the date of manufacture.
Ship and store in ambient temperature.
6x1L, 4x 3.78L, 10L, 200L and 1000 liter
(Please contact us for more specific information about your package size and Chain of Custody.)
India
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.