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PHR1007

Supelco

Mannitol

Pharmaceutical Secondary Standard; Certified Reference Material

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

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

storage temp.

2-30°C

SMILES string

OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO

InChI

1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2/t3-,4-,5-,6-/m1/s1

InChI key

FBPFZTCFMRRESA-KVTDHHQDSA-N

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General description

Mannitol is an osmotic diuretic with a variety of clinical applications, one of which is the reduction of intracranial pressure. It is also found to be protective against ischemic and nephrotoxic acute renal failure.
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.
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

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.
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.

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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

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Mannitol
Warren ES and Blantz CR
Archives of Internal Medicine, 141(4), 493-497 (1981)
Mannitol-induced acute renal failure
RHD, et al.
Medicine, 69(3), 153-159 (1990)
Separation and determination of pharmaceutically important polyols in dosage forms by capillary isotachophoresis
Pospisilova M, et al.
Journal of Chromatography A, 772(1-2), 277-282 (1997)
Heikki O Koskela et al.
Chest, 124(6), 2171-2177 (2003-12-11)
To compare a new bronchial provocation test, the mannitol challenge, with cold air and histamine challenges to demonstrate airway hyperresponsiveness (AHR) in patients with difficult-to-diagnose asthma. A prospective study. Thirty-seven consecutive patients with recently diagnosed, steroid-naive, mild, or atypical asthma
Heikki O Koskela et al.
Chest, 124(4), 1341-1349 (2003-10-14)
To compare the sensitivity and validity of mannitol, histamine, and cold air challenges to demonstrate the effect of inhaled corticosteroids (ICS) in asthma. A prospective study. Seventeen patients with recently diagnosed, steroid-naive asthma who fulfilled the diagnostic criteria of Finnish
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