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Trehalose USP NF BP Ph Eur FCC Food Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Trehalose and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.

We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.

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Trehalose SDS of Manufacturers

Trehalose Manufacturers

Synonyms: Trehalose
CAS Number: 99-20-7 Anhydrous and 6138-23-4 Dihydrate, Molecular Weight: 342.30 anhydrous and 378.33 dihydrate, Chemical Formula: C12H22O11 Anhydrous and C12H22O11-2H2O Dihydrate, EINECS EC Number: 202-739-6, FEMA: ----,

Trehalose is a sugar consisting of two molecules of glucose. Trehalose has high water retention capabilities, and is used in food, cosmetics and as a drug.

General Properties and Specifications of Trehalose Dihydrate and Anhydrous:
Appearance: White to almost white powder.
Assay: 99% minimum.
pH of 5% solution in water: 4.5 to 6.5
Melting point: 203C (anhydrous) and 97C (dihydrate)
Solubility: Soluble in water and ethanol.


Specifications of Trehalose USP NF Grade:
C12H22O11 --- 342.30
C12H22O11- 2H2O --- 378.33
α-d-Glucopyranosyl α-d-glucopyranoside.
Anhydrous --- CAS 99-20-7
Dihydrate --- CAS 6138-23-4

DEFINITION
Trehalose is a stable, nonreducing disaccharide with two glucose molecules linked in an α,α-1,1 configuration. It is obtained through enzymatic conversion of food-grade starch. It contains NLT 97.0% and NMT 102.0% of trehalose (C12H22O11 ), calculated on the anhydrous basis.

IDENTIFICATION
A.
Infrared Absorption
B.
Sample solution: 400 mg/mL of Trehalose
Analysis: Add 0.4 mL of a solution containing 1-naphthol in 95% alcohol (1 in 20) to 1 mL of the Sample solution. Gently add 2 mL of sulfuric acid to the solution.
Acceptance criteria: A violet color develops at the interface between the two solutions. C.
Glycine solution: 40 mg/mL of glycine
Sample solution: 40 mg/mL of Trehalose
Analysis: Add 1 mL of diluted hydrochloric acid to 2 mL of the Sample solution. Allow to stand for 20 min at room temperature. Add 4 mL of sodium hydroxide TS and 2 mL of Glycine solution to the Sample solution. Heat the solution for 10 min in boiling water.
Acceptance criteria: A brown color does not develop.

Residue on Ignition: NMT 0.1%, determined on 2.0 g of Trehalose
Related Substances: To pass the test by Chromatographic system
Acceptance criteria: For the Sample solution, the areas of any peaks corresponding to maltotriose and other polysaccharrides and eluting before trehalose are NMT half of the area of the peak corresponding to trehalose in the chromatogram of the Standard solution (0.5%). The areas of any peaks corresponding to glucose and eluting after trehalose are NMT half of the area of the peak corresponding to trehalose in the chromatogram of the Standard solution (0.5%).
Color and Clarity of Solution: To pass the test.
Optical Rotation, Specific Rotation:
Sample solution: 100 mg/mL
Acceptance criteria: +197° to +201° at 20C
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count is NMT 100 cfu/g, and the total combined molds and yeasts count is NMT 100 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
pH:
Sample solution: 100 mg/mL
Acceptance criteria: 4.5–6.5
Water Determination:
Sample: 0.1 g
Acceptance criteria
Anhydrous: NMT 1.0%
Dihydrate: 9.0%–11.0%
Bacterial Endotoxins Test: If labeled for use in preparing parenteral dosage forms, it also meets the following requirements. The level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Trehalose is used can be met. Where the label states that Trehalose must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Trehalose is used can be met.
Chloride and Sulfate, Chloride:
Sample: 2.0 g
Acceptance criteria: No more chloride than corresponds to 0.70 mL of 0.01 M hydrochloric acid (NMT 0.0125%)
Chloride and Sulfate, Sulfate:
Sample: 2.0 g
Acceptance criteria: No more sulfate than corresponds to 0.83 mL of 0.005 M sulfuric acid (NMT 0.0200%)
Nitrogen Determination:
Sample: 5.0 g
Analysis: Proceed as directed in Method II, except increase the volume of sulfuric acid for digestion to 30 mL and the volume of the sodium hydroxide solution (2 in 5) to 45 mL.
Acceptance criteria: NMT 0.005%
Soluble Starch:
Sample solution: 10% Trehalose (w/v)
Analysis: Add several drops of iodine TS to the Sample solution.
Acceptance criteria: No blue color develops.


