D-(+)- Mannitol, Sterile

USP,EP,Injectable Grade

CAS #:

69-65-8

Molecular Formula:

C6H14O6

Synonym:

Mannite

Molecular Weight:

182.17 g/mol

Overview

D-Mannitol (Sterile) is used as an osmotic diuretic, as a diagnostic agent for kidney function, as an adjunct in the treatment of acute renal failure, and as an agent to reduce intracranial pressure, treat cerebral edema, and reduce intraocular pressure.

Characters Unit Specification
Identity (EP<2.2.24>) (USP<197k>) IR
Identity (EP<2.2.27>) TLC
Identity (EP<2.2.7>) Sp. Rot., [α]D: +23° to 25°
Identity (EP<2.2.14>) (USP<741>) °C MP: 165-170 °C
Appearance White microcryst. solid
Solubility Freely soluble in water, practically insoluble in Ethanol (96%)
Appearance of solution (EP) (USP) Clear (2.2.1), colorless (2.2.2, Method II) solution
Conductivity (EP<2.2.38>) (USP) 20 pScm-1
Assay (EP<2.2.29>) (USP) % 97 - 102
Related Substances (EP<2.2.29>) (USP)
Impurity A (D-Sorbitol) % ≤ 2
Impurity B (D-Malttitol) +Impurity C (Isomalt) % ≤ 2
Unknown impurities % ≤ 0.1
Total impurities % ≤ 2
Reducing Sugars USP, EP
LOD (EP<2.2.32>) (USP<731>) % 0.5
Residual Solvents (USP) Meets USP <467> specifications
Bulk Density (USP<616>) Report Results
Tap Density (USP<616>) Report Results
Heavy metals (Pb) (EP) ppm ≤ 5
Ni (EP<2.4.15>) (AAS : USP<852>) ppm ≤ 1.0
Sterility Test (USP<71>) No growth observed after 14 days at 30-35 °C
E Coli Negative
Salmonella Negative
Staphylococcus aureus Negative
Pseudomonas Negative
Endotoxin Level+ (EP <2.6.14>)(USP<85>)* IU/g ≤ 4
Endotoxin Level+ (EP <2.6.14>) (USP<85›)** IU/g ≤ 2.5
+If intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of bacterial endotoxins.
* - For parenteral dosage forms having a concentration of 100 WI. or less of Mannitol
** - For parenteral dosage forms having a concentration of more than 100 of Mannitol.

Shelf Life/Retest Date: The minimal shelf-life of D-Mannitol (Sterile) CAS 69-65-8 is 2 years when stored under recommended conditions.

Storage/Shipping Conditions:

  • Keep container tightly closed in a dry and well-ventilated place.
  • Keep in a dry place.
  • Storage class (TRGS 510): Non-combustible solids.

Pack Sizes: 5 Kg

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