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Description Back to Top
Glycerin, Synthetic, USP, EP, BP, JP is one of two USP grade Glycerins available from Spectrum with the other being Glycerin, Natural, USP, EP, BP. For those products requiring FDA approvals, if the initial formulation was done with Glycerin, Synthetic, USP, EP, BP, JP, the use of Glycerin, Natural, USP, EP, BP, JP is not interchangeable but would require the new formulation to undergo a new FDA approval process.
Specifications Back to Top
| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY (ANHYDROUS BASIS) | 99.0 | 101.0% |
| SPECIFIC GRAVITY @ 25oC | 1.249 | |
| SPECIFIC GRAVITY @ 20oC | 1.258 | |
| APPEARANCE OF SOLUTION | CLEAR AND COLORLESS | |
| REFRACTIVE INDEX | 1.470 | 1.475 |
| ALDEHYDES | 10 ppm | |
| COLOR | LESS THAN STANDARD | |
| RESIDUE ON IGNITION (SULPHATED ASH) | 0.01% | |
| CHLORIDE (Cl) | 0.001% | |
| SULFATE (SO4) | 0.002% | |
| ELEMENTAL IMPURITIES | AS REPORTED | |
| HEAVY METALS (JP) | 5 ppm | |
| CHLORINATED COMPOUNDS (HALOGENATED COMPOUNDS as Cl) | 30 ppm | |
| WATER | 2.0% | |
| FATTY ACIDS AND ESTERS | 1 ml | |
| RELATED COMPOUNDS: | . | |
| INDIVIDUAL IMPURITIES | 0.1 % | |
| TOTAL IMPURITIES | 1.0 % | |
| IMPURITY A | 0.1 % | |
| RELATED SUBSTANCES: | . | |
| OTHER IMPURITIES | 0.1 % EACH | |
| TOTAL IMPURITIES WITH RETENTION TIMES GREATER THAN GLYCERIN | 0.5 % | |
| ACIDITY OR ALKALINITY | NEUTRAL | |
| SUGARS | REMAINS BLUE /NO PRECIPITATE | |
| AMMONIUM (NH4) | NO BLUE COLOR | |
| CALCIUM (Ca) | NO CHANGE TO SOLUTION | |
| ARSENIC (As) | 2 ppm | |
| ACROLEIN, GLUCOSE OR OTHER[nREDUCING SUBSTANCES | NO TURBIDITY | |
| READILY CARBONIZABLE SUBSTANCES | LESS COLOR THAN STANDARD | |
| ESTERS | 8.0 ML | |
| IDENTIFICATION | . | |
| IDENTIFICATION: A (USP) | SPECTRUM MATCHES REFERENCE | |
| IDENTIFICATION: B (USP) | 0.10 % EACH | |
| IDENTIFICATION: C (USP) | RETENTION TIME CORRESPONDS TO STANDARD | |
| CERTIFIED KOSHER | ||
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | AS REPORTED | |
| MONOGRAPH EDITION | ||
| MONOGRAPH EDITION. | ||
| MONOGRAPH EDITION.. | ||
Certifications Back to Top
- Certificate Of Analysis this document gives the exact details about the item's quality and compliance to specifications and relates specifically to the result of testing a representative sample drawn from the specific batch or lot material by Spectrum personnel.
- Kosher Certificate Spectrum-labeled kosher products with the Kosher Supervision of America symbol are a firm guarantee to all Spectrum customers that the products bearing the symbol are in full compliance with the most demanding of Kosher and Pareve standards.
- BSE / TSE Statement certifies that the product produced by Spectrum is free from Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) and is manufactured wholly from synthetic or manufactured materials and do not contain any raw materials produced from or substances derived of animal origin.
- Residual Solvents Statement Spectrum certifies that this item meets the requirements found in USP-NF General Chapter <467> Residual Solvents / Organic Volatile Impurities.
- Country of Origin this is an item/lot specific document that certifies the goods have been wholly produced, manufactured or processed in a particular country.
Shipping & Storage Back to Top
Storage Information
HYGROSCOPIC: Keep tightly closed.
Shipping Information
Tariff No. 2905450000
WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov
Shipping Costs
HYGROSCOPIC: Keep tightly closed.
Shipping Information
Tariff No. 2905450000
WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov
Shipping Costs
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