Specifications of Trehalose Dihydrate BP Ph Eur Grade:
C12H22O11-2H2O --- 378.3 --- CAS 6138-23-4

DEFINITION
α-d-Glucopyranosyl α-d-glucopyranoside dihydrate (α,α-trehalose dihydrate). It is obtained by enzymatic modification of starch.
Content: 97.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Freely soluble in water, slightly soluble in methanol, practically insoluble in ethanol (96 per cent).

IDENTIFICATION
A. Infrared absorption spectrophotometry.
Comparison trehalose dihydrate CRS.
B. Dissolve 2 g in 5 mL of water. To 1 mL of this solution add 0.4 mL of a 50 g/L solution of α-naphthol in ethanol (96 per cent) and mix thoroughly. Carefully add 2& mL of sulfuric acid. A violet colour develops at the interface.
C. Dissolve 1 g in 25 mL of water. To 2 mL of this solution add 1 mL of dilute hydrochloric acid and mix. Keep the solution for 20 min at room temperature. Add 4 mL of a 40 g/L solution of sodium hydroxide and 2 mL of a 40 g/L solution of glycine and mix. Heat the solution in a water-bath for 10 min. No brown colour develops.

TESTS
Solution S: Dissolve 10.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100.0 mL with the same solvent.
Appearance of solution: Solution S is clear and colourless.
pH: 4.5 to 6.5 for solution S.
Specific optical rotation: + 197 to + 201 (anhydrous substance), determined on solution S.
Related substances: To pass the test by Liquid chromatography.
Limits:
-impurities A, B: for each impurity, not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);
-unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.2 per cent);
-total: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
-disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).
Chlorides: Maximum 125 ppm.
Sulfates: Maximum 200 ppm.
Soluble starch: Dissolve 1 g in 10 mL of water. Add 0.1 mL of iodine solution. No blue colour develops.
Water: 9.0 per cent to 11.0 per cent, determined on 0.10 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Microbial contamination:
If intended for use in the manufacture of parenteral preparations:
-TAMC: acceptance criterion 100 CFU/g.
If not intended for use in the manufacture of parenteral preparations:
-TAMC: acceptance criterion 1000 CFU/g;
-TYMC: acceptance criterion 100 CFU/g;
-absence of Escherichia coli;
-absence of Salmonella.
Bacterial endotoxins:
If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins:
-less than 4 IU/g for parenteral preparations having a concentration of 100 g/L or less of trehalose dihydrate;
-less than 2.5 IU/g for parenteral preparations having a concentration of more than 100 g/L of trehalose dihydrate.


Specifications of Trehalose FCC Food Grade:
C12H22O11-2H2O Formula weight 378.33
CAS: anhydrous 99-20-7
CAS: dihydrate 6138-23-4

DESCRIPTION
Trehalose occurs as a nonhygroscopic, white, crystalline powder. It is obtained through enzymatic conversion of food-grade starch into a stable, nonreducing disaccharide with two glucose molecules linked in an _,_-1,1 configuration. The powder is freely soluble or readily dispersible in water. Trehalose is typically used in its dihydrate form.
Function: Humectant; nutritive sweetener; stabilizer; thickener; texturizer.

REQUIREMENTS
Identification: Observe a sample with a light microscope at 50×. Trehalose is composed of colorless, rectangular crystals with a prismatic structure.
Assay: Not less than 98.0% Trehalose, calculated on a dry basis.
Color in Solution: Less than or equal to 0.100.
Lead: Not more than 0.1 mg/kg.
Loss on Drying: Not more than 1.5%.
pH of a 30% Solution: Between 4.5 and 6.5.
Residue on Ignition: Less than or equal to 0.05%.
Turbidity of a 30% Solution: Less than or equal to 0.050

Keywords: Trehalose IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

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ANMOL CHEMICALS
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Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

e-mail: info@anmol.org

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Last updated 12-feb-24

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Trehalose
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Trehalose