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Mannitol 200SD

  • Category: Chemicals
  • CAS NO.: 69-65-8
  • Appearance: White crystalline powder
  • Standard: CP, EP, USP, USP43-NF38, DC grade (For tablet)
  • Usage: Pharmaceutical Excipient, Sweetener, Food additive etc.
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Product name: Mannitol powder, Mannitol 200SD
Other name: D-Mannitol, Pearlitol
CAS NO.: 69-65-8
EINECS No.:201-770-2
Chemical Formula: C6H14O6
Appearance: White crystalline powder
Standard: CP, EP, USP, USP43-NF38, 200SD
Usage: Pharmaceutical Excipient, Sweetener, Food additive etc.



Specification Sheet of Mannitol 200SD:


Product Name

Mannitol 200SD

Country Origin:

China

Standard:

BP2019

Package:

25kgs/Drum

 

ITEMS

SPECIFICATIONS

STANDARD

Appearance

White cryatalline powder

BP

Odor

Odorless

BP

Identification A

Specific optical rotation: +23°~ +25°

BP

Identification B

Melting point: 165°C~170°C

BP

Identification C

Infrared absorption

Spectrophotometry: Conformity

BP

Identification D

TLC: Conformity

BP

Solubility

Freely soluble in water; soluble in alkaline solutions; slightly soluble in pyridine; very slightly soluble in alcohol; practically insoluble in ether.

BP

Clarity and color in room temperature water

Clear and colorless

BP

Loss on drying

0.5%

BP

Particle Size

Residue on 200 Mesh94%

Sieve

Residue on 50 Mesh5%

Nickel

1ppm

BP

Sorbitol

2.0%

BP

Residue solvent

USP<467>

USP<467>

Maltitol and Isomalt

2.0%

BP

Unspecified impurities

0.1%

BP

Total impurities

2.0%

BP

Assay

98.0%~102.0%

BP

Reducing sugar

0.1%

BP

Conductivity

20μs/ cm

BP

Total Plate Count

1000cfu/g

BP

Yeast & Mold

100cfu/g

BP

Escherichia Coli

Negative

BP

Salmonella

Negative

BP

Bacterial endotoxins

<2.5IU/g

BP

Packing:

25kgs/Drum

Storage:

Store in a well closed place with constant low temperature (10~30) and no direct sun light

Shelf life:

Two years when properly stored



Specification Sheet of Mannitol Powder:
Product Name: Mannitol
Country Origin: China CAS NO.: 69-65-8
Standard: USP43-NF38 Solvent used: Purified water
ITEMS SPECIFICATIONS
Appearance White cryatalline powder
Odor Odorless
Identification By IR: The IR absorption spectra of the sample should exhibit maxima only at the same wavelenth as that of a similar preparation of Mannitol standard.
Solubility Freely soluble in water; soluble in alkaline solutions; slightly soluble in pyridine; very slightly soluble in alcohol; practically insoluble in ether.
Clarity and color in room temperature water Clear and colorless
Loss on drying ≤0.5%
Melting point 165~170ºC
Nickel ≤1ppm
Sorbitol ≤2.0%
Maltitol and Isomalt ≤2.0%
Unspecified impurities ≤0.1%
Total impurities ≤2.0%
Assay 97.0%~102.0%
Reducing sugar ≤0.1%
Conductivity ≤20μs/ cm
Total Plate Count ≤1000cfu/g
Yeast & Mold ≤100cfu/g
Escherichia Coli Negative
Packing: 25kg/bag
Storage: Store in a well closed place with constant low temperature (10ºC~30ºC) and no direct sun light
Shelf life: Three years when properly stored

Product Description:
Mannitol is a polyol or sugar alcohol, its natural products widely exist in plants, algae, edible fungi and lichens and other organisms. Mannitol is widely used in food, medicine and chemical industry because of its special physical and chemical properties.
Mannitol, also known as mannitol, molecular formula C6H14O6, relative molecular weight 182.17, colorless to white needle or oblique column crystal or crystalline powder. Odorless, with cool and sweet taste. The sweetness is about 57%~72% of sucrose.


Application:

1) Food additive: The absorbency of mannitol in sugar and sugar alcohols is in minimum level. It is of refreshing sweet taste and used in the anti-adherence of food such as malt sugar, gum and rice cake etc, as well as used as adhesion-proof powders of general cake. It can also be used as low calorific value and low sugar content sweeteners like food and body-building food for diabetes patients.

2) Pharmaceutical Excipient: Mannitol is a good diuretic, it can be used to reduce intracranial pressure, intraocular pressure and to be as renal medicine, dehydrating agent, substitutes of sugar, etc. It can also be used as excipient of tablet and diluent agent of solid or liquid. As a hypotensor with high permeability, mannitol injection is commonly used in clinical rescue, particularly in brain disorders. It is of the characteristics of reducing pressure fast and accurate curative effect, which are what the drug of reducing intracranial pressure requires. As excipients of tablets, mannitol is non-hygroscopic, and of drying quickly, good chemical stability. It is also refreshing and easy to form particles. It can be used in most tablets such as anticancer drugs, antibiotics, antihistamines and vitamin, etc. In addition, it can be used in chewing tablets such as sobering up medicine and mouth refreshing agent, etc.
3) Other usage: Mannitol can be used in plastics industry to produce rosin ester, synthetic glycerol resin, explosives and detonators ( nitromannite ) etc. It can also be applied to determinate boron in chemical analysis and as bacterial culture agent in biological test, etc.
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