PHR1007

Mannitol

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): D-Mannitol, Mannite
• Empirical Formula (Hill Notation): C₆H₁₄O₆
• CAS Number: 69-65-8
• Molecular Weight: 182.17
• Beilstein/REAXYS Number: 1721898
• EC Number: 200-711-8
• MDL number: MFCD00064287
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823038
• E Number: E421
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. M0200000; traceable to USP 1375105
• API family: mannitol
• CofA: current certificate can be downloaded
• analyte chemical class(es): oligosaccharides
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 167-170 °C (lit.)
• application(s): cleaning products; cosmetics; food and beverages; personal care; pharmaceutical (small molecule)
• format: neat

Description

General description

Mannitol is an osmotic diuretic with a variety of clinical applications,[1] one of which is the reduction of intracranial pressure. It is also found to be protective against ischemic and nephrotoxic acute renal failure.[2]
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Mannitol may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using capillary isotachophoresis technique.[3]

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

A sugar alcohol sweet tastant. Used in sweetness inhibition studies.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

Ion Mobility: TWCCSN2 value of 132.3 Å2 [M-H]- The collision cross section (CCS) measurement was provided by Waters Corporation, using the SYNAPT XS mass spectrometer. For a description and overview of how ion mobility enables the measurement of the CCS of an ion visit ims.waters.com. Further information on the SYNAPT XS mass spectrometer can be found on the IMS microsite and product webpage. TWCCS measurements are expected to be within 2% of this reference value. P/N PHR1007 is part of the Waters Extractables & Leachables UNIFI scientific library which can be downloaded from Waters Marketplace.

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB7668 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable